SUMMARY

S4 ■ State of Pharmacy Compounding ■ April 2015

Compounding Options Expand

W ith increasing regulatory scrutiny from accredi-tors, CMS, and state boards of pharmacy, many health systems have been inspired to reexamine their compounding practices and related tech-

nology options. Our 8th annual State of Pharmacy Compound-ing 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 re-ceived yielding a confidence interval of 5.08 (95% +/-5.08) based on the total population of pharmacy direc-tors 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 phar-macy directors rely on PP&P as a resource for compounding information.

Regulatory FamiliarityIn any situation, familiarity with the regu-lations is necessary to achieve compli-ance. 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, suggest-ing that many pharmacy directors are unlikely to read the chap-ter. 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 com-pounding 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.

Technology OptionsMirroring pharmacy’s growing commitment to compliant compounding practices, many of the products available in this marketplace have benefitted from the vendors’ increas-ing 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 direc-

tors can reap the benefits of a maturing marketplace and take advantage of im-proved features and price competition.

Confidence in OutsourcingThe number of facilities that curtailed their outsourcing partnerships in order to bring all CSP production in-house ap-pears to have leveled off this year. While some hospitals have reduced the amount of outsourcing they conduct out of con-cern 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.

Hazardous CompoundingWith the release of the updated, proposed USP <800> Haz-ardous 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 con-tinue to advocate for nursing’s use of these devices during drug

Summary

PP&P as a Resource for <797> Questions

Summary

PP&P as a Resource for <797> Questions

77% Yes

23% No

By Deanne Halvorsen

administration. By leveraging their exper-tise, pharmacy is in an excellent position to help ensure smooth implementations for nursing staff.

While some of the requirements out-lined in proposed Chapter <800> will not be difficult for most facilities to at-tain, others may require an investment of time and resources. For example, the vast majority of facilities currently unpack their HDs in a neutral- or nega-tive-pressure area as required in the pro-posed 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 in-creasing interest in this area from accredi-tors, CMS, and state boards of pharmacy. Remaining abreast of the developments surrounding HDs in particular, and com-pounding in general, will be imperative, and PP&P is committed to bringing this information to you. ■

Deanne Halvorsen is the editorial di-rector at Ridgewood Medical Media, publishers of Pharmacy Purchasing & Products and Medical Lab Man-agement. She can be reached at dhalvorsen@ridgewoodmedia.com.

For more information visit www.pppmag.com/info and click #19

April 2015 ■ www.pppmag.com ■ S5

SIDEBAR

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 environ-mental 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.

Overall, just over one-quarter of facilities report having experienced a patient incident involving a com-pounding error in the past 5 years.

Summary

PP&P as a Resource for <797> Questions