Tuesday, October 9, 2012

Drug Compounding Pharmacies

In the past few weeks, 119 people have come down with a rare condition called fungal meningitis (a fungal infection of the meninges of the central nervous system), according to the CDC. Eleven people have died. An investigation into the rapidly rising number of cases of the condition (which, by the way, is not contagious) quickly focused on a batch of steroid drugs that had been prepared at a Massachusetts-based drug compounding pharmacy.

Drug compounding pharmacies provide an important service to the health care industry. Drug compounding pharmacies don’t actually make drugs; they buy FDA-regulated drugs in bulk from the drug’s manufacturer and then repackage or reformulate them according to the needs of their customers. Perhaps the customer (such as a major hospital or a chain of medical clinics) requests a specific dose of a drug in a specific-sized vial, or wants several different drugs combined in a single vial or pill. Drug compounding pharmacies prepare the vials or pills accordingly.  In the current case, the compounding pharmacy was preparing vials of steroids in a liquid form for injection into patients’ spinal cords, for the control of pain.  Apparently some of the vials of steroid became infected with an unknown fungus.

Because drug compounding pharmacies don’t actually make the drugs, they are not subject to the same oversight by the FDA as are the drugs’ manufacturers. Instead, like all pharmacies, they are regulated by state laws. Perhaps this recent outbreak of meningitis will lead to a review of how the industry is regulated and inspected by the various states, because here’s a case where a mistake at a compounding pharmacy in one state has apparently lead to cases of fungal meningitis in 10 states at last count, and deaths in four. We need to have confidence that our drugs (and their various formulations) are safe when they cross state lines.

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