Development of a sterile compounding training and competency program at a large academic medical center

Purpose. This article is one of the 5 articles describing steps taken to enhance sterile compounding compliance at a large, multisite academic medical center. This article focuses on the development of a comprehensive personnel training and assessment program for sterile compounding. Summary. Increased regulatory oversight and the release of new United States Pharmacopeia chapters motivated the reenvisioning of the medical center's sterile compounding personnel training and assessment program. The main challenges facing any entity undertaking sterile compounding include identification of compounding staff, development of policies and procedures, and baseline and ongoing training including observational competency assessments and record keeping. These challenges are exacerbated by high work volumes and variation in compounding practices encountered within a large multisite institution. Our organization developed a team of specialized pharmacists and pharmacy technicians to implement and enforce changes promoting the safe production and use of compounded sterile products and meet rising regulatory requirements. This team worked within various operational areas to customize purchased policies and procedures and group compounding staff based on training needs. The team performs ongoing personnel monitoring and training of new compounders in a shared training space. Challenges encountered and future considerations for program enhancement are described. Conclusion. Implementation of standards and enforcement of staff behaviors in a large academic medical center is perhaps best completed by a team of highly trained experts working in collaboration with supervisors and using a dedicated training and testing space, as evidenced by the success of the described program in overecoming past challenges.