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Editorial: Meningitis outbreak underscores the need for stricter oversight

Oct. 09, 2012 @ 11:32 PM

A meningitis outbreak that has sickened more than 100 people -- and killed 11 of them, at last count -- has cast a light on the practices of pharmacies that custom-mix medicinal compounds.

The conclusion that many are drawing is that these labs lack sufficient oversight and some have been supplying medicines on a wider scale than they should.

More than 17,000 single-dose vials of the steroid compound believed to be linked to the current fungal meningitis outbreak were distributed to clinics in 23 states, including West Virginia, by a specialty pharmacy in Massachusetts. Of the cases of meningitis cited by the Centers for Disease Prevention and Control, all of the patients had received injections of the compound for back pain. All of those doses have now been recalled.

This isn't the first outbreak linked to such custom-mixed medicines. Several deaths have been reported in recent years, and this year 33 people in seven states had fungal eye infections.

Health experts say that compounding pharmacies do not receive the level of oversight that drug manufacturers do, either from the U.S. Food and Drug Administration or state pharmacy boards.

Another trouble spot is that some of the compounding pharmacies can cross a line if they supply a product on a large scale to a clinic or hospital, according to health experts. They are supposed to supply products to meet unique patient needs and to prepare drug products that are not available commercially, based on an individual prescription.

The extent of the current outbreak remains to be seen, because symptoms can take a month or so to appear. But the toll is a clear signal for federal and state regulators to assess what needs done to regulate these compounding pharmacies and do a better job of protecting the public.



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