The American Society for Dermatologic Surgery Association (ASDSA) is calling for tighter, tougher regulations of compounding pharmacies following the fungal meningitis outbreak attributed to a contaminated batch of steroid injections made at the New England Compounding Center of Framingham, Mass.
According the FDA, fungal contamination is possible in all of the supposedly-sterile products made by this pharmacy on or after May 21, 2012. People who got shots of any of these medicines are at risk – not just those who received steroid injections.
Dermatologic surgeons are familiar with the issue of contamination at compounding pharmacies. A 2011 study published in the Dermatologic Surgery journal found that five out of six samples of compounding pharmacy-made Polidocanol did not contain the claimed concentrations of the active ingredient, and all six contained impurities. Such discrepancies put patients at risk of inappropriate dosage and infection.
ASDSA President-Elect Mitchel P. Goldman, MD, also testified before the FDA in 2004 about a study he published that found that sodium tetradecyl sulfate manufactured in three different compounding pharmacies not only contained varying concentrations but also was diluted with an industrial detergent not manufactured for use in humans.
"We are seeing too many cases of patients becoming ill or dying due to lack of appropriate oversight of compounded pharmacies," says ASDSA President Timothy C. Flynn, MD, in a news release.[Source:media reports]