ISMP survey reveals major compliance gaps
56% Rate of Adherence to Sterile Compounding SOPs Is ‘Crazy’
By Bruce Buckley
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 ISMP launched a Pulse Check survey. More than 600 pharmacists, technicians and others allied with pharmacy responded.
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Read and react to your environmental monitoring reports. Environmental monitoring results get even more scrutiny than certification elements. Your microbial environmental monitoring program must be designed to adequately detect excursions. The minimum elements need to include staff training and competency, frequency of monitoring at least as much as defined in the USP chapters, and reaction to results. (Remember: The USP chapters are minimum standards; many best practices exceed the minimum frequency.) Many organizations have their certifiers perform the semiannual electronic air and surface sampling, but the proposed frequency of monthly surface sampling is unlikely to be able to be consistently supported by your certifier if the revision requires that. In any case, your ability to do your own surface sampling—either every month or just those months when the certifier isn’t at your facility—will enhance the ability to react to concerns.
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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, BSPharm, RPh, FASHP, the ISMP medication safety specialist who presented the findings. The errors ranged from incorrect dose or concentration to faulty labeling to wrong see SOP ADHERENCE, page 20
Benchmark your practices. Much of USP’s guidance focuses on existing best practices in compounding, including the requirements for master formulation records, compounding allergenic extracts, procedures for media fill and gloved fingertip testing, procedures for air and surface sampling, cleaning procedures, evaluation of environmental monitoring excursions, and certification of facilities. Review those procedural aspects and explanations and incorporate them into your own policies and procedures. To ensure that your practices meet the USP minimum standards as well as changes that evolve as practices mature, conduct gap analyses at least annually. Gap analysis tools are available at the ASHP Compounding Resource Center (www.ashp.org/Pharmacy-Practice/ Resource-Centers/Compounding), CriticalPoint (www. criticalpoint.info) and other sources. Ms. Kienle is an employee of Cardinal Health and a member of the USP Compounding Expert Committee. The comments in this article are her own.
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