Hospital Concerns Over Drug Supplies Mount as Meningitis Outbreak Spreads
The 12 patients who died and the 137 patients sickened so far from a Massachusetts compounding pharmacy's fungus-infected steroid should put more than a few hospital executives on edge.
Many providers in recent years have grown to depend on these companies for some of their products.
But organizations impacted by this especially tragic story of medical harm shouldn't be surprised by it. There have been several eerily similar incidents over the years that should have been plenty of warning.
Ten years ago, a similar fungus contaminated the same injectable product, methylprednisolone acetate. It was also administered to patients to alleviate pain. And it caused the same acute meningitis as in the current outbreak. In the 2002 event, at least five patients were sickened and one died in North Carolina.
The December 2002 Morbidity and Mortality Weekly Report on the contaminated steroids said a South Carolina company referred to as compounding pharmacy "A," "had been supplying the compounded product to hospitals and pain management clinics in five states after a proprietary form of methylprednisolone acetate injectable suspension...became difficult to obtain from the manufacturer."
An investigation by the state's Board of Pharmacy "found improper performance of an autoclave with no written procedures for autoclave operation, no testing for sterility or appropriate checking of quality indicators, and inadequate clean-room practices as outlined in the American Society of Health-System Pharmacists (ASPH) guidance for pharmacy prepared sterile products."
History repeats itself
And earlier this year, federal charges were filed against an unaccredited Texas pharmacy for killing patients far away in Washington and Oregon with a gout treatment it shipped, called colchicine. Its potency levels were allegedly far stronger than appropriate.
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Chris Cahill (10/11/2012 at 6:52 PM)
Same thing happened in California in 2001 or 2002. The organism was Serratia. Lack of supervison and failure to follow policies and procedures is the cause.