Lingering Problems With Sterile Compounded Drug Manufacturing Found in ISMP Survey

Many compounding pharmacies have questionable dispensing practices, which may lead to medication errors and serious risks for patients, according to a recent survey conducted by medication safety experts.

Researchers with the Institute for Safe Medication Practices (ISMP) found at least one dispensing error occurred in the past year at nearly 75% of compounding pharmacies in the United States.

The findings were outlined in a recent issue of the ISMPs Medication Safety Alert newsletter, involving data collected from more than 600 responses provided by pharmacy employees. Roughly 80% were pharmacists and 18% were pharmacy techs working in hospital pharmacies.

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Three-quarters of respondents said at least one compounding error occurred at their pharmacy in the past year. The errors included those not caught before the medication was dispensed and errors discovered before dispensing. More than half of the errors, 58%, involved incorrect medication doses. About 51% resulted from incorrect base solutions.

The pharmacy errors occurred despite nearly 60% of respondents saying they use specialized technology when filling compounded medications, including barcode verification technology.

Overall, only 63% of respondents of the survey said they used images to verify medications and stopped producing the medication for verification of specific drugs, diluents, and doses before mixing the ingredients. This includes hazardous drugs, high-alert medications like opioids, and blood products. Two-thirds of pharmacies ensuring quality does not help prevent contamination issues as seen previously.

Despite the issues, nearly three-quarters of pharmacies indicated there were enough workbenches in the cleanroom/compounding areas to support one staff member working at a time per primary engineering control devices. This was considered the highest level of best practices to help prevent errors.

Conversely, less than half of respondents reported that dose volume information is always available on a preparation label, master formula record, or other approved document.

Only half of survey respondents said it was always easy to identify which drugs, diluents, and volumes were used when verifying compounded drugs.

The findings come several years after a multi-state fungal meningitis outbreak led to thousands of illnesses and dozens of deaths spanning 23 states in 2012. The outbreak stemmed from tainted steroid injections compounded at a Massachusetts compounding pharmacy.

In the wake of that outbreak, federal regulators released guidance documents in 2015 regarding oversight of compounding pharmacies. The focus was to prevent future contamination issues in compounding pharmacies. Despite the guidance documents, compounding pharmacies continue to experience quality issues and errors when dispensing medications, according to the new survey.

“We hope that pharmacies will use the results of this survey to prompt internal discussions about improvements that may be needed in their sterile compounding practices to reduce the risk of errors,” wrote ISMP researchers.

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