ISMP Releases New Sterile Compounding Guidelines By Bruce Buckley
H
ow to drive the odds of sterile compounding errors to nearly zero through advanced technology: That’s the challenge taken on by the newly published compounding safety guidelines from the Institute for Safe Medication Practices (ISMP). “We have sophisticated technology and automation available on the market today that can prevent or catch compounding errors and provide safe patient care. However, the adoption of this technology throughout the nation is extremely low, leaving our patients vulnerable to harm from preventable errors,” said Kevin Hansen, PharmD, MS, BCPS, BCSCP, the systemwide director of pharmacy at Cone Health in Greensboro, N.C. “It has become inexcusable to not use some extent of compounding technology or automation in most pharmacy practice settings that perform sterile compounding,” said Dr. Hansen, who was a member of the expert panel that paerticipated in ISMP’s virtual summit last September to revise the organization’s existing compounding guidelines with a new focus on evolving technology. Implementing sterile compounding technology has been shown to greatly reduce the risk for medication errors. A 2019 multicenter study, for example, found that the use of technology-assisted IV workflow management systems (IV-WMS) were associated with a 14-fold increase in error detection compared with nonuse of such technology (Am J Health Syst Pharm 2019;76[15]:895-901).
‘The data have definitely proven that adding technology can prevent errors that we are not as good at capturing when we only have manual systems.’ —Christina Michalek, BSPharm, RPh, FASHP “The data have definitely proven that adding technology can prevent errors that we are not as good at capturing when we only have manual systems,” said Christina Michalek, BSPharm, RPh, FASHP, the director of membership and patient safety organization for ISMP, and one of the architects of the new guidelines.
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The 24-page document is packed with concise bullet points—more than 160 in total—all designed to boil down complex advisory information into the most essential and practicable form possible: the essential technology attributes, safe pharmacy processes, safety gaps and best practices for automated compounding devices, IV-WMS and IV robots. The guidelines also specify nearly three dozen general best practices for sterile compounding safety, and take a look at what technology vendors and designers, moving forward, can do to advance compounding safety. One example of the latter is a recommendation to investigate the feasibility of developing a common language among technologies so that practitioners do not need to reenter data into each system. The guidelines also stress the need for collaboration, advising use of the document “in concert” with other sources, including guidelines and recommendations from the American Society for Parenteral and Enteral Nutrition, ASHP and USP. And, indeed, representatives of those organizations showed up in force for the three-day virtual summit, along with others from the FDA, the Joint Commission, the THRIV Coalition for IV Accuracy and ECRI, ISMP’s parent organization. Also in attendance were representatives from 15 health systems and hospitals and nine leading tech vendors.
Vendors Add Value The presence of the vendor group was one key to the summit’s success, according to Rita K. Jew, PharmD, MBA, BCPPS, FASHP, who was named the president of ISMP in January, succeeding Michael R. Cohen, RPh, MS, ScD (hon.), FASHP, who became ISMP’s president emeritus.
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see GUIDELINES, page 24
