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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 com-
pounding. 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.
Be familiar with the expectations of your health system’s accreditation organization and other
professional organizations. The four hospital accreditation organizations deemed by the Centers for Medicare & Medicaid Services include the Joint Commission (TJC), DNV Healthcare, Healthcare Facilities Accreditation Program and the Center for Improvement in Healthcare Quality. All of these organizations focus on sterile compounding, as they survey facilities.
TJC’s most recent information discussed at the ASHP 2021 Midyear Clinical Meeting and Exhibition identified several problem areas TJC has found during surveys: competency assessments, proper facilities, and response to certification and environmental monitoring reports. Specific issues have included pre-spiking IV bags and preparation of allergen extracts in practitioner offices and clinics. Make sure you have these items addressed before these organizations visit your site. Whatever accreditation organization you use, be sure to stay current with its guidance.
When accreditation organizations survey, they expect compliance with applicable laws and regulations, their standards, your organizational policies, and best practices. Several professional organizations provide best-practice documents that supplement the minimum standards established by USP. For more details, check out information at the ASHP, Institution for Safe Medication 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.
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—Patricia Kienle, RPh, MPA
We have seen similar situations when weather or other natural disasters affected supply of drugs and supplies. The COVID-19 crisis allowances were obviously lengthier and more comprehensive, but we need to be prepared for future emergency management needs.
Compounding pharmacists should monitor key sources of information: ASHP Connect, USP compounding pages, ISMP’s website and newsletters, the CDC, and FDA guidance pages. It’s important to remember that these allowances are usually only meant for the duration of a public health emergency and not intended to be permanent policies. Given the potential for new COVID-19 variants and an uptick in cases, it’s important to become familiar with these resources (Table).
States also have issued alerts concerning their compounding expectations during a public health emergency, and many state health-system pharmacy societies provide summaries and notices to their members.
It’s critically important to keep current with state-level changes by monitoring your state’s board of pharmacy website. Limit exposure to hazardous drugs. USP <800> is designed to protect healthcare workers, so work toward full compliance with the chapter. One piece of guidance in the chapter is to ensure your assessment of risk reflects best practices as well as how you handle hazardous drugs used in your institution. This practice requires a team-based, interprofessional effort to ensure your practices are appropriate throughout the health system.
We h Use the right technology/safety practices. Two key natural strategies are to use closed system drug-transfer The CO devices (CSTDs) and surface sampling. CSTDs are required and mo in the chapter for administration of National Institute for future Occupational Safety and Health Table 1 antineoplastic
Com agents and recommended for compounding. Evaluation of of inf CSTD use needs to be part of your assessment of risk evalues, IS ation and review. As for sampling for hazardous drug conguida tamination, this practice is a form of environmental moniallow toring and is growing as a way to monitor for contamination pu icbli and mitigate potential exposure to personnel and patients. nent vari Read and react to your daily monitors and certifibeco cation reports. Surveyors and state board inspectors
St often tell me that when they ask for the most recent certifipou cation and environmental monitoring reports, they find that gen the person supervising compounding operations hasn’t even ies reviewed the report.
It’s Now is the time to evaluate what’s in the reports and take c a ha action based on the results. Nonviable monitors aren’t limitweb ed to your twice-yearly certification. You also need to record daily temperature, humidity and pressure differentials of your compounding areas. Be sure you have a process to react to excursions and correct them when necessary. Make sure your certification reports summarize all the key required elements, and have your certifier review the areas that pass, fail or need attention after their evaluation. Be sure you receive a written report within a few days of the certifier’s visit, and schedule the return visit within six months to be sure you will have the certification completed before six months elapses, per USP requirements.
