16 Operations & Management
Pharmacy Practice News • February 2021
Sterile Compounding
ISMP survey reveals major compliance gaps
56% Rate of Adherence to Sterile Compounding SOPs Is ‘Crazy’
T
he USP’s sterile compounding standards have been in place for nearly two decades, and most large health systems now employ technological tools to safeguard the sterile drug workflow process. But have health systems reached the optimal level of compliance? That’s what the Institute for Safe Medication
Practices (ISMP) wanted to know. So last July, ISMP launched a Pulse Check survey. More than 600 pharmacists, technicians and others allied with pharmacy responded. The answer, detailed in survey results described at a virtual Omnicell Illuminate meeting, was that although progress in achieving compounding
safety has been made, significant gaps remained.Three-fourths of respondents, for example, reported being aware of at least one pharmacy compounding error in the past 12 months, said Christina Michalek, RPh, the ISMP medication safety specialist who presented the findings. The errors ranged from incorrect dose or concentration to faulty labeling
to wrong drug used (Table). Some were found and corrected before dispensing, Michalek said, while others came to light only after leaving the pharmacy. Michalek noted that the well-documented risks of sterile compounding were not just confined to the pharmacy. “It begins with the products we decide to bring into an organization,” she said.
Table. Sterile Compounding Errors Error
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Percentage Of Mentions
Incorrect dose or concentration
58
Incorrect base solution
51
Incorrect base solution volume
43
Issue or error with 41 labeling of CSP (including omission) Incorrect reconstitution of drug (volume or diluent)
36
Incorrect drug
35
Wrong preparation technique (e.g., improper filtering, wrong tubing)
26
Expired drug, base solution or CSP
16
Wrong timing (e.g., preparing antineoplastic on wrong date)
12
Omission of a drug
5
CSP, compounded sterile preparation
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The risks involve when and how medications are prescribed and the processes of verification and communication, she added; they also extend to the workplace environment, the lack of standardized practices, production pressures and the absence of technology. “These are all risks,” she said. An even more complete picture of compounding safety challenges emerged from an open-ended question that drew more than 600 responses. By far the biggest barrier, she said, “was the inability of pharmacists to accurately verify compounded sterile preparations using indirect processes like the syringe pull-back method.” Closely following was the difficulty in complying with USP General Chapter <797> and <800> standards. Rounding out the list were staff
