CADHA24X • California Dental Hygienists & Assistants 2024

Table of Contents

CADHA24X • California Dental Hygienists & Assistants 2024

How to Receive Credit

NetCE 2 Hour Course #51293 • The California Dental Practice Act

51293 • The California Dental Practice Act

1. INTRODUCTION

2. DENTISTRY DEFINED: SCOPE OF PRACTICE

3. LICENSURE

4. VIOLATIONS AND PENALTIES

5. LAWS GOVERNING THE PRESCRIPTION OF DRUGS

6. REPORTING OF ABUSE AND NEGLECT

7. CONCLUSION

8. RESOURCES

Works Cited

NetCE 2 Hour Course #58583 • Infection Control for Dental Professionals: The California Requirement

58583 • Infection Control for Dental Professionals: The California Requirement

1. INTRODUCTION

2. OSHA AND CAL/OSHA REGULATIONS

3. MODES OF TRANSMISSION

4. BLOODBORNE PATHOGENS

5. PREVENTION STRATEGIES

6. ENVIRONMENTAL CONTROL MEASURES

7. ENGINEERING AND WORK PRACTICE CONTROLS

8. PROTECTING DENTAL HEALTHCARE WORKERS

9. CONCLUSION

10. DENTAL BOARD OF CALIFORNIA GENERAL PROVISIONS: SECTION 1005. MINIMUM STANDARDS FOR INFECTION CONTROL

11. CAL/OSHA COVID-19 STANDARD

Works Cited

NetCE 2 Hour Course #55290 • Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs

55290 • Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs

1. INTRODUCTION

2. SCOPE OF THE PROBLEM

3. PAIN MANAGEMENT APPROACHES IN DENTISTRY

4. CREATING A TREATMENT PLAN AND ASSESSMENT OF ADDICTION RISK

5. DENTAL OFFICE PROCEDURES FOR MANAGING VULNERABLE OR SUBSTANCE USE DISORDER PATIENTS

6. REGULATORY REQUIREMENTS FOR PRESCRIBERS AND DISPENSERS

7. CONCLUSION

8. APPENDIX: LAWS AND REGULATIONS IN CALIFORNIA

Works Cited

NetCE 2 Hour Course #58020 • Commonly Abused Supplements

58020 • Commonly Abused Supplements

1. INTRODUCTION

2. ABUSE POTENTIAL RELATED TO WEIGHT LOSS AND/OR ATHLETIC PERFORMANCE

3. LAXATIVES

4. ABUSE POTENTIAL RELATED TO RECREATIONAL USE

5. ABUSE POTENTIAL RELATED TO OPIOID-LIKE EFFECTS

6. CONSIDERATIONS FOR NON-ENGLISH-PROFICIENT PATIENTS

7. CONCLUSION

Works Cited

NetCE 4 Hour Course #58030 • Getting to the Point: Acupuncture and Acupoint Therapies

58030 • Getting to the Point: Acupuncture and Acupoint Therapies

1. HISTORY: A BRIEF GLIMPSE

2. ACUPUNCTURE

3. MOXIBUSTION

4. ACUPRESSURE

5. TRANSCUTANEOUS ELECTRICAL ACUSTIMULATION (TEAS)

6. CONSIDERATIONS AND COMPARISONS

7. CONSIDERATIONS FOR NON-ENGLISH-PROFICIENT PATIENTS

8. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

CADHA24X • California Dental Hygienists & Assistants 2024

William E. Frey, DDS, MS, FICD

Mark Rose, BS, MA, LP

Chelsey McIntyre, PharmD

www.netce.com

Copyright © 2024 NetCE, All rights reserved.

CADHA24X • California Dental Hygienists & Assistants 2024

Expiration Date: 03/31/2025

How to Receive Credit

To complete this Special Offer for continuing education credit please go to http://www.netce.com/specials in your browser.

For assistance with receiving continuing education credit, please contact us at help@netce.com.

51293 • The California Dental Practice Act

William E. Frey, DDS, MS, FICD

www.netce.com

Copyright © 2022 NetCE, All rights reserved.

Although its primary objective is to safeguard the public, the California Dental Practice Act is an excellent resource for dental professionals to ensure compliance with state law. The California Dental Practice Act is the body of laws in the California Business and Professions Code and the California Code of Regulations governing dental professionals, including dentists, oral and maxillofacial surgeons, orthodontists, dental assistants, and dental hygienists. The Act is intended to serve as a legal guideline for both professionals and the public regarding all aspects of dental practice.

Table of Contents

51293 • The California Dental Practice Act

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Special Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planner

Division Planner Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. DENTISTRY DEFINED: SCOPE OF PRACTICE

DENTISTS

DENTAL ASSISTANTS (UNLICENSED)

REGISTERED DENTAL ASSISTANTS

DENTAL HYGIENISTS

3. LICENSURE

LICENSE RENEWAL

ACTS LEADING TO SUSPENSION OF A LICENSE AND IN VIOLATION OF THE DENTAL PRACTICE ACT

4. VIOLATIONS AND PENALTIES

5. LAWS GOVERNING THE PRESCRIPTION OF DRUGS

6. REPORTING OF ABUSE AND NEGLECT

CHILD ABUSE AND NEGLECT REPORTING LAW

IDENTIFYING, DOCUMENTING, AND REPORTING ABUSE AND NEGLECT

ELDER AND DEPENDENT ADULT ABUSE AND NEGLECT

INTIMATE PARTNER VIOLENCE

7. CONCLUSION

8. RESOURCES

Works Cited

51293 • The California Dental Practice Act

Education Category. Management

Release Date. 02/01/2022

Expiration Date. 01/31/2025

Course Overview

Although its primary objective is to safeguard the public, the California Dental Practice Act is an excellent resource for dental professionals to ensure compliance with state law. The California Dental Practice Act is the body of laws in the California Business and Professions Code and the California Code of Regulations governing dental professionals, including dentists, oral and maxillofacial surgeons, orthodontists, dental assistants, and dental hygienists. The Act is intended to serve as a legal guideline for both professionals and the public regarding all aspects of dental practice.

Audience

This course is designed for all California dentists, dental hygienists, and dental assistants in all practice settings.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU.

Designations of Credit

NetCE designates this activity for 2 continuing education credits. AGD Subject Code 563. This course meets the Dental Board of California's requirements for 2 unit(s) of continuing education. Dental Board of California course #02-3841-24343. NetCE is authorized by IACET to offer 0.2 CEU(s) for this program.

Special Approvals

This course fulfills the California requirement for 2 hours of Dental Practice Act education.

Course Objective

The purpose of this course is to provide California dental professionals with a working knowledge of the contents of the California Dental Practice Act, ensuring that they practice legally and safely.

Learning Objectives

Upon completion of this course, you should be able to:

1. Define the scope of practice of dental professionals in California.

2. Describe the standards of licensure of and medication prescription by dental professionals in California.

3. Identify possible victims of violence or neglect and outline the appropriate response.

Faculty

William E. Frey, DDS, MS, FICD, graduated from the University of California School of Dentistry, San Francisco, California, in 1966. In 1975, he completed residency training in Periodontics and received a Master's degree from George Washington University.
Dr. Frey retired from the United States Army Dental Corps in 1989 after 22 years of service. Throughout the course of his professional career, he has continuously practiced dentistry, the first 7 years as a general dentist and the past more than 40 as a periodontist. His military experience included the command of a networked Dental Activity consisting of five dental clinics. In his last assignment, he was in charge of a 38-chair facility. Colonel Frey was selected by the Army to serve on two separate occasions as the Chair of the Periodontal Department in Army General Dentistry Residency Training Programs.
Dr. Frey is the founder and president of Perio Plus, a practice management firm specializing in creating individually-designed hygiene and periodontal care programs for general dentists. He is also the creator of the Inspector Gum patient education series.

Faculty Disclosure

Contributing faculty, William E. Frey, DDS, MS, FICD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planner

Mark J. Szarejko, DDS, FAGD

Division Planner Disclosure

The division planner has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

The California Dental Practice Act is the body of laws in the California Business and Professions Code (CBPC) and the California Code of Regulations (CCR) governing all dental professionals, including dentists, oral and maxillofacial surgeons, orthodontists, unlicensed dental assistants, registered dental assistants, and dental hygienists. The Act is intended to serve as a legal guideline for both professionals and the public regarding all aspects of dental practice. As defined in Section 1016.(b)1 of the CCR, continuing education on the California Dental Practice Act is required and must include instruction on utilization, scope of practice, prescribing laws, violations, citations, fines, licensure, the identification of abuse, and mandatory abuse reporting [1]. Of course, the Act is a much larger volume, so much so that it is beyond the scope of this course to elucidate every section. The Dental Practice Act is not intended to replace professional oaths and codes of ethics but does define actions and omissions that may lead to legal action and revocation of a license to practice dentistry in the State of California, the laws of which are continually evolving.

The Dental Board of California (a division of the California Department of Consumer Affairs), which consists of eight practicing dentists, one registered dental hygienist, one registered dental assistant (each practicing for at least five years), and five public members, is responsible for licensure of qualified dental health professionals, enforcement of the California Dental Practice Act, and improving the education of consumers and licensees [19]. The Board's highest priority is to protect the health and safety of the public.

In addition, the practice of dental hygiene is regulated by the Dental Hygiene Board of California, the first of its kind in the United States [20].

2. DENTISTRY DEFINED: SCOPE OF PRACTICE

According to the American Dental Association, dentistry is defined as "the evaluation, diagnosis, prevention, and treatment of diseases, disorders, and conditions of the oral cavity, the craniomaxillofacial area and the adjacent structures and their impact on the human body. This care is provided by dentists within the scope of their education, training and experience in accordance with the ethics of the profession and applicable law" [2]. The CBPC and the CCR provide specific information regarding utilization and scope of practice for dentists, unlicensed dental assistants, registered dental assistants, and registered dental hygienists, as evidenced in the following sections [1].

DENTISTS

CBPC Section 1625. Dentistry is the diagnosis or treatment, by surgery or other method, of diseases and lesions and the correction of malpositions of the human teeth, alveolar process, gums, jaws, or associated structures; and such diagnosis or treatment may include all necessary related procedures as well as the use of drugs, anesthetic agents, and physical evaluation. Without limiting the foregoing, a person practices dentistry within the meaning of this chapter who does any one or more of the following [24]:

(a) By card, circular, pamphlet, newspaper, Internet website, social media, or in any other way advertises themselves or represents themselves to be a dentist.

(b) Performs, or offers to perform, an operation or diagnosis of any kind, or treats diseases or lesions of the human teeth, alveolar process, gums, jaws, or associated structures, or corrects malposed positions thereof.

(c) In any way indicates that the person will perform by themselves or their agents or servants any operation upon the human teeth, alveolar process, gums, jaws, or associated structures, or in any way indicates that the person will construct, alter, repair, or sell any bridge, crown, denture or other prosthetic appliance or orthodontic appliance.

(d) Makes, or offers to make, an examination of, with the intent to perform or cause to be performed any operation on the human teeth, alveolar process, gums, jaws, or associated structures.

(e) Manages or conducts as manager, proprietor, conductor, lessor, or otherwise, a place where dental operations are performed.

The Board requires that dentists ensure that each patient of record receives a copy of the Dental Materials Fact Sheet (provided by the Board) prior to the placement of his or her first dental restoration [25]. The Dental Materials Fact Sheet details the comparative risks and benefits of available dental restorative materials. The patient must sign an acknowledgment of receipt of the fact sheet, and a copy of the acknowledgment must be placed in the patient's record.

DENTAL ASSISTANTS (UNLICENSED)

Although unlicensed dental assistants are not Board approved, their duties and actions are governed by the Act and they are required to complete coursework in the Dental Practice Act, infection control, and basic life support. Failure to follow the regulations set forth by California law can result in fines and/or imprisonment. As defined in CBPC Section 1750.(a), "A dental assistant is an individual who, without a license, may perform basic supportive dental procedures, as authorized by Section 1750.1 and by regulations adopted by the board, under the supervision of a licensed dentist" [1]. Basic supportive dental procedures are those procedures that have technically elementary characteristics, are completely reversible, and are unlikely to precipitate potentially hazardous conditions for the patient being treated. A licensed dentist is responsible for assuring unlicensed dental assistants' competence and ensuring that they complete required coursework (e.g., two-hour Dental Practice Act, eight-hour infection control, basic life support) and maintain certification in basic life support (if employed for longer than 120 days). Specific duties pertaining to dental assistant practice can be found in CCR Section 1085 [28]. General information regarding regulations pertaining to dental assistants is located in CBPC Sections 1740–1777; although these sections are not discussed in this course, they should be periodically reviewed to ensure self-compliance with the act. The CBPC may include additional duties for various dental assistant professions.

CCR Section 1085. Dental Assistant Duties and Settings.

(a) Unless specifically so provided by regulation, a dental assistant may not perform the following functions or any other activity which represents the practice of dentistry or requires the knowledge, skill and training of a licensed dentist:

1. Diagnosis and treatment planning;

2. Surgical or cutting procedures on hard or soft tissue;

3. Fitting and adjusting of correctional and prosthodontic appliances;

4. Prescription of medicines;

5. Placement, condensation, carving or removal of permanent restorations, including final cementation procedures;

6. Irrigation and medication of canals, try-in cones, reaming, filing or filling of root canals;

7. Taking of impressions for prosthodontic appliances, bridges or any other structures which may be worn in the mouth;

8. Administration of injectable and/or general anesthesia;

9. Oral prophylaxis procedures.

(b) A dental assistant may perform such basic supportive dental procedures as the following under the general supervision of a licensed dentist:

1. Extra-oral duties or functions specified by the supervising dentist;

2. Operation of dental radiographic equipment for the purpose of oral radiography if the dental assistant has complied with the requirements of section 1656 of the Code;

3. Examine orthodontic appliances.

(c) A dental assistant may perform such basic supportive dental procedures as the following under the direct supervision of a licensed dentist when done so pursuant to the order, control and full professional responsibility of the supervising dentist. Such procedures shall be checked and approved by the supervising dentist prior to dismissal of the patient from the office of said dentist.

1. Take impressions for diagnostic and opposing models, bleaching trays, temporary crowns and bridges, and sports guards;

2. Apply non-aerosol and non-caustic topical agents;

3. Remove post-extraction and periodontal dressings;

4. Placement of elastic orthodontic separators;

5. Remove orthodontic separators;

6. Assist in the administration of nitrous oxide analgesia or sedation; however, a dental assistant shall not start the administration of the gases and shall not adjust the flow of the gases unless instructed to do so by the dentist who shall be present at the patient's chairside at the implementation of these instructions. This regulation shall not be construed to prevent any person from taking appropriate action in the event of a medical emergency.

7. Hold anterior matrices;

8. Remove sutures;

9. Take intra-oral measurements for orthodontic procedures;

10. Seat adjusted retainers or headgears, including appropriate instructions;

11. Check for loose bands;

12. Remove arch wires;

13. Remove ligature ties;

14. Apply topical fluoride, after scaling and polishing by the supervising dentist or a registered dental hygienist;

15. Place and remove rubber dams;

16. Place, wedge and remove matrices;

17. Cure restorative or orthodontic materials in operative site with light-curing device.

For the purpose of this section, a supervising licensed dentist is defined as a dentist whose patient is receiving the services of a dental assistant in the treatment facility and is under the direct control of said licensed dentist [1]. Direct supervision is defined as supervision of dental procedures based on instructions given by a licensed dentist who must be physically present in the facility when the procedures are performed.

REGISTERED DENTAL ASSISTANTS

Registered dental assistants (RDAs) are Board-licensed professionals who may perform a greater range of duties than unlicensed dental assistants. Specific information pertaining to RDAs' scope of practice can be found in CCR Section 1086, and general information regarding regulations pertaining to RDAs is located in CBPC Sections 1740–1777, which should be reviewed periodically to ensure self-compliance with the act [28].

CCR Section 1086. RDA Duties and Settings.

(a) Unless specifically so provided by regulation, the prohibitions contained in section 1085 of these regulations apply to registered dental assistants.

(b) A registered dental assistant may perform all functions which may be performed by a dental assistant.

(c) Under general supervision, a registered dental assistant may perform the following duties:

1. Mouth-mirror inspection of the oral cavity, to include charting of obvious lesions, existing restorations and missing teeth;

2. Placement and removal of temporary sedative dressings.

(d) A registered dental assistant may perform the following procedures under the direct supervision of a licensed dentist when done so pursuant to the order, control and full professional responsibility of the supervising dentist. Such procedures shall be checked and approved by the supervising dentist prior to dismissal of the patient from the office of said dentist.

1. Obtain endodontic cultures;

2. Dry canals, previously opened by the supervising dentist, with absorbent points;

3. Test pulp vitality;

4. Place bases and liners on sound dentin;

5. Remove excess cement from supragingival surfaces of teeth with a hand instrument or floss;

6. Size stainless steel crowns, temporary crowns and bands;

7. Fabrication of temporary crowns intra-orally;

8. Temporary cementation and removal of temporary crowns and removal of orthodontic bands;

9. Placement of orthodontic separators;

10. Placement and ligation of arch wires;

11. Placement of post-extraction and periodontal dressings;

12. Apply bleaching agents;

13. Activate bleaching agents with non-laser light-curing device;

14. Take bite registrations for diagnostic models for case study only;

15. Coronal polishing (Evidence of satisfactory completion of a board-approved course of instruction in this function must be submitted to the board prior to any performance thereof). The processing times for coronal polishing course approval are set forth in section 1069.
This procedure shall not be intended or interpreted as a complete oral prophylaxis (a procedure which can be performed only by a licensed dentist or registered dental hygienist). A licensed dentist or registered dental hygienist shall determine that the teeth to be polished are free of calculus or other extraneous material prior to coronal polishing.

16. Removal of excess cement from coronal surfaces of teeth under orthodontic treatment by means of an ultrasonic scaler. (Evidence of satisfactory completion of a board-approved course of instruction or equivalent instruction in an approved RDA program in this function must be submitted to the board prior to any performance thereof.) The processing times for ultrasonic scaler course approval are set forth in section 1069.

(e) Settings. Registered dental assistants may undertake the duties authorized by this section in a treatment facility under the jurisdiction and control of the supervising licensed dentist, or in an equivalent facility approved by the board.

Registered Dental Assistants in Extended Functions

Registered dental assistants in extended functions (RDAEFs) are Board-licensed dental professionals who have a greater breadth of permitted duties than RDAs. Specifics regarding these allowed duties can be found in CCR Section 1087 [28].

CCR Section 1087. RDAEF Duties and Settings.

(a) Unless specifically so provided by regulation, the prohibitions contained in Section 1085 apply to RDAEFs.

(b) An RDAEF may perform all duties assigned to dental assistants and registered dental assistants.

(c) An RDAEF may perform the procedures set forth below under the direct supervision of a licensed dentist when done so pursuant to the order, control and full professional responsibility of the supervising dentist. Such procedures shall be checked and approved by the supervising dentist prior to dismissal of the patient from the office of said dentist.

1. Cord retraction of gingivae for impression procedures;

2. Take impressions for cast restorations;

3. Take impressions for space maintainers, orthodontic appliances, and occlusal guards;

4. Prepare enamel by etching for bonding;

5. Formulate indirect patterns for endodontic post and core castings;

6. Fit trial endodontic filling points;

7. Apply pit and fissure sealants;

8. Remove excess cement from subgingival tooth surfaces with a hand instrument;

9. Apply etchant for bonding restorative materials.

(d) Settings. Registered dental assistants in extended functions may undertake the duties authorized by this section in a treatment facility under the jurisdiction and control of the supervising licensed dentist, or in an equivalent facility approved by the board.

In addition to the duties outlined in CCR section 1087, section 1753.5 of the CBPC states that RDAEFs may conduct preliminary evaluation of the patient's oral health, including, but not limited to, charting, intraoral and extra-oral evaluation of soft tissue, classifying occlusion, and myofunctional evaluation, and perform oral health assessments in school-based, community health project settings under the direction of a dentist, registered dental hygienist, or registered dental hygienist in alternative practice [1]. RDAEFs may hold an orthodontic assistant permit, a dental sedation assistant permit, or both.

DENTAL HYGIENISTS

Registered dental hygienists (RDHs), registered dental hygienists in extended functions (RDHEFs), and registered dental hygienists in alternative practice (RDHAPs) are Board-licensed occupations administered by the Dental Hygiene Committee of California, and the California Dental Practice Act contains the main body of laws and regulations that govern their practice.

The Dental Hygiene Committee of California was created by the Board and consists of nine governor-appointed positions: four public members, four dental hygienists, and one practicing dentist [20]. Responsibilities of the Dental Hygiene Committee include adopting regulations; issuing, reviewing, and revoking licenses; developing and administering examinations; determining fees; and updating continuing education requirements for all dental hygiene licensure categories. The Act contains specific information regarding the permitted duties and settings of RDH practice (CCR Section 1088), RDHEF practice (CCR Section 1089), and RDHAP practice (CCR Section 1090) [28]. Additional laws and regulations pertaining specifically to dental hygiene practice are located in CBPC Sections 1900–1966.6. These sections should be periodically reviewed to ensure self-compliance with the Act.

Registered Dental Hygienists

CCR Section 1088. RDH Duties and Settings.

(a) Unless specifically so provided by regulation, the prohibition contained in Section 1085(a), subsections (1) through (8) of these regulations shall apply to duties performed by a registered dental hygienist.

(b) A registered dental hygienist may perform all duties assigned to dental assistants and registered dental assistants, under the supervision of a licensed dentist as specified in these regulations.

(c) Under general supervision, a registered dental hygienist may perform the following duties in addition to those provided by Section 1760(b) of the Code:

1. Root planing;

2. Polish and contour restorations;

3. Oral exfoliative cytology;

4. Apply pit and fissure sealants;

5. Preliminary examination, including but not limited to:

1. Periodontal charting;

2. Intra and extra-oral examination of soft tissue;

3. Charting of lesions, existing restorations and missing teeth;

4. Classifying occlusion;

5. Myofunctional evaluation.

6. Irrigate sub-gingivally with an antimicrobial and/or antibiotic liquid solution(s).

7. The following direct supervision duties of dental assistants and registered dental assistants:

1. Dental Assistant.

1. Taking impressions for diagnostic and opposing models;

2. Applying non-aerosol and non-caustic topical agents;

3. Removing post-extraction and periodontal dressings;

4. Removing sutures;

5. Taking intra-oral measurements for orthodontic procedures;

6. Checking for loose bands;

7. Removing ligature ties;

8. Applying topical fluoride;

9. Placing elastic separators.

2. Registered Dental Assistant

1. Test pulp vitality;

2. Removing excess cement from supragingival surfaces of teeth;

3. Sizing stainless steel crowns, temporary crowns and bands;

4. Temporary cementation and removal of temporary crowns and removal of orthodontic bands;

5. Placing post-extraction and periodontal dressings.

(d) A registered dental hygienist may perform the procedures set forth below under the direct supervision of a licensed dentist when done so pursuant to the order, control and full professional responsibility of the supervising dentist. Such procedures shall be checked and approved by the supervising dentist prior to dismissal of the patient from the office of said dentist.

1. Placement of antimicrobial or antibiotic medicaments which do not later have to be removed;

2. All duties so assigned to a dental assistant or a registered dental assistant, unless otherwise indicated;

3. Periodontal soft tissue curettage (Evidence of satisfactory completion of a board-approved course of instruction in this function must be submitted to the board prior to any performance thereof);

4. Administration of local anesthetic agents, infiltration and conductive, limited to the oral cavity (Evidence of satisfactory completion of a board-approved course of instruction in this function must be submitted to the board prior to any performance thereof);

5. Administration of nitrous oxide and oxygen when used as an analgesic, utilizing fail-safe type machines containing no other general anesthetic agents. (Evidence of satisfactory completion of a board-approved course of instruction in this function must be submitted to the board prior to any performance thereof.)

(e) A registered dental hygienist may undertake the duties authorized by this section in the following settings, provided the appropriate supervision requirements are met:

1. The treatment facility of a licensed dentist;

2. Licensed health facilities as defined in Section 1250 of the Health and Safety Code,

3. Licensed clinics as defined in Section 1203 of the Health and Safety Code,

4. Licensed community care facilities as defined in Section 1502 of the Health and Safety Code,

5. Schools of any grade level whether public or private,

6. Public institutions, including but not limited to federal, state and local penal and correctional facilities.

7. Mobile units operated by a public or governmental agency or a nonprofit and charitable organization approved by the board; provided, however, that the mobile unit meets the statutory and regulatory requirements for mobile units,

8. Home of a non-ambulatory patient, provided there is a written note from a physician or registered nurse stating that the patient is unable to visit a dental office.

9. Health fairs or similar non-profit community activities. Each such fair or activity shall be approved by the board.

Any other facility must be approved by the board.

Registered Dental Hygienists in Extended Functions

CCR Section 1089. RDHEF Duties and Settings.

(a) Unless specifically provided by regulation, the prohibitions contained in Section 1085(a) (1) through (8) shall apply to RDHEFs.

(b) An RDHEF may perform all duties assigned to dental assistants, registered dental assistants and registered dental hygienists.

(c) An RDHEF may perform the procedures set forth below under the direct supervision of a licensed dentist when done so pursuant to the order, control and full professional responsibility of the supervising dentist. Such procedures shall be checked and approved by the supervising dentist prior to dismissal of the patient from the office of said dentist.

1. Cord retraction of gingivae for impression procedures;

2. Take impressions for cast restorations;

3. Take impressions for space maintainers, orthodontic appliances and guards;

4. Prepare enamel by etching for bonding;

5. Formulate indirect patterns for endodontic post and core castings;

6. Fit trial endodontic filling points;

7. Apply etchant for bonding restorative materials.

(d) Settings. Registered dental hygienists in extended functions may undertake the duties authorized by this section in a treatment facility under the jurisdiction and control of the supervising licensed dentist, or an equivalent facility approved by the Board.

Registered Dental Hygienists in Alternative Practice

CCR Section 1090. RDHAP Duties and Settings.

(a) Unless specifically so provided by regulation, an RDHAP may not perform the following functions or any activity which represents the practice of dentistry or requires knowledge, skill and training of a licensed dentist:

1. Diagnosing and treatment planning;

2. Surgical or cutting procedures on hard or soft tissue;

3. Fitting and adjusting of correctional and prosthodontic appliances;

4. Prescribing medication;

5. Placing, condensing, carving or removal of permanent restorations, including final cementation procedures;

6. Irrigating and medicating canals, try-in cones, reaming, filing or filling of root canals;

7. Taking of impressions for prosthodontic appliances, bridges, or any other devices which may be worn in the mouth;

8. Administering local or general anesthesia, oral or parental conscious sedation.

(b) Under the supervision of a licensed dentist, an RDHAP may perform the duties assigned to registered dental hygienists by Section 1088, under the same levels of supervision and in the same settings as specified in that section, in addition to those duties permitted by Section 1768(b)(3).

(c) Independently and without the supervision of a licensed dentist, an RDHAP may, upon the prescription of a dentist or a physician and surgeon licensed in California, perform the duties assigned to a registered dental hygienist by Section 1088(c).

1. All prescriptions shall contain the following information:

1. The pre-printed name, address, license number, and signature of the prescribing dentist or physician and surgeon.

2. The name, address and phone number of the patient.

3. The date the services are prescribed and the expiration date of the prescription. The prescription shall be for dental hygiene services and, if necessary, include special instructions for the care of that patient.

Prior to the establishment of an independent practice, an RDHAP shall provide to the board documentation of an existing relationship with at least one dentist for referral, consultation, and emergency services [1].

3. LICENSURE

All individuals practicing dentistry in California, with the exception of unlicensed dental assistants, must hold a current, valid license issued by the Board; California does not grant reciprocity with other states or nations. The Act requires that dental professionals meet certain education requirements, submit the correct applications and fees, pass the appropriate examinations, and submit a set of fingerprints. Fingerprinting is also required for license renewal if not previously conducted by the California Department of Justice (DOJ) or if records no longer exist [21]. Fingerprinting within California must be conducted using the DOJ Live Scan system; fingerprint records from other institutions (e.g., Department of Motor Vehicles) are not suitable, although ink-on-card fingerprints made at a law enforcement agency are acceptable if unable to travel to California. The required fingerprint cards must be requested from the Dental Board by phone or email [21]. The fingerprints will be used to conduct a criminal history record check and a state and federal level criminal offender record information search.

Issuance, review, and revocation of RDH/RDHEF/RDHAP licenses and the development and administration of license examinations for these auxiliaries are handled by the Dental Hygiene Board of California. All other licensure, including that for RDAs/RDAEFs, is handled by the Dental Board (despite the existence of the Dental Assisting Council, whose purpose is to consider matters related to dental assisting practice and make recommendations to the board). Complaints, investigations, and enforcement are handled by either the Dental Hygiene Board or the Dental Board, according to profession, but the governing regulations and laws set forth in the California Dental Practice Act pertain to all dental professionals. Information about application for licensure to practice as a dentist or dental auxiliary can be found in CCR Section 1028 and CCR Sections 1076–1079.3, respectively. Specific information about the licensure application requirements and process for dentists and dental assistants can be found at https://www.dbc.ca.gov/applicants and for hygienists at https://www.dhbc.ca.gov/applicants.

Effective July 2012, application for licensure may be denied based on delinquent state tax payments [1]. Similarly, current licenses/certifications/registrations may be revoked for failure to pay taxes.

LICENSE RENEWAL

Licenses for all dental professions must be renewed every two years before the last day of the professional's birth month. Practicing without renewing after this date is considered practicing without a license [1]. It is required that dentists have completed 50 hours of continuing education and dental auxiliaries (excluding RDHAPs) have completed 25 hours of continuing education (maximum of 25 hours and 12.5 hours of home study, respectively) upon renewal submission. The continuing education requirement is 35 hours for RDHAPs. Coursework regarding the Dental Practice Act, infection control, and basic life support is mandatory every two years for all licensees. To receive credit, all courses must be from Board-approved providers. In addition, the Board has identified topics that may only constitute a portion of the full continuing education requirement or that are not acceptable at all. A complete listing of allowable and non-allowable courses is available on the Board website.

Links to information regarding license renewal for dentists and dental assistants can be found at https://www.dbc.ca.gov/licensees, and renewal information for hygienists can be found at https://www.dhbc.ca.gov/licensees/renewals.

ACTS LEADING TO SUSPENSION OF A LICENSE AND IN VIOLATION OF THE DENTAL PRACTICE ACT

Violations of the Act by Board licensees are grounds for suspension of a license/certification and are handled by the Board's Enforcement Program, which is composed of five sections: complaint intake, complaint analysis, inspection, investigation, and probation [22]. Complaints originate from many sources, including dental professionals, healthcare providers, insurance companies, law enforcement agencies, and patients. Complaint intake specialists route these to the appropriate section; for example, an allegation of an unsafe or unsanitary office condition is routed to the inspection section, whereby Board enforcement inspectors may be sent out and are authorized to issue citations and fines. In addition to Board enforcement action, other law enforcement or regulatory agencies are involved when indicated [1]. Dental professionals placed on probation status by the Board for violations of the Act are monitored by the Enforcement Program's probation section. The Board's Enforcement Unit may be contacted at (916) 274-6326. Violations of the Act by hygienists are handled by the Hygiene Board's Complaint Unit, which operates in a similar manner and can be contacted at (866) 810-9899 or by email at DHBCEnforcement@dca.ca.gov.

According to CBPC Section 1670.1, conviction of crimes committed by dental professionals outside of the workplace may also be grounds for Board discipline and can impact licensure status if the crime is "substantially related to the qualifications, functions, or duties of a dentist or dental assistant licensed under this chapter" [1]. These vary considerably on a case-by-case basis. Various lesser convictions, for example, driving under the influence (DUI), illicit drug possession, and prescription drug diversion, may not necessarily lead to license revocation provided the proper steps are taken toward remediation (e.g., entering the Board diversion program, submitting to periodic drug testing) [23]. In general, convictions for assaults, sex crimes, multiple misdemeanors (e.g., second DUI/controlled substance charge), and other egregious violations constitute a basis for denial or revocation of licenses or certifications. In addition to violations outside the workplace, unprofessional conduct, in its many forms, is grounds for Board Enforcement action. Acts and omissions that characterize unprofessional conduct are covered extensively in CBPC Sections 1680, 1681, and 1682 and CCR Section 1018.05.

CBPC Section 1680. Unprofessional conduct by a person licensed under this chapter is defined as, but is not limited to, any one of the following:

(a) The obtaining of any fee by fraud or misrepresentation.

(b) The employment directly or indirectly of any student or suspended or unlicensed dentist to practice dentistry as defined in this chapter.

(c) The aiding or abetting of any unlicensed person to practice dentistry.

(d) The aiding or abetting of a licensed person to practice dentistry unlawfully.

(e) The committing of any act or acts of sexual abuse, misconduct, or relations with a patient that are substantially related to the practice of dentistry.

(f) The use of any false, assumed, or fictitious name, either as an individual, firm, corporation, or otherwise, or any name other than the name under which the person is licensed to practice, in advertising or in any other manner indicating that the person is practicing or will practice dentistry, except that name as is specified in a valid permit issued pursuant to Section 1701.5.

(g) The practice of accepting or receiving any commission or the rebating in any form or manner of fees for professional services, radiograms, prescriptions, or other services or articles supplied to patients.

(h) The making use by the licensee or any agent of the licensee of any advertising statements of a character tending to deceive or mislead the public.

(i) The advertising of either professional superiority or the advertising of performance of professional services in a superior manner. This subdivision shall not prohibit advertising permitted by subdivision (h) of Section 651.

(j) The employing or the making use of solicitors.

(k) The advertising in violation of Section 651.

(l) The advertising to guarantee any dental service, or to perform any dental operation painlessly. This subdivision shall not prohibit advertising permitted by Section 651.

(m) The violation of any of the provisions of law regulating the procurement, dispensing, or administration of dangerous drugs, as defined in Chapter 9 (commencing with Section 4000) or controlled substances, as defined in Division 10 (commencing with Section 11000) of the Health and Safety Code.

(n) The violation of any of the provisions of this division.

(o) The permitting of any person to operate dental radiographic equipment who has not met the requirements of Section 1656.

(p) The clearly excessive prescribing or administering of drugs or treatment, or the clearly excessive use of diagnostic procedures, or the clearly excessive use of diagnostic or treatment facilities, as determined by the customary practice and standards of the dental profession. Any person who violates this subdivision is guilty of a misdemeanor and shall be punished by a fine of not less than one hundred dollars ($100) or more than six hundred dollars ($600), or by imprisonment for a term of not less than 60 days or more than 180 days, or by both a fine and imprisonment.

(q) The use of threats or harassment against any patient or licensee for providing evidence in any possible or actual disciplinary action, or other legal action; or the discharge of an employee primarily based on the employee's attempt to comply with the provisions of this chapter or to aid in the compliance.

(r) Suspension or revocation of a license issued, or discipline imposed, by another state or territory on grounds that would be the basis of discipline in this state.

(s) The alteration of a patient's record with intent to deceive.

(t) Unsanitary or unsafe office conditions, as determined by the customary practice and standards of the dental profession.

(u) The abandonment of the patient by the licensee, without written notice to the patient that treatment is to be discontinued and before the patient has ample opportunity to secure the services of another dentist, registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions and provided the health of the patient is not jeopardized.

(v) The willful misrepresentation of facts relating to a disciplinary action to the patients of a disciplined licensee.

(w) Use of fraud in the procurement of any license issued pursuant to this chapter.

(x) Any action or conduct that would have warranted the denial of the license.

(y) The aiding or abetting of a licensed dentist, dental assistant, registered dental assistant, registered dental assistant in extended functions, dental sedation assistant permitholder, orthodontic assistant permitholder, registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions to practice dentistry in a negligent or incompetent manner.

(z)

1. The failure to report to the board in writing within seven days any of the following:

1. the death of the licensee's patient during the performance of any dental or dental hygiene procedure;

2. the discovery of the death of a patient whose death is related to a dental or dental hygiene procedure performed by the licensee; or

3. except for a scheduled hospitalization, the removal to a hospital or emergency center for medical treatment of any patient to whom oral conscious sedation, conscious sedation, or general anesthesia was administered, or any patient as a result of dental or dental hygiene treatment. With the exception of patients to whom oral conscious sedation, conscious sedation, or general anesthesia was administered, removal to a hospital or emergency center that is the normal or expected treatment for the underlying dental condition is not required to be reported. Upon receipt of a report pursuant to this subdivision the board may conduct an inspection of the dental office if the board finds that it is necessary. A dentist shall report to the board all deaths occurring in the licensee's practice with a copy sent to the Dental Hygiene Board of California if the death was the result of treatment by a registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions. A registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions shall report to the Dental Hygiene Board of California all deaths occurring as the result of dental hygiene treatment, and a copy of the notification shall be sent to the board.

2. The report required by this subdivision shall be on a form or forms approved by the board. The form or forms approved by the board shall require the licensee to include, but not be limited to, the following information for cases in which patients received anesthesia: the date of the procedure; the patient's age in years and months, weight, and sex; the patient's American Society of Anesthesiologists (ASA) physical status; the patient's primary diagnosis; the patient's coexisting diagnoses; the procedures performed; the sedation setting; the medications used; the monitoring equipment used; the category of the provider responsible for sedation oversight; the category of the provider delivering sedation; the category of the provider monitoring the patient during sedation; whether the person supervising the sedation performed one or more of the procedures; the planned airway management; the planned depth of sedation; the complications that occurred; a description of what was unexpected about the airway management; whether there was transportation of the patient during sedation; the category of the provider conducting resuscitation measures; and the resuscitation equipment utilized. Disclosure of individually identifiable patient information shall be consistent with applicable law. A report required by this subdivision shall not be admissible in any action brought by a patient of the licensee providing the report.

3. For the purposes of paragraph (2), categories of provider are: General Dentist, Pediatric Dentist, Oral Surgeon, Dentist Anesthesiologist, Physician Anesthesiologist, Dental Assistant, Registered Dental Assistant, Dental Sedation Assistant, Registered Nurse, Certified Registered Nurse Anesthetist, or Other.

4. The form shall state that this information shall not be considered an admission of guilt, but is for educational, data, or investigative purposes.

5. The board may assess a penalty on any licensee who fails to report an instance of an adverse event as required by this subdivision. The licensee may dispute the failure to file within 10 days of receiving notice that the board had assessed a penalty against the licensee.

(aa) Participating in or operating any group advertising and referral services that are in violation of Section 650.2.

(ab) The failure to use a fail-safe machine with an appropriate exhaust system in the administration of nitrous oxide. The board shall, by regulation, define what constitutes a fail-safe machine.

(ac) Engaging in the practice of dentistry with an expired license.

(ad) Except for good cause, the knowing failure to protect patients by failing to follow infection control guidelines of the board, thereby risking transmission of bloodborne infectious diseases from dentist, dental assistant, registered dental assistant, registered dental assistant in extended functions, dental sedation assistant permitholder, orthodontic assistant permitholder, registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions to patient, from patient to patient, and from patient to dentist, dental assistant, registered dental assistant, registered dental assistant in extended functions, dental sedation assistant permitholder, orthodontic assistant permitholder, registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions. In administering this subdivision, the board shall consider referencing the standards, regulations, and guidelines of the State Department of Public Health developed pursuant to Section 1250.11 of the Health and Safety Code and the standards, guidelines, and regulations pursuant to the California Occupational Safety and Health Act of 1973 (Part 1 (commencing with Section 6300) of Division 5 of the Labor Code) for preventing the transmission of HIV, hepatitis B, and other blood-borne pathogens in health care settings. The board shall review infection control guidelines, if necessary, on an annual basis and proposed changes shall be reviewed by the Dental Hygiene Board of California to establish a consensus. The Board shall submit any recommended changes to the infection control guidelines for review to establish a consensus. As necessary, the board shall consult with the Medical Board of California, the California Board of Podiatric Medicine, the Board of Registered Nursing, and the Board of Vocational Nursing and Psychiatric Technicians, to encourage appropriate consistency in the implementation of this subdivision.

The board shall seek to ensure that all appropriate dental personnel are informed of the responsibility to follow infection control guidelines, and of the most recent scientifically recognized safeguards for minimizing the risk of transmission of bloodborne infectious diseases.

(ae) The utilization by a licensed dentist of any person to perform the functions of any registered dental assistant, registered dental assistant in extended functions, dental sedation assistant permitholder, orthodontic assistant permitholder, registered dental hygienist, registered dental hygienist in alternative practice, or registered dental hygienist in extended functions who, at the time of initial employment, does not possess a current, valid license or permit to perform those functions.

(af) The prescribing, dispensing, or furnishing of dangerous drugs or devices, as defined in Section 4022, in violation of Section 2242.1.

(ag) Using water, or other methods used for irrigation, that are not sterile or that do not contain recognized disinfecting or antibacterial properties when performing dental procedures on exposed dental pulp.

(ah) The failure by the treating dentist, prior to the initial diagnosis and correction of malpositions of human teeth or initial use of orthodontic appliances, to perform an examination pursuant to subdivision (b) of Section 1684.5, including the review of the patient's most recent diagnostic digital or conventional radiographs or other equivalent bone imaging suitable for orthodontia. New radiographs or other equivalent bone imaging shall be ordered if deemed appropriate by the treating dentist.

Section 1681. In addition to other acts constituting unprofessional conduct within the meaning of this chapter, it is unprofessional conduct for a person licensed under this chapter to do any of the following:

(a) Obtain or possess in violation of law, or except as directed by a licensed physician and surgeon, dentist, or podiatrist, administer to himself, any controlled substance, as defined in Division 10 (commencing with Section 11000) of the Health and Safety Code, or any dangerous drug as defined in Article 8 (commencing with Section 4211) of Chapter 9.

(b) Use any controlled substance, as defined in Division 10 (commencing with Section 11000) of the Health and Safety Code, or any dangerous drug as defined in Article 8 (commencing with Section 4211) of Chapter 9, or alcoholic beverages or other intoxicating substances, to an extent or in a manner dangerous or injurious to himself, to any person, or the public to the extent that such use impairs his ability to conduct with safety to the public the practice authorized by his license.

(c) The conviction of a charge of violating any federal statute or rules, or any statute or rule of this state, regulating controlled substances, as defined in Division 10 (commencing with Section 11000) of the Health and Safety Code, or any dangerous drug, as defined in Article 8 (commencing with Section 4211) of Chapter 9, or the conviction of more than one misdemeanor, or any felony, involving the use or consumption of alcohol or drugs, if the conviction is substantially related to the practice authorized by his license. The record of conviction or certified copy thereof, certified by the clerk of the court or by the judge in whose court the conviction is had, shall be conclusive evidence of a violation of this section; a plea or verdict of guilty or a conviction following a plea of nolo contendere is deemed to be a conviction within the meaning of this section; the board may order the license suspended or revoked, or may decline to issue a license, when the time for appeal has elapsed or the judgment of conviction has been affirmed on appeal, or when an order granting probation is made suspending imposition of sentence, irrespective of a subsequent order under any provision of the Penal Code, including, but not limited to, Section 1203.4 of the Penal Code, allowing such person to withdraw his plea of guilty and to enter a plea of not guilty, or setting aside the verdict of guilty, or dismissing the accusation, information or indictment.

Section 1682. In addition to other acts constituting unprofessional conduct under this chapter, it is unprofessional conduct for:

(a) Any dentist performing dental procedures to have more than one patient undergoing moderate sedation, deep sedation, or general anesthesia on an outpatient basis at any given time unless each patient is being continuously monitored on a one-to-one ratio while sedated by either the dentist or another licensed health professional authorized by law to administer moderate sedation, deep sedation, or general anesthesia.

(b) Any dentist with patients recovering from moderate sedation, deep sedation, or general anesthesia to fail to have the patients closely monitored by licensed health professionals experienced in the care and resuscitation of patients recovering from moderate sedation, deep sedation, or general anesthesia. If one licensed professional is responsible for the recovery care of more than one patient at a time, all of the patients shall be physically in the same room to allow continuous visual contact with all patients and the patient to recovery staff ratio should not exceed three to one.

(c) Any dentist with patients who are undergoing deep sedation, general anesthesia, or moderate sedation to fail to have these patients continuously monitored during the dental procedure with a pulse oximeter or similar or superior monitoring equipment and ventilation continuously monitored using at least two of the three following methods:

1. Auscultation of breath sounds using a precordial stethoscope.

2. Monitoring for the presence of exhaled carbon dioxide with capnography.

3. Verbal communication with a patient under moderate sedation. This method shall not be used for a patient under deep sedation or general anesthesia.

(d) Any dentist with patients who are undergoing moderate sedation to have dental office personnel directly involved with the care of those patients who are not certified in basic cardiac life support (CPR) and recertified biennially.

(e)

1. Any dentist to fail to obtain the written informed consent of a patient prior to administering moderate sedation, deep sedation, general anesthesia. In the case of a minor, the consent shall be obtained from the child's parent or guardian.

2. The written informed consent for general anesthesia, in the case of a minor, shall include, but not be limited to, the following information:
"The administration and monitoring of deep sedation or general anesthesia may vary depending on the type of procedure, the type of practitioner, the age and health of the patient, and the setting in which anesthesia is provided. Risks may vary with each specific situation. You are encouraged to explore all the options available for your child's anesthesia for their dental treatment, and consult with your dentist, family physician, or pediatrician as needed."

3. Nothing in this subdivision shall be construed to establish the reasonable standard of care for administering or monitoring oral moderate sedation, moderate sedation, deep sedation, or general anesthesia.

Section 1683. (a) Every dentist, dental health professional, or other licensed health professional who performs a service on a patient in a dental office shall identify himself or herself in the patient record by signing his or her name, or an identification number and initials, next to the service performed and shall date those treatment entries in the record. Any person licensed under this chapter who owns, operates, or manages a dental office shall ensure compliance with this requirement.

(b) Repeated violations of this section constitute unprofessional conduct.

Section 1683.1 (a) Any individual, partnership, corporation, or other entity that provides dental services through telehealth shall make available the name, telephone number, practice address, and California state license number of any dentist who will be involved in the provision of services to a patient prior to the rendering of services and when requested by a patient.

(b) A violation of this section shall constitute unprofessional conduct.

Section 1684. In addition to other acts constituting unprofessional conduct under this chapter, it is unprofessional conduct for a person licensed under this chapter to perform, or hold himself or herself out as able to perform, professional services beyond the scope of his or her license and field or fields of competence as established by his or her education, experience, training, or any combination thereof. This includes, but is not limited to, the use of any instrument or device in a manner that is not in accordance with the customary standards and practices of the dental profession. This section shall not apply to research conducted by accredited dental schools or colleges, or to research conducted pursuant to an investigational device exemption issued by the United States Food and Drug Administration.

1684.5. (a) In addition to other acts constituting unprofessional conduct under this chapter, it is unprofessional conduct for any dentist to perform or allow to be performed any treatment on a patient who is not a patient of record of that dentist. A dentist may, however, after conducting a preliminary oral examination, require or permit any dental auxiliary to perform procedures necessary for diagnostic purposes, provided that the procedures are permitted under the auxiliary's authorized scope of practice. Additionally, a dentist may require or permit a dental auxiliary to perform all of the following duties prior to any examination of the patient by the dentist, provided that the duties are authorized for the particular classification of dental auxiliary pursuant to Article 7 (commencing with Section 1740):

1. Expose emergency radiographs upon direction of the dentist.

2. If the dental auxiliary is a registered dental assistant in extended functions, a registered dental hygienist, or a registered dental hygienist in alternative practice, determine and perform radiographs for the specific purpose of aiding a dentist in completing a comprehensive diagnosis and treatment plan for a patient using telehealth, as defined by Section 2290.5, for the purpose of communication with the supervising dentist pursuant to Sections 1753.55, 1910.5, and 1926.05. A dentist is not required to review patient records or make a diagnosis using telehealth.

3. Perform extra-oral duties or functions specified by the dentist.

4. Perform mouth-mirror inspections of the oral cavity, to include charting of obvious lesions, malocclusions, existing restorations, and missing teeth.

(b) For purposes of this section, "patient of record" refers to a patient who has been examined, has had a medical and dental history completed and evaluated, and has had oral conditions diagnosed and a written plan developed by the licensed dentist.

(c) For purposes of this section, if dental treatment is provided to a patient by a registered dental assistant in extended functions, a registered dental hygienist, or a registered dental hygienist in alternative practice pursuant to the diagnosis and treatment plan authorized by a supervising dentist, at a location other than the dentist's practice location, it is the responsibility of the authorizing dentist that the patient or the patient's representative receive written notification that the care was provided at the direction of the authorizing dentist and that the notification include the authorizing dentist's name, practice location address, and telephone number. This provision shall not require patient notification for dental hygiene preventive services provided in public health programs as specified and authorized in Section 1911, or for dental hygiene care when provided as specified and authorized in Section 1926.

(d) A dentist shall not concurrently supervise more than a total of five registered dental assistants in extended functions, registered dental hygienists, or registered dental hygienists in alternative practice providing services pursuant to Sections 1753.55, 1910.5, and 1926.05.

(e) This section shall not apply to dentists providing examinations on a temporary basis outside of a dental office in settings including, but not limited to, health fairs and school screenings.

(f) This section shall not apply to fluoride mouth rinse or supplement programs administered in a school or preschool setting.

Section 1685. In addition to other acts constituting unprofessional conduct under this chapter, it is unprofessional conduct for a person licensed under this chapter to require, either directly or through an office policy, or knowingly permit the delivery of dental care that discourages necessary treatment or permits clearly excessive treatment, incompetent treatment, grossly negligent treatment, repeated negligent acts, or unnecessary treatment, as determined by the standard of practice in the community.

CCR Section 1018.05 Unprofessional Conduct Defined. In addition to those acts detailed in Business and Professions Code Sections 1670, 1680, 1681 and 1682, the following shall also constitute unprofessional conduct:

(a) Failure to provide records requested by the Board within 15 days of the date of receipt of the request or within the time specified in the request, whichever is later, unless the licensee is unable to provide the documents within this time period for good cause. For the purposes of this section, "good cause" includes physical inability to access the records in the time allowed due to illness or travel.

(b) Failure to report to the Board, within 30 days, any of the following:

1. The bringing of an indictment or information charging a felony against the licensee.

2. The conviction of the licensee, including any verdict of guilty, or pleas of guilty or no contest, of any felony or misdemeanor.

3. Any disciplinary action taken by another professional licensing entity or authority of this state or of another state or an agency of the federal government or the United States military.

4. For the purposes of this section, "conviction" means a plea or verdict of guilty or a conviction following a plea of nolo contendere or "no contest" and any conviction that has been set aside or deferred pursuant to Sections 1000 or 1203.4 of the Penal Code, including infractions, misdemeanors, and felonies. "Conviction" does not include traffic infractions with a fine of less than one thousand dollars ($1,000) unless the infraction involved alcohol or controlled substances.

4. VIOLATIONS AND PENALTIES

As discussed, various acts or omissions can be cause for revocation or suspension of a license. Violation of any section of the Dental Practice Act can also lead to civil and criminal prosecution, including [1]:

Section 1700. Any person, company, or association is guilty of a misdemeanor, and upon conviction thereof shall be punished by imprisonment in the county jail not less than 10 days nor more than one year, or by a fine of not less than one hundred dollars ($100) nor more than one thousand five hundred dollars ($1,500), or by both fine and imprisonment, who:

(a) Assumes the degree of "doctor of dental surgery," "doctor of dental science," or "doctor of dental medicine" or appends the letters "DDS," or "DDSc" or "DMD" to his or her name without having had the right to assume the title conferred upon him or her by diploma from a recognized dental college or school legally empowered to confer the same.

(b) Assumes any title, or appends any letters to his or her name, with the intent to represent falsely that he or she has received a dental degree or license.

(c) Engages in the practice of dentistry without causing to be displayed in a conspicuous place in his or her office the name of each and every person employed there in the practice of dentistry.

(d) Within 10 days after demand is made by the executive officer of the board, fails to furnish to the board the name and address of all persons practicing or assisting in the practice of dentistry in the office of the person, company, or association, at any time within 60 days prior to the demand, together with a sworn statement showing under and by what license or authority this person, company, or association and any employees are or have been practicing dentistry. This sworn statement shall not be used in any prosecution under this section.

(e) Is under the influence of alcohol or a controlled substance while engaged in the practice of dentistry in actual attendance on patients to an extent that impairs his or her ability to conduct the practice of dentistry with safety to patients and the public.

Section 1700.5. Notwithstanding Section 1700, any person who holds a valid, unrevoked, and unsuspended certificate as a dentist under this chapter may append the letters "DDS" to his or her name, regardless of the degree conferred upon him or her by the dental college from which the licensee graduated.

Section 1701. Any person is for the first offense guilty of a misdemeanor and shall be punishable by a fine of not less than two hundred dollars ($200) or more than three thousand dollars ($3,000), or by imprisonment in a county jail for not to exceed six months, or both, and for the second or a subsequent offense is guilty of a felony and upon conviction thereof shall be punished by a fine of not less than two thousand dollars ($2,000) nor more than six thousand dollars ($6,000), or by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, or by both such fine and imprisonment, who:

(a) Sells or barters or offers to sell or barter any dental degree or any license or transcript made or purporting to be made pursuant to the laws regulating the license and registration of dentists.

(b) Purchases or procures by barter any such diploma, license or transcript with intent that the same shall be used in evidence of the holder's qualification to practice dentistry, or in fraud of the laws regulating such practice.

(c) With fraudulent intent, makes or attempts to make, counterfeits or alters in a material regard any such diploma, certificate or transcript.

(d) Uses, attempts or causes to be used, any such diploma, certificate or transcript which has been purchased, fraudulently issued, counterfeited or materially altered, either as a license to practice dentistry, or in order to procure registration as a dentist.

(e) In an affidavit, required of an applicant for examination, license or registration under this chapter, willfully makes a false statement in a material regard.

(f) Practices dentistry or offers to practice dentistry as it is defined in this chapter, either without a license, or when his license has been revoked or suspended.

(g) Under any false, assumed or fictitious name, either as an individual, firm, corporation or otherwise, or any name other than the name under which he is licensed, practices, advertises or in any other manner indicates that he is practicing or will practice dentistry, except such name as is specified in a valid permit issued pursuant to Section 1701.5.

Section 1701.1. (a) Notwithstanding Sections 1700 and 1701, a person who willfully, under circumstances or conditions that cause or create risk of bodily harm, serious physical or mental illness, or death, practices or attempts to practice, or advertises or holds himself or herself out as practicing dentistry without having at the time of so doing a valid, unrevoked, and unsuspended certificate, license, registration, or permit as provided in this chapter, or without being authorized to perform that act pursuant to a certificate, license, registration, or permit obtained in accordance with some other provision of law, is guilty of a public offense, punishable by a fine not exceeding ten thousand dollars ($10,000), by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, by imprisonment in a county jail not exceeding one year, or by both the fine and either imprisonment.

(b) A person who conspires with or aids and abets another to commit any act described in subdivision (a) is guilty of a public offense and subject to the punishment described in subdivision (a).

(c) The remedy provided in this section shall not preclude any other remedy provided by law.

5. LAWS GOVERNING THE PRESCRIPTION OF DRUGS

The California Dental Practice Act states that only doctors of dentistry are permitted to prescribe drugs, including analgesics, sedatives, and antibiotics, although prescription of oral conscious sedation to children younger than 13 years of age requires a permit. Dental assistants and dental hygienists are not permitted to write prescriptions [1]. There are many federal and state laws and regulations pertaining to prescribing. It is the responsibility of each Drug Enforcement Administration (DEA)-registered prescriber (or those exempted) to be familiar with and maintain knowledge of all applicable laws and regulations. Pertinent citations of federal laws governing the prescription of controlled substances are included in the DEA Practitioner's Manual, available at https://www.deadiversion.usdoj.gov/pubs/manuals. The California Uniform Controlled Substances Act (part of the California Health and Safety Code) can be found at https://leginfo.legislature.ca.gov/faces/codesTOCSelected.xhtml?tocCode=HSC. The Substances Act begins at Section 11000, and information regarding prescriptions begins in Section 11150.

There must be careful consideration when prescribing to addicts or suspected addicts, particularly when patients are requesting specific drugs. As of 2016, California legislation requires that all prescribers of controlled substances register to access CURES, the state prescription drug monitoring program database intended to aid prescribers and dispensers in identifying fraudulent activity, thereby reducing prescription drug abuse and diversion without affecting legitimate medical practice or patient care. As of October 2018, all licensees authorized to prescribe, order, administer, furnish or dispense controlled substances in California must, with some exceptions, check a patient's prescription history in CURES 2.0 before prescribing a Schedule II, III, or IV substance [27].

The following section of the California Business and Professional Code addresses unprofessional conduct related to furnishing prescription drugs and excessive prescribing.

Section 725. (a) Repeated acts of clearly excessive prescribing, furnishing, dispensing, or administering of drugs or treatment, repeated acts of clearly excessive use of diagnostic procedures, or repeated acts of clearly excessive use of diagnostic or treatment facilities as determined by the standard of the community of licensees is unprofessional conduct for a physician and surgeon, dentist, podiatrist, psychologist, physical therapist, chiropractor, optometrist, speech-language pathologist, or audiologist.

(b) Any person who engages in repeated acts of clearly excessive prescribing or administering of drugs or treatment is guilty of a misdemeanor and shall be punished by a fine of not less than one hundred dollars ($100) nor more than six hundred dollars ($600), or by imprisonment for a term of not less than 60 days nor more than 180 days, or by both that fine and imprisonment.

(c) A practitioner who has a medical basis for prescribing, furnishing, dispensing, or administering dangerous drugs or prescription controlled substances shall not be subject to disciplinary action or prosecution under this section.

(d) No physician and surgeon shall be subject to disciplinary action pursuant to this section for treating intractable pain in compliance with Section 2241.5.

The following sections of the Uniform Controlled Substances Act addresses the facilitation of abuse by prescribing practices, including the new CURES reporting requirements.

Section 11150.2. (a) Notwithstanding any other law, if cannabinoids are excluded from Schedule I of the federal Controlled Substances Act and placed on a schedule of the act other than Schedule I, or if a product composed of cannabinoids is approved by the federal Food and Drug Administration and either placed on a schedule of the act other than Schedule I, or exempted from one or more provisions of the act, so as to permit a physician, pharmacist, or other authorized healing arts licensee acting within their scope of practice, to prescribe, furnish, or dispense that product, the physician, pharmacist, or other authorized healing arts licensee who prescribes, furnishes, or dispenses that product in accordance with federal law shall be deemed to be in compliance with state law governing those acts.

(b) For purposes of this chapter, upon the effective date of one of the changes in federal law described in subdivision (a), notwithstanding any other state law, a product composed of cannabinoids may be prescribed, furnished, dispensed, transferred, transported, possessed, or used in accordance with federal law and is authorized pursuant to state law.

(c) This section does not apply to any product containing cannabinoids that is made or derived from industrial hemp, as defined in Section 11018.5 and regulated pursuant to that section.

Section 11153. (a) A prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. Except as authorized by this division, the following are not legal prescriptions: (1) an order purporting to be a prescription which is issued not in the usual course of professional treatment or in legitimate and authorized research; or (2) an order for an addict or habitual user of controlled substances, which is issued not in the course of professional treatment or as part of an authorized narcotic treatment program, for the purpose of providing the user with controlled substances, sufficient to keep him or her comfortable by maintaining customary use.

(b) Any person who knowingly violates this section shall be punished by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, or in a county jail not exceeding one year, or by a fine not exceeding twenty thousand dollars ($20,000), or by both that fine and imprisonment.

(c) No provision of the amendments to this section enacted during the second year of the 1981–82 Regular Session shall be construed as expanding the scope of practice of a pharmacist.

Section 11164.1. (a)

1. Notwithstanding any other law, a prescription for a controlled substance issued by a prescriber in another state for delivery to a patient in another state may be dispensed by a California pharmacy, if the prescription conforms with the requirements for controlled substance prescriptions in the state in which the controlled substance was prescribed.

2. A prescription for Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances dispensed pursuant to this subdivision shall be reported by the dispensing pharmacy to the Department of Justice in the manner prescribed by subdivision (d) of Section 11165.

(b) A pharmacy may dispense a prescription for a Schedule III, Schedule IV, or Schedule V controlled substance from an out-of-state prescriber pursuant to Section 4005 of the Business and Professions Code and Section 1717 of Title 16 of the California Code of Regulations.

(c) This section shall become operative on January 1, 2021.

Section 11165. (a) To assist health care practitioners in their efforts to ensure appropriate prescribing, ordering, administering, furnishing, and dispensing of controlled substances, law enforcement and regulatory agencies in their efforts to control the diversion and resultant abuse of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances, and for statistical analysis, education, and research, the Department of Justice shall, contingent upon the availability of adequate funds in the CURES Fund, maintain the Controlled Substance Utilization Review and Evaluation System (CURES) for the electronic monitoring of, and Internet access to information regarding, the prescribing and dispensing of Schedule II, Schedule III, Schedule IV, and Schedule V controlled substances by all practitioners authorized to prescribe, order, administer, furnish, or dispense these controlled substances.

(b) The Department of Justice may seek and use grant funds to pay the costs incurred by the operation and maintenance of CURES. The department shall annually report to the Legislature and make available to the public the amount and source of funds it receives for support of CURES.

(c)

1. The operation of CURES shall comply with all applicable federal and state privacy and security laws and regulations.

1. CURES shall operate under existing provisions of law to safeguard the privacy and confidentiality of patients. Data obtained from CURES shall only be provided to appropriate state, local, and federal public agencies for disciplinary, civil, or criminal purposes and to other agencies or entities, as determined by the department, for the purpose of educating practitioners and others in lieu of disciplinary, civil, or criminal actions. Data may be provided to public or private entities, as approved by the department, for educational, peer review, statistical, or research purposes, if patient information, including information that may identify the patient, is not compromised. The University of California shall be provided access to identifiable data for research purposes if the requirements of subdivision (t) of Section 1798.24 of the Civil Code are satisfied. Further, data disclosed to an individual or agency as described in this subdivision shall not be disclosed, sold, or transferred to a third party, unless authorized by, or pursuant to, state and federal privacy and security laws and regulations. The department shall establish policies, procedures, and regulations regarding the use, access, evaluation, management, implementation, operation, storage, disclosure, and security of the information within CURES, consistent with this subdivision.

2. Notwithstanding subparagraph (A), a regulatory board whose licensees do not prescribe, order, administer, furnish, or dispense controlled substances shall not be provided data obtained from CURES.

3. The department shall, no later than January 1, 2021, adopt regulations regarding the access and use of the information within CURES. The department shall consult with all stakeholders identified by the department during the rulemaking process. The regulations shall, at a minimum, address all of the following in a manner consistent with this chapter:

1. The process for approving, denying, and disapproving individuals or entities seeking access to information in CURES.

2. The purposes for which a health care practitioner may access information in CURES.

3. The conditions under which a warrant, subpoena, or court order is required for a law enforcement agency to obtain information from CURES as part of a criminal investigation.

4. The process by which information in CURES may be provided for educational, peer review, statistical, or research purposes.

4. In accordance with federal and state privacy laws and regulations, a health care practitioner may provide a patient with a copy of the patient's CURES patient activity report as long as no additional CURES data are provided and the health care practitioner keeps a copy of the report in the patient's medical record in compliance with subdivision (d) of Section 11165.1.

(d) For each prescription for a Schedule II, Schedule III, Schedule IV, or Schedule V controlled substance, as defined in the controlled substances schedules in federal law and regulations, specifically Sections 1308.12, 1308.13, 1308.14, and 1308.15, respectively, of Title 21 of the Code of Federal Regulations, the dispensing pharmacy, clinic, or other dispenser shall report the following information to the department or contracted prescription data processing vendor as soon as reasonably possible, but not more than one working day after the date a controlled substance is released to the patient or patient's representative, in a format specified by the department:

1. Full name, address, and, if available, telephone number of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services, and the gender, and date of birth of the ultimate user.

2. The prescriber's category of licensure, license number, national provider identifier (NPI) number, if applicable, the federal controlled substance registration number, and the state medical license number of a prescriber using the federal controlled substance registration number of a government-exempt facility.

3. Pharmacy prescription number, license number, NPI number, and federal controlled substance registration number.

4. National Drug Code (NDC) number of the controlled substance dispensed.

5. Quantity of the controlled substance dispensed.

6. The International Statistical Classification of Diseases (ICD) Code contained in the most current ICD revision, or any revision deemed sufficient by the State Board of Pharmacy, if available.

7. Number of refills ordered.

8. Whether the drug was dispensed as a refill of a prescription or as a first-time request.

9. Prescribing date of the prescription.

10. Date of dispensing of the prescription.

11. The serial number for the corresponding prescription form, if applicable.

(e) The department may invite stakeholders to assist, advise, and make recommendations on the establishment of rules and regulations necessary to ensure the proper administration and enforcement of the CURES database. A prescriber or dispenser invitee shall be licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, in active practice in California, and a regular user of CURES.

(f) The department shall, prior to upgrading CURES, consult with prescribers licensed by one of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, one or more of the boards or committees identified in subdivision (d) of Section 208 of the Business and Professions Code, and any other stakeholder identified by the department, for the purpose of identifying desirable capabilities and upgrades to the CURES Prescription Drug Monitoring Program (PDMP).

(g) The department may establish a process to educate authorized subscribers of the CURES PDMP on how to access and use the CURES PDMP.

(h)

1. The department may enter into an agreement with an entity operating an interstate data sharing hub, or an agency operating a prescription drug monitoring program in another state, for purposes of interstate data sharing of prescription drug monitoring program information.

2. Data obtained from CURES may be provided to authorized users of another state's prescription drug monitoring program, as determined by the department pursuant to subdivision (c), if the entity operating the interstate data sharing hub, and the prescription drug monitoring program of that state, as applicable, have entered into an agreement with the department for interstate data sharing of prescription drug monitoring program information.

3. An agreement entered into by the department for purposes of interstate data sharing of prescription drug monitoring program information shall ensure that all access to data obtained from CURES and the handling of data contained within CURES comply with California law, including regulations, and meet the same patient privacy, audit, and data security standards employed and required for direct access to CURES.

4. For purposes of interstate data sharing of CURES information pursuant to this subdivision, an authorized user of another state's prescription drug monitoring program shall not be required to register with CURES, if the authorized user is registered and in good standing with that state's prescription drug monitoring program.

5. The department shall not enter into an agreement pursuant to this subdivision until the department has issued final regulations regarding the access and use of the information within CURES as required by paragraph (3) of subdivision (c).

(j) If the dispensing pharmacy, clinic, or other dispenser experiences a temporary technological or electrical failure, it shall, without undue delay, seek to correct any cause of the temporary technological or electrical failure that is reasonably within its control. The deadline for transmitting prescription information to the department or contracted prescription data processing vendor pursuant to subdivision (d) shall be extended until the failure is corrected. If the dispensing pharmacy, clinic, or other dispenser experiences technological limitations that are not reasonably within its control, or is impacted by a natural or manmade disaster, the deadline for transmitting prescription information to the department or contracted prescription data processing vendor shall be extended until normal operations have resumed.

Section 11165.1. (a)

1. A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 shall, upon receipt of a federal Drug Enforcement Administration (DEA) registration, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to that practitioner or their delegate the electronic history of controlled substances dispensed to an individual under the practitioner's care based on data contained in the CURES Prescription Drug Monitoring Program (PDMP).

2. A pharmacist shall, upon licensure, submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of a patient that is maintained by the department. Upon approval, the department shall release to the pharmacist or their delegate the electronic history of controlled substances dispensed to an individual under the pharmacist's care based on data contained in the CURES PDMP.

3. A licensed physician and surgeon who does not hold a DEA registration may submit an application developed by the department to obtain approval to electronically access information regarding the controlled substance history of the patient that is maintained by the department. Upon approval, the department shall release to the physician and surgeon or their delegate the electronic history of controlled substances dispensed to a patient under their care based on data contained in the CURES PDMP.

4. The department shall implement its duties described in clauses (i), (ii), and (iii) upon completion of any technological changes to the CURES database necessary to support clauses (i), (ii), and (iii), or by October 1, 2022, whichever is sooner.

2. The department may deny an application or suspend a subscriber, for reasons that include, but are not limited to, the following:

1. Materially falsifying an application to access information contained in the CURES database.

2. Failing to maintain effective controls for access to the patient activity report.

3. Having their federal DEA registration suspended or revoked.

4. Violating a law governing controlled substances or another law for which the possession or use of a controlled substance is an element of the crime.

5. Accessing information for a reason other than to diagnose or treat a patient, or to document compliance with the law.

3. An authorized subscriber shall notify the department within 30 days of a change to the subscriber account.

4. An approved health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist pursuant to subdivision (b) of Section 209 of the Business and Professions Code may use the department's online portal or a health information technology system that meets the criteria required in subparagraph (E) to access information in the CURES database pursuant to this section. A subscriber who uses a health information technology system that meets the criteria required in subparagraph (E) to access the CURES database may submit automated queries to the CURES database that are triggered by predetermined criteria.

5. An approved health care practitioner or pharmacist may submit queries to the CURES database through a health information technology system if the entity that operates the health information technology system certifies all of the following:

1. The entity will not use or disclose data received from the CURES database for any purpose other than delivering the data to an approved health care practitioner or pharmacist or performing data processing activities that may be necessary to enable the delivery unless authorized by, and pursuant to, state and federal privacy and security laws and regulations.

2. The health information technology system will authenticate the identity of an authorized health care practitioner or pharmacist initiating queries to the CURES database and, at the time of the query to the CURES database, the health information technology system submits the following data regarding the query to CURES:

1. The date of the query.

2. The time of the query.

3. The first and last name of the patient queried.

4. The date of birth of the patient queried.

5. The identification of the CURES user for whom the system is making the query.

3. The health information technology system meets applicable patient privacy and information security requirements of state and federal law.

4. The entity has entered into a memorandum of understanding with the department that solely addresses the technical specifications of the health information technology system to ensure the security of the data in the CURES database and the secure transfer of data from the CURES database. The technical specifications shall be universal for all health information technology systems that establish a method of system integration to retrieve information from the CURES database. The memorandum of understanding shall not govern, or in any way impact or restrict, the use of data received from the CURES database or impose any additional burdens on covered entities in compliance with the regulations promulgated pursuant to the federal Health Insurance Portability and Accountability Act of 1996 found in Parts 160 and 164 of Title 45 of the Code of Federal Regulations.

6. No later than October 1, 2018, the department shall develop a programming interface or other method of system integration to allow health information technology systems that meet the requirements in subparagraph (E) to retrieve information in the CURES database on behalf of an authorized health care practitioner or pharmacist.

7. The department shall not access patient-identifiable information in an entity's health information technology system.

8. An entity that operates a health information technology system that is requesting to establish an integration with the CURES database shall pay a reasonable fee to cover the cost of establishing and maintaining integration with the CURES database.

9. The department may prohibit integration or terminate a health information technology system's ability to retrieve information in the CURES database if the health information technology system fails to meet the requirements of subparagraph (E), or the entity operating the health information technology system does not fulfill its obligation under subparagraph (H).

2. A health care practitioner authorized to prescribe, order, administer, furnish, or dispense Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances pursuant to Section 11150 or a pharmacist shall be deemed to have complied with paragraph (1) if the licensed health care practitioner or pharmacist has been approved to access the CURES database through the process developed pursuant to subdivision (a) of Section 209 of the Business and Professions Code.

(b) A request for, or release of, a controlled substance history pursuant to this section shall be made in accordance with guidelines developed by the department.

(c) In order to prevent the inappropriate, improper, or illegal use of Schedule II, Schedule III, Schedule IV, or Schedule V controlled substances, the department may initiate the referral of the history of controlled substances dispensed to an individual based on data contained in CURES to licensed health care practitioners, pharmacists, or both, providing care or services to the individual.

(d) The history of controlled substances dispensed to an individual based on data contained in CURES that is received by a practitioner or pharmacist from the department pursuant to this section is medical information subject to the provisions of the Confidentiality of Medical Information Act contained in Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code.

(e) Information concerning a patient's controlled substance history provided to a practitioner or pharmacist pursuant to this section shall include prescriptions for controlled substances listed in Sections 1308.12, 1308.13, 1308.14, and 1308.15 of Title 21 of the Code of Federal Regulations.

(f) A health care practitioner, pharmacist, or a person acting on behalf of a health care practitioner or pharmacist, when acting with reasonable care and in good faith, is not subject to civil or administrative liability arising from false, incomplete, inaccurate, or misattributed information submitted to, reported by, or relied upon in the CURES database or for a resulting failure of the CURES database to accurately or timely report that information.

(g) For purposes of this section, the following terms have the following meanings:

1. "Automated basis" means using predefined criteria to trigger an automated query to the CURES database, which can be attributed to a specific health care practitioner or pharmacist.

2. "Department" means the Department of Justice.

3. "Entity" means an organization that operates, or provides or makes available, a health information technology system to a health care practitioner or pharmacist.

4. "Health information technology system" means an information processing application using hardware and software for the storage, retrieval, sharing of or use of patient data for communication, decisionmaking, coordination of care, or the quality, safety, or efficiency of the practice of medicine or delivery of health care services, including, but not limited to, electronic medical record applications, health information exchange systems, or other interoperable clinical or health care information system.

(h) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its Internet website, whichever date is earlier.

Section 11165.2. (a) The Department of Justice may conduct audits of the CURES Prescription Drug Monitoring Program system and its users.

(b) The Department of Justice may establish, by regulation, a system for the issuance to a CURES Prescription Drug Monitoring Program subscriber of a citation which may contain an order of abatement, or an order to pay an administrative fine assessed by the Department of Justice if the subscriber is in violation of any provision of this chapter or any regulation adopted by the Department of Justice pursuant to this chapter.

(c) The system shall contain the following provisions:

1. Citations shall be in writing and shall describe with particularity the nature of the violation, including specific reference to the provision of law or regulation of the department determined to have been violated.

2. Whenever appropriate, the citation shall contain an order of abatement establishing a reasonable time for abatement of the violation.

3. In no event shall the administrative fine assessed by the department exceed two thousand five hundred dollars ($2,500) for each violation. In assessing a fine, due consideration shall be given to the appropriateness of the amount of the fine with respect to such factors as the gravity of the violation, the good faith of the subscribers, and the history of previous violations.

4. An order of abatement or a fine assessment issued pursuant to a citation shall inform the subscriber that if the subscriber desires a hearing to contest the finding of a violation, a hearing shall be requested by written notice to the CURES Prescription Drug Monitoring Program within 30 days of the date of issuance of the citation or assessment. Hearings shall be held pursuant to Chapter 5 (commencing with Section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.

5. In addition to requesting a hearing, the subscriber may, within 10 days after service of the citation, request in writing an opportunity for an informal conference with the department regarding the citation. At the conclusion of the informal conference, the department may affirm, modify, or dismiss the citation, including any fine levied or order of abatement issued. The decision shall be deemed to be a final order with regard to the citation issued, including the fine levied or the order of abatement which could include permanent suspension to the system, a monetary fine, or both, depending on the gravity of the violation. However, the subscriber does not waive its right to request a hearing to contest a citation by requesting an informal conference. If the citation is affirmed, a formal hearing may be requested within 30 days of the date the citation was affirmed. If the citation is dismissed after the informal conference, the request for a hearing on the matter of the citation shall be deemed to be withdrawn. If the citation, including any fine levied or order of abatement, is modified, the citation originally issued shall be considered withdrawn and a new citation issued. If a hearing is requested for a subsequent citation, it shall be requested within 30 days of service of that subsequent citation.

6. Failure of a subscriber to pay a fine within 30 days of the date of assessment or comply with an order of abatement within the fixed time, unless the citation is being appealed, may result in disciplinary action taken by the department. If a citation is not contested and a fine is not paid, the subscriber account will be terminated:

1. A citation may be issued without the assessment of an administrative fine.

2. Assessment of administrative fines may be limited to only particular violations of law or department regulations.

(d) Notwithstanding any other provision of law, if a fine is paid to satisfy an assessment based on the finding of a violation, payment of the fine shall be represented as a satisfactory resolution of the matter for purposes of public disclosure.

(e) Administrative fines collected pursuant to this section shall be deposited in the CURES Program Special Fund, available upon appropriation by the Legislature. These special funds shall provide support for costs associated with informal and formal hearings, maintenance, and updates to the CURES Prescription Drug Monitoring Program.

(f) The sanctions authorized under this section shall be separate from, and in addition to, any other administrative, civil, or criminal remedies; however, a criminal action may not be initiated for a specific offense if a citation has been issued pursuant to this section for that offense, and a citation may not be issued pursuant to this section for a specific offense if a criminal action for that offense has been filed.

(g) Nothing in this section shall be deemed to prevent the department from serving and prosecuting an accusation to suspend or revoke a subscriber if grounds for that suspension or revocation exist.

Section 11165.4. (a)

1. A health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance shall consult the patient activity report or information from the patient activity report obtained from the CURES database to review a patient's controlled substance history for the past 12 months before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.

2. If a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required, pursuant to an exemption described in subdivision (c), to consult the patient activity report from the CURES database the first time the health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient, the health care practitioner shall consult the patient activity report from the CURES database to review the patient's controlled substance history before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.

3. A health care practitioner who did not directly access the CURES database to perform the required review of the controlled substance use report shall document in the patient's medical record that they reviewed the CURES database generated report within 24 hours of the controlled substance prescription that was provided to them by another authorized user of the CURES database.

2. For purposes of this paragraph, "first time" means the initial occurrence in which a health care practitioner, in their role as a health care practitioner, intends to prescribe, order, administer, or furnish a Schedule II, Schedule III, or Schedule IV controlled substance to a patient and has not previously prescribed a controlled substance to the patient.

2. A health care practitioner shall review a patient's controlled substance history that has been obtained from the CURES database no earlier than 24 hours, or the previous business day, before the health care practitioner prescribes, orders, administers, or furnishes a Schedule II, Schedule III, or Schedule IV controlled substance to the patient.

(b) The duty to consult the CURES database, as described in subdivision (a), does not apply to veterinarians or pharmacists.

(c) The duty to consult the CURES database, as described in subdivision (a), does not apply to a health care practitioner in any of the following circumstances:

1. If a health care practitioner prescribes, orders, or furnishes a controlled substance to be administered to a patient while the patient in any of the following facilities or during an emergency transfer between any of the following facilities, or for use while on facility premises:

1. A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2.

2. An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2.

3. A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2.

4. A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2.

5. Another medical facility, including, but not limited to, an office of a health care practitioner and an imaging center.

6. A correctional clinic, as described in Section 4187 of the Business and Professions Code, or a correctional pharmacy, as described in Section 4021.5 of the Business and Professions Code.

2. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use.

3. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patient's treatment for a surgical, radiotheraputic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use, in any of the following facilities:

1. A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2.

2. An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2.

3. A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2.

4. A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2.

5. A place of practice, as defined in Section 1658 of the Business and Professions Code.

6. Another medical facility where surgical procedures are permitted to take place, including, but not limited to, the office of a health care practitioner.

4. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient who is terminally ill, as defined in subdivision (c) of Section 11159.2.

1. If all of the following circumstances are satisfied:

1. It is not reasonably possible for a health care practitioner to access the information in the CURES database in a timely manner.

2. Another health care practitioner or designee authorized to access the CURES database is not reasonably available.

3. The quantity of controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use and no refill of the controlled substance is allowed.

2. A health care practitioner who does not consult the CURES database under subparagraph (A) shall document the reason they did not consult the database in the patient's medical record.

6. If the CURES database is not operational, as determined by the department, or cannot be accessed by a health care practitioner because of a temporary technological or electrical failure. A health care practitioner shall, without undue delay, seek to correct the cause of the temporary technological or electrical failure that is reasonably within the health care practitioner's control.

7. If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner.

8. If consultation of the CURES database would, as determined by the health care practitioner, result in a patient's inability to obtain a prescription in a timely manner and thereby adversely impact the patient's medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use.

(d)

1. A health care practitioner who fails to consult the CURES database, as described in subdivision (a), shall be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board.

2. This section does not create a private cause of action against a health care practitioner. This section does not limit a health care practitioner's liability for the negligent failure to diagnose or treat a patient.

(e) All applicable state and federal privacy laws govern the duties required by this section.

(f) The provisions of this section are severable. If any provision of this section or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.

(g) This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.

6. REPORTING OF ABUSE AND NEGLECT

In accordance with California Penal Code Section 11165.7, dentists, dental assistants, and dental hygienists are mandated reporters of child abuse and neglect [3]. Reporting suspected abuse is not only an ethical duty but is also a legal obligation.

CHILD ABUSE AND NEGLECT REPORTING LAW

Section 11164. (a) This article shall be known and may be cited as the Child Abuse and Neglect Reporting Act.

(b) The intent and purpose of this article is to protect children from abuse and neglect. In any investigation of suspected child abuse or neglect, all persons participating in the investigation of the case shall consider the needs of the child victim and shall do whatever is necessary to prevent psychological harm to the child victim.

Section 11166. (a) Except as provided in subdivision (d), and in Section 11166.05, a mandated reporter shall make a report to an agency specified in Section 11165.9 whenever the mandated reporter, in the mandated reporter's professional capacity or within the scope of the mandated reporter's employment, has knowledge of or observes a child whom the mandated reporter knows or reasonably suspects has been the victim of child abuse or neglect. The mandated reporter shall make an initial report by telephone to the agency immediately or as soon as is practicably possible, and shall prepare and send, fax, or electronically transmit a written follow-up report within 36 hours of receiving the information concerning the incident. The mandated reporter may include with the report any nonprivileged documentary evidence the mandated reporter possesses relating to the incident.

Section 11165.9. Reports of suspected child abuse or neglect shall be made by mandated reporters, or in the case of reports pursuant to Section 11166.05, may be made, to any police department or sheriff's department, not including a school district police or security department, county probation department, if designated by the county to receive mandated reports, or the county welfare department. Any of those agencies shall accept a report of suspected child abuse or neglect whether offered by a mandated reporter or another person, or referred by another agency, even if the agency to whom the report is being made lacks subject matter or geographical jurisdiction to investigate the reported case, unless the agency can immediately electronically transfer the call to an agency with proper jurisdiction. When an agency takes a report about a case of suspected child abuse or neglect in which that agency lacks jurisdiction, the agency shall immediately refer the case by telephone, fax, or electronic transmission to an agency with proper jurisdiction. Agencies that are required to receive reports of suspected child abuse or neglect may not refuse to accept a report of suspected child abuse or neglect from a mandated reporter or another person unless otherwise authorized pursuant to this section, and shall maintain a record of all reports received.

IDENTIFYING, DOCUMENTING, AND REPORTING ABUSE AND NEGLECT

Preventing serious morbidity and mortality involves intervening at the first suspicion or indication of abuse and/or neglect. Dentists and dental hygienists are often the healthcare professionals who have the most frequent interactions with children and should be attentive to any signs of neglect and physical abuse—as abusive injuries commonly involve the face, jaw, mouth, teeth, and tongue [4]. One study found that orofacial trauma was concurrent with 49% of documented cases of child physical abuse [5]. Other studies show that craniofacial and neck injuries occur in 50% to 65% of child abuse victims and that the lips are a site for abusive injury in 54% of cases [6,7].

Clinical Signs of Abuse

The American Academy of Pediatrics (AAP) Committee on Child Abuse and Neglect and the California Dental Association have published useful articles regarding the identification of the orofacial signs of abuse and particular injuries of concern. According to these sources, possible signs of abuse include [6,7,12]:

- Forced feeding injuries caused by eating utensils, bottles, hands, fingers, and other objects; scalding liquids; or caustic substances. These may be responsible for burns, contusions, or lacerations of the lips, tongue, buccal mucosa, gingival alveolar mucosa, frenum, or palate (soft and hard). Objects forced into the face/mouth may also cause facial bone and jaw fractures and avulsed, displaced, or fractured teeth.

- Mouth gagging injuries resulting in bruises, lichenification, or scarring at the corners of the mouth

- Strangulation injuries resulting in bruising, a hoarse or raspy voice, and difficulty breathing

- Discolored teeth from previous trauma

- Serious trauma (e.g., retropharyngeal abscesses, posterior pharyngeal injuries) resulting from caregivers with factitious disorder (i.e., Münchausen syndrome) by proxy

- Injury to the petechiae of the palate (particularly at the junction of soft and hard palate) resulting from forced oral sex

- Sexually transmitted oral/perioral infections (e.g., gonorrhea, human papillomavirus warts), although these can be transmitted by other means as well

- Bite marks or bruises on the head or face, strangulation marks, or black eyes

- Missing hair from hair pulling

- Welts in the shape of objects (e.g., belt buckle, clothes iron)

- Other suspicious trauma/bruises indicative of abuse (e.g., rope marks)

During examination, excessive caries, gingivitis, and oral infections/diseases should be noted as possible signs of neglect. (Parents or caretakers with an ignorance of proper oral care, who have no perceived value of oral health, with limited access to health care or insurance, and/or geographic isolation should be differentiated from those with a willful disregard for the child's health [6].) Perioral and intraoral injuries and infections in various stages of healing, especially those that seem inappropriate for the child's developmental age, should be documented. Additionally, abuse and neglect are more prevalent (up to four times more common) in individuals with developmental or physical disability [12].

Although accidental injuries are common in pediatric patients, the history of trauma, including mechanism and timing, must be weighed against the injury features. Characteristics of the injury that do not seem to match the reported history should spur suspicion of abuse. The acronym RADAR is commonly used to assist in the routine abuse screening of patients [29]:

- Routinely screen for signs and symptoms of abuse/neglect

- Ask direct, non-judgmental questions with compassion

- Document your findings

- Assess patient safety before the patient leaves the medical setting

- Review, refer, report

A parent or primary caretaker may be genuinely unaware of the abuse or injuries and may not be able to offer information relevant to the history. It is important not to make judgments of family members (either innocent or guilty), apportion blame, or attempt to personally undertake a criminal investigation. The scope of dental practice does not include these actions, and they may interfere with a law enforcement investigation. The AAP notes that the dental professional's role in a criminal investigation is to interpret medical information for nonmedical professionals in an understandable manner that accurately reflects the medical evidence [8]. Identify the medical problem, document the suspected abuse (e.g., names, photos, body map, preserve evidence), treat the injuries, and offer honest, factual medical information to parents, families, law enforcement, and justice officials.

Reporting Abuse

As noted in the California Dental Practice Act, dental healthcare professionals have a legal and ethical responsibility to report suspected child abuse to the proper authorities, not to punish perpetrators of abuse but to protect the abuse victims. One author writes, "The dentist must view himself as a child advocate. Simply treating dental and facial injuries of abused children while ignoring the social needs of the child and family is unacceptable" [9].

Nonetheless, the decision of whether or not to report suspected abuse is ethically challenging. Although healthcare professionals are obligated to report suspected abuse, suspicion of abuse is somewhat of a judgment call and certain biases may influence the decision to report. It has been noted that well-intentioned professionals in all fields are swayed by both negative and positive social biases (e.g., sex, race, socioeconomic status, physical appearance, job status), and it is advisable to challenge personal biases and weigh only the facts of the case. A 2008 prospective, observational AAP study found that, "clinicians did not report 27% of injuries considered likely or very likely caused by child abuse and 76% of injuries considered possibly caused by child abuse" because of various biases and experiences [10]. However, patients who had an injury that was not a laceration, who had more than one family risk factor, who had a serious injury, who had a child risk factor other than an inconsistent injury, who had a parental history of substance abuse, or who were unfamiliar to the clinician were more likely to be reported.

Professionally mandated reporters are protected from civil or criminal prosecution in consequence of a good-faith report of abuse, and no clinician in the aforementioned AAP study was sued for malpractice as a result of reporting abuse [7,10]. However, it is possible for dental professionals to be sued, and a state petition for up to $50,000 in recompensatory legal fees is available for dentists having to defend themselves in court [7]. On the other hand, civil or criminal penalties for willfully not reporting abuse or impeding a report when abuse has been found to have occurred include 6 months in jail and/or a fine of $1,000 or, in cases of serious injury/death following a failure to report, 12 months in jail, and/or a fine of $5,000.

ELDER AND DEPENDENT ADULT ABUSE AND NEGLECT

Abusive injuries to the mouth and oral cavity of elder or dependent (e.g., developmentally or physically disabled) adults are similar in type and causation to those sustained by pediatric patients, including trauma from forced feeding, object insertion, mouth gagging, and being slapped, hit, or strangled, but also include damage to and from prostheses. The number of new elder and dependent adult abuse cases is usually about 18,000 per month in California alone, with family members constituting two-thirds of perpetrators [11,26]. However, researchers estimate that for each incident of reported abuse there are at least five (and perhaps up to 14) unreported incidents [11]. Studies have shown that dental professionals are reluctant to report elder or dependent abuse/neglect and that they have a low index of suspicion of this category of abuse [13].

The national frequency of elder abuse is estimated at up to 10%, with a steady increase in reporting over the last few decades [14]. Contrary to popular belief, the overwhelming majority of abuse and neglect occurs in domestic, rather than institutional (e.g., residential care) settings, largely due to the shift in care in the last 50 years from state institutions to the home (particularly for younger disabled individuals) [12,14]. Women are the victims of elder abuse two-thirds of the time.

Elder and dependent adults are also at risk for poor oral health due to caretaker neglect. In fact, neglect is one of the most common causes of elder injury reporting (roughly 500,000 cases per year in the United States) [14]. These populations are also at a high risk for self-neglect, accounting for more than 500,000 additional reported cases in the United States per year. A 2010 study revealed that 40% of individuals 65 years of age or older suffer from some form of neglect [15].

Elder and Dependent Adult Abuse Laws

Laws pertaining to mandatory elder and dependent adult abuse reporting are found in the California Welfare and Institutions Code Sections 15600 to 15632 [16].

Section 15600. (a) The Legislature recognizes that elders and dependent adults may be subjected to abuse, neglect, or abandonment and that this state has a responsibility to protect these persons.

(i) Therefore, it is the intent of the Legislature in enacting this chapter to provide that adult protective services agencies, local long-term care ombudsman programs, and local law enforcement agencies shall receive referrals or complaints from public or private agencies, from any mandated reporter submitting reports pursuant to Section 15630, or from any other source having reasonable cause to know that the welfare of an elder or dependent adult is endangered, and shall take any actions considered necessary to protect the elder or dependent adult and correct the situation and ensure the individual's safety.

Section 15630. (a) Any person who has assumed full or intermittent responsibility for the care or custody of an elder or dependent adult, whether or not he or she receives compensation, including administrators, supervisors, and any licensed staff of a public or private facility that provides care or services for elder or dependent adults, or any elder or dependent adult care custodian, health practitioner, clergy member, or employee of a county adult protective services agency or a local law enforcement agency, is a mandated reporter.

(b) (1) Any mandated reporter who, in his or her professional capacity, or within the scope of his or her employment, has observed or has knowledge of an incident that reasonably appears to be physical abuse, abandonment, abduction, isolation, financial abuse, or neglect, or is told by an elder or dependent adult that he or she has experienced behavior, including an act or omission, constituting physical abuse, abandonment, abduction, isolation, financial abuse, or neglect, or reasonably suspects that abuse, shall report the known or suspected instance of abuse by telephone or through a confidential Internet reporting tool, as authorized by Section 15658, immediately or as soon as practicably possible. If reported by telephone, a written report shall be sent, or an Internet report shall be made through the confidential Internet reporting tool established in Section 15658, within two working days.

INTIMATE PARTNER VIOLENCE

Intimate partner violence is defined as violence directed at a "spouse, former spouse, cohabitant, former cohabitant, or person with whom the suspect has had a child or is having or has had a dating or engagement relationship" [7]. In the United States in 2011, severe physical violence by an intimate partner (including acts such as being hit with something hard, being kicked or beaten, or being burned on purpose) had been experienced by an estimated 22.3% of women and 14.0% of men during their lifetimes [17].

Dental professionals should be vigilant in recognizing signs of abuse among adolescent and adult patients. One-half to two-thirds of abusive injuries occur to the head (particularly areas covered with hair) and neck, and facial injuries occur in 94% of intimate partner violence cases and are similar to those already discussed [7,18]. Again, dental visits may be a patient's only contact with healthcare professionals, making identification of abuse an important part of dental visits [7]. A history of intimidation, fear, isolation, and dependency is often present in victims of abuse, so it is especially important to determine the origin of orofacial or craniofacial injuries through the use of nonjudgmental questions. The Stanford School of Medicine recommends the following lines of indirect questioning for most age groups [31]:

- How is everything going at home?

- Is there anything going on at work/school or at home that's difficult for you to talk about or is stressful for you?

- Are you having any problems with your parents/caretakers/partner/husband?

Alternately, lines of direct questioning may be used [31]:

- Did someone kick, hit, hurt, or threaten to hurt you? Was it your parent/caretaker or partner/husband?

- Are you in a relationship with (or do you live with) someone who hits, kicks, or threatens to hurt you?

- Have you ever been slapped, pushed, or shoved by your parent/partner?

- Have there been times when you felt afraid at home being around another person?

- Have you been hit or scared since the last time I saw you?

- Is it safe for you to go home today?

It is up to the practitioner's judgment which line of questioning to employ. Remember that the objectives are to advocate for and protect the patient. The questions can be framed in a way that does not cause a patient to feel singled out [31]:

- I don't know if this is (or has ever been) a problem for you, but many of the patients I see are dealing with abuse/abusive relationships. Some are too afraid or uncomfortable to bring it up themselves, so I have started asking everyone about it.

- From past experience with other patients, I'm concerned that some of your medical problems or injuries may be the result of someone hurting you. Is that happening?

When working cross-culturally, it is helpful to learn the colloquialisms used to describe abuse. For example, in some Latino cultures "disrespected me" refers to intimate partner violence or sexual assault [30]. If abuse is suspected and there is a cultural disconnect, consider the assistance of a knowledgeable co-worker, who may be able to act as a cultural broker.

7. CONCLUSION

Although its primary objective is to safeguard the public, the California Dental Practice Act is an excellent resource for dental professionals to ensure compliance with state law. Dental professionals with a good knowledge of the Dental Practice Act and its effects on dental care will practice legally and safely.

8. RESOURCES

California Dental Practice Act

https://www.dbc.ca.gov/about_us/lawsregs/laws.shtml

California Dental Association

https://www.cda.org

Dental Hygiene Board of California

https://dhbc.ca.gov

Works Cited

1. Dental Board of California. Dental Practice Act. Available at https://www.dbc.ca.gov/about_us/lawsregs/laws.shtml. Last accessed January 12, 2022.

2. American Dental Association. General Dentistry. Available at https://www.ada.org/resources/careers/practicing-dentistry. Last accessed January 12, 2022.

3. California Legislative Information. CA Penal Code Section 11164-11174.3. Available at https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=PEN&division=&title=1.&part=4.&chapter=2.&article=2.5. Last accessed January 12, 2022.

4. American Academy of Pediatrics. Oral and dental aspects of child abuse and neglect. Pediatrics. 1999;104(2 Pt 1):348-350.

5. Becker DB, Needleman HL, Kotelchuck M. Child abuse and dentistry: orofacial trauma and its recognition by dentists. J Am Dent Assoc. 1978;97(1):24-28.

6. Kellogg N, American Academy of Pediatrics Committee on Child Abuse and Neglect. Oral and dental aspects of child abuse and neglect. Pediatrics. 2005;116(6):1565-1568.

7. Spencer DE. Child abuse: dentists' recognition and involvement. J Calif Dent Assoc. 2004;32(4):299-303.

8. Christian CW, Block R, Committee on Child Abuse and Neglect, American Academy of Pediatrics. Abusive head trauma in infants and children. Pediatrics. 2009;123(5):1409-1411.

9. Bernat JE. Child abuse and neglect: dentistry's role. N Y State Dent J. 1989;55(3):34-37.

10. Flaherty EG, Sege RD, Griffith J, et al. From suspicion of physical child abuse to reporting: primary care clinician decision-making. Pediatrics. 2008;122(3):611-619.

11. California State Legislature. Assembly Bill 2435. Available at http://www.leginfo.ca.gov/pub/09-10/bill/asm/ab_2401-2450/ab_2435_cfa_20100405_092058_asm_comm.html. Last accessed January 12, 2022.

12. Glassman P, Miller C, Ingraham R, Woolford E. The extraordinary vulnerability of people with disabilities: guidelines for oral health professionals. J Calif Dent Assoc. 2004;32(5):379-386.

13. Johnson TE, Boccia AD, Strayer MS. Elder abuse and neglect: detection, reporting, and intervention. Spec Care Dentist. 2001;21(4):141-146.

14. National Center on Elder Abuse. Research: Statistics/Data. Available at https://ncea.acl.gov/What-We-Do/Research/Statistics-and-Data.aspx. Last accessed January 12, 2022.

15. Mattoo KA, Shalabh K, Khan A. Geriatric forensics: a dentist's perspective and contribution to identify existence of elder abuse among his patients. J Forensic Dent Sci. 2010;2(2):81-85.

16. California Legislative Information. California Welfare and Institutions Code. Available at https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?sectionNum=15600&lawCode=WIC. Last accessed January 12, 2022.

17. Centers for Disease Control and Prevention. Prevalence and Characteristics of Sexual Violence, Stalking, and Intimate Partner Violence Victimization: National Intimate Partner and Sexual Violence. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6308a1.htm?s_cid=ss6308a1_e. Last accessed Janaury 12, 2022.

18. Barkley Burnett L, Adler J. Domestic Violence: Clinical Presentation. Available at http://emedicine.medscape.com/article/805546-clinical#b4. Last accessed January 12, 2022.

19. California Legislative Code. Business and Professions Code Section 1600-1621. Available at https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=BPC&division=2.&title=&part=&chapter=4.&article=1. Last accessed January 12, 2022.

20. Dental Hygiene Board of California. Home Page. Available at https://dhbc.ca.gov/index.shtml. Last accessed January 12, 2022.

21. Dental Board of California. Fingerprint Requirement for License Renewal. Available at https://www.dbc.ca.gov/licensees/fingerprint_faq.shtml. Last accessed January 12, 2022.

22. Dental Board of California. Enforcement Program. Available at https://www.dbc.ca.gov/consumers/enforcement.shtml. Last accessed January 12, 2022.

23. Shouse Law Group. How Criminal Convictions Affect California Dental Board Licenses. Available at https://www.shouselaw.com/dentists.html. Last accessed January 12, 2022.

24. California Legislative Code. Business and Professions Code Section 1625–1636.6. http://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=BPC&division=2.&title=&part=&chapter=4.&article=2. Last accessed January 12, 2022.

25. California Legislative Code. Business and Professions Code Section 1648.10–1648.20. Available at http://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=BPC&division=2.&title=&part=&chapter=4.&article=2.9. Last accessed January 12, 2022.

26. California Department of Social Services. Adult Protective Services and County Block Grant Monthly Statistical Report. Available at https://www.cdss.ca.gov/inforesources/Research-and-Data/Disability-Adult-Programs-Data-Tables/SOC-242 . Last accessed January 12, 2022.

27. California Dental Association. Mandatory CURES Consultation in Effect Oct 2. Available at https://www.cda.org/Home/Practice/Practice-Support/Regulatory-Compliance/CURES-and-Opioid-Pain-Management. Last accessed January 12, 2022.

28. Westlaw. California Code of Regulations. Available at https://govt.westlaw.com/calregs/Browse/Home/California/CaliforniaCodeofRegulations?transitionType=Default&contextData=%28sc.Default%29. Last accessed January 12, 2022.

29. County of Orange Social Services Agency. RADAR: A Domestic Violence Intervention. Available at https://www.factoc.org/ radar-a-domestic-violence-intervention. Last accessed January 12, 2022.

30. U.S. Department of Justice Office for Victims of Crime. Existe Ayuda (Help Exists) Toolkit. Available at https://ovc.ojp.gov/sites/ g/files/xyckuh226/files/pubs/existeayuda/pfv.html. Last accessed January 12, 2022.

31. Stanford Medicine. Domestic Abuse: How to Ask. Available at https://domesticabuse.stanford.edu/screening/how.html. Last accessed January 12, 2022.

58583 • Infection Control for Dental Professionals: The California Requirement

William E. Frey, DDS, MS, FICD

www.netce.com

Copyright © 2022 NetCE, All rights reserved.

Effective infection control techniques are critical to reducing the incidence of infections in dental facilities. Antiseptic techniques and antibiotics will kill micro-organisms, while proper hand hygiene will block their transmission. Gloves, gowns, and masks remove dental professionals from the transmission cycle by protecting them from contact with micro-organisms. Contact Precautions and isolation techniques help patients avoid being vectors of transmission. Lastly, ensuring that dental professionals are immune or vaccinated can help decrease the availability of potential hosts.

Table of Contents

58583 • Infection Control for Dental Professionals: The California Requirement

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Special Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planner

Division Planner Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. OSHA AND CAL/OSHA REGULATIONS

BLOODBORNE PATHOGENS STANDARD

CALIFORNIA AEROSOL TRANSMISSIBLE DISEASE STANDARD

3. MODES OF TRANSMISSION

AEROSOLS, DROPLETS, AND SPLATTER

FOMITE TRANSMISSION

4. BLOODBORNE PATHOGENS

HEPATITIS B VIRUS

HEPATITIS C VIRUS

HIV/AIDS

5. PREVENTION STRATEGIES

STANDARD PRECAUTIONS

RESPIRATORY HYGIENE

ASEPTIC TECHNIQUE

SAFE INJECTION PRACTICES

HAND HYGIENE

PERSONAL PROTECTIVE EQUIPMENT

6. ENVIRONMENTAL CONTROL MEASURES

ENVIRONMENTAL CLEANING

MEDICAL WASTE MANAGEMENT

DENTAL UNIT WATERLINES, BIOFILM, AND WATER QUALITY

7. ENGINEERING AND WORK PRACTICE CONTROLS

CLEANING, DISINFECTION, AND STERILIZATION

8. PROTECTING DENTAL HEALTHCARE WORKERS

OCCUPATIONAL EXPOSURES

TUBERCULOSIS PREVENTION

VACCINATION

TRAINING AND EDUCATION

9. CONCLUSION

10. DENTAL BOARD OF CALIFORNIA GENERAL PROVISIONS: SECTION 1005. MINIMUM STANDARDS FOR INFECTION CONTROL

11. CAL/OSHA COVID-19 STANDARD

Works Cited

58583 • Infection Control for Dental Professionals: The California Requirement

Education Category. Infection Control / Internal Medicine

Release Date. 02/01/2022

Expiration Date. 01/31/2025

Course Overview

Effective infection control techniques are critical to reducing the incidence of infections in dental facilities. Antiseptic techniques and antibiotics will kill micro-organisms, while proper hand hygiene will block their transmission. Gloves, gowns, and masks remove dental professionals from the transmission cycle by protecting them from contact with micro-organisms. Contact Precautions and isolation techniques help patients avoid being vectors of transmission. Lastly, ensuring that dental professionals are immune or vaccinated can help decrease the availability of potential hosts.

Audience

This course is designed for all dentists, dental hygienists, and dental assistants in all practice settings, particularly those practicing in California.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU.

Designations of Credit

NetCE designates this activity for 2 continuing education credits. AGD Subject Code 148. This course meets the Dental Board of California's requirements for 2 unit(s) of continuing education. Dental Board of California course #02-3841-24344. NetCE is authorized by IACET to offer 0.2 CEU(s) for this program.

Special Approvals

This course fulfills the California requirement for 2 hours of infection control education.

Course Objective

The purpose of this course is to familiarize dental professionals with infection control techniques in order to minimize the risks of microbial transmission in the dental healthcare setting.

Learning Objectives

Upon completion of this course, you should be able to:

1. Outline OSHA and Cal/OSHA regulations that impact the provision of dental care.

2. Analyze potential modes of transmission and pathogens that can result in infection in dental facilities.

3. Discuss potential prevention strategies for infection control, including the use of precautions, hand hygiene, and personal protective equipment.

4. Describe effective environmental control measures that should be applied in dental care.

5. Identify steps that should be taken to protect dental professionals, including vaccination, education, and exposure responses.

Faculty

William E. Frey, DDS, MS, FICD, graduated from the University of California School of Dentistry, San Francisco, California, in 1966. In 1975, he completed residency training in Periodontics and received a Master's degree from George Washington University.
Dr. Frey retired from the United States Army Dental Corps in 1989 after 22 years of service. Throughout the course of his professional career, he has continuously practiced dentistry, the first 7 years as a general dentist and the past more than 40 as a periodontist. His military experience included the command of a networked Dental Activity consisting of five dental clinics. In his last assignment, he was in charge of a 38-chair facility. Colonel Frey was selected by the Army to serve on two separate occasions as the Chair of the Periodontal Department in Army General Dentistry Residency Training Programs.
Dr. Frey is the founder and president of Perio Plus, a practice management firm specializing in creating individually-designed hygiene and periodontal care programs for general dentists. He is also the creator of the Inspector Gum patient education series.

Faculty Disclosure

Contributing faculty, William E. Frey, DDS, MS, FICD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planner

Mark J. Szarejko, DDS, FAGD

Division Planner Disclosure

The division planner has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

In 2018, there were more than 750,000 jobs in dental occupations in the United States [1]. In California alone there are approximately 91,000 dental healthcare professionals (DHCPs), including dentists, dental hygienists, and dental assistants. Most of these dental workers come in daily contact with a variety of infectious diseases in their workplace and are at risk for both transmitting and contracting these diseases. In California, there are three regulatory agencies involved in infection control in the dental healthcare setting: the Dental Board of California (DBC), which sets the minimum standards, the California Division of Occupational Safety and Health (Cal/OSHA), which publishes the Bloodborne Pathogens Standard, and the California Department of Public Health, which established the Waste Management Act.

To address the issue of infection control and reduce the potential for harm, the DBC established a requirement that dental healthcare licensees in California complete a course on infection control and prevention. DBC regulations also require that licensees comply with and enforce precautions and workplace practices that minimize the transmission of pathogens in dental settings. "Standard Precautions" is the DBC term for infection control measures that encompasses both "Universal Precautions"—a term the Occupational Safety and Health Administration (OSHA) uses—and the Cal/OSHA mandate for bloodborne pathogen transmission. The DBC mandates that Standard Precautions must be practiced in the care of all patients. The same infection control precautions apply to all patients, and all body fluids, except sweat, are considered potentially infectious. Universal Precautions are measures taken when exposed to blood, while Standard Precautions apply to all potentially infectious materials. While most elements of Standard Precautions evolved from Universal Precautions, developed for protection of healthcare personnel, additional elements of Standard Precautions focus on protection of patients. Contact Precautions are used to prevent transmission of an infectious agent associated with environmental contamination (e.g., treating all environmental surfaces as potentially contaminated) that is not interrupted by Standard Precautions alone.

A written protocol should be developed for proper instrument processing, operatory cleanliness, and management of injuries, and a copy of infection control regulations should be conspicuously posted in each dental office [2]. The DBC Standard Precaution guidelines are reviewed annually. Current guidelines may be downloaded at https://govt.westlaw.com/calregs/Document/I3F75D9A0B95D11E0A3CAA6663E6464AA and are found at the conclusion of this course. Significant changes in the 2011 revision include application of the guidelines to all dental healthcare professionals (not just "registered" professionals) and specific steps for disinfection [2]. The goal of these guidelines is to reduce the number of healthcare-associated infections in California dental practice settings.

2. OSHA AND CAL/OSHA REGULATIONS

Legal issues first began to impact infection control practices at the beginning of the acquired immunodeficiency syndrome (AIDS) epidemic in the early 1980s. The need to protect healthcare workers from bloodborne exposures resulted in the publication of the Bloodborne Pathogens Standard by OSHA in 1991 [3]. The OSHA Standard requires employers whose employees have exposure to blood or other potentially infectious material to implement safe work practices, education, and barriers to exposure. The Standard was later amended to cover the safe use of sharps.

BLOODBORNE PATHOGENS STANDARD

The OSHA Bloodborne Pathogens Standard requires that every healthcare worker who may have contact on the job with blood or other bodily fluids (referred to as other potentially infectious material or OPIM) must receive specific annual education, which includes instruction in the basics of infection control and prevention. Training must also cover bloodborne pathogens, modes of transmission, the proper use of needles, and Contact Precautions.

CALIFORNIA AEROSOL TRANSMISSIBLE DISEASE STANDARD

In 2009, Cal/OSHA adopted the nation's first aerosol transmissible disease (ATD) standard, which remains in effect today. The standard is designed to protect healthcare workers from diseases spread by an airborne or droplet route. The ATD standard requires healthcare employers to develop exposure control procedures and train employees to follow those procedures [4,5]. Basic exposure precautions, such as source screening, infection control, hand hygiene, and cleaning and decontamination procedures, are a fundamental part of the standard. Employees must be included in the periodic review and assessment of these procedures.

California dental offices whose patients have suspected or confirmed illnesses that require Airborne or Droplet Precautions, such as tuberculosis (TB) or other respiratory illnesses, must comply with the ATD standards [4]. Key points include:

- Dental employees must be trained to screen patients for ATDs.

- The screening process must be described in a written office procedure.

- Screening must be consistently implemented.

- Elective dental treatment should be deferred until the patient is non-infectious for TB or other diseases requiring Airborne or Droplet Precautions.

A simple screening procedure can be done by the first person who comes in contact with a patient. For example, the patient may be asked "How are you feeling today?" or "Do you have any coughs, fever, or flu-like symptoms?" If the patient is not feeling well or gives a positive answer to any part of the second question, the dental treatment should be rescheduled.

Outpatient dental clinics or offices are not required to comply with this standard if they meet all of the following conditions [4,6,7]:

- Dental procedures are not performed on patients identified as ATD cases or suspected ATD cases (e.g., persons with TB or other respiratory illnesses).

- The clinic's injury and illness prevention program includes a written procedure for screening patients for ATDs that is consistent with the Centers for Disease Control and Prevention (CDC) guidelines for infection control in dental settings. This procedure must be followed before performing any dental work on a patient.

- Employees have been trained in the screening procedure in accordance with state law.

- Aerosol-generating dental procedures are not performed on a patient identified through the screening procedure as presenting a possible ATD exposure risk unless a licensed physician determines that the patient does not currently have an ATD.

3. MODES OF TRANSMISSION

Almost all pathogens are transmitted by being carried from one place to another. The mode or means of transmission is the weakest link in the chain of infection, and it is the only link that can be eliminated entirely. Most infection control efforts are aimed at preventing transmission of pathogens from a reservoir to a susceptible host. Both Standard and Contact Precautions are designed to interrupt the mode of transmission.

The most common modes of transmission in the healthcare setting are the hands of healthcare workers and items that move from patient to patient, both of which are examples of indirect transmission (Table 1). Items moving between patients should be cleaned and sterilized after each use to avoid indirect transmission of pathogens. Because it addresses the weakest link in the chain of transmission, hand hygiene is still the single most important procedure for preventing the spread of infection.

Table 1: Common Modes of Infection Transmission

Category

Definition

Direct

Person-to-person transmission of pathogens

Indirect

An intermediate person or item (e.g., an instrument) acts as a transport between the portal of exit in one person and the portal of entry to the next person (e.g., unwashed hands)

Fomites

Contact with soiled objects, such as used gloves, pens, used tissues, and soiled laundry

Source: Compiled by Author

AEROSOLS, DROPLETS, AND SPLATTER

Aerosols, droplets (produced by the respiratory tract), and splatter contaminated with blood and bacteria are produced during many dental procedures [8]. Devices such as dental handpieces, ultrasonic and sonic scalers, air polishers, air-water syringes, and air abrasion units produce visible aerosol clouds and possible airborne contamination. Splatter generated by dental procedures such as drilling is a primary risk for transmission of bloodborne pathogens. In general, because of their smaller size, aerosols pose the greatest risk for airborne infection.

Several studies have shown that aerosol or droplet nuclei may extend up to 6 feet away from the source and can remain airborne for up to 30 minutes after a procedure. TB is of special concern because it is a large particle that can remain airborne or can dry on a surface and become airborne again as part of a dust particle.

The American Dental Association recommends that in addition to using standard barriers, such as masks, gloves, and eye protection, the proper sterilization of instruments and treatment of dental unit waterlines is necessary to reduce or eliminate this source of potentially contaminated dental aerosols. Preprocedural rinsing with an antimicrobial mouthwash such as chlorhexidine is also recommended, although it is only effective for oral bacteria found in saliva and those adhering to mucous membranes. It does not penetrate subgingivally and likely has no effect on bacteria in the nasopharynx [9].

Diseases known to spread by aerosols or droplet include:

- TB

- Pneumonic Yersinia pestis infection (plague)

- Influenza

- Legionellosis (Legionnaires disease)

- Severe acute respiratory syndrome (SARS)

Procedures or equipment aimed at eliminating the means of transmission include [9]:

- Universal preprocedural rinses

- Dental dams for certain procedures

- High-volume evacuator (HVE) at the treatment site (An HVE can only remove airborne contamination if it removes a large volume of air. A saliva ejector does not remove enough air to be classified as an HVE.)

- High-efficiency particulate arresting and ultraviolet filters in the ventilation system

- Gloves to minimize contamination of hands, discarded after each patient

- Cleaning, disinfection, and sterilization of equipment used by more than one patient

- Environmental cleaning and disinfection, especially of high-touch surfaces

FOMITE TRANSMISSION

Devices can transmit pathogens if they are contaminated with blood or bodily fluids or are shared without cleaning, disinfecting, and sterilizing between patients; these are classified as fomites. Surgical instruments that are inadequately cleaned between patients or that have manufacturing defects that interfere with the effectiveness of reprocessing may transmit bacterial, fungal, and viral pathogens. Clothing, uniforms, laboratory coats, or gowns used as personal protective equipment (PPE) may become contaminated with potential pathogens after care of a patient colonized or infected with an infectious agent [10].

Contaminated clothing and laboratory coats can potentially transmit infectious agents to successive patients. A 2007 study in a Maryland teaching hospital revealed that 27% of the white coats worn by 109 physicians and other healthcare professionals were colonized with Staphylococcus aureus and 6% were colonized with methicillin-resistant S. aureus (MRSA). In a follow-up questionnaire, 65% of the healthcare workers reported they had last washed their white coat more than a week ago and nearly 16% had last washed their coat more than 30 days ago [11]. A study presented at the American Society of Microbiology Conference in 2012 identified clothing and household linens (e.g., cotton towels) as a significant transmission source of infectious pathogens [12]. However, evidence linking clothing to hospital infection rates is lacking, and additional research is necessary to determine the actual extent of this risk [13].

Dental equipment and dental unit waterlines are both potential sources of transmission and potential reservoirs. Routine cleaning and sterilization and adherence to the American Dental Association's recommended procedures for treating dental unit waterlines have been shown to be effective in eliminating transmission of infectious organisms via these devices. If a surgical procedure involves soft tissue or bone, California regulations require the use of sterile coolants or irrigants, delivered using a sterile delivery system. In addition, a new infection control standard that took effect on January 1, 2019, requires that water or other methods for irrigation must be sterile or contain recognized disinfecting or antibacterial properties when performing procedures on exposed dental pulp. This requirement is in response to a 2016 outbreak of mycobacterial infection from a Southern California dental clinic that led to the hospitalization of more than 60 children. The cause was determined to be bacteria introduced through water during pulpotomies [14].

4. BLOODBORNE PATHOGENS

Healthcare employees can be exposed to blood through needlestick and other sharps injuries, damaged mucous membranes, and broken skin exposures. The pathogens of primary concern to dental professions are human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus.

HEPATITIS B VIRUS

Healthcare personnel who have received the hepatitis B vaccine and developed immunity to the virus are at virtually no risk for infection. For a susceptible person, the risk from a single needlestick or cut exposure to hepatitis B-infected blood ranges from 6% to 30%, depending on the hepatitis B antigen status of the source individual [8,15]. While there is a risk for hepatitis B infection from exposures of mucous membranes or nonintact skin, there is no known risk for infection from exposure to intact skin [16].

HEPATITIS C VIRUS

Hepatitis C is transmitted primarily through percutaneous exposure to infected blood. The average risk for infection after a needlestick or cut exposure to hepatitis C virus-infected blood is approximately 1.8% [17]. The risk following a blood exposure to the eye, nose, or mouth is unknown but is believed to be very small; however, hepatitis C virus infection from blood splashes to the eye has been reported [17]. There also has been a report of hepatitis C virus transmission that may have resulted from exposure to nonintact skin, but there is no known risk from exposure to intact skin [8]. Documented transmission of hepatitis C or hepatitis B virus has resulted from using the same syringe or vial to administer medication to more than one patient, even if the needle was changed.

The prevalence of hepatitis C virus infection among dentists and surgeons is similar to that among the general population, approximately 1% to 2% [15]. No studies of transmission from hepatitis C virus-infected dental healthcare personnel to patients have been reported, and the risk for such transmission appears limited [6].

HIV/AIDS

The average risk of HIV infection after a needlestick or cut exposure to HIV-infected blood is 0.3%; 99.7% of needlestick or cut exposures do not lead to infection [8,17]. The risk after exposure of the eye, nose, or mouth to HIV-infected blood is estimated to be 0.1%. There have been no documented cases of HIV transmission due to an exposure involving a small amount of blood on intact skin (i.e., a few drops of blood on skin for a short period of time) [8,17].

In the United States, the risk of HIV transmission in dental settings is extremely low. According to surveillance data from 1981 to 2010, a total of 57 cases of HIV seroconversion had been documented among healthcare personnel after occupational exposure to a known HIV-infected source, but none were among dental care personnel [18]. Transmission of HIV to 6 patients of a single dentist with AIDS has been reported, but the mode of transmission could not be determined [19].

Certain factors affect the risk of HIV transmission after an occupational exposure. Laboratory studies have determined if needles that pass through latex gloves are solid rather than hollow-bore or are of small gauge (e.g., anesthetic needles), less blood is transferred. In a retrospective, case-control study of healthcare personnel, an increased risk for HIV infection was associated with exposure to a relatively large volume of blood, as with a deep injury with a device that was visibly contaminated with the patient's blood or a procedure that involved a needle placed in a vein or artery [20]. The risk was also increased if the exposure was to blood from patients with terminal illnesses, possibly reflecting the higher titer of HIV in late-stage AIDS patients.

5. PREVENTION STRATEGIES

In 1986, California became the first state to pass a comprehensive bloodborne pathogen standard [9]. The California standard provided a model for federal legislation, and in 1991, OSHA published its Bloodborne Pathogens Standard. Since then, regulatory and legislative activity has focused on implementing a hierarchy of prevention and control measures to improve infection control in healthcare settings. Respiratory hygiene, safe injection practices, aseptic technique, hand hygiene, and the use of PPE are now accepted as essential components of an effective infection prevention strategy. The Cal/OSHA ATD standard passed into law in 2009 was expected to be a blueprint for federal standards addressing aerosol transmissible diseases [5,9]. Although permanent federal standards have not come to fruition, in June 2021, OSHA issued an emergency temporary standard addressing occupational exposure to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), commonly referred to as COVID-19, including patient screening and management, use of Standard and Transmission-Based Precautions, PPE, and controls for aerosol-generating procedures [21].

STANDARD PRECAUTIONS

The gradual acceptance of various infection prevention standards has changed the way we work in the provision of dental care. The use of Standard Precautions reduces the risk of infection to staff and patients and ensures that the right precautions are used with both known and unknown carriers of diseases due to bloodborne pathogens. Standard Precautions apply to contact with:

- Blood

- All bodily fluids, secretions, and excretions (except sweat), regardless of whether they contain blood

- Intact or nonintact skin

- Mucous membranes

A central tenet of Standard Precautions is to consider all patients to be potentially infected with a bloodborne pathogen. Saliva has always been considered a potentially infectious material in dental infection control; thus, no operational difference exists in clinical dental practice between Universal Precautions and Standard Precautions. For organisms other than bloodborne pathogens, early identification and prompt isolation are critical.

When adhering to Standard Precautions, always:

- Use good hand hygiene.

- Use gloves for contact with blood, bodily fluids, nonintact skin (including rashes), mucous membranes, used equipment, linens, and trash.

- Use a gown any time your clothing is soiled and if a patient has uncontained bodily fluids (e.g., blood, saliva).

- Use a mask and eye protection if you may be splashed or be exposed to droplets; glasses do not adequately protect you.

- Change gloves if they become heavily soiled when working on a patient or if you must go from a potentially more infective area to a lesser one.

In addition, never:

- Wear artificial fingernails.

- Touch a second patient with the same pair of gloves used on the first patient.

- Reuse gowns, even for repeated contacts with the same patient.

- Contaminate the environment with dirty gloves.

- Wear gloves outside the treatment area unless you can say why you are wearing them.

RESPIRATORY HYGIENE

If dental clinics and offices comply with state regulations for screening of patients with ATDs, they are not required to comply with the new standards for prevention of transmission of ATDs [4]. However, because no screening process is universally effective, dental professionals should be aware of the potential dangers associated with transmission of pathogens via the airborne and droplet routes.

Respiratory droplets can transmit infection when they travel directly from the respiratory tract of the infected individual to the mucosal surfaces of the recipient, generally over short distances (i.e., 6 feet or less). Airborne transmission occurs with only a few organisms that can survive the drying of respiratory droplets. When the droplets evaporate, they leave behind droplet nuclei, which are so small they remain suspended in the air and can travel over longer distances. Respiratory droplets and droplet nuclei are generated when an infected person coughs, sneezes, or talks during procedures. Facial masks or shields generally provide direct protection from droplet transmission. Some pathogens transmitted via the airborne route (e.g., TB) require the use of an N95 respirator or better (e.g., N99, N100) due to the small particle size.

ASEPTIC TECHNIQUE

Aseptic technique involves the handling, preparation, and storage of medications in a manner that prevents microbial contamination. It also applies to the handling of all supplies used for injections and infusions. To avoid contamination, medications should be drawn in a clean medication preparation area. Any item that may have come in contact with blood or other potentially infectious material should be kept separate from medications.

SAFE INJECTION PRACTICES

In 2000, the Federal Needlestick Safety and Prevention Act authorized OSHA to revise its Bloodborne Pathogens Standard to require the use of safety-engineered sharp devices in healthcare settings [22]. Guidelines on the design, implementation, and evaluation of a sharps injury prevention program have been developed by the CDC.

Safe injection practices are designed to prevent disease transmission within the healthcare setting. The absence of visible blood or other signs of contamination in a used syringe does not mean the item is free from potentially infectious agents. Bacteria and other microbes can be present without any visible evidence of contamination. All used injection supplies and materials should be considered potentially contaminated and should be discarded.

To ensure safe injection practices, use aseptic technique throughout all aspects of injection preparation and administration. A new, sterile syringe and needle should be used to draw up medications while preventing contact between the injection materials and the nonsterile environment. Practice proper hand hygiene before handling medications, and discard medication vials upon expiration or any time there are concerns regarding the sterility of the medication.

Never leave a needle or other device inserted into a vial or bottle for multiple uses. This provides a direct route for micro-organisms to enter the vial and contaminate the fluid. Medications should never be administered from the same syringe to more than one patient, even if the needle is changed.

Dental professionals should follow proper technique when using and handling needles, cannulae, and syringes. Whenever possible, use sharps with engineered sharps injury protections (e.g., non-needle or needle devices with built-in safety features or mechanisms that effectively reduce the risk of an exposure incident). Do not disable or circumvent the safety feature on devices.

Cases of bloodborne pathogen transmission as a result of improper injection practices have common themes [22]. Often, aseptic technique and Standard Precautions were not carefully followed. Infection control programs may be lacking or responsibilities unclear. In several instances, failure to recognize an infection control breach has led to prolonged transmission and a growing number of infected patients. In all cases, investigations were time-consuming and costly and required the notification, testing, and counseling of hundreds and sometimes thousands of patients.

HAND HYGIENE

Despite the simplicity and effectiveness of hand hygiene in preventing the spread of infectious disease, adherence to hand hygiene practice remains unacceptably low [23]. Adherence varies among professional categories of healthcare workers but is usually estimated as less than 50%, a rate that has not changed in more than a decade [23,24,25]. Healthcare providers might need to clean their hands as many as 100 times in a 12-hour shift, depending on the number of patients and intensity of care [25]. For dental healthcare workers, strict adherence to hand hygiene protects both the patient and the worker. Hand hygiene should be done when you first come to work, before you touch your first patient or clean equipment, and before and after every patient contact—including after touching intact skin. In addition, perform hand hygiene:

- After contact with any bodily fluids, including your own

- Before any non-invasive or invasive procedure

- Each time you remove your gloves

- When your hands feel or look dirty

- After contact with contaminated things or environments, such as charts

- After handling used equipment or linen

- After using the bathroom

- Before contact with any portal of entry, your patient's or your own

- Before and after eating

A number of conditions restrict dental healthcare professionals from participating in direct patient care. These include weeping dermatitis, exudative lesions, or any hand conditions that increase the risk of disease transmission.

Good handwashing is difficult to practice, is rarely known or taught, and is one of the single most effective ways to prevent transmission of many diseases, including influenza. Everyone knows to wash their hands before eating and after using the restroom. However, few do little more than remove obvious dirt. Good handwashing involves removing the skin oils where organisms can remain even when the hands look clean. A quick pass under the water faucet and fast dry with a towel may remove visible dirt, but the oils and organisms remain.

To effectively remove the oils and organisms, the process should take at least 20 seconds, or the amount of time it takes to sing "Twinkle, Twinkle Little Star." The hands should be soaped and rubbed vigorously for 15 seconds to create a good lather and to assure that all parts of each hand are soaped and rubbed well. Then, the hands should be rinsed thoroughly and dried, preferably with a paper towel. The towel should be used to turn off the water faucet and then properly thrown away. Such handwashing removes the oils that harbor the organisms. However, 20 seconds is a long time in the busy life of a healthcare provider, and this 20 seconds has been identified as a major barrier to handwashing, particularly among those who consider themselves "too busy" to wash their hands [23]. If there is no visible dirt or contamination, a waterless hand sanitizer with at least 60% alcohol can be used between patients. However, nothing is as good as washing well with soap and water. Some mistakenly think that hot water must be used to kill the organisms. Water hot enough to kill organisms would be too hot to touch. Warm water softens oils but mainly adds to comfort and encourages better washing technique (i.e., longer duration). Careful attention to handwashing and cleansing may result in chapped skin, so the dental professional must find effective lotions to care for his/her hands.

Certain soaps contain stronger antiseptic compounds, such as chlorhexidine, and these soaps may be considered in cases in which exposure to potentially infectious material is likely. Antiseptic soaps or surgical preparation liquids have been found more effective than plain soap in removing bacteria from healthcare workers hands both pre- and postprocedure [26,27]. In addition, antiseptics may be added to alcohol-based handrubs in order to achieve persistent germicidal activity [6]. Possible side effects associated with frequent use of antiseptic hand scrubs include skin irritation, dermatitis, allergic reactions, and potential development of microbial resistances. Chlorhexidine products are considered safe for regular use in dental practice; however, if associated side effects are bothersome, they may result in decreased hand hygiene compliance.

In summary, start and end each work day using an antibacterial soap. Gloves provide a breeding ground for microbial growth, and washing before and after use is encouraged. If hands are not visibly soiled, a waterless hand sanitizer (at least 60% alcohol) may be used. For surgical procedures, wash hands with antimicrobial soap prior to gowning and gloving.

PERSONAL PROTECTIVE EQUIPMENT

PPE is defined as special coverings designed to protect healthcare personnel from exposure to or contact with infectious agents [28]. Cal/OSHA regulations require use of PPE in dental care settings to protect personnel from exposure to bloodborne pathogens. Under OSHA's General Duty Clause, PPE is also required for any potential infectious disease exposure. Employers must provide their employees with appropriate PPE and ensure its proper disposal. If reusable, it must be properly cleaned or laundered, repaired, and stored after use [29]. PPE must fit the individual user, and it is up to the employer to ensure that PPE is available in sizes appropriate for all their workers. Employees are prohibited from taking PPE home to launder.

In addition to the familiar gloves and gowns, PPE includes a variety of barriers and respirators used alone or in combination to protect skin, mucous membranes, and airways from contact with infectious agents. The selection of PPE is based on the nature of the patient/provider interaction and the likely mode of transmission. Primary PPE used in oral healthcare settings includes gloves, surgical masks, protective eyewear, face shields, and protective clothing.

Procedures that generate splashes or sprays of blood, bodily fluids, secretions, excretions, or chemical agents require either a face shield (disposable or reusable) or mask and goggles. The wearing of masks, eye protection, and face shields in specified circumstances (when blood or other potentially infectious material exposures are likely to occur) is mandated by the OSHA Bloodborne Pathogens Standard. Sterile barriers for invasive procedures and masks or respirators for the prevention of droplet contamination are also required.

The use of PPE is not a substitute for safe work practices. Avoid contaminating yourself by keeping your hands away from your face and not touching or adjusting equipment. PPE is a potential means of transmission if not changed between patients. All PPE should be removed when leaving patient care areas.

Gloves

Dental personnel should wear gloves to prevent contamination of their hands when touching mucous membranes, blood, saliva, or other potentially infectious material. Gloves reduce the likelihood that micro-organisms present on the hands will be transmitted to patients during surgical or other patient-care procedures. Gloves used in the healthcare setting are subject to U.S. Food and Drug Administration (FDA) evaluation and clearance. Nonsterile, disposable medical gloves made of latex or nitrile should be available for routine patient care. Dental professionals should always use gloves when [28,30]:

- Anticipating direct contact with blood or bodily fluids, mucous membranes, nonintact skin, and other potentially infectious material

- Engaging in direct contact with patients who are colonized or infected with pathogens transmitted by the contact route, such as vancomycin-resistant enterococci or MRSA

- Handling or touching visibly or potentially contaminated patient care equipment and environmental surfaces

Studies have repeatedly shown that vinyl gloves have higher failure rates than latex or nitrile gloves. For this reason, either latex or nitrile gloves are preferable for clinical procedures that require manual dexterity or those involving more than brief patient contact. Heavier, reusable utility gloves should be used for non-patient-care activities, such as handling or cleaning contaminated equipment or surfaces, handling chemicals, or disinfecting contaminated tools [28,30].

During dental procedures, patient examination gloves commonly contact multiple types of chemicals and materials, such as disinfectants and antiseptics, composite resins, and bonding agents, and these materials can compromise the integrity of latex, nitrile, and other synthetic glove materials. In addition, latex gloves can interfere with the setting of vinyl polysiloxane impression materials. Given the diverse selection of dental materials on the market, dental practitioners should consult glove manufacturers regarding the chemical compatibility of glove materials [6].

Wearing sterile surgeon's gloves during surgical procedures has a strong theoretical rationale. Sterile gloves minimize transmission of micro-organisms from the hands of surgical personnel to patients and prevent contamination of the hands of surgical personnel with the patient's blood and bodily fluids. In addition, sterile surgeon's gloves are more rigorously regulated by the FDA and may provide an increased level of protection for the provider if exposure to blood is likely [6].

Gloves should be removed and replaced if torn or punctured and discarded between patients to prevent transmission of infectious material. They should never be washed and reused, as micro-organisms cannot be removed reliably from glove surfaces. Glove reuse has been associated with transmission of MRSA and gram-negative bacilli [28,30].

When gloves are worn in combination with other PPE, they should be put on last. Gloves that fit snugly around the wrist are preferred for use with a gown because they will cover the gown cuff and provide a more reliable continuous barrier for the arms, wrists, and hands. Removing gloves properly also prevents hand contamination. Hand hygiene following glove removal ensures that the hands will not carry potentially infectious material that might have penetrated through unrecognized tears or contaminated the hands during glove removal [28,30]. When processing contaminated sharp instruments, needles, and devices, heavy utility gloves should be used to prevent puncture injuries.

Cover Garb

Gowns are intended to protect the arms and exposed body areas and prevent contamination of clothing with blood, bodily fluids, and other potentially infectious material. The type of gown selected is based on the nature of the patient/provider interaction, including the anticipated degree of contact with infectious material and potential for blood and bodily fluid penetration of the barrier. Laboratory coats or jackets worn over personal clothing for comfort or purposes of identity are not considered PPE [28,30].

California regulations require that dental personnel wear reusable or disposable protective attire when their clothing or skin is likely to be soiled with blood or other potentially infectious material. Gowns must be changed daily or between patients if they become moist or visibly soiled. Protective attire must be removed when leaving laboratories or areas of patient care activities. Reusable gowns should be laundered in accordance with Cal/OSHA Bloodborne Pathogens Standards [2].

Masks, Protective Eyewear, and Face Shields

In California, dental professionals are required to wear surgical masks that cover both the nose and mouth, in combination with either chin-length plastic face shields or protective eyewear when there is potential for splashing or spattering of blood or other potentially infectious material. After each patient and during patient treatment (if applicable), masks must be changed if moist or contaminated. After each patient, face shields and protective eyewear shall be cleaned and disinfected, if contaminated [2].

Masks should fit snuggly and fully cover the nose and mouth to prevent fluid penetration. For this reason, masks that have a flexible nose piece and can be secured to the head with string ties or elastic are preferable. Surgical masks protect against micro-organisms generated by the wearer and also protect dental personnel from large-particle droplet spatter that might contain bloodborne pathogens or other potentially infectious material. If the mask becomes wet or contaminated, it should be changed between patients or even during patient treatment. For employees at increased risk of exposure to ATDs, such as those working in endemic areas (e.g., Southeast Asia) or in areas designated for isolation or quarantine, the employer must provide a respirator at least as effective as an N95 respirator.

Most surgical masks are not National Institute for Occupational Safety and Health (NIOSH)-certified as respirators, do not protect the user adequately from exposure to TB, and do not satisfy OSHA requirements for respiratory protection. However, certain surgical masks (i.e., N95 respirators) do meet the requirements and are certified by NIOSH. The level of protection a respirator provides is determined by the efficiency of the filter material for incoming air (e.g., 95% for N95) and how well the face piece fits or seals to the face. N95 respirators are required to be labeled as such on the device.

Respirators are used when treating patients with diseases requiring Airborne Precautions and should be used in the context of a complete respiratory protection program. This program should include training and fit testing to ensure an adequate seal between the edges of the respirator and the wearer's face.

Goggles with side shields provide barrier protection for the eyes and should fit snuggly over and around the eyes or personal prescription lenses. Personal prescription lenses do not provide optimal eye protection and should not be used as a substitute for goggles. If goggles or face shields are reusable, they must be placed in a designated receptacle for subsequent reprocessing. If they are not reusable, they may be discarded in a designated waste receptacle.

Face shields extending from chin to crown provide better face and eye protection from splashes and sprays than goggles. Shields that wrap around the sides may reduce splashes around the edge. Removal of a face shield, goggles, and mask can be performed safely after gloves have been removed and hand hygiene performed. The ties, ear pieces, or headband used to secure the equipment to the head are considered clean and therefore safe to touch with bare hands. The front of the face shield is considered contaminated [30].

6. ENVIRONMENTAL CONTROL MEASURES

As discussed, contaminated surfaces and objects can serve as the means of transmission for potential pathogens. The transfer of a micro-organism from an environmental surface to a patient is largely via hand contact with the surface. Although hand hygiene is important to minimize the impact of this transfer, cleaning and disinfecting environmental surfaces is fundamental in reducing their potential contribution to the incidence of infections [31].

ENVIRONMENTAL CLEANING

All work areas, including contact surfaces and barriers, must be maintained in a clean and sanitary condition. Employers are required to determine and implement a written schedule for cleaning and disinfection based on the location, type of surface to be cleaned, type of soil present, and tasks or procedures being performed. All equipment and environmental and working surfaces must be properly cleaned and disinfected after contact with blood or other potentially infectious material.

If items or surfaces likely to be contaminated are difficult to clean and disinfect, they must be protected with disposable impervious barriers. Clean and disinfect all clinical contact surfaces that are not protected by impervious barriers using a California Environmental Protection Agency (Cal/EPA)-registered, hospital grade low- to intermediate-level disinfectant after each patient. The low-level disinfectants used must be labeled effective against hepatitis B virus and HIV. Use disinfectants in accordance with the manufacturer's instructions. Clean all housekeeping surfaces (e.g., floors, walls, sinks) with a detergent and water or a Cal/EPA-registered, hospital-grade disinfectant. Chemical-resistant utility gloves should be worn when handling hazardous chemicals [31].

MEDICAL WASTE MANAGEMENT

Federal, state, and local guidelines and regulations specify the categories of medical waste subject to regulation and outline the requirements associated with treatment and disposal. Regulated medical waste is defined as [6,31]:

- Liquid or semi-liquid blood or other potentially infectious materials

- Contaminated items that would release blood or other potentially infectious material in a liquid or semi-liquid state if compressed

- Items that are caked with dried blood or other potentially infectious material capable of releasing these materials during handling

- Contaminated sharps (e.g., needles, burs, scalpel blades, endodontic files)

- Pathologic and microbiologic wastes containing blood or other potentially infectious material

Regulated medical waste accounts for only 9% to 15% of total waste in hospitals and 1% to 2% of total waste in dental offices [6]. Examples of regulated waste found in dental practice settings are solid waste soaked or saturated with blood or saliva (e.g., gauze saturated with blood after surgery), extracted teeth, surgically removed hard and soft tissues, and contaminated sharp items such as needles, scalpel blades, and wires [6].

Medical waste requires careful disposal and containment before collection and consolidation for treatment. A single, leak-resistant biohazard bag is usually adequate for containment of regulated medical wastes, provided the bag is sturdy and the waste can be discarded without contaminating the bag's exterior. Contamination or puncturing of the bag requires placement into a second biohazard bag. All bags should be securely closed for disposal.

Medical waste requiring storage should be kept in labeled, leak-proof, puncture-resistant containers under conditions that minimize or prevent foul odors. The storage area should be well-ventilated and inaccessible to pests. Any facility that generates regulated medical waste should have a regulated medical waste management plan to ensure health and environmental safety in accordance with federal, state, and local regulations [31].

DENTAL UNIT WATERLINES, BIOFILM, AND WATER QUALITY

The following information is taken from the Centers for Disease Control and Prevention publication Guidelines for Infection Control in Dental Health-Care Settings [6].

Studies have shown that dental unit waterlines, such as narrow-bore plastic tubing that carries water to high-speed handpieces, air/water syringes, and ultrasonic scalers, can become colonized with micro-organisms, including bacteria, fungi, and protozoa. Protected by a polysaccharide layer known as a glycocalyx, these micro-organisms colonize and replicate on the interior surfaces of the tubing and form a biofilm. This biofilm serves as a reservoir that can increase the number of micro-organisms in the water used during dental treatment.

In 1993, the CDC recommended that dental waterlines be flushed at the beginning of the clinic day to reduce the microbial load. Dental unit water that remains untreated or unfiltered is unlikely to meet drinking water standards.

Commercial devices and procedures shown to improve the quality of water used in dental treatment include self-contained water systems with chemical treatment, in-line microfilters, and combinations of these treatments. Simply using tap, distilled, or sterile water will not eliminate bacterial contamination in treatment water if biofilms in the system are not controlled. Removal or inactivation of dental waterline biofilms requires use of chemical germicides. California law defines "germicide" as a chemical agent that can be used to disinfect items and surfaces based on the level of contamination [2].

Patient material, such as oral micro-organisms, blood, and saliva, can enter the dental water system during treatment. Devices connected to the dental water system that enter the patient's mouth should be flushed to discharge water and air for a minimum of 20 to 30 seconds after each patient to remove patient material that might have entered the turbine, air, or waterlines.

Manufactured dental units are now engineered to prevent retraction of oral fluids, but some older units are equipped with antiretraction valves that require periodic maintenance. Users should consult the owner's manual or contact the manufacturer to determine whether testing or maintenance of antiretraction valves or other devices is required. Even with antiretraction valves, flushing devices for a minimum of 20 to 30 seconds after each patient is recommended. The DBC standards require that, at the beginning of each work day, dental lines and devices must be purged with air or flushed with water for at least two minutes prior to attaching handpieces, scales, air/water syringe tips, or other devices [2].

7. ENGINEERING AND WORK PRACTICE CONTROLS

The following information is taken from the OSHA Bloodborne Pathogens Standard, 1910.1030.

Engineering controls such as sharps disposal containers, self-sheathing needles, and safer medical devices (e.g., sharps with engineered sharps injury protections and needleless systems) isolate or remove the bloodborne pathogens hazard from the workplace. On the other hand, work practice controls reduce the likelihood of exposure by specifying the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique).

Engineering and work practice controls are intended to work synergistically to eliminate or minimize employee exposure. These controls must be examined and maintained or replaced on a regular basis to ensure their effectiveness. To maintain a safe workplace, employers must provide handwashing facilities that are readily accessible to employees.

Contaminated needles and other contaminated sharps should not be bent, recapped, or removed unless the employer can demonstrate that there is no alternative or that such action is required by a specific procedure. Necessary bending, recapping, or needle removal must be accomplished through the use of a mechanical device or a one-handed scoop technique. Shearing or breaking of contaminated needles is prohibited. Immediately, or as soon as possible after use, contaminated reusable sharps (e.g., scalpels, dental knives) must be placed in appropriate containers until properly reprocessed. These containers must be:

- Puncture resistant

- Labeled or color-coded

- Leak-proof on the sides and bottom

- Maintained in accordance with OSHA requirements for reusable sharps

- Designed so personnel are not required to reach by hand into the container

- Located as close as possible to the point of use

Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure. Food and drink should not be kept in refrigerators, freezers, shelves, or cabinets or on countertops where blood or other potentially infectious material is present.

All procedures involving blood or other potentially infectious material must be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. Splatter shields should be used on medical equipment associated with risk-prone procedures.

Equipment that may become contaminated with blood or other potentially infectious material must be examined before servicing or shipping and should be decontaminated as necessary, unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible. A readily observable label should be attached to the equipment stating which portions remain contaminated. The employer must ensure that this information is conveyed to all affected employees, the servicing representative, and the manufacturer before handling, servicing, or shipping, so appropriate precautions may be taken.

CLEANING, DISINFECTION, AND STERILIZATION

Application of accepted infection control principles helps maintain a safe environment for both patients and dental care workers. This includes proper use of Standard Precautions and application of approved techniques for cleaning, disinfection, sterilization, and reprocessing of dental equipment. Healthcare policies must identify—primarily on the basis of an item's intended use—whether cleaning and disinfection or sterilization is indicated (Table 2) [7].

Table 2: METHODS FOR STERILIZING AND DISINFECTING PATIENT-CARE ITEMS AND ENVIRONMENTAL SURFACES

Process

Result

Method

Examples

Patient Care Items

Environmental Surfaces

Sterilization

Destroys all micro-organisms, including bacterial spores.

Heat-automated, high temperature

Steam, dry heat, unsaturated chemical vapor

Heat-tolerant critical and semicritical

NA

Heat-automated, low temperature

Ethylene oxide gas, plasma sterilization

Heat-sensitive critical and semicritical

Liquid immersiona

Glutaraldehyde, glutaraldehydes with phenols, hydrogen peroxide, hydrogen peroxide with peracetic acid, peracetic acid

High-level disinfection

Destroys all micro-organisms, but not necessarily high numbers of bacterial spores.

Heat-automated

Washer disinfector

Heat-sensitive semicritical

NA

Liquid immersiona

Glutaraldehyde, glutaraldehydes with phenols, hydrogen peroxide, hydrogen peroxide with peracetic acid, ortho-phthalaldehyde

Intermediate-level disinfection

Destroys vegetative bacteria and most fungi and viruses. Inactivates Mycobacterium bovisb. Not necessarily capable of killing bacterial spores.

Liquid contact

EPA-registered hospital disinfectant with label claim of tuberculocidal activity (e.g., chlorine-containing products, quaternary ammonium compounds with alcohol, phenolics, bromides, iodophors, EPA-registered chlorine-based product)

Noncritical with visible blood

Clinical contact surfaces, blood spills on housekeeping surfaces

Low-level disinfection

Destroys most vegetative bacteria and certain fungi and viruses. Does not inactivate Mycobacterium bovis.

Liquid contact

EPA-registered hospital disinfectant with no label claim regarding tuberculocidal activity. OSHA also requires label claim of HIV and HBV potency for use of low-level disinfectant for use on clinical contact surfaces (e.g., quaternary ammonium compounds, some phenolics, some iodophors)

Noncritical without visible blood

Clinical contact surfaces, housekeeping surfaces

aContact time is the single critical variable distinguishing the sterilization process from high-level disinfection with FDA-cleared liquid chemical sterilants. High-level disinfection uses shorter submersion times.

bInactivation of the more resistant Mycobacterium bovis is used as a benchmark to measure germicidal potency.

Source: [6]

Cleaning is defined as the removal of visible soil (organic and inorganic material) from objects and surfaces; normally, it is accomplished manually or mechanically using water with detergents or enzymatic products. Decontamination reduces the number of pathogenic micro-organisms on objects, usually with a 0.5% chlorine solution [7]. Thorough cleaning and decontamination are essential before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes.

Disinfection is a process that eliminates many or all pathogenic micro-organisms, except bacterial spores, on inanimate objects. In healthcare settings, objects are usually disinfected using liquid chemicals or wet pasteurization (i.e., the use of hot water to destroy micro-organisms). There are three levels of disinfection:

- High-level disinfection: Used to disinfect patient-care equipment that touches mucous membranes or blood.

- Intermediate-level disinfection: Used mainly to disinfect items that have contact with intact skin, but is appropriate for certain semicritical items (e.g., chair arms).

- Low-level disinfection: Used to disinfect the healthcare environment or items that touch intact skin.

Surface disinfection is an important part of environmental cleaning. Most bacteria and mycobacteria (e.g., TB) survive for months on dry surfaces [32]. Respiratory viruses, such as coxsackie or influenza, can persist on surfaces for a few days. Hepatitis viruses and HIV can persist for more than one week, and herpes viruses have been shown to persist from only a few hours up to seven days [32]. All surfaces in patient care areas should be cleaned then disinfected according to the manufacturer's instructions and allowed to dry completely.

Sterilization is a process that destroys or eliminates all forms of microbial life and is carried out in healthcare facilities by physical or chemical methods. Sterile and nonsterile are absolute concepts. If a sterile item is touched by anything nonsterile, the formerly sterile item is contaminated.

The sterilization area should be separate from any patient care or staff break areas. The sterilization section of the processing area should include the sterilizers and related supplies, with adequate space for loading, unloading, and cool down [6]. The area can also include incubators for analyzing spore tests and enclosed storage for sterile items and single-use items. Manufacturer and local building code specifications will determine placement and room ventilation requirements.

According to the CDC guideline, heat-tolerant dental instruments usually are sterilized by steam under pressure (autoclaving), dry heat, or unsaturated chemical vapor [6]. All sterilization should be performed by using medical sterilization equipment cleared by the FDA. The sterilization times, temperatures, and other operating parameters recommended by the manufacturer of the equipment used, as well as instructions for correct use of containers, wraps, and chemical or biological indicators, should always be followed [6]. Sterilization most often fails due to overloading.

Devices being sterilized should first be cleaned, as debris interferes with the sterilization process. If an ultrasonic unit is utilized, it should be covered while actively in use. Instruments should be fully dry prior to packaging and storage.

Storage practices for wrapped sterilized instruments can be either date- or event-related. Packages containing sterile supplies should be inspected before use to verify barrier integrity and dryness. Although some facilities continue to date every sterilized package and use shelf-life practices, other facilities have switched to event-related practices [6]. This approach recognizes that the product should remain sterile indefinitely, unless an event causes it to become contaminated (e.g., torn or wet packaging). Even for event-related packaging, the date of sterilization should be placed on the package, and if multiple sterilizers are used in the facility, the sterilizer used should be indicated on the outside of the packaging material to facilitate the retrieval of processed items in the event of a sterilization failure [6,7]. If packaging is compromised, the instruments should be re-cleaned, sterilized again, and packaged in new wrap [7].

Categorizing Patient-Care Items

Patient-care items (e.g., dental instruments, devices, and equipment) are categorized using the Spaulding classification system as critical, semicritical, or noncritical, depending on the potential risk for infection associated with their intended use. Critical items are those items that enter sterile spaces, such as soft tissue or bone. These items pose the greatest risk of transmitting infection and require sterilization.

Semicritical items touch intact mucous membranes and have a lower risk of transmission. Because the majority of semicritical items in dentistry are heat-tolerant, they should be sterilized using heat. If a semicritical item is heat-sensitive, it should, at a minimum, be processed with high-level disinfection, which kills all microbial life except spores [6,7].

Noncritical items pose the least risk of transmission of infection, contacting only intact skin, an effective barrier to most micro-organisms. In the majority of cases, cleaning and disinfection with an EPA-registered hospital disinfectant is adequate. When the item is visibly contaminated with blood or other potentially infectious material, an EPA-registered hospital disinfectant with a tuberculocidal claim (i.e., intermediate-level disinfectant) should be used [6,7].

High-speed dental hand pieces, low-speed hand piece components used intraorally, and other dental unit attachments (e.g., reusable air or water syringe tips and ultrasonic scaler tips) must be heat-sterilized between patients. Single-use disposable instruments such as prophylaxis angles, cups, brushes, tips for high-speed evacuators, saliva ejectors, and air and water syringe tips must be used for one patient only and discarded. Proper functioning of the sterilization cycle must be verified at least weekly through the use of a biologic indicator (such as a spore test). Test results should be maintained for 12 months [2]. Studies have demonstrated variability among dental practices in meeting sterilization standards. In one study, 49% of respondents did not challenge autoclaves with biological indicators. Other studies using biologic indicators found a high proportion (15% to 65%) of positive spore tests after assessing the efficacy of sterilizers used in dental offices [7].

Dental unit water lines must be anti-retractive. At the beginning of each workday, dental unit lines should be purged with air or flushed with water for at least two minutes prior to attaching handpieces, scalers, and other devices. The dental unit line must be flushed between each patient for a minimum of 20 seconds [2]. Single-use barriers may be used on those environmental surfaces that are difficult to clean and disinfect.

Laboratory Areas

According to California regulations, splash shields and equipment guards must be used on dental laboratory lathes. Fresh pumice and a disinfected, sterilized, or new ragwheel should be used for each patient. Devices used to polish, trim, or adjust contaminated intraoral devices must be disinfected or sterilized [2].

Intraoral items, such as impressions, bite registrations, and prosthetic or orthodontic appliances, must be cleaned and disinfected with an intermediate-level disinfectant before manipulation in the laboratory and before placement in the patient's mouth. Such items should be thoroughly rinsed prior to placement in the patient's mouth [2].

Reprocessing Reusable Medical Equipment

Reusable instruments, medical devices, and equipment should be managed and reprocessed according to recommended and appropriate methods. Industry guidelines as well as equipment and chemical manufacturer recommendations should be used to develop and update reprocessing policies and procedures. Written instructions should be available for each instrument, medical device, and equipment reprocessed. The FDA has issued guidance on ensuring the safety of reusable medical devices [33].

Single-Use Devices

A single-use device is a device that is intended for use on a single patient during a single procedure. An unused single-use device is referred to as an original device. A reprocessed single-use device is an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient [34].

8. PROTECTING DENTAL HEALTHCARE WORKERS

Protecting dental professionals is an integral part of every dental organization's general program for infection prevention and control. The objectives usually include [35,36]:

- Educating personnel about the principles of infection control and emphasizing individual responsibility

- Providing care to personnel for work-related illnesses or exposures

- Identifying work-related infection risks and implementing appropriate preventive measures

- Containing costs by preventing infectious diseases that result in absenteeism and disability

OCCUPATIONAL EXPOSURES

An occupational exposure is defined as a percutaneous injury or contact of mucous membrane or nonintact skin with blood, tissue, or other potentially infectious material, most commonly a needlestick injury. The risk of infection depends on several factors, including:

- Whether the exposure was from a hollow-bore needle or other sharp instrument

- Whether the exposure was to nonintact skin or mucous membranes

- The amount of blood involved

- The amount of contagion present in the source person's blood

If a sharps injury occurs, wash the exposed area with soap and water. Do not "milk" or squeeze the wound. There is no evidence that using antiseptics will reduce the risk of transmission for any bloodborne pathogens; however, the use of antiseptics is not contraindicated. In the event that the wound needs suturing, emergency treatment should be obtained. The risk of contracting HIV from this type of exposure is extremely rare. Only 58 cases of confirmed occupational HIV transmission to healthcare personnel have been reported in the United States, with an additional 150 possible transmissions reported to the CDC [37]. There are no documented cases of a dental healthcare professional contracting HIV from an occupational exposure.

OSHA's final rule for occupational exposure to bloodborne pathogens requires dental employers to arrange a confidential medical evaluation and follow-up for any employee reporting an exposure incident [3]. An exposure incident is any eye, mouth, mucous membrane, nonintact skin, or other parenteral contact with blood or other potentially infectious material. Saliva in dental procedures is treated as potentially infectious material.

Following an exposure, the dental employer must refer the exposed employee to a licensed healthcare professional who can provide information and counseling and discuss how to prevent further spread of a potential infection. The exposed employee is entitled to appropriate follow-up and evaluation of any reported illness to determine if the symptoms may be related to HIV or hepatitis B infection.

Prompt response is necessary whenever an occupational exposure occurs. If possible, the patient should be interviewed to determine if any risk factors or bloodborne pathogens not previously disclosed are present. The patient may be tested along with the employee, if he or she agrees, in order to obtain the most information possible. Testing and postexposure prophylaxis may be conducted at an occupational injury clinic. All events leading up to and after the exposure should be documented in a written report.

Postexposure Prophylaxis

Postexposure prophylaxis (PEP) involves the provision of medications to someone who has had a substantial exposure, usually to blood, in order to reduce the likelihood of infection. PEP is available for HIV and hepatitis B virus. Although there is no PEP recommended for hepatitis C virus, limited data indicate that antiviral therapy might be beneficial when started early in the course of infection [38]. For employees who have not received the hepatitis B vaccine series, the vaccine (and in some circumstances hepatitis B immunoglobulin) should be offered as soon as possible (within seven days) after the exposure incident. The effectiveness of hepatitis B immunoglobulin administered more than seven days after exposure is unknown. PEP has been the standard of care for healthcare providers with substantial occupational exposures since 1996 and must be provided in accordance with the recommendations of the U.S. Public Health Service [38].

TUBERCULOSIS PREVENTION

California has one of the highest incidence rates of TB in the country, primarily because of its large immigrant and other high-risk populations (e.g., homeless persons) [39]. The TB infection rate is 14 times higher among foreign-born individuals than among those born in the United States. The rates among Asian and Black individuals born outside the United States were 50 and 51 times higher, respectively, than that of U.S.-born White persons [39]. To prevent the transmission of Mycobacterium tuberculosis in dental care settings, infection-control policies should be developed based on the community TB risk assessment and reviewed annually. The policies should include appropriate screening for latent or active TB disease in dental care providers, education about the risk for TB transmission, and provisions for detection and management of patients who have suspected or confirmed TB disease.

The CDC recommends that all dental care providers be screened for TB upon hire, using either a tuberculin skin test or blood test [40]. In addition, the California Department of Public Health requires that healthcare facilities in California perform initial and annual TB screening of employees [41].

Patients with symptoms of TB should be identified by screening; dental treatment should be deferred until active TB has been ruled out or the patient is no longer infectious following treatment. The potentially active TB patient should be promptly referred to an appropriate medical setting for evaluation of possible infectiousness and should be kept in the dental care setting only long enough to arrange for referral. Standard Precautions are not sufficient to prevent transmission of active TB.

A diagnosis of active respiratory TB should be considered for any patient with the following symptoms:

- Coughing for more than three weeks

- Loss of appetite

- Unexplained weight loss

- Night sweats

- Bloody sputum or hemoptysis

- Hoarseness

- Fever

- Fatigue

- Chest pain

A person with latent TB (positive skin test and no symptoms) can be treated in a dental office using standard infection control precautions [42]. This person has no symptoms and cannot transmit TB to others as there are no spores in his or her sputum.

The American Dental Association recommends that all patients be asked about any history of TB or exposure to TB, including signs and symptoms and medical conditions that increase their risk for TB disease. The Health History Form, developed by the U.S. Department of Health and Human Services, can be used to ask these questions.

If a patient with suspected or confirmed infectious TB disease requires urgent dental care, that care should be provided in a setting that meets the requirements for California ATD standards and airborne infection isolation. Respiratory protection (with a fitted N95 disposable respirator) should be used while performing procedures on such patients. Standard surgical masks are not designed to protect against TB transmission [42].

VACCINATION

Hepatitis B

Cal/OSHA guidelines require that healthcare workers who perform tasks that may involve exposure to blood or bodily fluids must have hepatitis B vaccination made available to them within 10 working days of initial assignment. The employee must also be given free information about the efficacy, safety, and benefits of vaccination [43].

The hepatitis B vaccine is given in a series of three injections at 0, 1, and 6 months. If one of the injections is missed, the series does not need to be restarted. The CDC recommends if the series is interrupted, the second or third dose should be administered as soon as possible; the second and third doses should be separated by an interval of at least eight weeks [44]. No booster is necessary. Follow-up serologic testing two months after vaccination (to ensure efficacy) is recommended. The provision of employer-supplied hepatitis B vaccination may be delayed until after probable exposure for employees whose sole exposure risk is the provision of first aid.

The high risk of hepatitis B virus exposure among healthcare personnel makes it imperative that clinical dental personnel be vaccinated. Vaccination can protect both workers and patients from hepatitis B virus infection and, whenever possible, should be completed when dentists or other dental care personnel are in training [6].

Influenza

Influenza is primarily transmitted from person to person via large, virus-laden droplets generated when infected persons cough or sneeze. These large droplets can settle on the mucosal surfaces of the upper respiratory tracts of susceptible persons who are within 3 feet of infected persons. Transmission may also occur through direct contact or indirect contact with respiratory secretions, such as when touching surfaces contaminated with influenza virus and then touching the eyes, nose, or mouth. The CDC strongly recommends that all healthcare personnel, especially those who have contact with patients at high risk, who have high-risk medical conditions, or who are older than 50 years of age, receive an annual (seasonal) influenza vaccination [45].

TRAINING AND EDUCATION

Dental professionals should also fulfill all federal and state requirements for infection control training. New employees, or employees being transferred into jobs involving tasks or activities with potential exposure to blood or other potentially infectious material, must receive bloodborne pathogen training before assignment to tasks in which an occupational exposure may occur. Retraining is required annually or when changes in procedures or tasks affecting occupational exposure occur. Employees should be provided access to a qualified trainer to answer questions during the training session.

9. CONCLUSION

Effective infection control techniques are critical to reducing the incidence of infections in dental facilities. Antiseptic techniques and antibiotics will kill micro-organisms, while proper hand hygiene will block their transmission. Gloves, gowns, and masks remove dental professionals from the transmission cycle by protecting them from contact with micro-organisms. Contact Precautions and isolation techniques help patients avoid being vectors of transmission. Engineering controls help to make the workplace safer, while administrative controls ensure that written protocols are in place and followed. Lastly, ensuring that dental professionals are immune or vaccinated can help decrease the availability of potential hosts.

10. DENTAL BOARD OF CALIFORNIA GENERAL PROVISIONS: SECTION 1005. MINIMUM STANDARDS FOR INFECTION CONTROL

The Dental Board of California General Provisions: Section 1005. Minimum Standards for Infection Control is available online at https://govt.westlaw.com/calregs/Document/I3F75D9A0B95D11E0A3CAA6663E6464AA.

11. CAL/OSHA COVID-19 STANDARD

In light of the ongoing COVID-19 pandemic, Cal/OSHA has developed an Emergency Temporary Standard to help protect healthcare providers and patients. The Standard must be re-authorized (and revised, if necessary) every six months. It may be accessed online at https://www.dir.ca.gov/oshsb/documents/Dec162021-COVID-19-Prevention-Emergency-txtcourtesy-2nd-Readoption.pdf.

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32. Kramer A, Schwebke I, Kampf G. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC Infectious Diseases. 2006;6:130.

33. U.S. Department of Health and Human Services. Food and Drug Administration. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff: 2011. Available at https://www.fda.gov/media/80265/download. Last accessed January 18, 2022.

34. U.S. Food and Drug Administration. Reprocessing of Reusable Medical Devices. Available at https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices. Last accessed January 18, 2022.

35. Occupational Safety and Health Administration. Personal Protective Equipment. Available at https://www.osha.gov/personal-protective-equipment. Last accessed January 18, 2022.

36. Centers for Disease Control and Prevention. Infection Control in Healthcare Personnel: Infrastructure and Routine Practices for Occupational Infection Prevention and Control Services: 2019. Available at https://www.cdc.gov/infectioncontrol/pdf/guidelines/infection-control-HCP-H.pdf. Last accessed January 18, 2022.

37. Centers for Disease Control and Prevention. HIV and Occupational Exposure. Available at https://www.cdc.gov/hiv/workplace/healthcareworkers.html. Last accessed January 18, 2022.

38. U.S. Public Health Service. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2001;50(RR-11):1-52.

39. California Department of Public Health. TB in California: 2020 Snapshot. Available at https://cchealth.org/tb/pdf/TB-In-California.pdf. Last accessed January 18, 2022.

40. Jensen PA, Lambert LA, Iademarco MF, Ridzon R. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR Recomm Rep. 2005;54(RR-17):1-141.

41. California Department of Public Health. Licensing and Certification. CCR, Title 22, Chapter 3. Skilled Nursing Facilities, Section 72535 (b). Available at https://www.cdph.ca.gov/Programs/CHCQ/LCP/Pages/Title-22-for-Use-of-TST.aspx. Last accessed January 18, 2022.

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44. Schillie S, Vellozzi C, Reingold A, et al. Prevention of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices. MMWR. 2018;67(1):1-31.

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55290 • Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs

Mark Rose, BS, MA, LP

www.netce.com

Copyright © 2024 NetCE, All rights reserved.

Opioid analgesic medications can bring substantial relief to patients suffering from pain. However, the inappropriate use, abuse, and diversion of prescription drugs in America, particularly prescription opioids, has increased dramatically in recent years and has been identified as a national public health epidemic. A set of clinical tools, guidelines, and recommendations are now available for prescribers who treat pain patients with opioids. By implementing these tools, clinicians can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge.

Table of Contents

55290 • Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Special Approvals

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planner

Division Planner Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. SCOPE OF THE PROBLEM

3. PAIN MANAGEMENT APPROACHES IN DENTISTRY

ACUTE PAIN

CHRONIC PAIN

4. CREATING A TREATMENT PLAN AND ASSESSMENT OF ADDICTION RISK

RISK ASSESSMENT TOOLS

INFORMED CONSENT AND TREATMENT AGREEMENTS

PERIODIC REVIEW AND MONITORING

CONCURRENT USE OF BENZODIAZEPINES

CONSULTATION AND REFERRAL

DOCUMENTATION

PATIENT EDUCATION ON THE USE AND DISPOSAL OF OPIOIDS

DISCONTINUING OPIOID THERAPY

5. DENTAL OFFICE PROCEDURES FOR MANAGING VULNERABLE OR SUBSTANCE USE DISORDER PATIENTS

IDENTIFICATION OF DRUG DIVERSION/SEEKING BEHAVIORS

INTERVENTIONS FOR SUSPECTED OR KNOWN ADDICTION OR DRUG DIVERSION

CONSIDERATIONS FOR PATIENTS UNDERGOING TREATMENT FOR OPIOID USE DISORDER

6. REGULATORY REQUIREMENTS FOR PRESCRIBERS AND DISPENSERS

COMPLIANCE WITH STATE AND FEDERAL LAWS

CONTROLLED SUBSTANCES LAWS/RULES

STATE-SPECIFIC LAWS AND RULES

7. CONCLUSION

8. APPENDIX: LAWS AND REGULATIONS IN CALIFORNIA

HEALTH AND SAFETY CODE

DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT

CALIFORNIA BUSINESS AND PROFESSIONS CODE

DIVISION 2. HEALING ARTS

Works Cited

55290 • Responsibilities and Requirements of Prescribing Schedule II Opioid Drugs

Education Category. Pharmacology

Release Date. 02/01/2024

Expiration Date. 01/31/2027

Course Overview

Opioid analgesic medications can bring substantial relief to patients suffering from pain. However, the inappropriate use, abuse, and diversion of prescription drugs in America, particularly prescription opioids, has increased dramatically in recent years and has been identified as a national public health epidemic. A set of clinical tools, guidelines, and recommendations are now available for prescribers who treat pain patients with opioids. By implementing these tools, clinicians can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge.

Audience

This course is designed for dental professionals who may alter prescribing practices or intervene to prevent drug diversion and inappropriate opioid use.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type. NetCE is accredited by the International Accreditors for Continuing Education and Training (IACET). NetCE complies with the ANSI/IACET Standard, which is recognized internationally as a standard of excellence in instructional practices. As a result of this accreditation, NetCE is authorized to issue the IACET CEU.

Designations of Credit

NetCE designates this activity for 2 continuing education credits. AGD Subject Code 346. This course meets the Dental Board of California's requirements for 2 unit(s) of continuing education. Dental Board of California course #02-3841-24409. NetCE is authorized by IACET to offer 0.2 CEU(s) for this program.

Special Approvals

This course fulfills the California requirement for 2 hours of education on responsibilities and requirements of prescribing Schedule II opioids.

Course Objective

The purpose of this course is to provide dental professionals who prescribe or distribute opioids with an appreciation for the complexities of opioid prescribing and the dual risks of litigation due to inadequate pain control and drug diversion or misuse in order to provide the best possible patient care and to prevent a growing social problem.

Learning Objectives

Upon completion of this course, you should be able to:

1. Apply epidemiologic trends in opioid use and misuse to current practice so at-risk patient populations can be more easily identified, assessed, and treated.

2. Outline practices for pain management in dentistry.

3. Evaluate behaviors that may indicate drug seeking or diverting as well as approaches for patients suspected of misusing opioids.

4. Discuss the regulatory requirements for prescribers and dispensers.

5. Describe the dental office procedures for managing vulnerable or substance use disorder patients.

Faculty

Mark Rose, BS, MA, LP, is a licensed psychologist in the State of Minnesota with a private consulting practice and a medical research analyst with a biomedical communications firm. Earlier healthcare technology assessment work led to medical device and pharmaceutical sector experience in new product development involving cancer ablative devices and pain therapeutics. Along with substantial experience in addiction research, Mr. Rose has contributed to the authorship of numerous papers on CNS, oncology, and other medical disorders. He is the lead author of papers published in peer-reviewed addiction, psychiatry, and pain medicine journals and has written books on prescription opioids and alcoholism published by the Hazelden Foundation. He also serves as an Expert Advisor and Expert Witness to law firms that represent disability claimants or criminal defendants on cases related to chronic pain, psychiatric/substance use disorders, and acute pharmacologic/toxicologic effects. Mr. Rose is on the Board of Directors of the Minneapolis-based International Institute of Anti-Aging Medicine and is a member of several professional organizations.

Faculty Disclosure

Contributing faculty, Mark Rose, BS, MA, LP, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planner

Mark J. Szarejko, DDS, FAGD

Division Planner Disclosure

The division planner has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

Pain is the leading reason for seeking medical care, and pain management is a large part of many dental professionals' practice. Opioid analgesics are approved by the U.S. Food and Drug Administration (FDA) for moderate and severe pain and are broadly accepted in acute pain, cancer pain, and end-of-life care, but are controversial in chronic noncancer pain. In response to the long-standing neglect of severe pain, indications for opioid analgesic prescribing were expanded in the 1990s, followed by inappropriate prescribing and increasing abuse, addiction, diversion, and overdose through the 2000s. In tandem with the continued under-treatment of pain, these practice patterns led to needless suffering from uncontrolled pain, opioid analgesic addiction, and overdose. Opioid analgesic prescribing and associated overdose peaked in 2011 with both now in multi-year decline.

Patients show substantial opioid response variations in analgesia and tolerability and may exhibit a range of psychological, emotional, and behavioral responses that reflect inadequate pain control, an emerging opioid use problem, or both. Clinician delivery of best possible care to patients with pain requires appreciation of the complexities of opioid prescribing and the dual risks of inadequate pain control and inappropriate use, drug diversion, or overdose. A foundation for appropriate opioid prescribing is the understanding of factual data that clarify the prevalence, causality, and prevention of serious safety concerns with opioid prescribing.

2. SCOPE OF THE PROBLEM

Inappropriate opioid analgesic prescribing for pain is defined as the non-prescribing, inadequate prescribing, excessive prescribing, or continued prescribing despite evidence of ineffectiveness of opioids [1]. Appropriate opioid prescribing is essential to achieve pain control; to minimize patient risk of abuse, addiction, and fatal toxicity; and to minimize societal harms from diversion. The foundation of appropriate opioid prescribing is thorough patient assessment, treatment planning, and follow-up and monitoring. Essential for proper patient assessment and treatment planning is comprehension of the clinical concepts of opioid abuse and addiction, their behavioral manifestations in patients with pain, and how these potentially problematic behavioral responses to opioids both resemble and differ from physical dependence and pseudo-dependence. Prescriber knowledge deficit has been identified as a key obstacle to appropriate opioid prescribing and, along with gaps in policy, treatment, attitudes, and research, contributes to widespread inadequate treatment of pain [2].

The extent of opioid analgesic use in the United States in the 2000s was unprecedented in the country's history and unparalleled anywhere in the world. Before 1990, physicians in the United States were skeptical of prescribing opioids for chronic noncancer pain. In 2017, 20% of adults are prescribed an opioid such as oxycodone and hydrocodone for chronic pain, and sales of opioid analgesics totaled approximately $7 billion in 2016 [10,33].

Worldwide consumption of opioid analgesics has increased dramatically in the past few decades, with the United States driving a substantial proportion of this increase. For example, the 1990 global consumption of hydrocodone was 4 tons (3,628 kg), compared with the 2009 consumption of 39 tons (35,380 kg); 99% of this was consumed in the United States. Similarly, 3 tons (2,722 kg) of oxycodone were consumed globally in 1990, versus 77 tons (69,853 kg) in 2009, of which 62 tons (56,245 kg or 81%) were consumed in the United States [3]. With only 4.5% of the world's population, the United States annually consumes more than 80% of all opioid supplies, including [4]:

- 99% of all hydrocodone

- 80% of all oxycodone

- 58% of all methadone

- 54% of all hydromorphone

- 49% of all fentanyl

- 43% of all meperidine

This disproportionate rate of opioid consumption reflects sociocultural and economic factors and standards of clinical medicine.

Before it was halted in 2011, the Drug Abuse Warning Network (DAWN) provided estimates of the health consequences of nonmedical use of individual drugs, including opioid medications [6]. DAWN indicates that opioid abuse is a growing problem in the United States. In 2005 and 2011, hydrocodone and its combinations accounted for 51,225 and 97,183 emergency department visits, respectively. Oxycodone and its combinations resulted in 42,810 visits to the emergency department in 2005; this number increased to 175,229 visits in 2011 [7,8]. Visits for nonmedical use of all opioids increased from 217,594 to 420,040 during the six-year period. In 2016–2017, there were 127,101 nonmedical opioid emergency department visits [39]. While this number is an improvement from previous years, nonmedical use accounts for 47.6% of all emergency department visits related to opioids [39].

A 2018 study found that dentists prescribe 8.6% of all opioids in the United States [5]. Dentists and other oral health practitioners have a key role in effectively managing acute pain conditions, including mild postoperative pain resulting from a simple dental extraction, in addition to chronic maxillofacial pain.

3. PAIN MANAGEMENT APPROACHES IN DENTISTRY

Dental professionals should know the best clinical practices in opioid prescribing, including the associated risks of opioids, approaches to the assessment of pain and function, and pain management modalities. Pharmacologic and nonpharmacologic approaches should be used on the basis of current knowledge in the evidence base or best clinical practices. Patients with moderate-to-severe chronic pain who have been assessed and treated, over a period of time, with non-opioid therapy or nonpharmacologic pain therapy without adequate pain relief, are considered to be candidates for a trial of opioid therapy [9,10]. Initial treatment should always be considered individually determined and as a trial of therapy, not a definitive course of treatment [11].

In 2022, the CDC published an updated guideline for the prescription of opioids to manage all types of pain [34]. The updated clinical practice guideline is intended to achieve improved communication between clinicians and patients about the risks and benefits of pain treatment, including opioid therapy for pain; improved safety and effectiveness for pain treatment, resulting in improved function and quality of life for patients experiencing pain; and a reduction in the risks associated with long-term opioid therapy, including opioid use disorder, overdose, and death [34]. It is important to remember that inappropriately limiting necessary opioid medications to address patients' pain can be damaging and should be avoided.

ACUTE PAIN

Long-term opioid use often begins with treatment of acute pain. Many acute pain conditions can be managed most effectively with nonopioid medications. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been found to be more effective than opioids for surgical dental pain, and the American Dental Association recommends NSAIDs as first-line treatment for acute dental pain management [5].

When opioids are used for acute pain, dentists should prescribe the lowest effective dose of immediate-release opioids in a quantity no greater than that needed for the expected duration of severe pain. In most cases, three days or less will be sufficient; more than seven days will rarely be needed [10]. However, it is important to note that this guideline is based on emergency department prescribing guidelines for non-traumatic non-surgical pain [12]. It may be necessary to prescribe for longer periods in patients with acute severe pain.

With postoperative, acute, or intermittent pain, analgesia often requires frequent titration, and the two- to four-hour analgesic duration with short-acting hydrocodone, morphine, and oxycodone is more effective than extended-release formulations. Short-acting opioids are also recommended in patients who are medically unstable or with highly variable pain intensity [13,14,15].

CHRONIC PAIN

If opioids are used, they should be combined with nonpharmacologic therapy and non-opioid pharmacologic therapy, as appropriate. Clinicians should consider opioid therapy only if expected benefits for pain and function are anticipated to outweigh risks to the patient [10].

Opioid therapy for chronic pain should be presented as a trial for a pre-defined period (e.g., ≤30 days). The goals of treatment should be established with all patients prior to the initiation of opioid therapy, including reasonable improvements in pain, function, depression, anxiety, and avoidance of unnecessary or excessive medication use [1,10]. The treatment plan should describe therapy selection, measures of progress, and other diagnostic evaluations, consultations, referrals, and therapies.

The need for frequent progress and benefit/risk assessments during the trial should be included in patient education. Patients should also have full knowledge of the warning signs and symptoms of respiratory depression. Prescribers should carefully reassess evidence of benefits and risks when increasing the dosage to ≥50 mg morphine equivalent dose (MED) per day. Decisions to titrate dose to ≥90 mg MED/day should be avoided or carefully justified [10,40].

Prescribers should be knowledgeable of federal and state opioid prescribing regulations. Issues of equianalgesic dosing, close patient monitoring during all dose changes, and cross-tolerance with opioid conversion should be considered. If necessary, treatment may be augmented, with preference for nonopioids and immediate-release opioids over long-acting/extended-release opioids. Taper opioid dose when no longer needed [16].

4. CREATING A TREATMENT PLAN AND ASSESSMENT OF ADDICTION RISK

Information obtained by patient history, physical examination, and interview, from family members, a spouse, or state prescription drug monitoring program (PDMP), and from the use of screening and assessment tools can help the clinician to stratify the patient according to level of risk for developing problematic opioid behavioral responses (Table 1[17,28]. Low-risk patients receive the standard level of monitoring, vigilance, and care. Moderate-risk patients should be considered for an additional level of monitoring and provider contact, and high-risk patients are likely to require intensive and structured monitoring and follow-up contact, additional consultation with psychiatric and addiction medicine specialists, and limited supplies of short-acting opioid formulations [10,26].

Table 1: RISK STRATIFICATION FOR PATIENTS PRESCRIBED OPIOIDS

Low Risk

Definable physical pathology with objective signs and reliable symptoms

Clinical correlation with diagnostic testing, including MRI, physical examination, and interventional diagnostic techniques

With or without mild psychological comorbidity

With or without minor medical comorbidity

No or well-defined and controlled personal or family history of alcoholism or substance abuse

Age 45 years or older

High levels of pain acceptance and active coping strategies

High motivation and willingness to participate in multimodal therapy and attempting to function at normal levels

Medium Risk

Significant pain problems with objective signs and symptoms confirmed by radiologic evaluation, physical examination, or diagnostic interventions

Moderate psychological problems, well controlled by therapy

Moderate coexisting medical disorders that are well controlled by medical therapy and are not affected by chronic opioid therapy (e.g., central sleep apnea)

Develops mild tolerance but not hyperalgesia without physical dependence or addiction

History of personal or family history of alcoholism or substance abuse

Pain involving more than three regions of the body

Defined pathology with moderate levels of pain acceptance and coping strategies

Willing to participate in multimodal therapy, attempting to function in normal daily life

High Risk

Widespread pain without objective signs and symptoms

Pain involving more than three regions of the body

Aberrant drug-related behavior

History of alcoholism or drug misuse, abuse, addiction, diversion, dependency, tolerance, or hyperalgesia

Major psychological disorders

Age younger than 45 years

HIV-related pain

High levels of pain exacerbation and low levels of coping strategies

Unwilling to participate in multimodal therapy, not functioning close to a near normal lifestyle

HIV = human immunodeficiency syndrome, MRI = magnetic resonance imaging.

Source: [17,28]

Before deciding to prescribe an opioid analgesic, clinicians should perform and document a detailed patient assessment that includes [1]:

- Pain indications for opioid therapy

- Nature and intensity of pain

- Past and current pain treatments and patient response

- Comorbid conditions

- Pain impact on physical and psychological function

- Social support, housing, and employment

- Home environment (i.e., stressful or supportive)

- Pain impact on sleep, mood, work, relationships, leisure, and substance use

- Patient history of physical, emotional, or sexual abuse

Evidence Based Practice Recommendation

Despite limited evidence for reliability and accuracy, screening for opioid use is recommended by the American Society of Interventional Pain Physicians, as it will identify opioid abusers and reduce opioid abuse.

https://painphysicianjournal.com/2012/july/2012;%2015;S67-S116.pdf

Last Accessed: January 24, 2024

Level of Evidence: Limited (Evidence is insufficient to assess effects on health outcomes because of limited number or power of studies, large and unexplained inconsistency between higher-quality trials, important flaws in trial design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes.)

If substance abuse is active, in remission, or in the patient's history, consult an addiction specialist before starting opioids [1]. In active substance abuse, do not prescribe opioids until the patient is engaged in treatment/recovery program or other arrangement made, such as addiction professional co-management and additional monitoring. When considering an opioid analgesic (particularly those that are extended-release or long-acting), one must always weigh the benefits against the risks of overdose, abuse, addiction, physical dependence and tolerance, adverse drug interactions, and accidental exposure by children [10,16].

Screening and assessment tools can help guide patient stratification according to risk level and inform the appropriate degree of structure and monitoring in the treatment plan. It should be noted that despite widespread endorsement of screening tools used to help determine patient risk level, most tools have not been extensively evaluated, validated, or compared to each other, and evidence of their reliability is poor [17,28].

RISK ASSESSMENT TOOLS

Opioid Risk Tool (ORT)

The Opioid Risk Tool (ORT) is a five-item, patient-administered assessment to help predict aberrant drug-related behavior. The ORT is also used to establish patient risk level through categorization into low, medium, or high levels of risk for aberrant drug-related behaviors based on responses to questions of previous alcohol/drug abuse, psychological disorders, and other risk factors [18].

Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R)

The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a patient-administered, 24-item screen with questions addressing history of alcohol/substance use, psychological status, mood, cravings, and stress. Like the ORT, the SOAPP-R helps assess risk level of aberrant drug-related behaviors and the appropriate extent of monitoring [18,19].

Screening Instrument or Substance Abuse Potential (SISAP)

The Screening Instrument or Substance Abuse Potential (SISAP) tool is a self-administered, five-item questionnaire addressing history developed used to predict the risk of opioid misuse. The SISAP is used to identify patients with a history of alcohol/substance abuse and improve pain management by facilitating focus on the appropriate use of opioid analgesics and therapeutic outcomes in the majority of patients who are not at risk of opioid abuse, while carefully monitoring those who may be at greater risk [18].

CAGE and CAGE-AID

The original CAGE (Cut down, Annoyed, Guilty, and Eye-opener) Questionnaire consisted of four questions designed to help clinicians determine the likelihood that a patient was misusing or abusing alcohol. These same four questions were modified to create the CAGE-AID (adapted to include drugs), revised to assess the likelihood of current substance abuse [20].

Diagnosis, Intractability, Risk, and Efficacy (DIRE) Score

The Diagnosis, Intractability, Risk, and Efficacy (DIRE) risk assessment score is a clinician-rated questionnaire that is used to predict patient compliance with long-term opioid therapy [18,21]. Patients scoring lower on the DIRE tool are poor candidates for long-term opioid analgesia.

INFORMED CONSENT AND TREATMENT AGREEMENTS

The initial opioid prescription is preceded by a written informed consent or "treatment agreement" [1]. This agreement should address potential side effects, tolerance and/or physical dependence, drug interactions, motor skill impairment, limited evidence of long-term benefit, misuse, dependence, addiction, and overdose. Informed consent documents should include information regarding the risk/benefit profile for the drug(s) being prescribed. The prescribing policies should be clearly delineated, including the number/frequency of refills, early refills, and procedures for lost or stolen medications.

The treatment agreement also outlines joint physician and patient responsibilities. The patient agrees to using medications safely, refraining from "doctor shopping," and consenting to routine urine drug testing (UDT). The prescriber's responsibility is to address unforeseen problems and prescribe scheduled refills. Reasons for opioid therapy change or discontinuation should be listed. Agreements can also include sections related to follow-up visits, monitoring, and safe storage and disposal of unused drugs.

PERIODIC REVIEW AND MONITORING

When implementing a chronic pain treatment plan that involves the use of opioids, the patient should be frequently reassessed for changes in pain origin, health, and function [1]. This can include input from family members and/or the state PDMP. During the initiation phase and during any changes to the dosage or agent used, patient contact should be increased. At every visit, chronic opioid response may be monitored according to the "5 A's" [1,23]:

- Analgesia

- Activities of daily living

- Adverse or side effects

- Aberrant drug-related behaviors

- Affect (i.e., patient mood)

Signs and symptoms that, if present, may suggest a problematic response to the opioid and interference with the goal of functional improvement include [24,29]:

- Excessive sleeping or days and nights turned around

- Diminished appetite

- Short attention span or inability to concentrate

- Mood volatility, especially irritability

- Lack of involvement with others

- Impaired functioning due to drug effects

- Use of the opioid to regress instead of re-engaging in life

- Lack of attention to hygiene and appearance

The decision to continue, change, or terminate opioid therapy is based on progress toward treatment objectives and absence of adverse effects and risks of overdose or diversion [1]. Satisfactory therapy is indicated by improvements in pain, function, and quality of life. Brief assessment tools to assess pain and function may be useful, as may UDTs. Treatment plans may include periodic pill counts to confirm adherence and minimize diversion.

Assessment Tools

VIGIL

VIGIL is the acronym for a five-step risk management strategy designed to empower clinicians to appropriately prescribe opioids for pain by reducing regulatory concerns and to give pharmacists a framework for resolving ambiguous opioid analgesic prescriptions in a manner that preserves legitimate patient need while potentially deterring diverters. The components of VIGIL are:

- Verification: Is this a responsible opioid user?

- Identification: Is the identity of this patient verifiable?

- Generalization: Do we agree on mutual responsibilities and expectations?

- Interpretation: Do I feel comfortable allowing this person to have controlled substances?

- Legalization: Am I acting legally and responsibly?

The foundation of VIGIL is a collaborative physician/pharmacist relationship [25].

Current Opioid Misuse Measure (COMM)

The Current Opioid Misuse Measure (COMM) is a 17-item patient self-report assessment designed to help clinicians identify misuse or abuse in patients being treated for chronic pain. Unlike the ORT and the SOAPP-R, the COMM identifies aberrant behaviors associated with opioid misuse in patients already receiving long-term opioid therapy [26]. Sample questions include: In the past 30 days, how often have you had to take more of your medication than prescribed? In the past 30 days, how much of your time was spent thinking about opioid medications (e.g., having enough, taking them, dosing schedule)?

Pain Assessment and Documentation Tool (PADT)

Guidelines by the CDC, the Federation of State Medical Boards (FSMB), and the Joint Commission stress the importance of documentation from both a healthcare quality and medicolegal perspective. Research has found widespread deficits in chart notes and progress documentation with patients with chronic pain receiving opioid therapy, and the Pain Assessment and Documentation Tool (PADT) was designed to address these shortcomings [46]. The PADT is a clinician-directed interview, with most sections (e.g., analgesia, activities of daily living, adverse events) consisting of questions asked of the patient. However, the potential aberrant drug-related behavior section must be completed by the physician based on his or her observations of the patient.

The Brief Intervention Tool

The Brief Intervention Tool is a 26-item, "yes-no," patient-administered questionnaire used to identify early signs of opioid abuse or addiction. The items assess the extent of problems related to drug use in several areas, including drug use-related functional impairment [22].

CONCURRENT USE OF BENZODIAZEPINES

Patients who are unable to undergo dental treatment due to excessive fear, anxiety, or phobias and who do not respond to dental behavior modification techniques require pharmacotherapy. In many cases, this involves the use of benzodiazepines, such as diazepam, triazolam, and lorazepam. However, in patients who are also prescribed opioids, there are risks. In 2019, 16% of persons who died of an opioid overdose also tested positive for benzodiazepines [44]. Combining benzodiazepines with opioids is unsafe because both classes of drug cause central nervous system depression and sedation and can decrease respiratory drive—the usual cause of overdose fatality. Both classes have the potential for drug dependence and addiction. The CDC recommends that dentists avoid prescribing benzodiazepines concurrently with opioids whenever possible [10].

CONSULTATION AND REFERRAL

It is important to seek consultation or patient referral when input or care from a pain, psychiatry, addiction, or mental health specialist is necessary. Dentists who prescribe opioids should become familiar with opioid addiction treatment options (including licensed opioid treatment programs for methadone and office-based opioid treatment for buprenorphine) if referral is needed [1].

Ideally, providers should be able to refer patients with active substance abuse who require pain treatment to an addiction professional or specialized program. In reality, these specialized resources are scarce or non-existent in many areas [1]. Therefore, each provider will need to decide whether the risks of continuing opioid treatment while a patient is using illicit drugs outweigh the benefits to the patient in terms of pain control and improved function [48].

DOCUMENTATION

As noted, documentation is a necessary aspect of all patient care, but it is of particular importance when opioid prescribing is involved. All clinicians should maintain accurate, complete, and up-to-date medical records, including all written or telephoned prescription orders for opioid analgesics and other controlled substances, all written instructions to the patient for medication use, and the name, telephone number, and address of the patient's pharmacy [1]. Good records demonstrate that a service was provided to the patient and that the service was medically necessary. Regardless of the treatment outcome, thorough medical records protect the prescriber.

PATIENT EDUCATION ON THE USE AND DISPOSAL OF OPIOIDS

Patients and caregivers should be counseled regarding the safe use and disposal of opioids. As part of its mandatory Risk Evaluation and Mitigation Strategy (REMS) for extended-release/long-acting opioids, the U.S. Food and Drug Administration (FDA) has developed a patient counseling document with information on the patient's specific medications, instructions for emergency situations and incomplete pain control, and warnings not to share medications or take them unprescribed [16]. A copy of this form may be accessed online at https://www.fda.gov/media/114694/download.

When prescribing opioids, clinicians should provide patients with the following information [16]:

- Product-specific information

- Taking the opioid as prescribed

- Importance of dosing regimen adherence, managing missed doses, and prescriber contact if pain is not controlled

- Warning and rationale to never break or chew/crush tablets or cut or tear patches prior to use

- Warning and rationale to avoid other central nervous system depressants, such as sedative-hypnotics, anxiolytics, alcohol, or illicit drugs

- Warning not to abruptly halt or reduce the opioid without physician oversight of safe tapering when discontinuing

- The potential of serious side effects or death

- Risk factors, signs, and symptoms of overdose and opioid-induced respiratory depression, gastrointestinal obstruction, and allergic reactions

- The risks of falls, using heavy machinery, and driving

- Warning and rationale to never share an opioid analgesic

- Rationale for secure opioid storage

- Warning to protect opioids from theft

- Instructions for disposal of unneeded opioids, based on product-specific disposal information

There are no universal recommendations for the proper disposal of unused opioids, and patients are rarely advised of what to do with unused or expired medications [49]. According to the FDA, most medications that are no longer necessary or have expired should be removed from their containers, mixed with undesirable substances (e.g., cat litter, used coffee grounds), and put into an impermeable, nondescript container (e.g., disposable container with a lid or a sealed bag) before throwing in the trash [50]. Any personal information should be obscured or destroyed. The FDA recommends that certain medications, including oxycodone/acetaminophen (Percocet), oxycodone (OxyContin tablets), and transdermal fentanyl (Duragesic Transdermal System), be flushed down the toilet instead of thrown in the trash [31,50]. The FDA provides a free toolkit of materials (e.g., social media images, fact sheets, posters) to raise awareness of the serious dangers of keeping unused opioid pain medicines in the home and with information about safe disposal of these medicines. The Remove the Risk Outreach toolkit is updated regularly and can be found at https://www.fda.gov/drugs/ensuring-safe-use-medicine/safe-opioid-disposal-remove-risk-outreach-toolkit[31]. Patients should be advised to flush prescription drugs down the toilet only if the label or accompanying patient information specifically instructs doing so.

The American College of Preventive Medicine has established best practices to avoid diversion of unused drugs and educate patients regarding drug disposal [49]:

- Consider writing prescriptions in smaller amounts.

- Educate patients about safe storing and disposal practices.

- Give drug-specific information to patients about the temperature at which they should store their medications. Generally, the bathroom is not the best storage place. It is damp and moist, potentially resulting in potency decrements, and accessible to many people, including children and teens, resulting in potential theft or safety issues.

- Ask patients not to advertise that they are taking these types of medications and to keep their medications secure.

- Refer patients to community "take back" services overseen by law enforcement that collect controlled substances, seal them in plastic bags, and store them in a secure location until they can be incinerated. Contact your state law enforcement agency or visit https://www.dea.gov to determine if a program is available in your area.

DISCONTINUING OPIOID THERAPY

The decision to continue or end opioid prescribing should be based on a physician-patient discussion of the anticipated benefits and risks. An opioid should be discontinued with resolution of the pain condition, intolerable side effects, inadequate analgesia, lack of improvement in quality of life despite dose titration, deteriorating function, or significant aberrant medication use [1,10].

Clinicians should provide patients physically dependent on opioids with a safely structured tapering protocol. Withdrawal is managed by the prescribing physician or referral to an addiction specialist. Patients should be reassured that opioid discontinuation is not the end of treatment; continuation of pain management will be undertaken with other modalities through direct care or referral.

As a side note, cannabis use by patients with chronic pain receiving opioid therapy has traditionally been viewed as a treatment agreement violation that is grounds for termination of opioid therapy. However, some now argue against cannabis use as a rationale for termination or substantial treatment and monitoring changes, especially considering the increasing legalization of medical use at the state level [48].

5. DENTAL OFFICE PROCEDURES FOR MANAGING VULNERABLE OR SUBSTANCE USE DISORDER PATIENTS

IDENTIFICATION OF DRUG DIVERSION/SEEKING BEHAVIORS

Research has more closely defined the location of prescribed opioid diversion into illicit use in the supply chain from the manufacturer to the distributor, retailer, and the end user (the pain patient). This information carries with it substantial public policy and regulatory implications. The 2019 National Survey on Drug Use and Health asked non-medical users of prescription opioids how they obtained their most recently used drugs [51]. Among persons 12 years of age or older, 38.6% obtained their prescription opioids from a friend or relative for free, 34.7% got them through a prescription from one doctor (vs. 17.3% in 2009–2010), 9.5% bought them from a friend or relative, and 3.2% took them from a friend or relative without asking [51]. Less frequent sources included a drug dealer or other stranger (6.5%); multiple doctors (2.0%); and theft from a doctor's office, clinic, hospital, or pharmacy (0.9%) (vs. 0.2% in 2009–2010) [51].

There are certain behaviors that are suggestive of an emerging opioid use disorder. The most suggestive behaviors are [45,47,48]:

- Selling medications

- Prescription forgery or alteration

- Injecting medications meant for oral use

- Obtaining medications from nonmedical sources

- Resisting medication change despite worsening function or significant negative effects

- Loss of control over alcohol use

- Using illegal drugs or non-prescribed controlled substances

- Recurrent episodes of:

- Prescription loss or theft

- Obtaining opioids from other providers in violation of a treatment agreement

- Unsanctioned dose escalation
−Running out of medication and requesting early refills

Behaviors with a lower level of evidence for their association with opioid misuse include [45,47,48]:

- Aggressive demands for more drug

- Asking for specific medications

- Stockpiling medications during times when pain is less severe

- Using pain medications to treat other symptoms

- Reluctance to decrease opioid dosing once stable

- In the earlier stages of treatment:

- Increasing medication dosing without provider permission

- Obtaining prescriptions from sources other than the pain provider

- Sharing or borrowing similar medications from friends/family

INTERVENTIONS FOR SUSPECTED OR KNOWN ADDICTION OR DRUG DIVERSION

There are a number of actions that prescribers and dispensers can take to prevent or intervene in cases of drug diversion. These actions can be generally categorized based on the various mechanisms of drug diversion.

Prevention is the best approach to addressing drug diversion. As noted, the most common source of nonmedical use of prescribed opioids is from a family member or friend, through sharing, buying, or stealing. To avoid drug sharing among patients, healthcare professionals should educate patients on the dangers of sharing opioids and stress that "doing prescription drugs" is the same as "using street drugs" [49]. In addition, patients should be aware of the many options available to treat chronic pain aside from opioids. To prevent theft, patients should be advised to keep medications in a private place and to refrain from telling others about the medications being used.

Communication among providers and pharmacies can help to avoid inappropriate attainment of prescription drugs through "doctor shopping." Prescribers should keep complete and up-to-date records for all controlled substance prescribing. When possible, electronic medical records should be integrated between pharmacies, hospitals, and managed care organizations [49]. If available, it is also best practice to periodically request a report from the state's prescription reporting program to evaluate the prescribing of opioids to your patients by other providers [49].

When dealing with patients suspected of drug seeking/diversion, first inquire about prescription, over-the-counter, and illicit drug use and perform a thorough examination [43,49]. Pill counting and/or UDT may be necessary to investigate possible drug misuse. Photo identification or other form of identification and social security number may be required prior to dispensing the drug, with proof of identity documented fully. If a patient is displaying suspicious behaviors, consider prescribing for limited quantities [43].

If a patient is found to be abusing prescribed opioids, this is considered a violation of the treatment agreement and the clinician must make the decision whether or not to continue the therapeutic relationship. While dentists have the option of withdrawing from a case, they should notify the patient (or authorized decision maker) long enough in advance to permit the patient to secure another care provider and facilitate transfer of care, when appropriate [42]. Patients may also be given resources and/or recommendations to help them locate a new dentist.

Patients with chronic pain found to have an ongoing substance abuse problem or addiction should be referred to a pain specialist for continued treatment. Theft or loss of controlled substances is reported to the DEA. If drug diversion has occurred, the activity should be documented and a report to law enforcement should be made [38].

CONSIDERATIONS FOR PATIENTS UNDERGOING TREATMENT FOR OPIOID USE DISORDER

Medication-assisted therapy for the treatment of opioid use disorder often includes the use of buprenorphine, which reduces withdrawal symptoms and the desire to use opioids without causing the cycle of highs and lows associated with opioid misuse. The comprehensive approach of buprenorphine combined with counseling and other behavioral therapies is often one of the most effective ways to treat opioid use disorder [27].

However, buprenorphine is highly acidic, and dental problems have been reported with orally dissolving buprenorphine-containing formulations, including increased risk for tooth decay, cavities, oral infections, and loss of teeth. These complications can be serious and have been reported even in patients with no history of dental issues. Despite these risks, buprenorphine is an important treatment option for opioid use disorder and pain, and the benefits of these medicines clearly outweigh the risks.

The American Dental Association recommends instructing patients taking oral buprenorphine therapy should be instructed to rinse their mouths 30 minutes after use of a strip/tab [30]. After one hour, patients should brush their teeth. These patients should also be instructed to adhere to good oral hygiene practices and to drink more water to combat potential xerostomia. Sugary beverages and smoking/vaping should be limited or avoided, if possible. Prescription fluoride toothpaste or trays should be considered [30].

It is also essential to consider the impact of medication-assistant opioid use disorder treatment on dental pain management. Naltrexone is an opioid antagonist and will block the action of opioids used to manage dental pain. In addition, buprenorphine/methadone therapy increases patients' tolerance for other opioids. Any dental pain management plans should take these potential issues into account.

6. REGULATORY REQUIREMENTS FOR PRESCRIBERS AND DISPENSERS

COMPLIANCE WITH STATE AND FEDERAL LAWS

In response to the rising incidence in prescription opioid abuse, addiction, diversion, and overdose since the late 1990s, the FDA has mandated opioid-specific REMS to reduce the potential negative patient and societal effects of prescribed opioids. Other elements of opioid risk mitigation include FDA partnering with other governmental agencies, state professional licensing boards, and societies of healthcare professionals to help improve prescriber knowledge of appropriate and safe opioid prescribing and safe home storage and disposal of unused medication [24].

Several regulations and programs at the state level have been enacted in an effort to reduce prescription opioid abuse, diversion, and overdose, including [37]:

- Physical examination required prior to prescribing

- Tamper-resistant prescription forms

- Pain clinic regulatory oversight

- Prescription limits

- Prohibition from obtaining controlled substance prescriptions from multiple providers

- Patient identification required before dispensing

- Immunity from prosecution or mitigation at sentencing for individuals seeking assistance during an overdose

CONTROLLED SUBSTANCES LAWS/RULES

The U.S. Drug Enforcement Administration (DEA) is responsible for formulating federal standards for the handling of controlled substances. In 2011, the DEA began requiring every state to implement electronic databases that track prescribing habits, referred to as PDMPs. Specific policies regarding controlled substances are administered at the state level [36].

According to the DEA, drugs, substances, and certain chemicals used to make drugs are classified into five distinct categories or schedules depending upon the drug's acceptable medical use and the drug's abuse or dependency potential [35]. The abuse rate is a determinate factor in the scheduling of the drug; for example, Schedule I drugs are considered the most dangerous class of drugs with a high potential for abuse and potentially severe psychological and/or physical dependence.

STATE-SPECIFIC LAWS AND RULES

Most states have established laws and rules governing the prescribing and dispensing of opioid analgesics. It is each prescriber's responsibility to have knowledge of and adhere to the laws and rules of the state in which he or she prescribes.

7. CONCLUSION

Opioid analgesic medications can bring substantial relief to patients suffering from pain. However, the inappropriate use, abuse, and diversion of prescription drugs in America, particularly prescription opioids, has increased dramatically in recent years and has been identified as a national public health epidemic. A set of clinical tools, guidelines, and recommendations are now available for prescribers who treat patients with opioids. By implementing these tools, the clinician can effectively address issues related to the clinical management of opioid prescribing, opioid risk management, regulations surrounding the prescribing of opioids, and problematic opioid use by patients. In doing so, healthcare professionals are more likely to achieve a balance between the benefits and risks of opioid prescribing, optimize patient attainment of therapeutic goals, and avoid the risk to patient outcome, public health, and viability of their own practice imposed by deficits in knowledge.

8. APPENDIX: LAWS AND REGULATIONS IN CALIFORNIA

HEALTH AND SAFETY CODE

DIVISION 10. UNIFORM CONTROLLED SUBSTANCES ACT

CHAPTER 4. Prescriptions

ARTICLE 1. Requirements of Prescriptions

§11165.4.

1. A health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance shall consult the patient activity report or information from the patient activity report obtained from the CURES database to review a patient's controlled substance history for the past 12 months before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.

2. If a health care practitioner authorized to prescribe, order, administer, or furnish a controlled substance is not required, pursuant to an exemption described in subdivision (c), to consult the patient activity report from the CURES database the first time the health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient, the health care practitioner shall consult the patient activity report from the CURES database to review the patient's controlled substance history before subsequently prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient and at least once every six months thereafter if the prescriber renews the prescription and the substance remains part of the treatment of the patient.

3. A health care practitioner who did not directly access the CURES database to perform the required review of the controlled substance use report shall document in the patient's medical record that they reviewed the CURES database generated report within 24 hours of the controlled substance prescription that was provided to them by another authorized user of the CURES database.

2. For purposes of this paragraph, "first time" means the initial occurrence in which a health care practitioner, in their role as a health care practitioner, intends to prescribe, order, administer, or furnish a Schedule II, Schedule III, or Schedule IV controlled substance to a patient and has not previously prescribed a controlled substance to the patient.

2. A health care practitioner shall review a patient's controlled substance history that has been obtained from the CURES database no earlier than 24 hours, or the previous business day, before the health care practitioner prescribes, orders, administers, or furnishes a Schedule II, Schedule III, or Schedule IV controlled substance to the patient.

2. The duty to consult the CURES database, as described in subdivision (a), does not apply to veterinarians or pharmacists.

3. The duty to consult the CURES database, as described in subdivision (a), does not apply to a health care practitioner in any of the following circumstances:

1. If a health care practitioner prescribes, orders, or furnishes a controlled substance to be administered to a patient in any of the following facilities or during a transfer between any of the following facilities, or for use while on facility premises:

1. A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2.

2. An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2.

3. A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2.

4. A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2.

5. Another medical facility, including, but not limited to, an office of a health care practitioner and an imaging center.

6. A correctional clinic, as described in Section 4187 of the Business and Professions Code, or a correctional pharmacy, as described in Section 4021.5 of the Business and Professions Code.

2. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance in the emergency department of a general acute care hospital and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use.

3. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient as part of the patient's treatment for a surgical, radiotherapeutic, therapeutic, or diagnostic procedure and the quantity of the controlled substance does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use, in any of the following facilities:

1. A licensed clinic, as described in Chapter 1 (commencing with Section 1200) of Division 2.

2. An outpatient setting, as described in Chapter 1.3 (commencing with Section 1248) of Division 2.

3. A health facility, as described in Chapter 2 (commencing with Section 1250) of Division 2.

4. A county medical facility, as described in Chapter 2.5 (commencing with Section 1440) of Division 2.

5. A place of practice, as defined in Section 1658 of the Business and Professions Code.

6. Another medical facility where surgical procedures are permitted to take place, including, but not limited to, the office of a health care practitioner.

4. If a health care practitioner prescribes, orders, administers, or furnishes a controlled substance to a patient who is terminally ill, as defined in subdivision (c) of Section 11159.2.

1. If all of the following circumstances are satisfied:

1. It is not reasonably possible for a health care practitioner to access the information in the CURES database in a timely manner.

2. Another health care practitioner or designee authorized to access the CURES database is not reasonably available.

3. The quantity of controlled substance prescribed, ordered, administered, or furnished does not exceed a nonrefillable seven-day supply of the controlled substance to be used in accordance with the directions for use and no refill of the controlled substance is allowed.

2. A health care practitioner who does not consult the CURES database under subparagraph (A) shall document the reason they did not consult the database in the patient's medical record.

6. If the CURES database is not operational, as determined by the department, or cannot be accessed by a health care practitioner because of a temporary technological or electrical failure. A health care practitioner shall, without undue delay, seek to correct the cause of the temporary technological or electrical failure that is reasonably within the health care practitioner's control.

7. If the CURES database cannot be accessed because of technological limitations that are not reasonably within the control of a health care practitioner.

8. If consultation of the CURES database would, as determined by the health care practitioner, result in a patient's inability to obtain a prescription in a timely manner and thereby adversely impact the patient's medical condition, provided that the quantity of the controlled substance does not exceed a nonrefillable seven-day supply if the controlled substance were used in accordance with the directions for use.

1. A health care practitioner who fails to consult the CURES database, as described in subdivision (a), shall be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board.

2. This section does not create a private cause of action against a health care practitioner. This section does not limit a health care practitioner's liability for the negligent failure to diagnose or treat a patient.

5. All applicable state and federal privacy laws govern the duties required by this section.

6. The provisions of this section are severable. If any provision of this section or its application is held invalid, that invalidity shall not affect other provisions or applications that can be given effect without the invalid provision or application.

7. This section shall become operative on July 1, 2021, or upon the date the department promulgates regulations to implement this section and posts those regulations on its internet website, whichever date is earlier.

CALIFORNIA BUSINESS AND PROFESSIONS CODE

DIVISION 2. HEALING ARTS

CHAPTER 1. General Provisions

ARTICLE 7.5. Health Care Practitioners

§688.

1. A health care practitioner authorized to issue a prescription pursuant to Section 4040 shall have the capability to issue an electronic data transmission prescription, as defined under Section 4040, on behalf of a patient and to transmit that electronic data transmission prescription to a pharmacy selected by the patient.

1. A pharmacy, pharmacist, or other practitioner authorized under California law to dispense or furnish a prescription pursuant to Section 4040 shall have the capability to receive an electronic data transmission prescription on behalf of a patient.

2. A pharmacy, pharmacist, or other practitioner authorized under California law to dispense or furnish a prescription pursuant to Section 4040 shall not refuse to dispense or furnish an electronic data transmission prescription solely because the prescription was not submitted via, or is not compatible with, the proprietary software of the pharmacy, pharmacist, or other dispensing practitioner.

3. A pharmacy, pharmacist, or other practitioner authorized under California law to dispense or furnish a prescription pursuant to Section 4040 may decline to dispense or furnish an electronic data transmission prescription submitted via a software that fails to meet any of the following:

1. Adheres to the National Council for Prescription Drug Programs SCRIPT standard, as modified from time to time.

2. Complies with the prescription content requirements set forth in Section 4040.

3. For a controlled substance prescription, complies with Parts 1300, 1304, 1306, and 1311 of Title 21 of the Code of Federal Regulations, as amended from time to time.

4. Complies with the federal Health Insurance Portability and Accountability Act of 1996, the California Confidentiality of Medical Information Act, or the security and confidentiality requirements prescribed to by the pharmacy, pharmacist, or other practitioner authorized pursuant to Section 4040.

3. For a prescription for a controlled substance, as defined by Section 4021, generation and transmission of the electronic data transmission prescription shall comply with Parts 1300, 1304, 1306, and 1311 of Title 21 of the Code of Federal Regulations, as amended from time to time.

4. A prescription prescribed by a health care practitioner shall be issued as an electronic data transmission prescription. This subdivision shall not apply to prescriptions issued pursuant to subdivision (e).

5. Subdivision (d) shall not apply to any of the following:

1. The prescription is issued pursuant to Section 11159.2 of the Health and Safety Code.

2. An electronic data transmission prescription is unavailable due to a temporary technological or electrical failure. For purposes of this paragraph, "temporary technological or electrical failure" means failure of a computer system, application, or device, or the loss of electrical power to that system, application, or device, or any other service interruption affecting the certified electronic data transmission prescription application used to transmit the prescription.

3. The prescribing health care practitioner is issuing a prescription to be dispensed by a pharmacy located outside California.

1. The prescription is issued in a hospital emergency department or urgent care clinic and one or more of the following conditions are present:

1. The patient resides outside California.

2. The patient resides outside the geographic area of the hospital.

3. The patient is homeless or indigent and does not have a preferred pharmacy.

4. The prescription is issued at a time when a patient's regular or preferred pharmacy is likely to be closed.

2. Under any of the conditions described in subparagraph (A), a prescription shall be electronically issued but does not require electronic transmission and may be provided directly to the patient.

5. The prescription is issued by a veterinarian.

6. The prescription is for eyeglasses or contact lenses.

7. The prescription is issued by a prescribing health care practitioner serving as a volunteer in a free clinic and receives no remuneration for their services.

8. The prescribing health care practitioner and the dispenser are the same entity.

9. The prescription is issued by a prescribing health care practitioner under circumstances whereby the practitioner reasonably determines that it would be impractical for the patient to obtain substances prescribed by an electronic data transmission prescription in a timely manner, and the delay would adversely impact the patient's medical condition.

10. The prescription that is issued includes elements not covered by the latest version of the National Council for Prescription Drug Programs' SCRIPT standard, as amended from time to time.

1. The prescriber registers with the California State Board of Pharmacy in a manner and format determined by the board, stating that they meet one or more of the following criteria:

1. Their practice is located in the area of an emergency or disaster declared by a federal, state, or local government.

2. They issue 100 or fewer prescriptions per calendar year.

3. They are unable to issue electronic data transmission prescriptions due to circumstances beyond their control.

2. The prescriber shall annually submit the registration required in subparagraph (A) to the California State Board of Pharmacy and maintain documentation of the circumstances qualifying them for exemption under subparagraph (A).

3. The California State Board of Pharmacy shall post a list of prescribers meeting the requirements of subparagraph (A) on its internet website.

6. A health care practitioner who issues a prescription for a controlled substance but does not transmit the prescription as an electronic data transmission prescription shall document the reason in the patient's medical record as soon as practicable and within 72 hours of the end of the technological or electrical failure that prevented the electronic data transmission of the prescription.

1. A pharmacy that receives an electronic data transmission prescription from a prescribing health care practitioner who has issued the prescription but has not dispensed the medication to the patient shall, at the request of the patient or a person authorized to make a request on behalf of the patient, immediately transfer or forward the electronic data transmission prescription to an alternative pharmacy designated by the requester, unless one of the following applies:

1. The action would result in a violation of any state or federal law.

2. The action is not supported by the latest version of the National Council for Prescription Drug Programs SCRIPT standard, as amended from time to time.

2. If a pharmacy is prohibited from transferring or forwarding electronic data transmission prescriptions, as specified in paragraph (1), to a designated alternative pharmacy, and that prohibition is subsequently removed, then that pharmacy shall implement, within one year from the date the prohibition is removed, the necessary provisions to allow for the transferring or forwarding of an electronic data transmission prescription.

8. If a pharmacy, or its staff, is aware than an attempted transmission of an electronic data transmission prescription failed, is incomplete, or is otherwise not appropriately received, the pharmacy shall immediately notify the prescribing health care practitioner.

9. A pharmacist who receives a written, oral, or faxed prescription shall not be required to verify that the prescription properly falls under one of the exceptions in subdivision (e). Pharmacists may continue to dispense medications from legally valid written, oral, or fax prescriptions pursuant to this division.

10. A health care practitioner, pharmacist, or pharmacy who fails to meet the applicable requirements of this section shall be referred to the appropriate state professional licensing board solely for administrative sanctions, as deemed appropriate by that board. This section does not create a private right of action against a health care practitioner. This section does not limit a health care practitioner's liability for the negligent failure to diagnose or treat a patient.

11. This section shall not apply to a health care practitioner, pharmacist, or pharmacy when providing health care services to an inmate, individual on parole, or youth under the jurisdiction of the Department of Corrections and Rehabilitation.

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21. Fine PG, Finnegan T, Portenoy RK. Protect your patients, protect your practice: practical risk assessment in the structuring of opioid therapy in chronic pain. J Fam Pract. 2010;59(9 Suppl 2):S1-S16.

22. Katz NP. Opioid Prescribing Toolkit: A Workbook for Clinicians. New York, NY: Oxford University Press; 2010.

23. American Chronic Pain Association. ACPA– Stanford Resource Guide to Pain Management: 2020 Edition. Available at https://www.theacpa.org/wp-content/uploads/2020/03/ACPA-Resource-Guide-2020-2-26-2020.pdf. Last accessed April 22, 2021.

24. Strickland JM, Huskey A, Brushwood DB. Pharmacist-physician collaboration in pain management practice. J Opioid Manag. 2007;3:295-301.

25. Brushwood DB. Screening Controlled Substance Prescriptions for Legitimacy: The VIGIL System. Available at http://www.empaa.org/downloads/EMPAA2010/presentation/BrushwoodDavid_VIGIL_EMPAA2010.pdf. Last accessed April 22, 2021.

26. Miner J, Babitz M, Dunn A, Fondario A, Smith M. Utah Clinical Guidelines on Prescribing Opioids for Treatment of Pain. Salt Lake City, UT: Utah Department of Health; 2018.

27. U.S. Food and Drug Administration. FDA Warns About Dental Problems with Buprenorphine Medicines Dissolved in the Mouth to Treat Opioid Use Disorder and Pain. Available at https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-dental-problems-buprenorphine-medicines-dissolved-mouth-treat-opioid-use-disorder. Last accessed January 12, 2024.

28. Kaye AD, Jones MR, Kaye AM, et al. Prescription opioid abuse in chronic pain: an updated review of opioid abuse predictors and strategies to curb opioid abuse (part 2). Pain Physician. 2017;20(Supp 2):S111-S133.

29. American Society of Anesthesiologists. Opioid Abuse. Available at https://www.asahq.org/madeforthismoment/pain-management/opioid-treatment/opioid-abuse. Last accessed April 22, 2021.

30. American Dental Association. Helping Dental Professionals Identify and Support Patients with Substance Use Disorders Available at https://www.ada.org/-/media/project/ada-organization/ada/ada-org/files/resources/practice/health-and-wellness/helping_dental_professionals_identify_and_sup.pdf. Last accessed January 12, 2024.

31. Federal Drug Administration. Safe Opioid Disposal: Remove the Risk Outreach Toolkit. Available at https://www.fda.gov/drugs/ensuring-safe-use-medicine/safe-opioid-disposal-remove-risk-outreach-toolkit. Last accessed January 12, 2024.

32. Oliver J, Coggins C, Compton P, et al. American Society for Pain Management Nursing position statement: pain management in patients with substance use disorders. Pain Manage Nurs. 2012;13(3):169-183.

33. U.S. Food and Drug Administration. FDA Analysis of Long-Term Trends in Prescription Opioid Analgesic Products: Quantity, Sales, and Price Trends. Available at https://www.fda.gov/media/111695/download. Last accessed January 12, 2024.

34. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC clinical practice guideline for prescribing opioids for pain—United States, 2022. MMWR. 2022;71(3);1-95.

35. U.S. Drug Enforcement Administration. Drug Scheduling. Available at https://www.dea.gov/drug-scheduling. Last accessed January 12, 2024.

36. Hannon K. The Prescription Drug Crisis in New York State: A Comprehensive Approach. Available at https://www.scribd.com/doc/82474334/Prescription-Drug-Abuse-Crisis-in-NYS-Comprehensive-Approach-New. Last accessed January 12, 2024.

37. American Medical Association. Code of Ethics: Opinion 1.1.5 Terminating the Patient-Physician Relationship. Available at https://www.ama-assn.org/sites/ama-assn.org/files/corp/media-browser/code-of-medical-ethics-chapter-1.pdf. Last accessed January 12, 2024.

38. U.S. Department of Health and Human Services Drug Diversion: What Is a Prescriber's Role in Preventing the Diversion of Prescription Drugs? Available at https://www.hhs.gov/guidance/document/drug-diversion-what-prescribers-role-preventing-diversion-prescription-drugs. Last accessed January 12, 2024.

39. Lovegrove MC, Dowell D, Geller AI, et al. US emergency department visits for acute harms from prescription opioid use, 2016–2017. Am J Pub Health. 2019;109:784-791.

40. Centers for Disease Control and Prevention. CDC Advises Against Misapplication of the Guideline for Prescribing Opioids for Chronic Pain. Available at https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html. Last accessed January 12, 2024.

41. Loeser JD, Schatman ME. Chronic pain management in medical education: a disastrous omission. Postgrad Med. 2017;129(3):332-335.

42. Donovan DM, Ingalsbe MH, Benbow J, Daley DC. 12-step interventions and mutual support programs for substance use disorders: an overview. Soc Work Public Health. 2013;28(3-4):313-332.

43. U.S. Department of Justice Office of Diversion Control. Don't Be Scammed By A Drug Abuser. Available at https://www.deadiversion.usdoj.gov/pubs/brochures/drugabuser.htm. Last accessed January 12, 2024.

44. National Institute on Drug Abuse. Benzodiazepines and Opioids. Available at https://www.drugabuse.gov/drugs-abuse/opioids/benzodiazepines-opioids. Last accessed January 12, 2024.

45. Holliday S, Hayes C, Dunlop A. Opioid use in chronic non-cancer pain. Part 2: prescribing issues and alternatives. Australian Family Physician. 2013;42:104-111.

46. Passik SD, Kirsh KL, Whitcomb L, et al. A new tool to assess and document pain outcomes in chronic pain patients receiving opioid therapy. Clin Ther. 2004;26:552-561.

47. Passik SD. Issues in long-term opioid therapy: unmet needs, risks, and solutions. Mayo Clin Proc. 2009;84:593-601.

48. National Institute on Drug Abuse. Minimizing the Misuse of Prescription Opioids in Patients with Chronic Nonmalignant Pain. Available at https://www.drugabuse.gov/nidamed/centers-excellence/resources/minimizing-misuse-prescription-opioids-in-patients-chronic-nonmalignant-pain. Last accessed January 12, 2024.

49. American College of Preventive Medicine. Use, Abuse, Misuse and Disposal of Prescription Pain Medication Patient Guide. Available at http://www.yuma.usmc-mccs.org/mccsyuma/assets/File/Drug%20Facts%20Sheets/painmedsclinicalreference.pdf. Last accessed January 12, 2024.

50. U.S. Food and Drug Administration. Disposal of Unused Medicines: What You Should Know. Available at https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know. Last accessed January 12, 2024.

51. Substance Abuse and Mental Health Services Administration. Results from the 2019 National Survey on Drug Use and Health: Detailed Tables. Available at https://www.samhsa.gov/data/report/2019-nsduh-detailed-tables. Last accessed January 12, 2024.

52. Evidence-Based Practice Recommendations Citation

53. Manchikanti L, Abdi S, Atluri S, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: part 2—guidance. Pain Physician. 2012;15(3 Suppl):S67-S116. Available at https://painphysicianjournal.com/2012/july/2012;%2015;S67-S116.pdf. Last accessed January 24, 2024.

58020 • Commonly Abused Supplements

Chelsey McIntyre, PharmD

www.netce.com

Copyright © 2022 NetCE, All rights reserved.

Dietary supplement use is increasingly common. In addition to their use for the management of medical conditions, dietary supplements are often misused or abused for recreation, body image concerns, athletic performance, and mood enhancement. Healthcare professionals should be well informed about these commonly abused supplements so that they can understand what they are and how they work and provide adequate safety warnings.

Table of Contents

58020 • Commonly Abused Supplements

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planner

Division Planner Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. INTRODUCTION

2. ABUSE POTENTIAL RELATED TO WEIGHT LOSS AND/OR ATHLETIC PERFORMANCE

1,3-DIMETHYLAMYLAMINE (1,3-DMAA)

BITTER ORANGE AND OCTOPAMINE

CAFFEINE

EPHEDRA

STIMULANT INTERACTION CONCERNS

3. LAXATIVES

SENNA

CASTOR OIL

SAFETY

4. ABUSE POTENTIAL RELATED TO RECREATIONAL USE

GHB

5. ABUSE POTENTIAL RELATED TO OPIOID-LIKE EFFECTS

KRATOM

6. CONSIDERATIONS FOR NON-ENGLISH-PROFICIENT PATIENTS

7. CONCLUSION

Works Cited

58020 • Commonly Abused Supplements

Education Category. Alternative Medicine

Release Date. 11/01/2022

Expiration Date. 10/31/2025

Course Overview

Dietary supplement use is increasingly common. In addition to their use for the management of medical conditions, dietary supplements are often misused or abused for recreation, body image concerns, athletic performance, and mood enhancement. Healthcare professionals should be well informed about these commonly abused supplements so that they can understand what they are and how they work and provide adequate safety warnings.

Audience

This course is designed for dental professionals whose patients are taking or are interested in taking dietary supplements.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type.

Designations of Credit

NetCE designates this activity for 2 continuing education credits. AGD Subject Code 149. This course meets the Dental Board of California's requirements for 2 unit(s) of continuing education. Dental Board of California course #02-3841-24370.

Course Objective

The purpose of this course is to provide dental professionals in all practice settings the knowledge necessary to increase their understanding of the commonly abused supplements and their adverse effects.

Learning Objectives

Upon completion of this course, you should be able to:

1. Outline supplements with abuse potential related to weight loss and/or athletic performance.

2. Describe how dietary supplements with laxative effects might be abused.

3. Discuss the potential to misuse specific supplements for recreational or opioid-like experiences.

Faculty

Chelsey McIntyre, PharmD, is a clinical pharmacist who specializes in drug information, literature analysis, and medical writing. She earned her Bachelor of Science degree in Genetics from the University of California, Davis. She then went on to complete her PharmD at Creighton University, followed by a clinical residency at the Children’s Hospital of Philadelphia (CHOP). Dr. McIntyre held the position of Drug Information and Policy Development Pharmacist at CHOP until her move to Washington state in 2017, after which she spent the next six years as a clinical editor for Natural Medicines, a clinical reference database focused on natural products and alternative therapies. She continues to create rigorous professional analysis and patient education materials for various publications while also practicing as a hospital pharmacist. Her professional interests include provider and patient education, as well as the application of evidence-based research to patient care.

Faculty Disclosure

Contributing faculty, Chelsey McIntyre, PharmD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planner

Mark J. Szarejko, DDS, FAGD

Division Planner Disclosure

The division planner has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. INTRODUCTION

Use of dietary supplements continues to increase. In addition to their use for the management of medical conditions, dietary supplements are often misused or abused for recreation, body image concerns, athletic performance, and mood enhancement. Poison control center data indicate that abuse and misuse of dietary supplements occurs across the life span, with reports in adolescents to those older than 60 years of age [1].

Abuse refers to the use of a substance to gain a psychotropic effect. Misuse refers to the use of a substance for reasons other than a psychotropic effect. While abuse and misuse of dietary supplements is similar in many ways to other forms of substance abuse, there are a few things that set it apart from that of prescription medications, alcohol, tobacco, and illicit drugs. Many consumers perceive products that are natural to be synonymous with safety, which is certainly not the case. Additionally, availability of supplements reduces barriers to their access and legality concerns [1].

The focus of this course will be on the following commonly abused supplements, how they work, and their associated safety concerns:

- Stimulants (1,3-dimethylamylamine [1,3-DMAA], bitter orange, caffeine, ephedra, octopamine)

- Laxatives (castor oil, senna)

- Gamma hydroxybutyrate (GHB)

- Kratom

Note that these select supplements are commonly abused in North America. Supplements commonly abused in other parts of the world are beyond the scope of this course.

2. ABUSE POTENTIAL RELATED TO WEIGHT LOSS AND/OR ATHLETIC PERFORMANCE

Stimulants are a class of substances that speed up the body's systems, and for this reason, they are commonly referred to as "uppers." There are numerous U.S. Food and Drug Administration (FDA)-approved stimulants that are safely used under medical supervision for accepted medical uses (e.g., nasal decongestants, treatment of attention deficit hyperactivity disorder [ADHD]). Stimulant supplements are commonly touted for their energy-boosting beneficial effects on athletic performance and for promoting weight loss.

1,3-DIMETHYLAMYLAMINE (1,3-DMAA)

1,3-DMAA, also called methylhexaneamine, is a synthetic stimulant, meaning that it is prepared in a lab. It was originally developed as an ingredient for relieving nasal congestion because of its stimulant and vasoconstrictive activity. It has more recently been marketed in dietary supplements for athletic performance and weight loss [2].

Quality Concerns

Formulations of 1,3-DMAA often list rose geranium oil, geranium oil, or geranium stems as an ingredient on the label. While some manufacturers claim that 1,3-DMAA is a natural compound found in geranium oil, this claim has not been confirmed by laboratory analysis. In 2011, Health Canada determined that there is no credible evidence that 1,3-DMAA is derived from the geranium plant. As a result, there is concern that formulations purportedly containing "rose geranium oil," "geranium oil," and "geranium stems" may actually be adding the synthetic drug to their supplements [2].

Regulatory Concerns

In 2011, Health Canada determined that 1,3-DMAA should be considered a drug and is not allowed to be included in dietary supplements [2]. In 2013, the FDA declared products containing 1,3-DMAA to be illegal and to have potential health risks. 1,3-DMAA has been included on the prohibited lists of the World Anti-Doping Agency (WADA) and the U.S. Department of Defense (DoD) for more than 10 years [2].

Safety

Although 1,3-DMAA has been associated with cardiovascular adverse effects, these concerns have rarely been reported in patients taking 1,3-DMAA alone. Most of the severe adverse effects related to 1,3-DMAA are associated with its use in combination products [2].

Palpitations and tachycardia are the most common adverse effects reported with 1,3-DMAA-containing products. Angina, atrial fibrillation, chest pressure, hypertension, hypotension, and myocardial infarction have also occurred. In case reports of healthy young adults taking 1,3-DMAA-containing combination products prior to exercise, cardiac arrest causing death has occurred [2].

BITTER ORANGE AND OCTOPAMINE

Bitter orange is a small, flowering, fruit-bearing tree whose flowers, leaves, and fruits (including peel) have stimulant effects. Bitter orange has numerous active constituents and pharmacologic effects which vary by plant part and preparation method [3].

The fruit and the peel of bitter orange contain the adrenergic agonists synephrine and octopamine, which are frequently cited on labels as active ingredients. Synephrine and octopamine are chemically similar and occur naturally in the body in small amounts. Structurally, synephrine is similar to epinephrine and octopamine is similar to norepinephrine [3,4].

Quality Concerns

Many marketed bitter orange products contain greater amounts of synephrine and other natural and synthetic amines than is stated on the label, increasing the risk for serious stimulant-related adverse effects. In a laboratory analysis of marketed bitter orange products, only 22% of the products tested had synephrine content within 20% of the amount stated on labels. The analysis also confirmed the presence of the synthetic amines methylsynephrine and isopropyloctopamine, neither of which are permitted in dietary supplements [3].

Similarly, the amount of octopamine found in products marketed for athletic performance is much greater than the quantity found naturally occurring in some plants (e.g., bitter orange). Natural levels of octopamine in bitter orange are less than 0.03%. A review of 32 products showed that octopamine was present in two products at levels as high as 11% and 12.9%, suggesting that manufacturers are adding synthetic octopamine to supplement products. In an analysis of bitter orange extract, octopamine was identified in all three products tested, although it only appeared on the label of two products. One analyzed product contained only 2.8% of the quantity of octopamine stated on the label [4].

Regulatory Concerns

Since the FDA banned ephedra in 2004, bitter orange has been frequently used in products labeled as "ephedra-free." Synephrine, a constituent of bitter orange, is considered a banned substance by the National Collegiate Athletic Association (NCAA). Similarly, octopamine has been included on the WADA prohibited list [3,4].

Safety

Most of the severe adverse effects related to bitter orange are associated with its use in combination products. Hypertension and tachycardia are the most common adverse effects reported with bitter orange-containing products, particularly in combination with caffeine and/or other stimulant ingredients. Other adverse effects reported with the use of bitter orange- or synephrine-containing multi-ingredient products, with or without other stimulants, include blackout, cardiac arrest, collapse, ischemic stroke, myocardial infarction, QT prolongation, tachyarrhythmia, tachycardia, variant angina, ventricular fibrillation, and death [3].

A clinical evaluation of safety outcomes has not been conducted for octopamine, but given its chemical similarity to synephrine, adverse effects similar to those seen with other stimulants can be expected [4].

CAFFEINE

Caffeine might be one of the best-known stimulants. It is a naturally occurring, bitter-tasting methylxanthine compound found in the leaves, seeds, or fruits of more than 60 plants, including coffee (Coffea arabica) beans, cacao (Theobroma cacao) beans, kola (Cola acuminata) nuts, guarana (Paullinia cupana) berries, and tea (Camellia sinensis) leaves. It is structurally related to theophylline, theobromine, and uric acid and is a nonselective adenosine antagonist [5].

Caffeine is present in a wide variety of beverages [5]:

- One cup of brewed coffee provides 95–200 mg of caffeine.

- An 8-ounce serving of black tea provides 25–110 mg of caffeine.

- An 8-ounce serving of green tea provides 30–50 mg of caffeine.

- A 12-ounce soft drink (e.g. cola) provides 20–80 mg of caffeine.

- A serving of sports or energy drink typically provides 48–300 mg of caffeine.

Caffeine is also available alone or in combination with other ingredients in some prescription and over-the-counter products that are approved for specific medical uses (e.g., to help restore mental alertness and wakefulness when experiencing fatigue or drowsiness). Caffeine tablets contain up to about 200 mg of caffeine [5].

Keep in mind that only the amount of added caffeine must be stated on product labels, and the amount of caffeine from caffeine-containing natural ingredients (e.g., coffee, green tea) is not required to be provided, making it difficult to determine the total amount of caffeine in a given product.

Caffeine has been demonstrated to improve athletic performance. It decreases perceived levels of exertion, enabling athletes to feel less tired and increase their performance. It can also improve anaerobic exercise performance. Within limits, the NCAA allows caffeine consumption. During competition, however, urine concentrations must not exceed 15 mcg/mL. Consumption of 600–800 mg of caffeine would need to be consumed two to three hours prior to performance in most people in order to achieve this urine concentration [5].

Safety

A review by Health Canada and a subsequent large meta-analysis conducted in the United States show that caffeine doses up to 400 mg daily are not associated with significant adverse cardiovascular, bone, behavioral, or reproductive effects in healthy adults. Similarly, the U.S. Dietary Guidelines Advisory Committee states that there is strong and consistent evidence that consumption of caffeine 400 mg daily is not associated with increased risk of major chronic diseases, such as cardiovascular disease or cancer, in healthy adults [5].

Caffeine is generally well tolerated, with regular use and in moderate doses. Common side effects include cause anxiety, diarrhea, diuresis, headache, insomnia, muscular tremors, nausea, and restlessness. But caffeine can become unsafe when used long-term and/or in high doses [5].

Acute use of high doses, typically those exceeding 400 mg daily, have been associated with significant adverse effects, such as tachyarrhythmia and sleep disturbances. Some people may experience serious toxicity even at lower doses, owing to caffeine's effects being impacted by smoking status, age, and prior caffeine use [5].

Some caffeine products for supplement use are highly concentrated or pure formulations. These are most concerning because they have a high risk for being mistakenly used in excessive and potentially dangerous doses. Powdered pure caffeine can contain as much as 3.2 grams of caffeine in a single teaspoon and concentrated liquid caffeine can contain about 2 grams of caffeine in as little as one-half cup [5].

With large amounts of caffeine (more than 10 mg per kg daily), there have been reports of aortic dissection, atrial fibrillation, cardiac arrest, celiac artery trunk dissection, chest pain, coronary artery vasospasm, extrasystoles, hemorrhagic stroke, ischemic stroke, tachycardia, transient ischemic attack, and ventricular tachycardia [5].

The acute oral dose of caffeine resulting in death in adults is estimated to be 10–14 grams (150–200 mg per kg), although fatality has occurred at lower doses. Deaths typically have been attributed to ventricular fibrillation [5]. At least two deaths have been linked to the use of highly concentrated and pure formulations. In 2018, the FDA announced that highly concentrated and pure formulations of caffeine are unlawful when sold directly to consumers in bulk quantities [5].

There have been numerous case reports of seizures with excessive caffeine intake and also when combining caffeine with other stimulants. Life-threatening events are also more common after taking caffeine-containing energy or weight loss products when compared with non-caffeine containing products. Deaths have occurred following consumption of caffeine alone or in combination with other stimulants or alcohol [5].

EPHEDRA

Ephedra, sometimes called ma huang, is a stimulant herb usually taken from the stem and branches of Ephedra sinica. It contains the principal alkaloid constituents ephedrine, pseudoephedrine, and sometimes small amounts of phenylpropanolamine. It has a long history of use in traditional Chinese medicine. It has traditionally been used for allergy symptoms, arthritis, asthma, bone pain, bronchitis, edema, headache, nephritis, and symptoms of the common cold and influenza. It has also been marketed as "herbal ecstasy," for use as a recreational drug [6].

While most Ephedra species contain ephedrine alkaloids, Mormon tea (Ephedra nevadensis or Ephedra viridis) is a plant in the Ephedra genus that is devoid of ephedrine and other alkaloids. Some other plants also contain ephedrine alkaloids, including Sida cordifolia and Pinellia ternate [6].

Regulatory Concerns

Because of the potential for serious safety concerns associated with its use, ephedra, Sida cordifolia, Pinellia ternata, or other ephedrine-containing herbs have been banned in the United States since 2004. Despite this ban, ephedra products can still be obtained on the Internet, often in combination products containing caffeine and/or other stimulants (e.g., synephrine, phenylethylamine [PEA], and yohimbine) [6].

Like other stimulants, ephedra is sometimes touted for its performance-enhancing effects, but these effects have not been substantiated in clinical studies. Ephedra appears on the prohibited list of many large sports and other organizations, including the NCAA [6].

Quality Concerns

There is considerable inter- and intra-product variability in labeled ephedra content. This increases concerns about ephedra toxicity.

There is also significant variability in the amounts of constituents found in ephedra supplements. In one study, ephedra supplements were found to contain 1.08–13.54 mg of ephedrine and 0.52–9.46 mg of pseudoephedrine per recommended dose. In other studies, 1 gram of a dry extract of ephedra was found to contain 58.9 mg of total ephedrine alkaloids, comprised of 0.44 mg of norephedrine, 1.09 mg of methylephedrine, 1.01 mg of norpseudoephedrine, 11.21 mg of pseudoephedrine, and 45.15 mg of ephedrine [6].

Norpseudoephedrine, a Schedule IV controlled substance, has been found to be a contaminant in some ephedra products [6].

Safety

Prior to its removal from the U.S. market, ephedra accounted for less than 1% of herbal product sales but was responsible for 64% of herbal adverse reaction reports to poison control centers. In a review of 926 cases of potential ephedra-related adverse effects reported to the FDA, 37 patients had serious or fatal adverse reactions [6].

Ephedra can cause severe life-threatening or disabling adverse effects in some people. It has been linked to significant cardiovascular effects, including cardiac arrhythmias, cardiac arrest, cardiomyopathy, heart failure, and myocardial infarction, as well as seizure, stroke, psychosis, and sudden death. There is some evidence that taking more than 32 mg daily might increase the risk of hemorrhagic stroke, including subarachnoid hemorrhage and intracerebral hemorrhage, by more than threefold [6].

While prolonged use and high doses might increase the risk of serious adverse effects, serious adverse effects have also been reported at low doses (e.g., 20–60 mg of ephedra alkaloids) in the short-term. It is impossible to determine who might be at the greatest risk from ephedra's adverse effects, but people with existing cardiovascular disease and those using combinations of stimulants might be at increased risk [6].

In addition to serious cardiovascular effects, cases of hepatotoxicity (e.g., acute hepatitis, liver failure) from ephedra-containing supplements have been reported after an average of three months of ephedra ingestion. Some cases of hepatotoxicity have resolved with discontinuation of ephedra, but others have required liver transplantation. Immune reactions and contamination have been proposed as potential causes of hepatotoxicity, but the majority of evidence suggests that ephedra-related hepatotoxicity is idiosyncratic in nature [6].

STIMULANT INTERACTION CONCERNS

Interactions with Lab Tests

Some stimulants might cause false-positive test results on urine amphetamine and/or methamphetamine drug screens. This should be considered when interpreting urine drug screen results in patients who deny amphetamine and/or methamphetamine use [5,6].

Interactions with Drugs and Supplements

Stimulants can have a fair amount of drug interactions. The most notable drug interaction concern is for the combination of a stimulant with other drugs or supplements that are stimulants or have stimulant properties. This combination can increase the risk of adverse effects, particularly cardiovascular adverse effects [2,3,4,5,6].

3. LAXATIVES

While laxatives themselves are not addicting, they are commonly misused for weight-loss effects. With the exception of senna, over-the-counter laxatives, which are not exempt from misuse, will not be covered in this course.

SENNA

Senna is the fruit (pod) or leaf of the plant Senna alexandrina. Senna contains sennosides, which are high molecular weight dianthrone glycosides [7].

Because sennosides are prodrugs, they are not absorbed in the gastrointestinal (GI) tract and are instead activated by enzymes in the colon. The cathartic properties of the senna leaf are greater than the fruit. Effects usually occur within 6 to 10 hours after oral administration [7].

Senna is an FDA-approved nonprescription stimulant laxative found in many commercially available products that are approved for the short-term treatment of constipation in adults and children 2 years of age or older. These products contain the active ingredient sennosides [7].

Senna is also available in dietary supplements containing variable amounts of the leaf. Senna leaf is sometimes added to weight loss products or "cleansing" teas, but these uses are unproven and may be unsafe [7].

CASTOR OIL

Castor oil is the oil that comes from castor beans (seeds). Unlike the beans, castor oil does not contain the deadly poison ricin [8].

Castor oil is a stimulant laxative that has been used as a laxative in multiple systems of medicine (e.g., Unani, Ayurvedic) in India since 2000 B.C.E. It is hydrolyzed in the duodenum by pancreatic lipase to release ricinoleic acid [8].

While the exact mechanism of ricinoleic acid is unknown, laxative effects appear to result from a combination of fluid secretion and increased peristalsis. The onset of action is usually within two, but sometimes up to six, hours [8].

Castor oil is sometimes flavored (e.g., with cinnamon, peppermint, or other flavorings) to mask its overall slightly bitter and nauseating taste [8].

SAFETY

Stimulant laxatives can cause abdominal pain and discomfort, bloating, cramping, diarrhea, faintness, flatulence, fecal urgency, and nausea. Use of laxatives at high doses and for long periods might be unsafe. Abuse of laxatives can cause fluid and electrolyte, particularly potassium, losses. Theoretically, this can increase the risk for arrhythmias. There is also a risk of malabsorption as a result of intestinal hypermotility [7,8].

Cases of "cathartic colon" have been described in the literature following chronic use of both senna and castor oil. Cathartic colon refers to radiographically diagnosed anatomic changes to the colon, such as benign narrowing, colonic dilation, and loss of colonic folds. The clinical relevance of such changes is unclear [7,8].

Chronic use of senna can also cause pseudomelanosis coli (pigmented spots along the intestinal mucosa), but this condition is harmless, reverses with cessation, and has not been shown to be associated with an increased risk of developing colorectal adenoma or carcinoma [7].

Long-term use of laxatives is thought to result in habituation and/or tolerance. Habituation refers to a reduced or even absent laxative response, and tolerance refers to the need for increased doses in order to maintain the desired laxative response. Both habituation and tolerance could theoretically be induced by damage to the colon or by an adaptive mechanism counteracting the laxative's effect on motility and/or secretion [9].

Uncontrolled observational studies in humans and conflicting data from prospective animal studies have raised concerns that chronic stimulant laxative use can actually cause nerve or muscle damage to the colon, but these concerns have been largely disproven by higher quality studies [9]. While tolerance may occur in patients with severely slow colonic transit in whom other types of laxatives are ineffective, development of tolerance seems to be uncommon in the majority of users.

Be sure to ask patients about dietary supplement usage while obtaining their medication history. And be on the lookout for purchasing practices that might suggest inappropriate use.

4. ABUSE POTENTIAL RELATED TO RECREATIONAL USE

Like prescription drugs, many supplements are abused on the party scene and for varying other recreational reasons. Among these is gamma-hydroxybutyrate (GHB) for its euphoric, amnestic, and calming effects.

GHB

GHB is a short-chain fatty acid made from gamma aminobutyric acid (GABA). GHB is naturally occurring in the brains of mammals in very small amounts. The highest concentrations in the brain are found in the basal ganglia. GHB is also found in other tissues, including the kidneys, liver, heart, skeletal muscle, and brown fat [10].

GHB is an agonist at GABA-B receptors and is also converted to GABA. The central nervous system (CNS) depressant effects of GHB, especially those observed at higher doses, can be attributed to direct agonist activity at GABA-B receptors. GHB has also been reported to raise dynorphin levels through its effects on the endogenous opioid system. Stimulation of GHB receptors also results in a reduction in dopamine release in the basal ganglia and influences dopamine release in the substantia nigra [10].

GHB abuse became popular among teens and young adults at dance clubs and raves in the 1990s, but use persists today. GHB is used as a party drug, for its euphoric and calming effects and for sexual arousal, and in cases of drug-facilitated sexual assault. It is usually sold as a clear, colorless liquid or as a white powder that can be dissolved in liquid [10].

In the United States, GHB is federally classified as a Schedule I controlled substance, making production, sale, and possession outside of medical use illegal. The major source of GHB is through clandestine synthesis by local operators [10].

An FDA-approved prescription form of the sodium salt of GHB, known as sodium oxybate (Xyrem), is labeled for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age or older with narcolepsy. Sodium oxybate is a Schedule III controlled substance and seems to be safe when used appropriately under medical supervision [10].

Several chemically related analogs of GHB, including gamma butyrolactone (GBL) and 1,4-butanediol (BD), are rapidly converted to GHB in the body and have similar effects to the parent compound. Popularity of these analogs increased with the regulatory restriction of GHB as a Schedule I controlled substance. These analogs are legally available as industrial solvents, but are also sold illicitly as supplements for bodybuilding, weight loss, reversal of baldness, drug addiction, and other uses. GBL and BD are abused for the same reasons as GHB. Routine toxicologic screens do not detect the presence of these analogs, so abuse can be difficult to identify [16].

Safety

When used orally without medical supervision (i.e., not as a prescription medicine), GHB is not safe for any use. Serious side effects include ataxia, cardiac arrest, coma, respiratory depression, tonic-clonic seizure, variable heart rate, and death. The analogs GBL and BD have also been associated with a large number of reports of such serious adverse reactions [10,16].

Evidence Based Practice Recommendation

The UK Department of Health asserts that persons providing services to patients who use GHB should advise these individuals to be aware of the added risks of mixing GHB with other sedative drugs.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/673978/clinical_guidelines_2017.pdf

Last Accessed: October 27, 2022

Level of Evidence: Consensus Statement/Expert Opinion

Concomitant use of GHB and its analogs with alcohol and some other co-ingestants can increase the risk of CNS and respiratory depression, as well as other severe adverse effects. Alcohol may also inhibit the clearance of GHB [10].

GHB is commonly used in cases of drug-facilitated sexual assault. Patients can help avoid becoming a victim by never taking a drink from a stranger and never leaving a drink unattended. If poisoning is suspected, call poison control at 1-800-222-1222 [10]. There is no antidote for GHB toxicity, and treatment is limited to supportive care. In patients with severe GHB intoxication, maintaining airway patency with intubation, if necessary, is the most important intervention. Because GHB can cause a rapid loss of consciousness, gastric lavage and induction of emesis are contraindicated. Symptomatic bradycardia can be managed with atropine, and seizures respond effectively to benzodiazepines [11,12]. Withdrawal symptoms are best managed with anxiolytics [13].

Regular GHB use can also cause dependence requiring inpatient detoxification. Withdrawal from GHB can cause agitation, anxiety, diaphoresis, delirium with auditory and visual hallucinations, hypertension, insomnia, panic, psychoses, rhabdomyolysis, tachycardia, terror, and tremor [10].

5. ABUSE POTENTIAL RELATED TO OPIOID-LIKE EFFECTS

KRATOM

Similar to an opioid, kratom is mainly used for its opioid-like effects. Kratom, Mitragyna speciosa, is a tropical tree that is native to Southeast Asia. The leaves are the part of the plant that garnered has interest, either when chewed as whole leaves, consumed as beverages prepared from the leaves (e.g., tea, juice), powdered and packaged into gel caps, or as an extract. The leaves have also been crushed and then smoked, but kratom is mostly abused through oral ingestion [14].

Kratom contains a long list of constituents, including corynantheidine, isopaynantheine, mitraciliatine, paynantheine, speciociliatine, speciogynine, and 9-hydroxycorynantheidine, but the alkaloids mitragynine and 7-hydroxymitraginine are thought to be its main active constituents. Twenty kratom leaves are estimated to contain about 18 mg of mitragynine [14].

Kratom contains the mu-opioid receptor agonist 7-hydroxymitragynine. 7-Hydroxymitragynine is estimated to be approximately 10 times as potent as morphine [14].

Kratom also contains a number of mu-opioid receptor partial agonists, including mitragynine. Mitragynine is estimated to be about 25% as potent as morphine, but it is present in much larger quantities than 7-hydroxymitragynine. Mitragynine makes up about 60% of kratom's alkaloid content and 7-hydroxymytragynine makes up 2% [14].

Kratom has both stimulant- and opioid-like properties, and its effects when taken by mouth are dose-dependent. Higher doses of kratom (e.g., 5–15 grams) are said to produce analgesic opioid-like effects, while lower doses (e.g., 1–5 grams) have stimulating effects [14].

Kratom has been used for its psychoactive properties and opium-like effects. It has been used for centuries in Thailand and Malaysia in socioreligious ceremonies, as an aid to combat fatigue in laborers, as an opioid substitute, and for other medical purposes. Several recent surveys have identified self-treatment of acute or chronic pain as the primary use for kratom. However, there is not enough information to support the use of kratom for any condition, and the risks certainly do not outweigh any potential benefits given its safety profile [14].

In the past, kratom use has not been widespread in the United States, but poison control center data show that interest seems to be growing. Between 2014 and 2019, U.S. poison control centers saw a rapid increase in kratom exposures [1].

In 2016, the Drug Enforcement Administration (DEA) attempted to ban kratom by making its mitragynine and 7-hydroxymitragynine constituents Schedule I substances in the United States under the Controlled Substances Act (CSA). This attempt to schedule these constituents was met with intense backlash from the public, industry, and some members of Congress [14]. While the DEA cited concerns of increases in the incidence of kratom-related seizures and calls to poison control centers related to kratom, the DEA ultimately withdrew its intent to schedule based on this strong opposition.

While the kratom tree and its leaves are illegal or restricted in some countries and states, it is not illegal in the United States. It is readily available for in-person purchase in many states, in addition to Internet sales. The manufacturing, sale, or possession of kratom products are not currently regulated by the FDA or DEA, but the DEA has listed kratom as a drug and chemical of concern [15].

Kratom has been reported to be contaminated with various substances, including heavy metals and phenethylamine (PEA), an amphetamine-like substance. In 2018, the Centers for Disease Control and Prevention (CDC) reported a Salmonella outbreak sickening at least 134 people in more than 35 states that was found to be linked to kratom products [14].

Some kratom products have been suspected to be adulterated with respect to the active constituents. In a laboratory analysis, samples of some commercially available kratom products were found to contain 4.5-fold higher concentrations of 7-hydroxymitragynine than are usually present in kratom leaves [14].

Safety

The FDA has warned consumers on multiple occasions that kratom is unsafe. Kratom has been linked to serious adverse effects, including respiratory depression, aggression, hallucinations, delusions, vomiting, seizures, liver damage, severe withdrawal, and death. Short-term use, especially in combination with other substances, has been associated with cases of intrahepatic cholestasis, rhabdomyolysis, seizure, encephalopathy syndrome, and death. Long-term use has been associated with tolerance and withdrawal symptoms, including aggression, anxiety, muscle aches and spasms, nausea and vomiting, shakiness and tremors, and QT interval prolongation [14].

Interactions with Drugs

Kratom seems to inhibit many enzymes commonly involved in the metabolism of drugs, potentially increasing their levels and effects. It also might have overlapping effects with drugs that have similar mechanisms [14].

Interactions with Conditions

In patients with alcohol use disorder or other psychiatric disorders, epidemiologic research suggests an increased risk of suicide with kratom use. In patients with existing cardiac conditions, kratom use can increase the risk of tachycardia [14].

In animal studies, kratom seems to cross the placenta. In humans, there have been multiple reports of neonatal abstinence syndrome (NAS) in infants born to patients using kratom during pregnancy [14].

Do not assume that potentially harmful use of supplements only occurs in young people. With kratom use on the rise among all demographics, increased use of kratom among older adults is particularly concerning as data have shown severe effects in this population [14].

6. CONSIDERATIONS FOR NON-ENGLISH-PROFICIENT PATIENTS

For patients who are not proficient in English, it is important that information regarding the benefits and risks associated with the use of dietary supplements be provided in their native language, if possible. When there is an obvious disconnect in the communication process between the practitioner and patient due to the patient's lack of proficiency in the English language, an interpreter is required. Interpreters can be a valuable resource to help bridge the communication and cultural gap between patients and practitioners. Interpreters are more than passive agents who translate and transmit information back and forth from party to party. When they are enlisted and treated as part of the interdisciplinary clinical team, they serve as cultural brokers who ultimately enhance the clinical encounter.

7. CONCLUSION

Dietary supplement use continues to increase. In 2020, U.S. supplement sales surpassed $10 billion for the first time ever [17]. Unfortunately, with increased use also comes increased abuse and misuse. Recreation, body image concerns, athletic performance, and mood enhancement continue to drive inappropriate use. Knowing the common culprits, how they work, and their potential adverse effects can enhance patient education and the detection of potential supplement abuse.

Works Cited

1. Biggs JM, Morgan JA, Lardieri AB, Kishk OA, Klein-Schwartz W. Abuse and misuse of selected dietary supplements among adolescents: a look at poison center data. J Pediatr Pharmacol Ther. 2017;22(6):385-393.

2. TRC Healthcare Natural Medicines Database. 1,3-DMAA. Available at https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=1258. Last accessed October 22, 2022.

3. TRC Healthcare Natural Medicines Database. Bitter Orange. Available at https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=976. Last accessed October 22, 2022.

4. TRC Healthcare Natural Medicines Database. Octopamine. Available at https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=1590. Last accessed October 22, 2022.

5. TRC Healthcare Natural Medicines Database. Caffeine. Available at https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=979. Last accessed October 22, 2022.

6. TRC Healthcare Natural Medicines Database. Ephedra. Available at https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=847. Last accessed October 22, 2022.

7. TRC Healthcare Natural Medicines Database. Senna. Available at https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=652. Last accessed October 22, 2022.

8. TRC Healthcare Natural Medicines Database. Castor Bean. Available at https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=897. Last accessed October 22, 2022.

9. Müller-Lissner SA, Kamm MA, Scarpignato C, Wald A. Myths and misconceptions about chronic constipation. Am J Gastroenterol. 2005;100(1):232-242.

10. TRC Healthcare Natural Medicines Database. Gamma-hydroxybutyrate (GHB). Available at https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=950. Last accessed October 22, 2022.

11. Smith KM, Larive LL, Romanelli F. Club drugs: methylenedioxymethamphetamine, flunitrazepam, ketamine hydrochloride, and gamma-hydroxybutyrate. Am J Health-Syst Pharm. 2002;59(11):1067-1076.

12. Benzer TI. Gamma-Hydroxybutyrate Toxicity. Available at https://emedicine.medscape.com/article/820531-overview. Last accessed October 22, 2022.

13. Greene JP, Ahrendt D, Stafford EM. Adolescent abuse of other drugs. Adolesc Med Clin. 2006;17(2):283-318.

14. TRC Healthcare Natural Medicines Database. Kratom. Available at https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=1513. Last accessed October 22, 2022.

15. Drug Enforcement Administration. Drugs of Abuse: A DEA Resource Guide. Washington, DC: U.S. Department of Justice; 2020.

16. TRC Healthcare Natural Medicines Database. Gamma Butyrolactone (GBL). Available at https://naturalmedicines.therapeuticresearch.com/databases/food,-herbs-supplements/professional.aspx?productid=820. Last accessed October 22, 2022.

17. Smith T, Majid, F, Eckl V, Reynolds CM. Herbal supplements sales in US increase by record-breaking 17.3% in 2020: sales of immune health, stress relief, and heart health supplements grow during COVID-19 pandemic. HerbalGram. 2021;(131):52-65.

58030 • Getting to the Point: Acupuncture and Acupoint Therapies

Chelsey McIntyre, PharmD

www.netce.com

Copyright © 2022 NetCE, All rights reserved.

Acupoint therapies have existed for thousands of years and are commonly practiced around the world. Patients may seek clarification regarding the various acupoint techniques used today, including information on safety and effectiveness. Healthcare professionals should be well informed about these practices so that they can provide evidence-based recommendations on the use of these treatments.

Table of Contents

58030 • Getting to the Point: Acupuncture and Acupoint Therapies

Course Overview

Audience

Accreditations & Approvals

Designations of Credit

Course Objective

Learning Objectives

Faculty

Faculty Disclosure

Division Planner

Division Planner Disclosure

Director of Development and Academic Affairs

Director Disclosure Statement

About the Sponsor

Disclosure Statement

Implicit Bias in Health Care

1. HISTORY: A BRIEF GLIMPSE

ACUPUNCTURE

MOXIBUSTION

ACUPRESSURE

TRANSCUTANEOUS ELECTRICAL ACUSTIMULATION (TEAS)

A NOTE ON THE EVIDENCE

2. ACUPUNCTURE

STYLES OF ACUPUNCTURE

REVIEWING THE EVIDENCE

SAFETY

3. MOXIBUSTION

MOXIBUSTION TECHNIQUES

REVIEWING THE EVIDENCE

SAFETY

4. ACUPRESSURE

REVIEWING THE EVIDENCE

SAFETY

5. TRANSCUTANEOUS ELECTRICAL ACUSTIMULATION (TEAS)

REVIEWING THE EVIDENCE

SAFETY

6. CONSIDERATIONS AND COMPARISONS

REPRODUCTIVE EFFECTS

INTERACTIONS WITH CONDITIONS

COMPARING THE EVIDENCE

7. CONSIDERATIONS FOR NON-ENGLISH-PROFICIENT PATIENTS

8. CONCLUSION

Works Cited

Evidence-Based Practice Recommendations Citations

58030 • Getting to the Point: Acupuncture and Acupoint Therapies

Education Category. Alternative Medicine

Release Date. 11/01/2022

Expiration Date. 10/31/2025

Course Overview

Acupoint therapies have existed for thousands of years and are commonly practiced around the world. Patients may seek clarification regarding the various acupoint techniques used today, including information on safety and effectiveness. Healthcare professionals should be well informed about these practices so that they can provide evidence-based recommendations on the use of these treatments.

Audience

This course is designed for dental professionals whose patients are using or are interested in using acupoint and/or acupressure therapies.

Accreditations & Approvals

NetCE Nationally Approved PACE Program Provider for FAGD/MAGD credit. Approval does not imply acceptance by any regulatory authority or AGD endorsement. 10/1/2021 to 9/30/2027 Provider ID #217994. NetCE is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. NetCE is approved as a provider of continuing education by the Florida Board of Dentistry, Provider #50-2405. NetCE is a Registered Provider with the Dental Board of California. Provider Number RP3841. Completion of this course does not constitute authorization for the attendee to perform any services that he or she is not legally authorized to perform based on his or her license or permit type.

Designations of Credit

NetCE designates this activity for 4 continuing education credits. AGD Subject Code 149. This course meets the Dental Board of California's requirements for 4 unit(s) of continuing education. Dental Board of California course #04-3841-24371.

Course Objective

The purpose of this course is to provide dental professionals in all practice settings the knowledge necessary to increase their understanding of acupoint and acupressure therapies.

Learning Objectives

Upon completion of this course, you should be able to:

1. Describe the principles from traditional Chinese medicine (TCM) that guide the practice of acupuncture and some related acupoint therapies.

2. Outline the various techniques of and available evidence regarding acupuncture.

3. Discuss the approaches to and evidence of moxibustion.

4. Review available research and techniques of acupressure.

5. Identify uses and safety concerns of trans- cutaneous electrical acustimulation (TEAS).

6. Compare and contrast the various acupoint techniques in terms of clinical uses and safety.

Faculty

Chelsey McIntyre, PharmD, is a clinical pharmacist who specializes in drug information, literature analysis, and medical writing. She earned her Bachelor of Science degree in Genetics from the University of California, Davis. She then went on to complete her PharmD at Creighton University, followed by a clinical residency at the Children’s Hospital of Philadelphia (CHOP). Dr. McIntyre held the position of Drug Information and Policy Development Pharmacist at CHOP until her move to Washington state in 2017, after which she spent the next six years as a clinical editor for Natural Medicines, a clinical reference database focused on natural products and alternative therapies. She continues to create rigorous professional analysis and patient education materials for various publications while also practicing as a hospital pharmacist. Her professional interests include provider and patient education, as well as the application of evidence-based research to patient care.

Faculty Disclosure

Contributing faculty, Chelsey McIntyre, PharmD, has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Division Planner

Mark J. Szarejko, DDS, FAGD

Division Planner Disclosure

The division planner has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

Director of Development and Academic Affairs

Sarah Campbell

Director Disclosure Statement

The Director of Development and Academic Affairs has disclosed no relevant financial relationship with any product manufacturer or service provider mentioned.

About the Sponsor

The purpose of NetCE is to provide challenging curricula to assist healthcare professionals to raise their levels of expertise while fulfilling their continuing education requirements, thereby improving the quality of healthcare.

Our contributing faculty members have taken care to ensure that the information and recommendations are accurate and compatible with the standards generally accepted at the time of publication. The publisher disclaims any liability, loss or damage incurred as a consequence, directly or indirectly, of the use and application of any of the contents. Participants are cautioned about the potential risk of using limited knowledge when integrating new techniques into practice.

Disclosure Statement

It is the policy of NetCE not to accept commercial support. Furthermore, commercial interests are prohibited from distributing or providing access to this activity to learners.

Implicit Bias in Health Care

The role of implicit biases on healthcare outcomes has become a concern, as there is some evidence that implicit biases contribute to health disparities, professionals' attitudes toward and interactions with patients, quality of care, diagnoses, and treatment decisions. This may produce differences in help-seeking, diagnoses, and ultimately treatments and interventions. Implicit biases may also unwittingly produce professional behaviors, attitudes, and interactions that reduce patients' trust and comfort with their provider, leading to earlier termination of visits and/or reduced adherence and follow-up. Disadvantaged groups are marginalized in the healthcare system and vulnerable on multiple levels; health professionals' implicit biases can further exacerbate these existing disadvantages.

Interventions or strategies designed to reduce implicit bias may be categorized as change-based or control-based. Change-based interventions focus on reducing or changing cognitive associations underlying implicit biases. These interventions might include challenging stereotypes. Conversely, control-based interventions involve reducing the effects of the implicit bias on the individual's behaviors. These strategies include increasing awareness of biased thoughts and responses. The two types of interventions are not mutually exclusive and may be used synergistically.

1. HISTORY: A BRIEF GLIMPSE

Traditional Chinese medicine (TCM) began more than 2,000 years ago. At that time there was no scientific concept of disease or pharmacology in terms that can be related to our modern understanding of medicine. Therefore, the principles of TCM were formed based on Taoism, a philosophical and religious system of beliefs, attitudes, and practices that focuses on harmony and nature, rather than science [1].

TCM is widely practiced in Asian countries, including China, Taiwan, and Singapore. TCM has also experienced a surge in popularity in Western countries, where it is sometimes used for promoting wellness, preventing illness, and treating chronic conditions. This ancient system of medicine encompasses a range of practices including acupoint therapies, meditation, martial arts, herbal medicine, feng shui, and massage [1].

These modalities and treatment techniques share a theoretical framework defined by the yin and yang relationship. In China, yin and yang are two forces that control the universe. Virtually all medical problems are considered to be due to imbalances in one of these forces. Chinese therapeutics intends to correct imbalances of these forces to cure disease [1].

Yin is the feminine side of nature and includes tranquility, darkness, cold, wetness, and depth. Yang is masculine and represents light, heat, activity, dryness, and height. Yin and yang are not the same as good and bad. Instead, they are considered complementary forces [1].

In TCM, it is thought that disease is caused by an imbalanced or blocked flow of energy, or qi. Additionally, there are 12 meridians that form a continuous pathway throughout the body; qi circulates through the body on these meridians (Figure 1).

Figure 1: BODY MERIDIANS

Source: [1]

According to TCM, acupoints are specifically chosen sites of manipulation located along meridians thought to stimulate or balance specific organs, emotions, or sensory feelings. One example is the P6 acupoint, which is found on the inner forearm, two inches above the wrist joint between the two prominent tendons (Figure 2). This point is frequently used in TCM modalities for the prevention and relief of nausea and vomiting in multiple settings (e.g., chemotherapy-induced, postoperative, motion-related) [1].

Figure 2: P6 ACUPOINT

Source: [1]

There are more than 350 recognized acupoints on the human body, and each acupoint is associated with a list of conditions for which it may be used. Some practitioners may also choose to use certain acupoints for nontraditional indications [2,3].

In this practice, people are diagnosed through evaluation of the tongue and the radial pulse, and by a series of signs and symptoms unique to TCM. Although these diagnostic methods have a long history of traditional use, the findings and diagnoses achieved from these techniques do not directly correlate to Western medicine. Their use as accurate indicators of medical conditions or disease has not been validated in clinical research [1].

Pulse diagnosis and tongue diagnosis are techniques used in many traditional systems of medicine. In pulse diagnosis, practitioners assess a person's pulse for rate, strength, length, and width. The wrist is most commonly used for pulse diagnosis, and the practitioner palpates at three different pressures (superficial, middle, and deep). With tongue diagnosis, practitioners assess the tongue for color, elasticity, veining, and various other qualities. In some cases, a digital device may be used to aid in tongue diagnosis [1].

TCM modalities of acupuncture, moxibustion, acupressure, and transcutaneous electrical acustimulation (TEAS) are thought to stimulate energy flow, unblock energy, and rebalance energy, which results in healing.

ACUPUNCTURE

The practice of acupuncture originated in China more than 2,000 years ago as the primary treatment modality of TCM and involves the insertion of fine needles into specific points on the body along meridians. This acupoint therapy remains one of the most common components of TCM. So common, in fact, that many healthcare plans will cover this treatment. As of 2018, there were more than 35,000 actively licensed acupuncturists and more than 60 accredited acupuncture and oriental medicine schools in the United States, suggesting interest continues to grow [2].

MOXIBUSTION

Another practice of TCM, moxibustion, involves burning an herb, usually mugwort (Artemisia vulgaris), above the skin or on the acupoints to introduce heat into an acupoint for therapeutic effects. Moxibustion may be performed by burning a cone, stick, or loose herb a short distance away from the skin. Additionally, the burning herb may be placed on the head of an acupuncture needle to increase the temperature gradient of the needle. Theoretically, moxibustion opens the 12 meridians and removes cold, dampness, and stagnation, which improves consciousness and prevents the collapse of qi, particularly the yang qi [4].

ACUPRESSURE

Acupressure is another common treatment modality of TCM. Acupressure is similar to acupuncture; however, it involves the use of applied pressure in place of needles. Pressure is applied using hands, thumbs, fingers, or devices to specific places, or acupoints, on the body [3].

TRANSCUTANEOUS ELECTRICAL ACUSTIMULATION (TEAS)

Lastly, acustimulation, another acupoint modality, involves stimulating specific acupoints on the body along meridians. TEAS involves applying a low-intensity electrical current to specific acupoints without puncturing the skin. While this modality is based on principles of TCM, it also incorporates aspects of modern practices by utilizing recently developed medical devices [5].

Although acupuncture, acupressure, and acustimulation are similar and may be used together in a single therapy session, they are individual and specific modalities and should not be confused with one another.

Additionally, TEAS differs from another therapeutic practice, transcutaneous electrical nerve stimulation (TENS), which does not utilize acupoints. It also differs from electroacupuncture, in which an electrical current is passed through embedded acupuncture needles [5].

A NOTE ON THE EVIDENCE

Although a large number of clinical trials show some evidence for the use of acupoint therapies for certain conditions, their ability to show superiority to placebo controls has been contradictory and inconclusive, suggesting that benefits may be due, at least in part, to a placebo effect. This potential effect may also be due to the environment in which these therapies are conducted and the preconceived notions related to acupoint therapies.

The quality of available evidence is also important to note. Most research is limited by a lack of appropriate blinding or sham controls, unclear methodological quality (e.g., heterogeneity, publication bias), overall small sample sizes, and prior expectations of outcomes. Another limiting factor is geographical location. Most available research has been conducted in China; therefore, it is unclear if outcomes are generalizable to other regions or populations.

Sham acupoint procedures were developed to be used as a control intervention in clinical trials, similar to placebo pills used in pharmacological studies. Sham acupuncture treatments include inserting needles into non-acupoints, using a device that masks the presence or absence of a needle (such as the Park Sham Device), or poking acupoints with a toothpick rather than inserting a needle. Essentially, sham acupuncture is placebo acupuncture—it mimics the experience of acupuncture without implementing the methods thought to be responsible for its effects.

In order to mitigate some of the quality concerns commonly observed in acupoint research, investigators have developed a variety of sham acupoint procedures intended to be used as a control intervention in clinical trials. It is important to note that there are several different sham devices available, and the quality of sham design may vary between studies. Additionally, there are controversies surrounding the validity of this technique.

2. ACUPUNCTURE

Acupuncture is a modality in which needles are inserted into more than 350 key points along meridians in the body. These points are referred to as acupoints, and stimulating acupoints through a needle is thought to stimulate the body to correct energy flow and balance [2].

Prior to treatment, traditional acupuncturists conduct a comprehensive medical history and examination similar to TCM practitioners. They may examine the tongue, the face, and the quality of the pulses. Both traditional and Western acupuncturists may palpate to identify points at which pressure causes tenderness or pain. Traditional acupuncturists may also add other modalities from TCM into the acupuncture therapy session [2].

Most states in the United Stated regulate the practice of acupuncture, for which different degrees and certifications are available. The National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) works with most states to validate the competency of acupuncture practitioners prior to licensure [2].

STYLES OF ACUPUNCTURE

Traditional "Manual" Acupuncture

In this practice, needles are inserted into acupoints. An acupuncture session may involve the insertion of up to 20 very fine needles which are kept in place for different durations, usually about 10 to 30 minutes. The needles can be inserted to a depth of 5–40 mm and can be stimulated by winding by hand [2].

Electroacupuncture

In this practice, acupuncture needles are stimulated by a weak electrical current.

Laser Acupuncture

In this practice, lasers are used to stimulate acupoints. A typical schedule of acupuncture administration is 6 to 12 sessions over three months [2].

Thread Embedding Acupuncture

In this practice, medical threads, such as catgut or polydioxanone (PDO) sutures, are inserted into subcutaneous tissue or muscle at specific points, thus providing long-term chemical stimulation in addition to the mechanical stimulation provided by traditional acupuncture. Typically, PDO threads take approximately four weeks to reach 50% tensile strength and six months to be completely absorbed [2].

REVIEWING THE EVIDENCE

Although there has been extensive research conducted on acupuncture, most data are inconclusive. Additionally, just as some research suggests evidence of benefit for certain indications, research for other indications suggests a lack of benefit.

Cancer-Related Conditions

Cancer-Related Fatigue

Low-quality studies suggest that acupuncture may modestly improve symptoms in patients with cancer-related fatigue. Guidelines from multiple oncology associations include acupuncture and electroacupuncture as a potential treatment option for reducing post-cancer fatigue [2].

Clinical research, mainly preliminary in design and low quality, shows that receiving acupuncture for a total of 6 to 10 sessions over two to ten weeks improves feelings of cancer-related mental and physical fatigue when compared with sham acupuncture or usual care alone [2].

The National Comprehensive Cancer Network (NCCN) guidelines for cancer-related fatigue list acupuncture as a potential nonpharmacologic treatment option for patients who have completed cancer treatment. Additionally, the American Society of Clinical Oncology (ASCO) and the Society for Integrative Oncology recommend acupuncture for patients who have finished cancer treatment and for cancer survivors [2].

Cancer-Related Pain

Evidence Based Practice Recommendation

The Society for Integrative Oncology and the American Society of Clinical Oncology assert that acupuncture should be offered to patients experiencing aromatase inhibitor-related joint pain in breast cancer.

https://ascopubs.org/doi/full/10.1200/JCO.22.01357

Last Accessed: October 27, 2022

Strength of Recommendation/Level of Evidence: Intermediate/Moderate

Low-quality studies suggest that acupuncture may modestly improve symptoms in patients with cancer-related pain. Meta-analyses and preliminary clinical research, mainly low quality, show that acupuncture has a small-to-moderate effect on malignancy-related and surgery-induced pain in patients with cancer when compared with baseline or a control group. Furthermore, when used in combination with analgesics, a meta-analysis of three studies shows that electroacupuncture decreases analgesic use by a small amount [2].

The NCCN guidelines for adult cancer pain highlight acupuncture and electroacupuncture as a potential integrative treatment for vulnerable populations, such as frail or elderly individuals who may not be able to tolerate pharmacological treatments [2].

Chemotherapy-Induced Nausea and Vomiting (CINV)

When used with antiemetics, some research shows that electroacupuncture, with or without manual acupuncture, modestly reduces nausea and vomiting associated with chemotherapy. Manual acupuncture alone also seems to be comparable to some antiemetics.

A clinical study in patients with advanced cancer shows that a combination of manual acupuncture and electroacupuncture with ondansetron during five days of chemotherapy reduces the severity of nausea and vomiting over a total period of 21 days when compared with sham acupuncture. However, it does not increase the number of patients that experience no nausea or vomiting [2].

Another clinical study shows that manual acupuncture is comparable to giving ondansetron 8 mg intravenously for preventing acute nausea and vomiting in the first 24 hours after chemotherapy with paclitaxel and carboplatin [2].

Clinical practice guidelines from the Society for Integrative Oncology (SIO) recommend that acupuncture or acupressure be considered as an adjunct to antiemetic medications for chemotherapy-induced nausea and vomiting (CINV) management [2].

Pain-Related Conditions

Some experts theorize that acupuncture may result in the release of the endogenous opioids known as enkephalins and endorphins, which naturally reduce pain. However, because some research shows acupuncture to be no more effective than sham acupuncture, it is unclear if the effectiveness is due to physiologic stimulation [2].

Back Pain

Clinical research shows that acupuncture reduces pain when compared with either sham acupuncture or no treatment in patients with either chronic or acute low back pain. For chronic low back pain, most clinical research suggests that after three months, acupuncture is no more effective than sham acupuncture, although it does seem to be beneficial when compared with no treatment. Finally, there is some evidence that the analgesic effects of acupuncture may be delayed, with greatest benefit seen months after treatment discontinuation [2].

The analgesic effect of acupuncture seems to be influenced by several factors [2]:

- Number of acupuncture sessions

- A greater number of patients achieve relief of low back pain after 10 treatments compared to only five treatments.

- Depth of needle insertion

- Deep acupuncture appears to be more effective than superficial acupuncture.

- Different acupuncture styles

Motion style acupuncture is a method combining acupuncture with Doin, a manual therapy used in Korean rehabilitation medicine. Research suggests that this treatment improves acute back pain to a greater degree than either traditional acupuncture or electroacupuncture [2].

Despite the uncertain and short-term benefits, guidelines published by the American College of Physicians recommend the use of nonpharmacologic therapy, such as acupuncture, prior to using pharmacologic therapy in patients with chronic low back pain [2].

Neurogenic Conditions

Fibromyalgia

Most preliminary clinical research and meta-analyses of clinical research show that acupuncture improves pain and stiffness and quality of life when compared with no treatment, standard therapy, or sham acupuncture, although older research shows that acupuncture is no different than sham acupuncture for reducing pain [2].

This discrepancy in results might be due to the type of sham acupuncture used and the integrity of blinding procedures. Acupuncture is more effective at relieving pain when compared with the sham acupuncture method that involves placing a needle in the acupoint with a bandage, without piercing the skin. This benefit is not observed when skin is pierced in both sham and real acupuncture groups [2].

HIV/AIDS-Related Peripheral Neuropathy

Research shows that acupuncture does not improve HIV/AIDS-related peripheral neuropathy. For instance, clinical research shows that acupuncture may not be effective for reducing peripheral neuropathy associated with HIV when compared with sham acupuncture at control sites [2].

Osteoarthritis

Meta-analyses of preliminary clinical research show that electrical, laser, and manual acupuncture modestly reduce pain and modestly improve function in patients with hip or knee osteoarthritis when compared with no treatment or sham treatment, or when used as an adjunct to standard treatment. Most individual preliminary clinical trials show sustained reductions in pain for up to 12 weeks [2].

However, available research is generally of low quality and is challenged by an array of conflicting evidence. A meta-analysis of two higher quality studies and some preliminary clinical research did not find a difference between acupuncture and sham acupuncture for improving pain in hip or knee osteoarthritis. Acupuncture is conditionally recommended by The American College of Rheumatology (ACR) for any form of osteoarthritis [2].

It is important to mention that there are a number of pain-related conditions with insufficient evidence to support the use of acupuncture. These conditions include myofascial pain syndrome, shoulder pain, sciatica, pregnancy-related pain, and others. More evidence is needed to rate acupuncture for these uses [2].

Gastrointestinal-Related Conditions

Constipation

A meta-analysis of preliminary clinical research, as well as individual clinical trials, in patients with functional constipation show that receiving manual acupuncture or electroacupuncture for 2 to 10 weeks modestly increases bowel movements and improves stool formation and symptoms when compared with sham acupuncture. However, acupuncture was no more effective than various conventional medications [2].

Dyspepsia

Meta-analyses of preliminary clinical research show that manual and electroacupuncture are more effective than sham acupuncture for improving symptoms of dyspepsia and quality of life. Some individual clinical studies have shown that acupuncture combined with Western medicine (including prokinetic agents, acid suppressants, and antidepressants) improves symptoms more than Western medicine alone [2].

There are also a variety of gastrointestinal-related conditions for which there is very limited evidence to support the use of acupuncture. These conditions include gastroparesis, ulcerative colitis, irritable bowel syndrome, and postoperative ileus [2].

Postoperative Nausea and Vomiting (PONV)

Meta-analyses suggest that acupoint stimulation with acupuncture, acupressure, and electrical stimulation can reduce PONV by up to 50% and may be as effective as conventional antiemetics. Furthermore, other analyses show that acupuncture of the P6 acupoint is effective in reducing incidence of nausea, vomiting, and need for rescue antiemetics postoperatively when compared with no treatment. The effects of acupuncture on acute and delayed vomiting and nausea appear to vary [2].

A meta-analysis of six small clinical trials suggest that acupuncture reduces postoperative vomiting in children when compared with control acupuncture surgery. Additionally, one small study shows that receiving acupuncture on the P6 acupuncture point is as effective as sham acupuncture and dexamethasone [2].

Thus far, the evidence on the use of acupuncture for PONV is promising, and patients may consider it as an adjunctive treatment option. However, there is currently very limited evidence on use for pregnancy-induced and radiation-induced nausea and vomiting.

Other Conditions

Asthma

Most research shows that acupuncture does not improve symptoms of asthma. While some preliminary clinical research suggests that acupuncture or laser acupuncture and probiotics may marginally improve asthma symptoms and pulmonary function, most clinical research supports that acupuncture has no effect on asthma or asthma parameters such as forced expiratory volume in one second and forced vital capacity [2].

Depression

When used with conventional antidepressants, most research shows that acupuncture modestly reduces symptoms of depression. However, it is unclear if acupuncture alone is more effective than conventional antidepressants.

Clinical evidence shows that using manual or electroacupuncture as an adjunct to antidepressants such as selective serotonin reuptake inhibitors modestly reduces depression severity when compared with antidepressants alone [2].

There is also some evidence that acupuncture may be more likely to alleviate symptoms of perimenopausal depression, post-stroke depression, or cancer-related depression when compared with antidepressants or hormone replacement therapy. However, because most of the available research has been conducted in China, it is unclear if these findings are generalizable to other geographic locations [2].

Insomnia

Clinical research shows that manual acupuncture modestly improves sleep quality and might reduce the need for medication when used as an adjunct to sleep hygiene instruction or conventional treatment, sham acupuncture, or a waitlist control group (i.e., a group that serves as an untreated comparator, but eventually goes on to receive treatment at a later date) [2].

Electroacupuncture does not seem to improve sleep efficiency, sleep onset, or insomnia severity when compared with conventional treatment or sham electroacupuncture [2].

Smoking Cessation

Clinical research shows that although acupuncture might have short-term benefits, it does not improve rates of long-term smoking cessation when compared with sham acupuncture [2].

SAFETY

Acupuncture, when used appropriately and performed with sterile needles, is generally well-tolerated and has been safely used in numerous clinical trials for up to 24 months. Some clinical research shows that acupuncture has been used in children without reports of significant adverse effects [2].

Most commonly, acupuncture is associated with dermatologic adverse effects, such as bruising, swelling, and pain. Acupuncture in the eyes can cause trauma to the eyes such as perforation and traumatic cataract. There have been case reports of epidural and subdural hematomas from improper acupuncture, resulting in paresthesia, hemiparesis, quadriparesis, and sensory deficit. There have been case reports of pneumocranium, pneumothorax, hemothorax, acute respiratory and circulatory failure, and death due to inappropriate acupuncture practices. Acupuncture needles that are not removed after treatment might embolize and cause damage to internal organs [2].

3. MOXIBUSTION

Moxibustion is another acupoint modality that is commonly utilized in TCM. Moxibustion involves burning moxa, a dried herbal preparation made of the aged, powdered mugwort herb, at prescribed acupoints on the body. These points are determined based on the patient's symptoms and diagnosis [4].

Moxa is considered to have a warming yang nature that is thought to prevent patients from experiencing a collapse of yang qi energy. There are various techniques used in moxibustion.

MOXIBUSTION TECHNIQUES

Indirect Moxibustion (Interposed Moxibustion)

The ignited moxa cone does not contact the skin directly. Instead, it is separated from the skin by ingredients such as ginseng, salt, garlic, ginger, or aconite cake. In clinical research, indirect moxibustion has improved levels of cellular mediators involved in pain [4].

Direct Moxibustion

The ignited moxa cone is used directly to warm the skin surface at the acupuncture point. Direct moxibustion can be scarring, which involves burning moxa directly on the skin, or "warming," which involves burning moxa above the skin [4].

Thunder-Fire Moxibustion

Moxa-cigars held by a moxibustion box are ignited over the treatment site. The fire head is held about an inch away from the skin and burned for about 30 minutes. To maintain the heat and reduce smoke in the air, the moxibustion treatment is covered with a thick towel [4].

Warm Needle Moxibustion/Acupuncture

This is an integration of acupuncture and moxibustion. A one-inch moxa stick is put on the handle of an acupuncture needle that has been inserted in the body, and the moxa stick is ignited. This method is purported to warm the meridians and promote the flow of qi and blood [4].

Electric Moxibustion

Electric moxibustion has been developed because there are safety concerns with traditional moxibustion, such as excessive heat or potentially toxic chemical components. Electric moxibustion has adjustable and constant heat stimulation that is applied either directly or indirectly to skin and has been shown to increase blood flow in healthy participants [4].

Jade Moxibustion

Involves wearing heated knee pads containing a jade stone for 20 minutes three times weekly for four weeks [4].

REVIEWING THE EVIDENCE

Pain-Related Conditions

Back Pain

Most low-quality clinical research suggests that moxibustion, when used alone or in conjunction with other treatments, may modestly reduce back pain.

A meta-analysis of small, low quality clinical studies in people with chronic low back pain shows that moxibustion reduces pain when compared with acupuncture, massage, or taking ibuprofen 300 mg daily or celecoxib 200 mg daily. Furthermore, adding moxibustion to other treatments such as massage, acupuncture, core stability training, or the medicines celecoxib or meloxicam, further reduces back pain when compared with the active treatment alone [4].

Osteoarthritis

Meta-analyses of small clinical studies in patients with knee osteoarthritis show that moxibustion modestly reduces pain and improves function when compared with sham moxibustion or usual care. A subgroup analysis suggests that moxibustion improves osteoarthritis pain when compared with taking diclofenac, but not when compared with taking celecoxib. However, this finding is limited due to the high heterogeneity of the available research, as well as a high risk for publication bias [4].

Research has also evaluated other types of moxibustion for the treatment of knee osteoarthritis. One clinical trial shows that receiving jade moxibustion improves pain to a greater degree when compared with receiving traditional moxibustion. Another clinical study shows that receiving moxibustion in 12 sessions over six weeks via a specific electrical device (Cettum) improves pain similarly to traditional indirect moxibustion and to a greater extent than usual care [4].

Gastrointestinal-Related Conditions

In human research, moxibustion has been shown to reduce levels of certain inflammatory markers. Other preliminary data suggest that moxibustion may help to protect the gastric mucosa. Due to its perceived anti-inflammatory effects, there is interest in using this therapy for gastrointestinal-related conditions.

Moxibustion has been investigated in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), constipation-predominant IBS (IBS-C), and inflammatory bowel diseases. Currently, there is not enough scientific evidence to support the use of moxibustion for Crohn disease and ulcerative colitis. Additionally, there is very limited evidence on use for constipation and gastritis.

IBS-D

Moxibustion with or without acupuncture appears to be more effective than sham moxibustion, sham acupuncture, or various pharmaceutical agents for improving abdominal pain, discomfort, gas, bloating, and stool consistency. There were also overall improvements in stool form and symptom severity [4].

Clinical research in patients with IBS-D shows that moxibustion three times weekly for six weeks produces adequate relief in about 77% to 82% of patients, compared with 37% to 42% of those given sham or placebo moxibustion. These data also suggest that beneficial effects lasted for up to an additional 18 weeks after treatment completion in up to 76% of patients [4].

Thus far, the evidence on the use of moxibustion for IBS-D is promising, and patients may consider it as an adjunctive treatment option.

IBS-C

The available research in patients with IBS-C is limited to a small clinical study showing no benefit with the use of warming moxibustion six times weekly for four weeks when compared with baseline or electroacupuncture [4]. As such, available research suggests that moxibustion may not be effective in patients with IBS-C.

Crohn Disease

Moxibustion administration has only been evaluated in combination with acupuncture; its effect when used alone is unclear. Clinical research in patients with Crohn disease shows that combining herb-partitioned moxibustion with acupuncture three times weekly for 12 weeks induces remission in 74% of patients, compared with only 36% of patients given sham moxibustion and superficial acupuncture [4].

Ulcerative Colitis

A meta-analysis of low-quality clinical research shows that moxibustion with or without acupuncture improves response rate by 24% when compared to control treatment. However, these results are limited by the small number, size, and low quality of the included studies [4].

Other Conditions

Cancer

Moxibustion administration does not seem to be beneficial for cancer treatment. A meta-analysis of five clinical studies shows that moxibustion does not improve treatment response in patients with various cancer types when compared with standard care. There is limited evidence on use of moxibustion for CINV and cancer-related fatigue [4].

Dysmenorrhea

Low-to-moderate quality clinical research in patients with dysmenorrhea shows that moxibustion with or without acupuncture reduces pain, usually when compared with no treatment or usual care. Additional clinical research shows that moxibustion reduces pain intensity similarly to ibuprofen 300 mg twice daily for three days, starting the day before menstruation and repeated for three cycles. Furthermore, at three months after treatment discontinuation, pain intensity remains 13% lower in the patients that received moxibustion [4].

Insomnia

It is unclear if moxibustion is beneficial for insomnia. Although some research has been conducted on the use moxibustion for insomnia, there is not enough reliable evidence to confirm a benefit for these indications [4].

SAFETY

Moxibustion is likely safe when administered appropriately by a qualified practitioner and has been used in clinical research without reports of serious adverse events.

Most commonly, moxibustion is associated with blisters, burns, dizziness, fainting, fatigue, gastrointestinal upset, headache, hypersomnia, itching, pain, rash, redness, and respiratory discomfort. Serious cases of adverse effects caused by moxibustion are generally related to inappropriate administration, such as not removing the moxa from the skin at the appropriate time or accidentally dropping ash onto the skin [4].

4. ACUPRESSURE

Acupressure involves applying pressure using hands, thumbs, fingers, or devices to acupoints. Acupressure can be self-administered or applied by a trained practitioner. Passive acupressure devices are also available that apply pressure continuously at a specific location. For example, wrist bands can apply pressure to the P6 acupoint, which is utilized for the treatment or prevention of nausea and vomiting. Most acupressure points are located near nervous tissue or structures. Duration and frequency of acupressure treatment is individualized to the patient and the condition being treated [3].

REVIEWING THE EVIDENCE

Although there is a large body of research evaluating acupressure for various purposes, most evidence is low quality and inconclusive.

Pain-Related Conditions

Most acupressure points are located near nervous tissue or structures. Researchers suggest that applying pressure at these points may block transmission of pain signals through certain neural gates [3].

Back Pain

Acupressure, administered either alone or as an adjuvant treatment, seems to reduce chronic low back pain. Clinical research in patients with lower back pain shows that acupressure, administered alone or with acupuncture, or acupressure massage with aromatic essential oil in combination with usual care, reduces pain and disability and improves walking ability when compared with physical therapy, usual care, or acupuncture alone [3].

Preliminary clinical research shows that using an acupressure backrest during sedentary work for one month reduces pain and disability by at least 30% when compared with no intervention. Other preliminary clinical research shows that using auricular acupressure for three minutes three times daily for five days each week for four weeks reduces pain by about 40% when compared with performing the same procedure on incorrect acupoints [3].

Auricular acupressure involves the taping of magnetic beads or plant seeds to the ear. In TCM, it is thought to relieve tension and improve circulation [3].

Osteoarthritis

Most research shows that manual acupressure does not improve pain or function in patients with knee osteoarthritis. Additionally, it is unclear if auricular acupressure is beneficial for osteoarthritis.

Clinical research in patients with osteoarthritis of the knee shows that self-administered acupressure alone for up to 16 weeks does not reduce knee pain intensity when compared with receiving sham acupressure, education on knee health, exercise, or no intervention [3].

A small clinical study shows that auricular acupressure four times daily for four weeks is associated with reductions in pain, stiffness, and function on days 3 and 7, but not days 14, 21, or 28, when compared with sham acupressure [3].

It is important to mention that there are a number of other pain-related conditions with insufficient evidence to support the use of acupressure. These conditions include neck and shoulder pain, postoperative pain, and neuropathic pain [3].

Cancer-Related Conditions

Cancer-Related Fatigue

Evidence Based Practice Recommendation

According to the Society for Integrative Oncology and the American Society of Clinical Oncology, reflexology or acupressure may be offered to patients experiencing pain during systemic therapy for cancer treatment.

https://ascopubs.org/doi/full/10.1200/JCO.22.01357

Last Accessed: October 27, 2022

Strength of Recommendation/Level of Evidence: Intermediate/Moderate

Acupressure seems to improve fatigue in patients with cancer. A meta-analysis of mostly small clinical studies in patients with cancer-related fatigue shows that various forms of acupressure, either self-administered or administered by a professional, reduces fatigue by a large amount when compared with usual care, sham acupressure, or acupuncture [3].

Thus far, the evidence on the use of acupressure for cancer-related fatigue is promising, and patients may consider acupressure as an adjunctive treatment option. However, there is very limited evidence on use for breast cancer, cancer-related pain, and chemotherapy-related fatigue [3].

Chemotherapy-Induced Nausea and Vomiting (CINV)

It is unclear if acupressure is beneficial in patients with CINV. Data are conflicting.

Some research, but not all, suggests that acupressure modestly reduces chemotherapy-induced acute and delayed nausea, but not acute or delayed vomiting. Research using acupressure wristbands for CINV is also mixed; some research shows that using a specific passive acupressure wristband product (Sea-Band) reduces nausea and vomiting when compared with usual care alone, but it does not appear to be more effective than sham acupressure [3].

The reasons for these mixed findings may be related to the type of cancer, the chemotherapy regimen used, or the severity of CINV. Larger, higher quality studies are needed to determine which patients, if any, may benefit the most from treatment.

Other Conditions

Dysmenorrhea

Acupressure seems to reduce pain in adults and adolescents with primary dysmenorrhea. Preliminary clinical research in adolescents with primary dysmenorrhea shows that beginning acupressure shortly after menstruation onset reduces the severity of dysmenorrhea for up to two hours after treatment and improves pain and anxiety. Self-administration of acupressure also seems to help reduce pain in dysmenorrhea [3].

Insomnia

Some small clinical studies suggest that manual and auricular acupressure improves sleep in patients with insomnia or sleep disturbances due to various underlying conditions.

Improvement in sleep was reported in small clinical studies, particularly in patients with hypertension or cancer, individuals who receive routine hemodialysis, and patients who are hospitalized or residing in long term care. Larger, higher quality studies are needed to determine which patients are more likely to benefit from treatment [3].

Motion Sickness

It is unclear if acupressure is beneficial in patients with motion sickness. Some clinical research shows that acupressure does not reduce motion sickness in elderly patients, females, or male college students. However, other research in experimentally induced motion sickness shows that acupressure at the P6 point reduces nausea when compared with baseline but has mixed findings when compared with sham acupressure [3].

There are a number of other conditions with insufficient evidence to support the use of acupressure. Some examples include, but are not limited to, PONV, smoking cessation, and irritable bowel syndrome (IBS) [3].

SAFETY

Acupressure in adults and children appears well tolerated when applied appropriately and has been safely used in numerous clinical trials. Most commonly, acupressure is associated with bruising, dizziness, headache, inflammation, and skin irritation [3].

5. TRANSCUTANEOUS ELECTRICAL ACUSTIMULATION (TEAS)

TEAS involves applying low-intensity electrical current to specific acupoints without puncturing the skin. TEAS can be given using electric units with a transcutaneous electrical nerve stimulation (TENS) unit or a Han's acupoint nerve stimulator (HANS) dual-channel unit. The electrodes are attached to specific acupoints on the body to which a small electric current is administered. Common currents include 2–100 Hz in constant or pulsed mode [5].

A specific acustimulation device (ReliefBand) has been used with apparent safety in clinical research with no reports of adverse effects. This device is commercially available and cleared by the U.S. Food and Drug Administration (FDA) for certain types of nausea, retching, and vomiting [5]. Note that FDA clearance and FDA approval are not interchangeable terms. "FDA cleared" typically refers to medical devices, which differs from the rigorous testing required for "FDA approval," which is generally applied to pharmaceutical drugs.

Common acupoints used for acustimulation are the P6 Neiguan point on the wrist, which is used for nausea and vomiting, and the ST36 Zusanli point below the knee, which is used for gastrointestinal discomfort, stress, and fatigue. These and other acupoints have been stimulated alone or in combination in clinical research [5].

Sessions normally last for 30 to 60 minutes and are conducted two to seven days per week for 2 to 12 weeks, or as multiple sessions daily. Occasionally, acustimulation is used in surgical patients, and may be administered prior to, during, and/or daily for up to three days after surgery [5].

REVIEWING THE EVIDENCE

Chemotherapy-Induced Nausea and Vomiting (CINV)

Acustimulation does not seem to be beneficial for CINV. Several clinical trials including patients with breast and liver cancer receiving highly emetogenic chemotherapy such as cisplatin or doxorubicin shows that acustimulation, administered by wearing a specific acustimulation device (ReliefBand) or given via electrodes does not improve CINV when compared with not wearing the device, wearing the device incorrectly, wearing acupressure bands, or sham acustimulation [5].

Additionally, there is insufficient evidence to support the use of TEAS in patients with fatigue or constipation related to chemotherapy [5].

Postoperative Complications

Postoperative Cognitive Dysfunction

Acustimulation seems to be beneficial for preventing postoperative cognitive dysfunction. A meta-analysis of generally good quality clinical research shows that acustimulation, alone or in combination with other therapies, reduces the incidence of postoperative cognitive dysfunction in the first week after surgery by approximately 60% when compared with control groups given sham intervention, no intervention, or other treatments. Although there were also improvements seven days after surgery, these benefits were not observed on day five [5].

Additional preliminary clinical research in elderly patients undergoing laparoscopic cancer surgery shows that acustimulation from 30 minutes before anesthesia induction to the end of surgery modestly reduces the cumulative duration of cognitive decline on postoperative days two and three when compared with no acustimulation. However, there was no effect on the incidence of cognitive decline [5].

Postoperative Ileus

Acustimulation seems to be beneficial for preventing postoperative ileus. A meta-analysis and individual clinical research show that acustimulation modestly improves the time to first flatus or first defecation, the number of spontaneous bowel movements, symptoms such as appetite, belching, and abdominal distension, and the overall incidence of postoperative ileus or gastrointestinal dysfunction when compared with sham acustimulation or routine treatment alone [5].

Acustimulation has been given during or after the operation until postoperative day three for cesarean section, gastric surgery, and colorectal surgery [5].

Postoperative Nausea and Vomiting (PONV)

Acustimulation seems to be effective for preventing PONV; however, it is unclear whether acustimulation is effective for treating PONV or whether it is more effective than antiemetics alone for preventing PONV.

Most clinical research from meta-analyses and individual trials shows that acustimulation reduces the risk of PONV by up to 46% for at least 2 hours, and in some cases for up to 48 hours, after surgery. In addition, a meta-analysis of four studies shows that acustimulation at the P6 acupoint reduces the need for antiemetic rescue [5].

Many studies used acustimulation of the P6 point starting before anesthesia and continuing for up to 72 hours after surgery using a specific acustimulation band (ReliefBand) or HANS electrodes. This device has shown benefit for PONV after gynecological laparoscopy, laparoscopic cholecystectomy, and plastic surgery and appears to be most effective for preventing PONV when used perioperatively and postoperatively as opposed to only preoperative use [5].

Other clinical research in children 4 to 12 years of age undergoing tonsillectomy shows that acustimulation of 20 Hz for five minutes before the induction of anesthesia and five minutes after surgery is as effective as ondansetron 0.15 mg/kg and more effective than no treatment for reducing the incidence of postoperative retching and vomiting on the day of surgery and the day after discharge, but not immediately after surgery or on postoperative day one [5].

Postoperative Pain

Acustimulation seems to be effective for reducing postoperative pain for certain surgeries. Clinical research shows that acustimulation modestly reduces postoperative pain and/or the need for postoperative analgesics when compared with sham acustimulation or routine treatment alone. Types of surgery have included caesarian section, inguinal hernia repair, thoracoscopic surgery, spinal cord surgery, total hip arthroplasty, radical mastectomy, ureteroscopic lithotripsy, gastrectomy, and others. In some cases, acustimulation is initiated prior to, and possibly during, surgery, as well as intermittently after surgery. In others it has only been used postoperatively for up to three days [5].

However, not all research agrees. When used in combination with the antiemetics dexamethasone and tropisetron in female patients undergoing laparoscopic sleeve gastrectomy, acustimulation does not reduce postoperative pain over 48 hours or the need for opioid medication [5].

There is very limited evidence on use for acustimulation in patients with acute or chronic pain. Additionally, it is unclear if acustimulation is beneficial in patients with neck pain or if it improves pain during labor [5].

SAFETY

TEAS is generally well tolerated when used appropriately, short-term. Acustimulation via other methods has also been used with apparent safety in clinical research for up to 12 weeks [5].

6. CONSIDERATIONS AND COMPARISONS

REPRODUCTIVE EFFECTS

Fertility

Until more is known about the safety of acupuncture, moxibustion, acupressure, or TEAS during in vitro fertilization (IVF), recommend against the use of these modalities [2,3,4,5].

Pregnancy and Lactation

Acupuncture

Some clinical research shows that acupuncture has been used during pregnancy and labor without reports of significant adverse effects when used appropriately at most acupoints and performed with sterile needles. There is insufficient reliable information available about the use of electroacupuncture or laser acupuncture during pregnancy; avoid using. There is some concern that acupuncture at the SP6 acupoint on the inner ankle can increase the risk of early contractions and miscarriage [2].

Acupressure

This therapy has been safely used during pregnancy in clinical trials without significant adverse effects [3].

Transcutaneous Electrical Acustimulation (TEAS)

There is currently insufficient reliable information available; however, there is no reason to expect safety concerns when used appropriately [5].

Moxibustion

While this therapy has been used with apparent safety during pregnancy in most clinical studies, some clinical evidence suggests that moxibustion may be associated with premature birth, premature membrane rupture, increased rate of contractions, abdominal pain due to contractions, placental bleeding, reduced or increased fetal movement, and reduced fetal heart rate [4].

There is insufficient reliable information available about the use of moxibustion during lactation; however, it is unlikely that maternal use of moxibustion would pose a significant safety risk to breastfeeding infants [4].

INTERACTIONS WITH CONDITIONS

Asthma

Theoretically, moxibustion may exacerbate asthma symptoms. Clinical reports of respiratory discomfort and asthma exacerbation due to the smoke associated with moxibustion suggest that moxibustion may not be safe for use in patients with asthma. However, some research has suggested a possible beneficial effect of moxibustion in patients with asthma. Until more is known, use with caution [4].

Other Considerations

Although there are no absolute contraindications, it is imperative that acupoint practitioners are fully informed on a patient's health history to ensure safety during treatment. Examples of conditions to watch out for include altered mental status, hemophilia, and needle phobia. Patients should inform their acupoint practitioners regarding any implanted devices, such as pacemakers. Additionally, dermatologic conditions such as cellulitis, burns, or ulcerations should be evaluated prior to treatment [2,3,4,5].

COMPARING THE EVIDENCE

Because these acupoint modalities share similar characteristics and may be used together in a therapy session, patients may have questions regarding specific therapies and their efficacy for specific indications.

Back Pain

Although multiple acupoint therapies have been evaluated for back pain, the study structures and comparators used in this research has varied widely.

Acupuncture

Most research shows that acupuncture seems to reduce back pain more than no treatment. However, it is unclear if acupuncture is more effective than sham acupuncture. Receiving more than five treatments with deep acupuncture seems to offer the most long-term benefit [2].

Moxibustion

Low-quality clinical research shows that moxibustion reduces back pain when compared with acupuncture, massage, or taking ibuprofen or celecoxib. Furthermore, adding moxibustion to other treatments such as massage, acupuncture, core stability training, or the medicines celecoxib or meloxicam, further reduces back pain when compared with the active treatment alone [4].

Acupressure

Clinical research in patients with lower back pain shows that acupressure, used alone or with acupuncture, or acupressure massage with aromatic essential oil in combination with usual care reduces pain and disability and improves walking ability when compared with physical therapy, usual care, or acupuncture alone [3].

Acupuncture, acupressure, and moxibustion have a growing body of evidence suggesting at least modest benefit for back pain. TEAS has not yet been adequately evaluated for this purpose [2,3,4,5].

Insomnia

Although multiple acupoint therapies have been evaluated for insomnia, research has varied widely. Take note of the differences in study structures and patient populations.

Acupuncture and acupressure have a growing body of evidence suggesting at least modest benefit for insomnia. There is currently insufficient evidence to rate the effectiveness of moxibustion for this condition; larger, higher quality studies are needed. TEAS has not yet been adequately evaluated for this purpose.

Acupuncture

Clinical research shows that manual acupuncture modestly improves sleep quality and might reduce the need for medication when used as an adjunct to sleep hygiene instruction or conventional treatment, sham acupuncture, or waitlist control [2].

Acupressure

Most small clinical studies suggest that manual and auricular acupressure modestly improves sleep in patients with insomnia or sleep disturbances due to various underlying conditions including patients with hypertension or cancer, those who are hospitalized or residing in long term care, or those receiving hemodialysis [3].

Moxibustion

Although some research has been conducted on the use of moxibustion for insomnia, there is not enough reliable evidence to confirm a benefit for these indications [4].

Osteoarthritis

Although multiple acupoint therapies have been evaluated for osteoarthritis, the affected joints, as well as the comparators used in clinical studies, have varied widely.

Acupuncture has a growing body of evidence suggesting at least modest benefit for patients with knee or hip osteoarthritis. Some research suggests moxibustion is beneficial for knee osteoarthritis, but it is unclear how it compares to the use of other therapies.

Most research shows that manual acupressure does not improve pain or function in patients with knee osteoarthritis. TEAS has not yet been adequately evaluated for this purpose.

Acupuncture

Meta-analyses of preliminary clinical research show that electrical, laser, and manual acupuncture modestly reduce pain and modestly improves function in patients with hip or knee osteoarthritis when compared with no treatment and sham treatment and when used as an adjunct to standard treatment. Furthermore, most individual preliminary clinical trials show that acupuncture is more effective than control treatments, such as advice or sham acupuncture, for reducing pain in knee and hip osteoarthritis for up to 12 weeks. Acupuncture is conditionally recommended by the ACR for any form of osteoarthritis [2].

Moxibustion

Meta-analyses of small clinical studies in patients with knee osteoarthritis show that moxibustion modestly reduces pain and improves function when compared with sham moxibustion or usual care. A subgroup analysis suggests that moxibustion improves osteoarthritis pain when compared with taking diclofenac, but not when compared with taking celecoxib; however, these findings are uncertain [4].

Acupressure

Most research in patients with osteoarthritis of the knee shows that self-administered acupressure alone for up to 16 weeks does not reduce knee pain intensity when compared with receiving sham acupressure, education on knee health, exercise, or no intervention [3].

Postoperative Nausea and Vomiting (PONV)

Although multiple acupoint therapies have been evaluated for PONV, the study structures and comparators used in this research has varied widely. Acupuncture and TEAS have a growing body of evidence suggesting at least modest benefit at preventing PONV. Currently, there is insufficient evidence to support the use of acupressure in this setting. Moxibustion has not yet been adequately evaluated for this purpose.

Acupuncture

Meta-analyses suggest that acupoint stimulation with acupuncture, acupressure, and electrical stimulation can reduce postoperative nausea and vomiting by up to 50% and may be as effective as conventional antiemetics. Furthermore, other analyses show that acupuncture of the P6 acupoint is effective in reducing incidence of nausea, vomiting, and need for rescue antiemetics postoperatively when compared with no treatment [2].

TEAS

Acustimulation seems to be effective for preventing PONV; however, it is unclear whether acustimulation is effective for treating PONV or whether it is more effective than antiemetics alone for preventing PONV [5].

7. CONSIDERATIONS FOR NON-ENGLISH-PROFICIENT PATIENTS

For patients who are not proficient in English, it is important that information regarding the benefits and risks associated with acupoint therapies be provided in their native language, if possible. When there is an obvious disconnect in the communication process between the practitioner and patient due to the patient's lack of proficiency in the English language, an interpreter is required. Interpreters can be a valuable resource to help bridge the communication and cultural gap between patients and practitioners. Interpreters are more than passive agents who translate and transmit information back and forth from party to party. When they are enlisted and treated as part of the interdisciplinary clinical team, they serve as cultural brokers who ultimately enhance the clinical encounter.

8. CONCLUSION

The popular practice of acupuncture has existed for centuries, with records dating back thousands of years. Acupuncture and related acupoint modalities are widely used on a global scale and continue to grow in popularity as patients seek alternative treatments for various acute and chronic medical conditions. Similarities between these modalities may make it difficult to decipher the effectiveness of individual treatments for certain conditions.

Additionally, quality of evidence remains a concern. The evidence supporting the use of acupoint therapies remains limited to low-quality research. Larger, higher quality studies are needed to determine which patients, if any, are most likely to benefit, and how these treatments compare to the use of other therapies.

Further, no treatment is without safety concerns, including adverse effects, condition interactions, and special considerations. It is imperative that clinicians provide accurate information regarding various acupoint therapies and evidence-based recommendations to help patients make informed decisions about their health.

Works Cited

1. TRC Healthcare Natural Medicines Database. Traditional Chinese Medicine (TCM). Available at https://naturalmedicines.therapeuticresearch.com/databases/health-wellness/professional.aspx?productid=1202. Last accessed October 24, 2022.

2. TRC Healthcare Natural Medicines Database. Acupuncture. Available at https://naturalmedicines.therapeuticresearch.com/databases/health-wellness/professional.aspx?productid=1219. Last accessed October 24, 2022.

3. TRC Healthcare Natural Medicines Database. Acupressure. Available at https://naturalmedicines.therapeuticresearch.com/databases/health-wellness/professional.aspx?productid=1240. Last accessed October 24, 2022.

4. TRC Healthcare Natural Medicines Database. Moxibustion. Available at https://naturalmedicines.therapeuticresearch.com/databases/health-wellness/professional.aspx?productid=1446. Last accessed October 24, 2022.

5. TRC Healthcare Natural Medicines Database. Transcutaneous Electrical Acustimulation. Available at https://naturalmedicines.therapeuticresearch.com/databases/health-wellness/professional.aspx?productid=1289. Last accessed October 24, 2022.

Evidence-Based Practice Recommendations Citations

1. Mao JJ, Ismaila N, Bao T, et al. Integrative medicine for pain management in oncology: Society for Integrative Oncology-ASCO guideline. J Clin Oncol. 2022; [Epub ahead of print]. Available at https://ascopubs.org/doi/full/10.1200/JCO.22.01357. Last accessed October 27, 2022.