Kienle’s 10 New Building Blocks of Compounding Safety Each year, Patricia Kienle, RPh, MPA, BCSCP, FASHP, the director of accreditation and medication safety at Cardinal Health, shares 10 points that she believes pharmacists need to consider to ensure compounding safety and compliance with USP, state boards of pharmacy, and other regulatory bodies and accreditation organizations. Follow the USP compounding-related chapter revision process. The 2019 proposed revisions of USP General Chapter <795> (nonsterile compounding) and USP <797> (sterile compounding) were appealed, but USP published updated revisions in September 2021. The 2019 appeals of the USP chapters were primarily about beyonduse dates (BUDs) and the ability to extend them. The information added to the proposed revised 2021 chapter <797>, particularly information in the boxes supplementing the text, is valuable to incorporate into policies. To keep up to date, institutions should subscribe to the USP Compounding Compendium (www.usp.org/ products/usp-compoundingcompendium) and follow the USP compounding page (www.usp.org/compounding). USP <800> (handling hazardous drugs) has been an official chapter since 2016. It was not appealed, but its federal enforceability is tied to its mention in the revised chapters. Some states have already chosen to incorporate all or portions of the requirements in their review. USP <825> (radiopharmaceuticals) has been an official chapter since 2020. It applies both to nuclear pharmacies and nuclear medicine departments in hospitals and clinics. Read the FDA document concerning unsanitary conditions and hospital/health-system compounding. Be sure to monitor the FDA website (bit.ly/ 3LGEX0A) for new and revised compounding-related documents, including those related to unsanitary conditions (bit.ly/2PvYQQe), which were updated in November 2020, and a revised draft version of hospital and healthsystem expectations, which were updated in October 2021. Other documents concern repackaging, compounding from bulk substances and outsourcing facilities. These documents may be in draft or final form, so be vigilant and make sure you have the most recent revision. Stay current with state rules and regulations. State regulations may be more stringent than USP standards, and some states already have incorporated aspects of the revised USP chapters into their inspections. Because of ongoing confusion about which standards to adhere to—USP or state regulations—especially around BUDs and frequency of personnel requalification, pharmacies should follow the more stringent regulations, which may be on the state side.
16
Be familiar with the expectations of your urr health nd d other system’s accreditation organization and ccreditaprofessional organizations. The four hospital ac accreditaedicare & tion organizations deemed by the Centers for Me Medicare o (TJC), on Medicaid Services include the Joint Commission reeditation DNV Healthcare, Healthcare Facilities Accreditation ealthcare Program and the Center for Improvement in He Healthcare errile comQuality. All of these organizations focus on sterile pounding, as they survey facilities. a the TJC’s most recent information discussed at ib bition ASHP 2021 Midyear Clinical Meeting and Exhibition nd d duridentified several problem areas TJC has found ing surveys: competency assessments, properr facilin nmental ties, and response to certification and environmental clluded monitoring reports. Specific issues have included r rgen pre-spiking IV bags and preparation of allergen ake extracts in practitioner offices and clinics. M Make h hese sure you have these items addressed before these diitaorganizations visit your site. Whatever accreditarent tion organization you use, be sure to stay current with its guidance. th hey When accreditation organizations survey, they gu ulaexpect compliance with applicable laws and regulaliitions, their standards, your organizational poligaacies, and best practices. Several professional orgahaat nizations provide best-practice documents that ed d supplement the minimum standards established maaby USP. For more details, check out informaon n tion at the ASHP, Institution for Safe Medication o or Practices (ISMP), and American Society for Parenteral and Enteral Nutrition websites. Be aware of allowances and restrictions when unusual circumstances occur. The COVID-19 pandemic created situations that no one anticipated. ASHP, the CDC, the FDA, ISMP and USP developed documents with allowances during the public health emergency. These included adjustments for BUDs, garb and personal protective equipment, as well as other components of compounding regulations and best practices, assuming appropriate oversight. As the situation evolved, the documents were updated.
P H A R M AC Y P R AC T I C E N E WS CO M P O U N D I N G S P E C I A L E D I T I O N • 2 0 2 2
