D uring the s, the practice of pharmacy began growing and evolving. In response to an increasing number of patient injuries due to medication delivery and sterile compounding, the industry began calling attention to safety. For the next 30 years, various pharmacy organizations published documents in an effort to establish a standard for the practice of compounding sterile preparations CSPs.
However, none of the documents were successful in providing a professional mandate and the handling of sterile product preparation by licensed pharmacies varied nationally through the s.
In , The U. The law introduced limits on pharmacy compounding and attempted to protect patients from unnecessary use of compounded drugs.
Supreme Court in , and so the efforts to improve the quality of pharmacy-prepared CSPs continued. Emerging compounding and testing technology is also discussed. Conclusion: Although the task of compliance with the requirements of USP chapter may appear overwhelming, complicated, expensive, and even unattainable, quality can be established via a methodical and organized approach.
After the systems have been implemented, maintaining them requires vigilance and follow-up. What should you do? The Advocacy Council has you covered We know there are a lot of changes to implement and document. Read More. Close Modal Close Modal. We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits.
Cookie settings Accept. Close Privacy Overview This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. 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 and 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 and 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.
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