With increasing regulatory scrutiny from accreditors, CMS, and state boards of pharmacy, many health systems have been inspired to reexamine their compounding practices and related technology options. Our 8th annual State of Pharmacy Compounding issue examines developing trends in compliance challenges, budget commitments, and technology adoptions related to compounding operations.
The State of Pharmacy Compounding survey responses are solicited via email, and this year a total of 349 responses were received yielding a confidence interval of 5.08 (95% +/-5.08) 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 reflect trends across the entirety of health system practices. Therefore, we are quite pleased to learn that 77% of pharmacy directors rely on PP&P as a resource for compounding information.
In any situation, familiarity with the regulations is necessary to achieve compliance. As such, the fact that only 57% of pharmacy directors have read the current version of USP Chapter <797> is fascinating. Furthermore, that percentage has not increased over the past few years, suggesting that many pharmacy directors are unlikely to read the chapter. In a notable development, the proposed Chapter <800>, which has been available for a much shorter time, has almost equal readership; 56% of pharmacy directors have read this chapter. Future surveys will clarify whether <800> is inherently more readable, or if only a subset of pharmacy directors are ever likely to read regulation source documents.
Nonetheless, pharmacy’s commitment to improving compounding operations continues to demonstrate results. Not only do an increasing number of facilities report having achieved full <797> compliance, but there also has been an uptick this year in the use of isolators, IV workflow automation, CSTDs, and ready-to-use IV products. Given the regulatory interest in compounding operations, by state boards of pharmacy in particular, perhaps it is not surprising that many facilities are investing in their compounding operations.
Mirroring pharmacy’s growing commitment to compliant compounding practices, many of the products available in this marketplace have benefitted from the vendors’ increasing expertise as well. As this market matures, the diversity of technology offerings and the number of competitors in any given segment are increasing. Recent new product launches, as well as product redesigns, have brought a wealth of choices to pharmacy directors looking to add automation and safety to their compounding operations. From redesigned CSTDs to new options in IV workflow automation, pharmacy directors can reap the benefits of a maturing marketplace and take advantage of improved features and price competition.
Confidence in Outsourcing
The number of facilities that curtailed their outsourcing partnerships in order to bring all CSP production in-house appears to have leveled off this year. While some hospitals have reduced the amount of outsourcing they conduct out of concern for product safety, these facilities are not in the majority. Rather, most facilities have focused on consolidating their outsourcing to one or two vendors and increasing their oversight. As a result, pharmacy directors declare marked confidence in their current outsourcers and few plan to switch vendors.
With the release of the updated, proposed USP <800> Hazardous Drugs—Handling in the Healthcare Setting, interest in hazardous drug (HD) handling practices is increasing at a rapid rate. Last year, we saw a lull in CSTD implementations as many facilities were waiting to see what the requirements would be. Now that it seems clear that CSTDs will be required during the administration of HDs and highly recommended for the preparation of HDs, there has been a corresponding increase in CSTD adoptions. This trend is expected to continue as most facilities plan to utilize CSTDs in an effort to reduce accidental exposures to HDs. Historically, pharmacy has been faster than nursing to adopt CSTDs. It is important that pharmacy continue to advocate for nursing’s use of these devices during drug administration. By leveraging their expertise, pharmacy is in an excellent position to help ensure smooth implementations for nursing staff.
While some of the requirements outlined in proposed Chapter <800> will not be difficult for most facilities to attain, others may require an investment of time and resources. For example, the vast majority of facilities currently unpack their HDs in a neutral- or negative-pressure area as required in the proposed chapter. Likewise, most facilities already have created a list of HDs used in their facility; the next step will be to stratify the list following the NIOSH format. Conversely, few facilities have a medical surveillance program in place for staff working with HDs, and some continue to compound HDs in the same room where non-hazardous drug compounding occurs.
As the requirements for HD handling continue to evolve, we expect to see increasing interest in this area from accreditors, CMS, and state boards of pharmacy. Remaining abreast of the developments surrounding HDs in particular, and compounding in general, will be imperative, and PP&P is committed to bringing this information to you.
Patient Incidents Resulting from Compounding Error
The smallest facilities report a low frequency of patient incidents related to compounding (13%), but facilities with at least 200 beds report a significantly higher likelihood of such incidents (34%). While this discrepancy may be attributed to the differences in compounding volumes between facilities of various bed sizes, it is more likely that the smallest facilities are underreporting patient incidents related to compounding errors. This could be due to a lack of sophisticated reporting tools in smaller facilities, the difficulty of tracing an event back to a compounded medication, or a lack of focus on quality assurance. Regardless of the cause, this discrepancy highlights an important truism: It is quite difficult to find errors we are not looking for.
Underpinning every successful compounding operation is the acknowledgement that errors will occur. In response, compounding systems must be designed to identify these errors, be it by reacting swiftly to negatively trending environmental conditions, relying on automation to identify inappropriate ingredients or amounts, implementing technology that reduces the chance of exposure to hazardous drugs, or developing effective policies and procedures for ensuring competency training for staff.
Deanne Halvorsen is the editorial director at Ridgewood Medical Media, publishers of Pharmacy Purchasing & Products and Medical Lab Management. She can be reached at email@example.com.
As we do every year, we invite you to take advantage of our Compounding Slide Kit. Pharmacy Purchasing & Products is happy to provide much of the data you find on the following pages as PowerPoint slides. You are welcome to use this data in your own presentations; we hope it serves as a valuable support as you make the case for additional investments at your facility. And you are certainly welcome to incorporate the data into presentations you may make externally to educate your colleagues on compounding opportunities they may be considering. Simply access the slides on our website (www.pppmag.com/slides).
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
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