The USP Chapter 797 was introduced in 2004 to provide regulation to pharmacies on quality standards for compounding sterile products (CSPs). USP 800 was subsequently introduced in 2016, with an implementation date of December 2019. The purpose of this chapter is to describe practice and quality standards for handling hazardous drugs. Both USP 797 and 800 have the intent to promote safety and prevent patient harm by warranting sterility and accuracy of all CSPs. Failure to comply with these recommendations and standards may result in the greatest risk of contamination, leading to potential patient harm. With the focus on sterile-compounding training in these USP chapters, sterile-compounding facilities are required to develop and implement training processes in order to ensure safe and adequate training of compounding personnel.
A recent study in Hospital Pharmacy sought to develop and implement a standardized sterile-compounding training program in a multihospital system to incorporate sterile-compounding best practices and recommendations in compliance with USP Chapters 797 and 800 standards. The multihospital system included 16 hospitals in eastern Wisconsin. Previously, each facility developed and implemented its own sterile-compounding training at each site, but this led to inconsistencies, with varying skills and knowledge levels across sites. In order to begin the standardization process, each facility identified site-specific super-users who attended a live, 1-day refresher course to review key concepts and aseptic techniques from USP Chapters 797 and 800. The super-users then returned to their sites to distribute information and perform evaluations of sterile-compounding employees within their facilities.
In the preintervention phase, sterile-compounding personnel completed three interventions. These interventions included a written sterile-compounding knowledge-based exam, a media fill challenge test, and an observation assessment of aseptic technique. A hazardous drug (HD) media fill challenge test was also required for HD personnel. Following the completion of these assessments, employees participated in a refresher training intervention to review pertinent sterile-compounding information and proper aseptic technique to standardize processes across the health system. This training included topics such as calculations, beyond-use-dating assignment, and other major, knowledge-based concepts within USP Chapter 797.
Personnel responsible for HD sterile compounding reviewed additional material specific to USP Chapter 800 content. In the postintervention phase, the same three assessments that were done in the preintervention phase were completed. For the written exam, a passing score was considered 80% or greater. For the media fill challenge test, the examination had to be negative or clear of any microbial contamination in order to pass.
A total of 386 written exams were collected and scored between the pre- and postintervention phases. The average percentage correct on the written exams for the preintervention and postintervention phases was 65.2% and 74.8% (P <.0001). There was a statistically significant improvement between the two phases, demonstrating increased retention of sterile-compounding knowledge. Additionally, in the preintervention phase, 19.6% of individuals had a passing score on the written exam, compared with 45.3% in the postintervention phase (P <.0001). For the media fill challenge tests, there was a statistically significant increase in pass rates on the aseptic technique rubrics between the two phases (32.3% and 89.1%, P <.0001).
Based on the data of the study, a new sterile-compounding training program was developed. This program included in-person interactive training courses, online learning modules, and repeated evaluations of proper aseptic technique. Step 1 of the new training program included an in-person, interactive training course reviewing pertinent information from USP Chapters 797 and 800, such as the importance of sterility, aseptic technique, quality assurance, and the handling of HDs, as well as hands-on practice. Step 2 of the training began with peer observation in order to understand the processes involved in sterile compounding and transition to the compounder practicing aseptic technique, with constant observation and assistance by the site trainer.
The 3rd step was designed for the compounder to gain independence in sterile-compounding practices. Lastly, in step 4, the compounder was required to work a minimum of two shifts with oversight from the site trainer and assistance, as needed. This new training program outlined all annual requirements for assessment, evaluation, and training as required by USP 797 and 800 for current sterile-compounding personnel.
There is currently a lack of literature on the development and implementation of sterile-compounding programs. Standardized, consistent sterile-compounding training programs may demonstrate improvement in sterile-compounding knowledge and skills, as it did for this health system in Wisconsin. This study found that developing training programs to fit the recommendations provided in USP 797 and 800 helps ensure safe sterile-compounding practices with a focus on patient safety.
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