Injections made by a Texas compounding pharmacy may be responsible for bloodstream infections, says the Food and Drug Administration (FDA).
The reports are the latest in a series of similar incidents that emerged since a fungal meningitis outbreak in September 2012 was tied to steroid injections produced by New England Compounding Center in Massachusetts. More than 60 people died, and 700 were infected by the shots, which were contaminated with a fungus. The cases prompted the FDA to increase pressure on state pharmacy boards, which oversee compounding pharmacies, to ensure they met quality and safety standards, since the FDA’s authority over the pharmacies is limited; state pharmacy boards license compounding pharmacies to produce limited amounts of custom-blended medications — in some cases without ingredients to which patients might be allergic, at a different dosage that is more tolerable for patients, or in a different formulation that patients prefer (liquid v. pill, for example). Some of the ingredients compounding pharmacies use are provided by the manufacturer of the original drug, but some pharmacies source their own active compounds for the medications, which can lower the drugs’ costs.
After 15 patients were hospitalized with blood infections after receiving calcium gluconate injections, the FDA announced a voluntary recall of all sterile products produced and distributed by Specialty Compounding, LLC in Cedar Park, Tex., which made the shots. Calcium gluconate is used to treat heart disease, high potassium levels and calcium deficiencies.
The recall highlights not only the uneven quality of compounding pharmacy products, but the widening reach of compound pharmacies, many of which are flouting laws that prevent them from distributing their products on a wide scale outside of the state in which they are made. But as TIME wrote in October during the New England Compounding Center fungal meningitis outbreak, states may not have the resources to monitor and regulate these pharmacies as intensely as they should:
The compounding industry has been growing in recent years as the cost of medications as risen, and while exact estimates are hard to confirm, a 2003 Government Accountability Office report estimates that anywhere from 1% to 10% of all U.S. prescriptions may come from compounding pharmacies.
Because they aren’t pharmaceutical manufacturers, compounding pharmacies and the products they make, are not regulated by the FDA. Instead, they are monitored by state pharmacy boards, which may not have the resources to ensure that all safety requirements are met. “FDA’s authority by law [over compounding pharmacists] is more limited than its authority over products made by non-pharmacists,” Kathleen Anderson, acting director of the FDA’s Office of Unapproved Drugs and Labeling Compliance, said. According to the Tennessean, the NECC has been cited by the FDA before for regulatory violations, including misbranding of drugs and promoting drugs for unapproved purposes — but not for issues related to compounding.
In a “60 Minutes” segment detailing the contamination at New England Compounding Center, FDA commissioner Dr. Margaret Hamburg acknowledged that the agency’s authority over compounded products is limited and may put consumers at risk. “What I think emerged in the meningitis outbreak was that many patients and their health care providers didn’t realize that they in fact were using a compounded product,” she said during the episode. The result, she said was that the FDA could not guarantee that all of the products made by these pharmacies were safe and effective.
As more quality control issues from other pharmacies emerged in the past year, the FDA has increased its presence in compounding pharmacies in support of state pharmacy boards to ensure that proper safety and quality measures are in place. And Congress is considering a bill that would clarify the government’s role in overseeing compounded products and prevent widespread distribution of what are supposed to be limited supply drugs made by these companies.
The FDA says it is working with the Centers for Disease Control and Prevention (CDC), as well as Texas state officials, in order to determine how widespread the latest contamination is. You can get more information on how to report cases here.