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.
Related: Summary of the Pharmacy Sterile Compounding Summit (PDF)
Table: U.S. Illnesses and Deaths Associated With Compounded Medications
Video: 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:
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.
Pew sent a comment letter to the Senate Committee on Health, Education, Labor and Pensions on the Pharmaceutical Compounding Quality and Accountability Act. This bill takes steps toward clarifying state and federal oversight of compounding, including an important increase in FDA supervision of certain activities—specifically, the compounding of sterile medicines that are shipped interstate.
More infoRepresentative Edward Markey, a Democrat from Massachusetts, on Thursday became the latest lawmaker to propose legislation that would give the U.S. Food and Drug Administration greater regulatory authority over drug compounding.
More infoOn Thursday, May 23, the House Energy & Commerce Subcommittee on Health held a hearing, entitled "Examining Drug Compounding." Gabrielle Cosel, a drug safety expert, testified on the need to clarify oversight of compounding pharmacies on the state and federal level.
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Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.
More info''A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S."
More info"As differing bills for securing the pharmaceutical supply chain wind their way through the US House and Senate, a key hurdle to passing legislation may have just been cleared. Earlier this week, the National Community Pharmacists Association – which is a member of an influential industry coalition that has been floating its own proposals – is now willing to back either bill."
More info"U.S. senators considering fundamental changes to how the practice of pharmacy compounding is regulated heard almost unanimous support for reform at a Washington committee hearing Thursday."
More info"At least 67 people have died in 20 outbreaks caused by contaminated drugs since 2001, experts told a Senate hearing Thursday. The Food and Drug Administration says there have likely been more cases than that, but they have no way of telling now."
More info"State pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications."
More infoThe U.S. Senate Committee on Health, Education, Labor and Pensions held a hearing on May 9 entitled "Pharmaceutical Compounding: Proposed Legislative Solution." Pew's Allan Coukell, a pharmacist and drug safety expert, testified on the need to strengthen oversight of the compounding industry.
More infoWhen a doctor sticks a needle in you, you expect that the drugs it carries won’t be tainted. But, possibly owing to a strange gray area in federal law, thousands of patients last October got injections for back pain that contained highly dangerous fungal meningitis, and dozens of them died. Members of the Senate Health, Education, Labor and Pensions Committee are now seeking to fix the government’s oversight of the obscure world of compounding pharmacies. The reforms they want are overdue.
More infoThe Pew Charitable Trusts commented on the draft proposal to secure drug distribution in the United States. Although recognizing that the draft is the product of a sustained effort to address a complex system and balance sometimes competing imperatives, Pew shared areas of significant concern.
More infoThe House Energy & Commerce Subcommittee on Health will hold a hearing on April 25 entitled "Securing Our Nation’s Prescription Drug Supply Chain." Allan Coukell, a pharmacist and drug safety expert, will testify on the need to establish a national system to track and authenticate medicine. The principles outlined in his prepared testimony are supported by other stakeholders in statements from consumer, patient, public health, and industry groups.
More infoThe Pew Charitable Trusts has identified 20 pharmacy compounding errors associated with 1022 adverse events, including 75 deaths, since 2001.
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