ISMP Survey on Sterile Compounding in Pharmacies Reveals Gaps, Challenges

HORSHAM, PA—Millions of compounded sterile preparations (CSPs) are produced each year, many in hospital pharmacies. A recent survey from the Institute for Safe Medication Practices (ISMP) provides insights into the state of sterile compounding systems and practices, and the need for improvements to reduce the risk of errors. Results were published in a recent issue of ISMP’s Medication Safety Alert!^® Acute Care newsletter.

The majority of survey participants were pharmacists (80%) and pharmacy technicians (18%) working in hospital pharmacies. ISMP asked respondents to indicate what types of medication errors are occurring in their organizations, which technologies they use for sterile compounding, and the degree to which they have implemented nine best practices.

Highlights of the survey findings include:

• Nearly three-quarters (74%) of respondents were aware of at least one pharmacy sterile compounding error during the past 12 months, including those caught and corrected as well as those discovered after dispensing
• The largest percentage of errors reported were incorrect doses or concentrations prepared (58%) and incorrect base solutions used (51%)
• More than half (57%) of respondents are using specialized technology when compounding CSPs, including barcode verification (48% of respondents use for approximately 75% of all CSPs)
• Sixty-three percent of respondents who utilize images to verify CSPs stop production for verification of certain drugs, diluents, and doses before mixing the ingredients as a safety measure
• The highest level of best practice implementation (73%) was with ensuring there are enough workbenches in the cleanroom/compounding area to support one staff member working at a time per primary engineering control device (e.g., laminar airflow workbench, biological safety cabinet, isolator)
• Alarmingly, only 52% of respondents indicated it is always easy to identify with certainty which drugs, diluents, and volumes were used when verifying CSPs
• Less than half of all respondents (49%) reported that dose volume information is always available on a preparation label, master formula record, or other approved document, so that there is no need for calculations.

ISMP also received more than 600 comments from survey respondents about the biggest challenges they face regarding sterile compounding in the pharmacy. The most commonly cited challenge was the inability for a pharmacist to accurately verify prepared CSPs if using an indirect process, such as the syringe pull-back method. Other challenges mentioned included the ability to properly train both technicians and pharmacists to prepare and/or verify CSPs and being unable to purchase and utilize sterile compounding technologies, such as cameras, workflow systems, gravimetrics, and bar-coding technology.

For a copy of the newsletter article summarizing survey results, visit: https://ismp.org/resources/ismp-survey-provides-insights-pharmacy-sterile-compounding-systems-and-practices. For a copy of the ISMP Guidelines for Safe Preparation of Compounded Sterile Preparations, visit: https://www.ismp.org/guidelines/sterile-compounding. Access may require free registration.

About the Institute for Safe Medication Practices

The Institute for Safe Medication Practices (ISMP) is the nation’s first 501c (3) nonprofit organization devoted entirely to preventing medication errors. ISMP is known and respected for its medication safety information. For more than 25 years, it also has served as a vital force for progress. ISMP’s advocacy work alone has resulted in numerous necessary changes in clinical practice, public policy, and drug labeling and packaging. Among its many initiatives, ISMP runs the only national voluntary practitioner medication error reporting program, publishes newsletters with real-time error information read and trusted throughout the global healthcare community, and offers a wide range of unique educational programs, tools, and guidelines. In 2020, ISMP formally affiliated with ECRI to create one of the largest healthcare quality and safety entities in the world, and ECRI and the ISMP PSO is a federally certified patient safety organization by the U.S. Department of Health and Human Services. As an independent watchdog organization, ISMP receives no advertising revenue and depends entirely on charitable donations, educational grants, newsletter subscriptions, and volunteer efforts to pursue its life-saving work. Visit www.ismp.org and follow @ismp1 to learn more.

For more information, contact:
Laurie Menyo, Director of Strategic Communications
(610) 825-6000, ext. 5310
lmenyo@ecri.org