#81090: Review of Texas Pharmacy Law for Pharmacists

During the COVID-19 public health emergency, the federal government, under the Public Health Readiness and Emergency Preparedness (PREP) Act, authorized qualified pharmacists to order and administer, and pharmacy technicians and pharmacy interns to administer, influenza and COVID-19 vaccines to any patient age 3 and older. Although the public health emergency has ended, this authority under the PREP Act has been extended through December 2024 [11]. If you are providing immunizations during the public health emergency under the PREP Act, make sure you are following both the federal requirements and your state's requirements for reporting and recordkeeping.

REFLECTION

You are working with a pharmacy technician trainee who is wondering what she needs to do to become registered as a pharmacy technician. What would you tell the technician-in-training? How long can the pharmacy technician trainee work as a technician-in-training before needing to become registered as a pharmacy technician?

Individuals interested in working as a pharmacy technician in Texas must first register with the Board of Pharmacy before they begin working in a pharmacy. He or she must meet several requirements to be eligible for pharmacy technician registration [23,24]:

Technicians who are waiting to take and pass one of the national certification exams can still work in a pharmacy. But they must first apply for registration as a pharmacy technician trainee. This registration as a trainee is only good for two years, and it's NOT renewable. This means that pharmacy technician trainees can't work as a technician-in-training for more than two years. To work in the pharmacy after that time, they must have passed one of the Board-approved national certification exams AND have obtained pharmacy technician registration from the Board. Maintaining national certification is completely voluntary. The Texas State Board of Pharmacy only requires that technicians be nationally certified for their initial registration, not to maintain their certification [25]. However, registration with the Board must be maintained at all times that a pharmacy technician will be working in a pharmacy [23].

Both technicians and technician trainees must complete initial "on-the-job" training when they start working at your pharmacy. This training must be outlined in a training manual. The training must include how technicians will be supervised, clarify technician duties, and instruct technicians on basic areas of pharmacy practice. Technicians and trainees must also complete continuing in-service education and training to supplement the initial training. Documentation of the training must be kept on file at the pharmacy [26].

A written record of initial and in-service training of pharmacy technicians and pharmacy technician trainees must be maintained at the pharmacy and should include the following information [26]:

Additional training, including ongoing continuing education, is required for pharmacy technicians and pharmacy technician trainees engaged in non-sterile or sterile compounding. The pharmacist-in-charge is responsible for determining that all personnel engaged in compounding possess the education, training, and proficiency needed. Training activities should be documented and covered by standard operating procedures [8,9].

Initial training for pharmacy technicians and pharmacy technician trainees who will be involved in sterile compounding must include either a single 40-hour course offered by an ACPE-accredited provider which provides a combination of instruction and experience, OR a training program accredited by ASHP. Pharmacy technicians and pharmacy technician trainees must also complete a structured, on-the-job didactic and experiential training program. All pharmacy personnel engaged in sterile compounding, including pharmacy technicians and pharmacy technician trainees, must pass written and skills testing initially and every 12 months for low- and medium-risk level compounding, or every six months for high-risk level compounding [8].

Once a pharmacy technician has registered with the Texas State Board of Pharmacy as a pharmacy technician, they will need to renew their pharmacy technician registration every two years. In order to renew their license, pharmacy technicians must complete and report 20 contact hours of approved continuing education obtained during the renewal period in pharmacy-related subjects. Up to five hours may be earned during in-service education and training from their employer. One hour must be related to Texas pharmacy laws or rules. Like pharmacists, all pharmacy technicians are also required to complete an HHSC-approved human trafficking prevention training course. Although this is a training requirement and not a CE requirement, if the course taken provides CE credit, it may count towards the technician's total 20 hours. Even pharmacy technicians in their initial renewal period must complete this human trafficking training requirement [27,28].

Like pharmacists, for the first renewal, technicians don't need to complete the required CE hours. Also, like pharmacists, technicians need to keep copies of the certificates (either hard copy or electronic) for CE activities for at least three years from the date of reporting the hours on a renewal application [27].

As mentioned for pharmacists, during each renewal period, pharmacy technicians who are engaged in sterile compounding need to complete at least two hours of CE related to sterile compounding if they are compounding low- or medium-risk sterile compounds, or four hours of CE if they are compounding high-risk compounds [8].

Keep in mind that pharmacy technician trainees do not have any continuing education requirements.

In Texas, pharmacy technicians are allowed to perform many tasks while assisting the pharmacist. But any activities a pharmacy technician performs must be done under the direct supervision of the pharmacist. Ultimately, the pharmacist is the one responsible for all activities that occur inside the pharmacy.

Examples of duties a registered pharmacy technician is allowed to do [15]:

The type of activities a pharmacy technician assists with will also depend on the practice setting. Depending on the specific activity, there may be additional Board requirements the technician will have to meet.

For example, the Board allows certain technicians who work in a hospital to check the work of another technician. This is often referred to as "tech-check-tech." But there are a few requirements before a technician can check another technician's work. The Board must approve the tech-check-tech process for your pharmacy. Then, a technician can only check the work of another technician for orders related to filling floor stock and unit-dose distribution [15].

Tasks that require the professional judgment of a pharmacist must be left to the pharmacist. The Texas Board of Pharmacy recognizes this, and says that pharmacy technicians may NOT [15]:

In addition, only a pharmacist may perform the final check of a completed prescription.

Texas has limits on how long prescriptions are valid. Noncontrolled prescriptions cannot be filled or refilled more than one year from the date the original prescription was written. Keep in mind that this includes prescriptions written by the prescriber, but never filled [15].

If a prescription is written for a smaller quantity of a noncontrolled drug with refills, you may dispense up to a 90-day supply of the prescription. However, you may only do this if the [15]:

Texas requires that the transfer of original prescription information must be completed within four business hours of the request.

A patient is allowed to transfer noncontrolled prescriptions that have refills from one pharmacy to another. These can be transferred up to the number of originally authorized refills. Transfers for noncontrolled drugs can be communicated by pharmacists, pharmacist-interns, or pharmacy technicians to another pharmacist, pharmacist-intern, or pharmacy technician [15].

The rules for transferring controlled substances in Schedules III through V are a little stricter. Prescriptions for controlled substances can be transferred between pharmacies, but only one time, and the remaining refills must be dispensed by the new pharmacy. Make sure patients who transfer prescriptions for controlled substances realize that they cannot transfer these prescriptions again. The exception is if pharmacies share a real-time, online database. In this case, the prescription can be transferred up to the maximum refills allowed by law and the prescriber's authorization. Also be aware that transfers for controlled substances can be communicated by pharmacists or pharmacy-interns to another pharmacist or pharmacy-intern. Pharmacy technicians cannot transfer controlled substance prescriptions [15].

The person transferring the prescription must [15]:

The person receiving the transferred prescription must [15]:

Pharmacies may also perform a one-time transfer of electronically prescribed Schedule II through V controlled substances for initial filling [30,31]. But this can only be done if both pharmacies are set up to forward and receive electronic controlled substance prescriptions. If this is not the case, the prescriber should be contacted to retract the electronic controlled substance prescription and resend to the pharmacy requested by the patient [15].

There will be times when a patient runs out of refills on a prescription that must be taken with little or no interruption. In most cases, you can dispense a one-time emergency refill when a patient is out of medication AND the prescriber can't be contacted. In these cases, the law says that you can give up to a 72-hour supply of medication. This includes all medications except Schedule II controlled substances. You must notify the patient that prescriber authorization is required and that the emergency refill is being done without prescriber authorization. You must also notify the prescriber of the emergency fill as soon as reasonably possible [15].

If the prescription was originally filled at another pharmacy, you can provide the patient with a 72-hour emergency supply if there are no refills remaining or if the other pharmacy can't be contacted for a transfer. However, the patient must have their prescription bottle (or other documentation that contains enough information to safely fill the prescription). There's one exception to this 72-hour emergency supply and that is if the prescription requiring an emergency supply is for insulin or insulin-related supplies. In this case, the quantity of the emergency refill may not exceed the lesser of a 30-day supply or the smallest available package [15].

Schedule II controlled substances are not included in this 72-hour rule. However, per federal and state law, emergency prescriptions of Schedule II controlled substances are allowed in certain situations. Prescribers can call in an emergency prescription for a Schedule II controlled substance with a quantity needed to cover the emergency period. "Emergency prescription" in this context means that the immediate administration of a drug is necessary for proper treatment of the patient, that no alternative treatment is available, and it's not possible for the prescriber to provide a written prescription at the time. Prescribers must then, within seven days, send an electronic prescription, or if exempt from the e-prescribing controlled substances mandate (discussed later), deliver a written, signed prescription (either in person or by mail). The written prescription must have written on its face "Authorization for Emergency Dispensing" and the date of the oral order. For electronic prescriptions, the pharmacist must annotate the record with the original authorization and date of the oral order. If a written or electronic prescription isn't received within seven days, the local DEA diversion field office must be notified [32,33].

In the event of a disaster, a pharmacist may be able to dispense up to a 30-day supply of a medication (other than a Schedule II prescription) without the authorization of a prescriber under specific circumstances, such as the governor has declared a state of emergency and the executive director of the Board of Pharmacy has notified pharmacies that pharmacists may dispense up to a 30-day supply of prescription drugs [15].

Pharmacists can accept prescriptions issued by prescribers licensed in other states, but there are specific rules for controlled substances. For Schedule III through V prescriptions from out-of-state practitioners, the prescription can be filled if it is issued by a physician, dentist, veterinarian, or podiatrist who is legally authorized to prescribe controlled substances in the state they practice (controlled substance prescriptions from out-of-state nurse practitioners or physician assistants may not be filled). However, in order to fill prescriptions from out-of-state prescribers for Schedule II prescriptions, your pharmacy must have a plan approved by and on file with the Board which allows the activity [15,34].

Prescriptions from prescribers licensed in Canada or Mexico in a health field that is recognized by the state of Texas as one that is legally authorized to prescribe drugs (e.g., physician, dentist, veterinarian, or podiatrist), may also be filled under certain circumstances. The prescription cannot be for a controlled substance, and it must be an original, written prescription with a manual signature [15].

The Texas State Board of Pharmacy provides a helpful quick reference guide for determining if you could dispense out-of-state prescriptions [35].

Pharmacies in Texas are required to maintain records of all prescriptions and dispensed medications. For prescriptions, the pharmacy must keep the original prescription or an electronic image of it for at least two yearsfrom the date it was last filled. Inventory records should also be kept for two years from the date of the inventory or record.

Additionally, in community pharmacies, a daily hard copy printout of all prescriptions dispensed and refilled should be produced within 72 hours and reviewed within seven days. Each individual pharmacist who dispenses or refills a prescription shall verify that the data indicated on the daily hard copy printout is correct, by dating and signing the document. Alternatively, the pharmacy can keep a logbook with each individual pharmacist signing (or electronically signing) a statement each day attesting that the information entered into the dispensing system has been reviewed and is correct. The hard copy printouts or logbook must be maintained for two years from the date of dispensing.

Another example of when Texas law is stricter than federal law can be seen with privacy laws. The federal Health Insurance Portability and Accountability Act (HIPAA) was created to protect a patient's health information. The Texas Medical Records Privacy Act (TMRPA) adds additional safeguards on top of HIPAA for protected health information (PHI). For example, TMRPA requires that covered entities, such as pharmacies, provide employee training on both federal and state laws related to the protection of PHI [37]. This training should be specific to the employee's responsibilities and the pharmacy's course of business. Each new employee must complete this training within 90 days after the hire date [37]. Employees must also be trained anytime there is a change in Texas or federal law that affects their duties by no later than the first anniversary of the date the change in law takes effect [37]. Contact your supervisor for more information on where to get this required state/employer-specific training.

Texas law also expands the definition of "covered entities" beyond the HIPAA definition [37]. In addition to healthcare providers, plans, and medical clearinghouses defined in federal law, Texas law broadened this to include any person, business, or organization that touches PHI in any way. Another more stringent state requirement is that patients must be given their electronic health records within 15 business days of their written request [37]. This is shorter than the 30-day federal requirement. Financial penalties related to inappropriate disclosure of PHI in Texas may also be higher compared to federal penalties. Make sure you are familiar with the Texas-specific laws for maintaining patient privacy. You can find more information about the various health information privacy laws that have been passed in Texas on the Attorney General of Texas' website [38].

Texas classifies controlled substances into five schedules, just like federal law. Practically all controlled substances are in the same schedules as federal law. For example, fentanyl is a Schedule II product. Buprenorphine is a Schedule III controlled substance. And diazepam is a Schedule IV controlled substance [39].

One difference is that Texas requires a prescription for codeine-containing Schedule V medications. Federal law allows some of these meds to be sold over the counter as long as they don't exceed certain quantities. In Texas, codeine-containing cough meds or any other products containing codeine or dihydrocodeine must have a prescription to be dispensed. Treat these Schedule V products like pregabalin (Lyrica), diphenoxylate/atropine (Lomotil), and other Schedule V prescription controlled substances [33].

The Texas Health and Safety Code requires prescriptions for controlled substances to be issued electronically [33,40]. There are some exceptions to this, such as prescriptions issued by veterinarians, prescriptions ordered in an emergency, or cases where a prescriber has applied for a waiver from the Texas Medical Board due to exceptional circumstances prohibiting e-prescribing implementation [41]. Keep in mind that pharmacists who receive an otherwise valid written, oral, or faxed controlled substance prescription after the implementation date do not have to verify that the prescription is exempt from the requirement of e-prescribing.

As mentioned above, all controlled substance prescriptions, including Schedule II prescriptions, are required to be sent electronically unless the prescriber is exempted from the requirement. If the prescriber is exempted, the only other acceptable format for a Schedule II prescription outside of an emergency is for it to be written on an "official Texas prescription form" that the prescriber orders from the Texas State Board of Pharmacy [40]. A Schedule II med must be filled within 30 days after the date the prescription was issued [40].

There is generally no days' supply limit set by the Board for a Schedule II prescription. However, for opioids for the treatment of acute pain, a prescriber may not issue a prescription for an opioid in an amount that exceeds a 10-day supply [40]. While pharmacists won't be subject to penalties for dispensing a prescription that exceeds this limit, it's important to remember that pharmacists have a corresponding responsibility to ensure the prescription is for a legitimate medical purpose in the usual course of professional practice [40].

Additionally, there is a days' supply limit when prescribers issue multiple Schedule II prescriptions. Prescribers can issue multiple prescriptions for the same Schedule II drug on the same day, but only up to a 90-day supply (in total for all prescriptions) [40].The prescriber must include the date each prescription was written AND the earliest date each prescription can be filled. In this case, the prescription must be dispensed within 30 days of the earliest fill date noted on each prescription (not necessarily the date of issue) [40].

Texas allows for partial filling of Schedule II controlled substances in accordance with federal law [33]. According to federal law, partial filling of Schedule II controlled substance prescriptions is allowed at the request of the prescribing practitioner or patient as long as the total quantity dispensed in all partial fillings doesn't exceed the total quantity prescribed. In addition, remaining portions of a partially filled Schedule II prescription cannot be filled beyond 30 days after the date the prescription was written [33,42]. If a Schedule II prescription is partially filled due to a pharmacy stock issue, DEA regulations specify that the remainder must be dispensed within 72 hours, otherwise the remaining quantity is voided, and the prescriber must be notified [32].

Pharmacists who dispense Schedule II controlled substances must provide patients with a written notice on the safe disposal of controlled substances, unless the pharmacy is able to accept the drugs back for safe disposal (e.g., pharmacies that are authorized collectors or pharmacies that provide at no cost a mail-in pouch for patients to dispose of drugs) [40]. This written notice must include information on locations where Schedule II drugs are accepted for safe disposal or provide a web address of a website specified by the Board, such as the DEA's Drug Disposal information website, that has a searchable database of locations where Schedule II prescriptions can be accepted for safe disposal [40,43]. The written notice can be provided in an electronic form, but only if the patient or patient's agent requests this and the request is documented [40].

In addition to limits on Schedule II prescriptions, Texas restricts who can write controlled substance prescriptions.

Like most states, Texas allows doctors, dentists, veterinarians, and podiatrists to write controlled substance prescriptions. However, it also allows other prescribers, such as nurse practitioners, optometrists, and physician assistants to order scheduled drugs, but with limits. For example, nurse practitioners and physician assistants can write for Schedule III, IV, and V meds. But the prescription, including refills, cannot exceed a 90-day supply. Nurse practitioners and physician assistants can only write for Schedule II prescriptions in the hospital setting, including for patients receiving services in the emergency department. They may also write Schedule II prescriptions for patients with a terminal illness receiving hospice care [35,44].

REFLECTION

How often does your pharmacy perform a full inventory of all the medications on the shelves? How does this frequency differ when comparing controlled substances to noncontrolled substances? How does it differ from federal pharmacy law? When must the inventories occur?

Under federal law, controlled substances must be inventoried every two years. This is another area where Texas law is stricter than federal law regarding scheduled medications. Pharmacies in Texas must inventory controlled substances every year. This coincides with the annual inventory requirement for noncontrolled drugs as well. However, inventory records for Schedule II drugs must be maintained separately from other controlled substances, and inventory records for Schedule III, IV, and V drugs must be maintained separately from noncontrolled drugs or be readily retrievable [15].

Inventory must occur on May 1st annually, or on the pharmacy's regular general physical inventory date (determined by the pharmacy). Both the person taking the inventory and the pharmacist-in-charge must sign and date the records and have the document notarized within three days of the inventory being completed. This inventory must be filed separately from all other records and be available at the pharmacy for inspection for at least two years [15].

Pharmacies must report all outpatient controlled substance prescriptions to the Texas Prescription Monitoring Program no later than the next business day after filling the prescription [45]. Pharmacists may delegate access to the Texas Prescription Monitoring Program to registered pharmacy technicians, but pharmacy technicians must register as a separate user [46]. Additionally, pharmacists dispensing an outpatient prescription for an opioid, benzodiazepine, barbiturate, or carisoprodol will be required to check the patient's Prescription Monitoring Program history before dispensing [47]. Exceptions to this requirement include prescriptions issued by veterinarians or if it's clearly noted on a prescription that the patient has a diagnosis of cancer or sickle cell disease or that the patient is in hospice care [47].