Pew’s drug safety project worked to ensure a trustworthy, reliable pharmaceutical manufacturing and distribution system free from stolen or counterfeit medicines. It focused on pharmaceutical compounding, the creation of medications for patients who cannot access commercially available products approved by the Food and Drug Administration because of drug shortages or because those products cannot meet these patients’ clinical needs.
Pew’s work on drug safety aimed to preserve access to compounded medications for people who require them while helping to protect those patients from the risks of drugs produced under dangerous and illegal conditions.
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.
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.
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.
Market for Compounded Drugs Needs Greater Transparency and Regulatory Certainty
Many hospitals and medical practices rely on compounding pharmacies to produce drugs that meet patients’ clinical needs when available medications approved by the U.S. Food and Drug Administration (FDA) cannot.
Traditional drug compounding—the creation of customized medicines to meet a patient's unique needs—has always been a part of pharmacy practice. But dramatic expansion of the sector in recent decades has resulted in production conditions on a scale closer to pharmaceutical manufacturing yet without the same oversight or quality standards. In fact, since 2001, over 25 pharmacy compounding errors have been associated with 1,049 adverse events, including 89 deaths.
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