Identifying, Improving Safety Gaps in Sterile Pharmacy Compounding Systems and Practices: Part I

By Damon Birkemeier, PharmD, FDA/ISMP safe medication management fellow

Millions of compounded sterile products (CSPs) are produced each year, many of which are in hospital pharmacies. The Institute of Safe Medication Practices (ISMP) launched a survey intended to gather insights into pharmacy sterile compounding systems and practices. The survey aimed to evaluate technologies, policies, and procedures in place, as well as identify major safety concerns surrounding sterile pharmacy compounding. Results described available compounding technologies, safe compounding best practices, and common sterile compounding errors and safety concerns. Over 600 pharmacy practitioners participated in the survey. Below we will briefly discuss the survey results concerning compounding technologies and common safety errors, as well as perceived biggest challenges. Part II will cover sterile compounding best practices identified by ISMP.

Compounding Technologies

As mentioned in a previous blog, technology has become an integral player in the realm of medication safety, especially during sterile compounding. ISMP survey results showed that:

• More than half of respondents (57%) reported using technologies when compounding sterile preparations. These included barcode verification systems without imaging, workflow systems with barcode verification and imaging and/or gravimetrics, automated multiple ingredient compounding devices, image sharing or remote video supervision of the sterile compounding process, and an intravenous compounding robot.
• Barcode verification systems without images and workflow systems using both barcode verification and images were the most used technologies reported.
• Sixty-three percent of respondents utilizing images to verify CSPs stated that they stop production for verification of certain drugs, diluents, and doses before mixing the ingredients and completing the compounding process. Some respondents further reported that all medications require verification prior to mixing.

Sterile Compounding Errors and Safety Challenges

• Nearly three-quarters (74%) of all respondents were aware of at least one pharmacy sterile compounding error that had occurred during the past 12 months. Not surprisingly, a higher percentage of pharmacists were aware of these errors than technicians.
• There were over a dozen different types of sterile compounding errors reported – the three most common errors reported were incorrect dose or concentration, incorrect base solution, and incorrect base solution volume.
• More than 600 comments were submitted from survey respondents regarding their biggest challenges relating to sterile compounding with the three most common categories reported being a lack of a direct verification of the compounded sterile preparation process, difficulty meeting USP standards, and insufficient staff training and competency.