Challenge of Complete Compliance

April 2012 : State of Pharmacy Compounding - Vol. 9 No. 4 - Page #2

Now in our fifth survey year, Pharmacy Purchasing & Product’s State of Pharmacy Compounding survey not only generates a wealth of data, but also provides a clear picture of trends in pharmacy compounding practice. Most evident this year is the elusive nature of complete compliance to USP Chapter <797>. We are almost four years on from the chapter update and those self-reporting full compliance have yet to break the one-third mark. Even among facilities that have completed renovations, the full compliance rates reach only 41%. While many areas of compounding practice showed improvement this year, including the frequency with which a gap analysis is conducted, there is still plenty of room for improvement.

Survey Methods
In the first quarter of 2012, PP&P surveyed a random nationwide sampling of directors of health-system pharmacies. We asked about inspection experiences, recall programs, satisfaction with vendors, and staffing levels.

Responses were solicited via email, and a total of 315 were received, yielding a confidence interval of 5.37 (95%+/-5.37) based on the total population of pharmacy directors, nationwide.

We purposefully surveyed a random sampling of pharmacy directors—not jut readers of PP&P—to ensure the following data reflects trends across the entirety of health system practices. Therefore, we are quite pleased to see that 77% of respondents rely on PP&P as a resource for <797>-related information.

Regulatory Challenges
The evident difficulty in attaining 100% compliance with <797> reflects pharmacy directors’ understanding of the complexity and level of detail necessary to implement a thorough sterile compounding program. For example, most facilities conduct daily cleanroom cleaning using dedicated personnel, however, those that then document the preparation of the cleaning solutions are in the minority.Questions on <797> practices are now commonplace during regulatory inspections, be they state board or accreditor inspections. As a result, pharmacy directors prepare for such inspections and consider the attendant regulatory requirements when planning policies or establishing procedures for ongoing data collection. However, it is now key to add CMS inspections to the list of regulatory experiences to plan for. Be aware of who is conducting your inspections, as survey data demonstrate that when pharmacists conduct TJC inspections, they apply a more critical examination of the pharmacy, including compounding practices.

New Trends
The increasing number of drug shortages clearly is impacting outsourcing decisions, as more pharmacy directors look to abate the effects of longer-lasting scarcities. This approach raises quality concerns, and given how few pharmacy directors have visited their outsource supplier or receive regular quality assurance reports, this may be an area that requires additional attention.

Awareness of the risks to staff and patients from hazardous drugs remains low. Closed system transfer device implementation is not widespread and many pharmacy directors continue to believe there is no need for such a safety device. Rarely does pharmacy conduct wipe analysis for HD residue even though a significant amount of chemotherapy preparation does not occur in a chemo hood in a negative pressure cleanroom venting outside. Chemotherapy and other hazardous drug use will continue to proliferate, so all pharmacies—not just cancer centers—need to develop on-staff expertise in the safe management of these dangerous, yet important, products.

Recalls, while not widespread, do require a well-planned response. Fewer than three quarters of facilities were able to identify all of the patients who received a recalled CSP in the past year, suggesting that more in-depth planning is needed in this area. One way to impact the identification of such patients is through new technology. IV workflow automation brings the same bar code driven safety into the  cleanroom that oral doses benefit from. Not only can this ensure the right products are used, but inventory tracking also can be improved. 

It is wise to remain informed of your supply options. There are many vendors providing products and services to ease your efforts in creating a robust, safe compounding practice, from ready-to-use products to outsourced compounding services. New vendors continue to join this marketplace so there is no need to settle for an inferior product or poor customer service—outsource where it makes sense and regularly evaluate your current vendors. For example, the outsourcing of environmental monitoring is becoming an increasingly popular option for many facilities.

As is the case in the CSTD marketplace, there may be new vendors offering different solutions since you last evaluated a given product. So if your media’s positive control shows no growth, consider evaluating other options. If you are not satisfied with your cobbled together compounding training program, review some of the new products offered in that arena. 

Benchmark to Similar Sized Institutions
We recognize that comparing your practice to that of your peers can be difficult when looking at aggregate numbers. To simplify the benchmarking process, we provide more detailed survey data online. For example, you can compare the average amounts spent on renovations by facility size, view staffing FTE allocations by compounding volume, and so on. Look for the Online Bonus Benchmarking Data noted on the pages that follow.

Perhaps the challenge of achieving full compliance should not be considered a negative, if it serves as a reminder that building systems to deliver patient safety is a constant process that will always remain on the to-do list, and no matter what improvements you implement, you will never get to check it off as fully completed. Consider <797> compliance to be an every day part of your job, but do not shoulder the burden alone. Review your outsourcing options, stay abreast of new products that simplify your tasks, and we will continue to share the success stories of your colleagues on the pages of PP&P.

Deanne Halvorsen is the editorial director at Ridgewood Medical Media, publishers of Pharmacy Purchasing & Products, and can be reached at

Download SOPC 2012 Powerpoint SlidesSelect graphs from the State of Pharmacy Compounding are available for your use as PowerPoint slides. Click here to download


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