■ 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 differ- ent 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 un- opened, 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?
According to TAC §291.34, an emergency refill may be issued when: ● Failure to refill the prescription could result in patient suffer - ing. ● 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 emer- gency refill procedure, questions remained about specific scenar - ios related to deciding to dispense an emergency refill. Consider - ing 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 emer- gency 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 require- ments 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 Adminis- tration. ● Be sealed in the manufacturer’s unopened original tamper-ev- ident packaging and meet the following (as appropriate de- ○ 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 Ad- ministration. ○ 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: Controlled substance management and dispensing The final update to controlled substance law in Texas went into effect in February 2023. TAC §315.6 reflects that, in conjunction with the Texas Prescription Monitoring Program, by the next busi- ness day following the dispensing, pharmacists are required to report each controlled substance dispensed. In an update to TAC §315.6, the Board included directions for what to report, which can be found in another Board publication, the Data Submission Guide for Dispensers. This guide explains the various steps for establishing regular reports through the Texas Prescription Moni- toring system. Following this guide ensures that pharmacies are in compliance with all Board requirements for controlled substance reporting. pending on the medication): ○ Be individually packaged. ○ Be packaged in unit-dose packaging.
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 health- care practitioners from mismanaging these potentially dangerous medications. However, despite the vast set of rules regarding con- trolled substances, additions and alterations are routinely made to pharmacy practice legislation. At the federal level, prescriptions written for medications belong- ing 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, hydro- morphone, 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. There- fore, 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 con - trolled substance prescriptions. If a prescriber writes multiple pre- scriptions 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. More recently, the Texas State Board of Pharmacy updated the 30- day window for Schedule II prescription validity again. Previously, this legislation applied only to in-state prescribers; prescriptions for Schedule II medications written outside of Texas remained valid for the shorter period of time. Starting in February 2022, however, out-of-state practitioners were ncluded in the update, allowing for 30-day prescription validity for Schedule II controlled substances. Pharmacy Practice Consideration: It is important to verify the legitimacy of controlled substance prescriptions before dis- pensing them. The Texas State Board of Pharmacy provides a list of “Red Flags” that may assist in determining if a pharmacy has become a target for invalid prescriptions. For instance, if numerous people come to the pharmacy with the same con- trolled substance prescriptions written by the same provider, the lack of individualized drug therapy may indicate that these prescriptions are fraudulent. For a full list of Red Flags, visit https://www.pharmacy.texas.gov/files_pdf/You_might_be_a_ pill_mill_if.pdf
Page 3
Book Code: RPTX3024
EliteLearning.com/Pharmacy
Powered by FlippingBook