Project

Drug Safety Project

Pew’s drug safety project works to ensure a trustworthy, reliable pharmaceutical manufacturing and distribution system. Our current focus is on pharmaceutical compounding, the creation of medications for patients whose clinical needs cannot be met by commercially available products approved by the Food and Drug Administration.

For example, if a patient who cannot swallow pills needs a medicine that is FDA-approved only in pill form, a compounding pharmacy can make the drug as a liquid. Pew’s work on drug safety aims to preserve access to compounded medications for people who need them while helping to protect those patients from the risks of drugs produced under dangerous and illegal conditions.

additional resources

Issue Brief

What Are Compounded Drugs, and How Can They Be Kept Safe?

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Issue Brief

Pharmaceutical compounding is the creation of medications for patients whose clinical needs cannot be met by commercially available products approved by the Food and Drug Administration. For example, if a patient who cannot swallow pills needs a liquid version of a medicine that is FDA-approved only in pill form, a compounding pharmacy can make the medication.

Report

State Oversight of Drug Compounding

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Report

More than five years have passed since contaminated injections compounded at a single pharmacy caused 76 deaths and 778 illnesses in a nationwide outbreak of fungal meningitis, a tragedy that made clear that the complex, technical practice of drug compounding was not subject to a level of oversight appropriate to its potential risks to patients. Since then, state and federal officials have been re-examining the laws and regulations governing compounding, and working to strengthen them. Compounding is the creation of medications tailored to patients whose clinical needs cannot be met by U.S. Food and Drug Administration-approved products. 

Data Visualization

U.S. Illnesses and Deaths Associated With Compounded or Repackaged Medications, 2001-19

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Data Visualization

Pew’s drug safety project has identified 73 reported compounding errors or potential errors associated with more than 1,562 adverse events, including at least 116 deaths, from 2001 to 2019. 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.1 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.2 Because many such events go unreported, this chart is an underestimation of the number of compounding errors since 2001. Contamination of sterile products was the most common error; others were the result of compounders’ miscalculations and mistakes in filling prescriptions.

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Our Work

Focus Area
Drug Compounding