Marking its 15th year, PP&P’s State of Pharmacy Compounding survey establishes the current status of compounding practice in the US. The results on the pages that follow illustrate the growth that has occurred, while also demonstrating the continual change that is driven by a constantly evolving regulatory focus.
The survey queries pharmacy directors on a wide range of compounding issues, from investments in technology and commitment to outsourced compounding to the frequency of compounding errors and the reasons behind accreditation citations. Survey responses are solicited via email, and this year a total of 315 responses were received, yielding a confidence interval of 5.36 (95% +/- 5.36) based on the total population of pharmacy directors nationwide.
86% of pharmacy directors rely on PP&P as a resource for <797> information.
As in-person inspections have returned and survey frequency is back to pre-pandemic rates, up-front preparation, including gap analyses and mock surveys, is key. Easing this process is the fact that inspections by accreditors and state boards focus on very similar topics. Rare is the inspection that doesn’t review PPE donning, hand hygiene, and aseptic technique. The main inspection theme that emerged this year is a focus on documentation, from certification reports and environmental monitoring logs, to cleaning logs and competency documentation; inspectors are reviewing documentation at a detailed level.
You can count on the suveyors being well versed in <797> and prepared with checklists to support a detailed and thorough inspection of your facility. Conversely, many inspectors are keeping their USP <800> queries rather general, asking about timelines to compliance, plans for segregated storage, and reviewing P&Ps. As such, it is highly recommended to use this time to ensure you will be prepared for the more rigorous <800> surveys that are to come.
The goal is to avoid citations—while still rare, these are increasing in frequency. Simple solutions are available for some of the most common citations; for example, ensure your ceiling tiles are undamaged and caulked to the grid and place a clock with a second hand by the sink to support proper handwashing. Many state boards will share their inspection checklist which can serve as an excellent tool for mock surveys.
As pharmacy is tasked to do more with less, the only reasonable way to accomplish this is through automation, be it IV workflow management systems, dedicated incubators for environmental sample management, or a new IV robot to remove the risk of human error from batch compounding. Pharmacy’s responsibility to minimize the chance of contamination will depend on technology to erase human error and create consistently reproducible processes.
In fact, ISMP strongly advocates for the adoption of technology into the cleanroom. At a minimum, CSPs should benefit from source ingredient bar code scanning and in-process image capture, and the pull-back method should be replaced. Gravimetrics, automated record keeping, and IV robotics should be strongly considered.
On the pages that follow, there are plenty of opportunities to benchmark your facility’s current accomplishments against those of your peers. With the recent focus on modernizing cleanrooms, most hospitals are now operating in cleanrooms that are less than 5 years old. If your facility has not reached this benchmark, now is the time to leverage USP compliance requirements to garner budgetary support for an up-to-date, compliant cleanroom. Ultimately, the introduction of automation into compliant cleanroom facilities will ensure the continued safety of all CSPs.
Deanne Halvorsen is the editorial director of Ridgewood Medical Media, publisher of Pharmacy Purchasing & Products and MedicalLab Management. She can be reached at email@example.com.