Julie Dohm, Of Counsel at Covington & Burling based in Silver Spring, Maryland, discusses some of the important issues that physicians and patients should understand regarding drug compounding. Between 2016 and 2019, Julie served as the lead on compounding for the U.S. Food and Drug Administration (FDA).
Although compounded drugs can serve an important medical need for patients (for example in addressing allergies and providing oral solutions for children who can’t swallow a pill and need liquid formulations), they do not have the same safety, quality, and effectiveness assurances as FDA approved drugs. Unnecessary use of compounded drugs can needlessly expose patients to potentially serious health risks.
Because compounded drugs are not FDA-approved, the FDA does not verify their safety, effectiveness, or quality before they are marketed. In addition, poor compounding practices can result in serious drug quality problems, such as contamination or a drug that contains too much active ingredient, which can lead to serious patient injury and death.
In this video, Julie mentions that in October 2012, the United States faced a serious outbreak associated with contaminated compounded drugs: A pharmacy in Massachusetts shipped compounded drugs that were contaminated with a fungus throughout the country, and these drugs were injected into patients’ spines and joints. More than 750 people in over 20 states developed fungal infections, and more than 60 people died. (See 2012 Fungal Meningitis Outbreak: Persons with Fungal Infections Linked to Steroid Injections, by State, Centers for Disease Control and Prevention for more information)
The 2012 fungal meningitis outbreak was not an isolated event. It was the most serious in a long history of serious adverse events associated with contaminated, super-potent, mislabeled, or otherwise poor quality compounded drugs.
For more information drug compounding including FDA resources, visit our drug compounding landing page here.