The pressure induced by the introduction of USP Chapter <797> almost three years ago has demonstrated quite clearly that ensuring safe compounding practices for patients and staff is a complex process rife with obstacles and variables that change over time. While pharmacy directors are knowledgeable about USP regulations and have invested great effort in improving compounding practices, achieving compliance has not turned out to be readily codified, wherein a target date is set and through a series of standard actions, total compounding safety is achieved. Rather, compliance is a continual, ongoing exercise, as evidenced by the number of facilities now considering how to bring radiopharmaceutical management under proper pharmacy control.
In the first quarter of 2011, PP&P surveyed a random nationwide sampling of directors of health-system pharmacies. We asked about staffing rates, inspection experiences, construction plans, satisfaction with compounding equipment, and outsourcing practices.
Responses were solicited via email, and a total of 413 were received, yielding a confidence interval of 4.64% (95% +/-4.64) based on the total population of pharmacy directors, nationwide.
We intentionally surveyed a random sampling of pharmacy directors—not just readers of PP&P—to capture data that reflect trends across the entirety of health-system pharmacy practices. Therefore, we are quite pleased to see that 72% of respondents rely on PP&P as a resource for <797>-related information.
Both TJC and state boards regularly focus on <797> compliance and their understanding and acceptance of the regulations is reflected in the increasing number of compounding recommendations issued. Now that more pharmacists have joined the inspector ranks of TJC, keep in mind that institutions inspected by a pharmacist are more likely to receive a recommendation related to compounding practices.
There is a growing awareness of the reality of compounding errors and more facilities are reporting the occurrence of patient incidents involving them. As we all know, reported error rates tend to underestimate actual rates. Therefore, the actual number of compounding-driven patient errors may be even higher. One area that requires more scrutiny is the dangerous practice of preparing medications on the floor. While nursing is moving toward limiting this practice only to emergencies, such situations still carry risk for contamination. Unfortunately, too often pharmacy is not providing nursing with proper training in aseptic technique to offset this risk. Those few institutions that are testing their nurses’ techniques are finding high contamination rates among the preparations.
Since <797> was finalized, significant action has been taken to improve compounding safety (eg, the installation of new cleanrooms, assigning dedicated personnel to cleaning tasks, and the increasing use of CSTDs and engineering controls). Nevertheless, the majority of hospitals have yet to achieve full compliance to these regulations.
Trends to Watch
IV workflow management automation is an area to keep an eye on. This product class is still in its infancy with only 6% of hospitals adopting this technology so far. Despite this low number, implementations are projected to grow at a rapid rate over the next few years (see bar chart below). As usage grows, the technology should continue to mature providing additional safety and efficiency benefits to all compounding practices.
Using outside resources to meet safety and efficiency goals continues to be a popular approach. This year both outsourcing and ready-to-use IVs enjoyed growth, a tendency projected to continue as more facilities increase their usage of these products. In particular, many facilities are looking to outsource OR syringe compounding; likewise, interest in outsourcing oncology drugs is on the rise.
There may be some truth to staff complaints of having too much to do. In most facilities, pharmacists are conducting the bulk of environmental monitoring and are now acquiring their own incubators rather than relying on those in the lab. At the same time, there is a growing trend of pharmacists taking over sole responsibility for cleaning the cleanroom rather than sharing that task with housekeeping. With this in mind, while environmental monitoring equipment gets high overall satisfaction marks from DoPs, more positive control tests are showing up without growth, underscoring the importance of scheduling regular challenge tests of your media.
The products and services available for compounding processes are generally well rated. Pharmacy directors are most satisfied with their LAFWs, outsourced compounding vendors, ready-to-use IV products, and CSTDs used during drug preparation. On the other hand, even though environmental monitoring equipment gets high marks, monitoring programs and processes could generally use additional improvements and few pharmacy directors give rave reviews to their often cobbled together compounding training programs. Interestingly, while CSTD use is well regarded in preparation activities, the same devices were not as highly rated when used for drug administration.
Benchmark to Similar Sized Institutions
Because many hospitals use the data on the following pages to benchmark their own compounding practices, we are making the process easier this year by providing more detailed data online. For example, you can now compare your compounding staffing levels to those of facilities with similar daily compounding volumes. Look for the special Bonus Benchmarking Data boxes to direct you to these additional results.
Pharmacy directors have their work cut out for them in ensuring safe and efficient compounding practices throughout their facilities. Instituting safeguards for radiopharmaceuticals in the nuclear medicine department should be an area of current focus, as few have ensured these products are handled, prepared, and stored according to <797>. Remember, achieving compounding safety throughout your facility will be an elusive goal, perhaps always just one or two steps away. Regardless, the act of seeking this goal with constant and continual vigilance will foster the best possible conditions.
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
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