Safety Problems at Compounding Pharmacies Confirm Need for Better Oversight

Issue Brief April 15, 2013 Read time:

Projects: Drug Safety

The U.S. Food and Drug Administration late last week said it found widespread safety violations at more than two dozen specialized compounding pharmacies. The agency’s announcement comes after a nationwide outbreak of meningitis that killed more than 50 people and sickened hundreds who received contaminated injections made at a Massachusetts pharmacy.

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U.S. Illnesses and Deaths Associated With Compounded Medications

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Briefing on Pharmacy Sterile Compounding Summit Proceedings

These recent events emphasize the need to strengthen oversight of the industry. An analysis by The Pew Charitable Trusts released this year found that 20 compounding errors over the previous decade were associated with 75 deaths and 1,022 illnesses. The call for better oversight was underscored by participants in a recent stakeholder summit convened by Pew, the American Society of Health-System Pharmacists, and the American Hospital Association, which today released the proceedings and recommendations on pharmacy sterile compounding.

The Pharmacy Sterile Compounding Summit included representatives of pharmacy organizations, doctors, hospitals and healthcare systems, compounding pharmacies, the FDA, state pharmacy boards, and the U.S. Centers for Disease Control and Prevention. Participants discussed how to address risks related to compounding -- reviewing the scope of the practice, quality standards, and oversight gaps.

Informed by these discussions, Pew, the American Society of Health-System Pharmacists, and the American Hospital Association offer the following recommendations:

Federal oversight must be strengthened for activities that go beyond traditional state-regulated pharmacy compounding and represent a high public health risk. Risk factors to be considered include volume of production, breadth of distribution, and inherent risk of the product itself.
Federal and state authorities should have clear roles and responsibilities to ensure the safety of compounded sterile drugs without leaving oversight gaps or duplicating efforts.
Regulators should consider establishing new quality standards for large-scale sterile compounding.
State pharmacy inspectors should have standardized training and assessment tools for consistent and robust oversight.

The deaths attributed to contaminated compounded medicines highlight the risks associated with facilities that no longer function as traditional pharmacies, yet are not regulated as manufacturers. Compounding pharmacies may prepare large batches of drugs and ship them to hospitals, clinics, and doctor’s offices across the United States. Current gaps in oversight of these operations have led to a regulatory limbo for the FDA, which oversees drug manufacturers, and states, which have primary authority over pharmacies in their jurisdiction.