Last fall’s deadly meningitis outbreak linked to contaminated steroid injections is a tragic reminder of the risk of errors inherent in manual pharmacy medication compounding. Unsanitary conditions at the Massachusetts compounding pharmacy that made the injections resulted in fungal contamination of the drugs. The resulting outbreak sickened more than 700 people in 20 states and killed more than 50.
Tennessee, where the unusual cases of meningitis first came to light, was particularly hard hit. One of only two states with more than 100 cases linked to the contaminated injections, Tennessee has seen 150 cases of illness to date and 15 deaths. New maladies related to the injections continue to be diagnosed six months later.
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1 comment:
Nice editorial from the president of a company that sells automated compounding systems. If lawmakers mandated his proposal, his companynwould rake in billions of dollars of revenue, but every "mom and pop" compounder (the ones that were not in any way associated with these compounding disasters) would be out of business because they couldn't afford to buy this guy's expensive compounding machine.
I have no problem with technology, but the problem with NECC, Apothecure, Franck's, etc was that "rogue compounding pharmacies" decided to become manufacturers without complying with all the safety mechanisms manufacturers are supposed to do, AND, their trade organization, the IACP, used its lawyers and linguists to thwart the FDA and local boards of pharmacy who attempted to regulate them. The solution isn't an expensive compounding machine, but it is clearer laws giving the FDA and boards of pharmacy authority to act, and the willingness of boards of pharmacy to hand out "death penalties" to rogue compounding pharmacies that have shown no moral or ethical responsibility to protect patient safety.
Kenneth Woliner, MD
www.holisticfamilymed.com
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