Compliance is a journey that requires committed, ongoing effort in order to avoid pitfalls. Not attainable through the completion of a checklist, compliance is maintained by establishing measurable objectives, and executing and reviewing tasks that uncover new goals.
For 11 years, PP&P’s State of Pharmacy Compounding Survey has measured the pulse of hospital pharmacy on its compounding compliance journey. The survey queries pharmacy directors on a wide range of compounding practices, from the frequency of isolator glove changes and the practice of assigning BUDs to issues that have led to state boards of pharmacy citations.
Survey responses were solicited via email, and this year a total of 370 responses were received, yielding a confidence interval of 4.93 (95% +/- 4.93) based on the total population of pharmacy directors nationwide. We purposely survey a random sampling of pharmacy directors, not just readers of PP&P, to ensure the data herein reflects trends across the entirety of health system practices. Therefore, we are quite pleased to learn that 84% of pharmacy directors rely on PP&P as a resource for their compounding questions (see FIGURE).
Experience drives practice improvements, as demonstrated this year by the significant compliance growth in cleaning and environmental monitoring practices within the compounding complex. Similarly, pharmacy’s commitment to leveraging technology to improve practice continues with CSTD and IV workflow system adoptions on the upswing.
Despite a commitment to conducting gap analyses and planning for compliance improvements, many pharmacy departments were beset this year by the dual challenges of drug recalls and shortages. The surge in drug recalls and shortages is a significant drain on resources. Even so, pharmacy directors typically report strong confidence in their outsourcing vendor’s ability to address the issues underlying recalls. Similarly, many pharmacy directors rely on outsourced vendors to offset medication shortages.
In planning for the future, there is clear recognition of the challenges that lie ahead in terms of meeting USP <800> requirements, given the relatively short time frame in which to implement compliant facilities and practices.
Keys to Success
Successful compounding programs do not all look the same, as some meet the needs of small facilities compounding 20 CSPs per day, while others manage 500+ CSPs daily utilizing pass-through carousels, gravimetric ingredient checks, and archived photos of each step along the way. Nonetheless, many successful compounding programs share the following common attributes: strong documentation practices and regular state board inspections.
Whether effective practice leads to good documentation or good documentation reinforces effective practices remains open to debate. Regardless, it is clear that accreditors and inspectors are interested in a deeper exploration of practices that are not well-documented. This underscores the value of focusing on documentation, not just to simplify the survey process, but also to create an early warning system that serves to point out potential weaknesses.
Similarly, the argument can be made that the expectation of stringent inspections leads to the development of conscientious procedures and rigorous oversight. This is supported by the fact that facilities in those states wherein the pharmacy board requires <797> compliance have higher compliance rates.
We hope the data on the pages that follow support you on your compounding compliance journey. As your efforts expand to include HD compounding, watch for PP&P’s special supplement in June on Hazardous Drug Handling, which will detail specific HD practices and monitor pharmacy’s current adherence to those practices. To support your compliance efforts, we are happy to provide many of the graphs and charts herein as PowerPoint slides at pppmag.com/slides. You are welcome to use these slides for your internal and external presentations; we simply require that you maintain our credit line on each slide. Good luck on your journey!
Deanne Halvorsen is the editorial director of Ridgewood Medical Media, publisher of Pharmacy Purchasing & Products and Medical Lab Management. She can be reached at email@example.com.
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
Conduct a Drug Diversion Investigation
Special PP&P Buyer's Guide: Temperature Monitoring
Develop a Pneumococcal Vaccination Program
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