U.S. Illnesses and Deaths Associated With Compounded Medications or Repackaged Medications
Update note: This chart was updated in March 2018 to include newly reported adverse events, and newly reported details of previously included adverse events. The updated chart also replaced the term “pharmacy” with “compounder,” to reflect the fact that drugs can be compounded by physicians and outsourcing facilities in addition to pharmacies.
Pew’s drug safety project has identified more than 71 reported compounding errors or potential errors associated with 1,416 adverse events, including 115 deaths, from 2001 to 2017. However, a 2015 survey found that only 30 percent of states (13 of the 43 that responded) require sterile compounding pharmacies to report serious adverse events. Of the states that require reporting, the type of information that is required to be reported may vary, further contributing to an incomplete picture of adverse events associated with compounded medications. Even in states with strong adverse event reporting requirements, illnesses and deaths caused by compounded drugs are not always linked to the compounding error. Because many such events may go unreported, this chart is likely an underestimation of the number of compounding errors since 2001. Contamination of sterile products was the most common error; others were the result of pharmacists’ and technicians’ miscalculations and mistakes in filling prescriptions.
Drug compounding can be an interstate operation; pharmacies may prepare medicines in one state and ship them to another. States may encounter oversight challenges if an out-of-state pharmacy shipping into their jurisdiction is held to a different quality or regulatory standard than in-state compounders. As a result, for each row below, the state where the compounding error or potential error occurred and the state(s) where the adverse event(s) occurred are listed. Harmonized minimum quality standards for anyone who compounds drugs in any setting across states would help address challenges in regulating out-of-state pharmacies and ensure that all compounding meets strong baseline criteria for preparing safe drugs and protecting patients.
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