Verifying and dispensing requirements The bulk of the pharmacy-specific aspects of the Texas Administrative Code focus on elements of pharmacy practice, such as the responsibilities and obligations for providing safe and effective care to patients. While the role of the pharmacist varies depending on the position they hold, the TAC contains information regarding appropriate and approved practice for every pharmacist. An important role of a pharmacist is verifying the validity of a prescription. TAC §291.29 outlines various requirements for prescription validity, including determining script authenticity, medically legitimate reasoning for prescribing, and identifying potentially inappropriate prescribing patterns in the community. As pharmacy practice scope and technology advance, however, pharmacists must adapt to continue performing this role successfully. In February 2022, the Board provided guidance on how to validate prescriptions originating from a teledentistry or telemedicine visit. An update to TAC §291.29 noted that teledentistry and telemedicine prescriptions must follow all in-person-visit-originating prescription requirements. Therefore, these prescriptions must be issued for a medically appropriate reason and meet all other applicable laws, such as the Controlled Substances Act, if necessary. Another aspect of pharmacy practice involves emergency refills of medication. If a prescriber is unable to be reached, a pharmacist may use professional judgement in determining the necessity of an emergency refill of medication. According to TAC §291.34, an emergency refill may be issued when: ● Failure to refill the prescription could result in patient suffering. ● Failure to refill the prescription may lead to a disturbance in a therapeutic regimen. ● The pharmacist does not dispense an amount of medication exceeding a 72-hour supply. ● The pharmacist informs the patient that the refill is provided without authorization, and practitioner authorization will be mandated for future refills. ● The pharmacist informs the prescriber of an emergency fill as soon as possible. ● The pharmacist maintains a record of the emergency refill, including all information regularly required for a prescription record. While these guidelines establish clear parameters for the emergency refill procedure, questions remained about specific scenarios related to deciding to dispense an emergency refill. Considering the importance of insulin therapy to patient health, the Board updated TAC §291.34 to reflect specific instructions for managing insulin emergency refills. Similar to other emergency refills, the pharmacist must attempt to contact the prescriber and assess the patient’s remaining insulin to determine the necessity of an emergency refill. However, unlike other emergency fills, insulin may be filled with up to a 30- day supply rather than a 72- hour supply. This also applies to supplies needed for administration of insulin. November 2022 Board proceedings resulted in various updates to Texas Administrative Code §291.33 and §291.8 regarding the redispensing of medications returned to a pharmacy. Chapters 431 and 442 of the Texas Health and Safety Code outline requirements for a returned medication to be redispensed to a charitable medical clinic. Chapter 431, which is the Texas Food, Drug, and Cosmetic Act, explains that for re-dispensing eligibility, a returned drug must: ● Be a drug that requires a prescription; however, no controlled substances are eligible for return and redispensing. ● Be a drug approved by the federal Food and Drug Administration.
● Be sealed in the manufacturer’s unopened original tamper- evident packaging and meet the following (as appropriate
depending on the medication): ○ Be individually packaged. ○ Be packaged in unit-dose packaging.
○ Be oral or parenteral medication in sealed single-dose containers designed with approval of the federal Food and Drug Administration. ○ Be a topical or inhalant medication in sealed units-of- use containers approved by the federal Food and Drug Administration. ○ Be a parenteral drug in a multidose container with no doses yet withdrawn. ○ Not be subjected to any recall initiated by state or federal agency, drug seller, or manufacturer. ○ Only be dispensed: ■ Before the expiration or within recommend use date of the drug. ■ After a licensed pharmacist has thoroughly inspected the medication and ensured acceptable integrity. Board updates to TAC §291.33 and §291.8 adopted this set of requirements for accepting returned medication, albeit in different situations than a charitable medical clinic. According to TAC §291.8, the requirements described in the Texas Food, Drug, and Cosmetic Act also apply to pharmacies accepting returned drugs from healthcare facilities and penal institutions. Assuming the aforementioned eligibility is met, such as remaining in an unopened, tamper-evident manufacturer container, a medication returned from a healthcare institution or penal institution may be redispensed by the pharmacist following a thorough inspection and confirmation of medication integrity. Self-Assessment Quiz Question #1 For noninsulin emergency refills, what quantity of medication are pharmacists able to dispense?
a. 15-day supply. b. 30-day supply. c. 3-day supply. d. 1-day supply.
Pharmacy practice involving controlled substances represents the most heavily legislated and regulated aspect of patient care. This is designed to improve patient safety, as well as protect healthcare practitioners from mismanaging these potentially dangerous medications. However, despite the vast set of rules regarding controlled substances, additions and alterations are routinely made to pharmacy practice legislation. At the federal level, prescriptions written for medications belonging to the Schedule II controlled substance class were considered valid for 30 days from the date the prescription was written. Some common medications in this class include oxycodone, hydromorphone, and methylphenidate. In Texas, however, the period during which prescriptions for Schedule II controlled substances were valid was much shorter. In May 2021, the Texas State Board of Pharmacy adopted changes to TAC §315.3 and §315.5 to make Texas pharmacy requirements consistent with federal law. Therefore, prescriptions for Schedule II controlled substances are valid for up to 30 days from the written date. This update is also reflected in the dispensing of multiple controlled substance prescriptions. If a prescriber writes multiple prescriptions for a Schedule II substance to give the patient a 90- day supply, the prescriptions are valid only within 30 days of the date written on the prescription.
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