2014

American Society for Dermatologic Surgery Association Urges Stronger Regulatory Oversight, Enforcement of Compounded Drugs

ATLANTA, Oct. 12, 2012 /PRNewswire/ -- In the wake of the meningitis outbreak tragedy attributed to a contaminated batch of steroid injections made in a compounding pharmacy, the American Society for Dermatologic Surgery Association (ASDSA) urges federal and state regulatory authorities to re-examine their oversight and enforcement of compounding pharmacies.

The highest priority must be ensuring that these compounded injectable drugs are made in an environment that has appropriate safeguards against the spread of disease and that the components of these compounded drugs are the appropriate strength and makeup to avoid placing patients in harm's way, said ASDSA President Timothy C. Flynn, M.D. Additionally, compounded injectable drugs must only be provided by prescription from a licensed physician with the appropriate training to diagnose pre-existing conditions, contraindications or other factors that might render treatment unsafe for the patient.

Unfortunately, dermatologic surgeons are familiar to the issue of patient fatality due to poorly made compounded drugs. A 2011 study published in the Dermatologic Surgery journal found that five out of six samples of compounding pharmacy-made Polidocanol – a drug used for the treatment of varicose veins – 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.[1]

ASDSA President-Elect Mitchel P. Goldman, M.D., testified before the U.S. Food and Drug Administration (FDA) in 2004 about a study he conducted with similar results. In his study of another drug used to treat varicose veins – sodium tetradecyl sulfate manufactured in three different compounding pharmacies – the drug not only contained varying concentrations but also was diluted with an industrial detergent not manufactured for use in humans.[2]

"Providing uncontaminated drugs at consistent, appropriate dosage levels must be of paramount concern," said Dr. Flynn. "We are seeing too many cases of patients becoming ill or dying due to lack of appropriate oversight of compounded pharmacies."

In Dr. Flynn's home state of North Carolina, a young woman fell into a coma and died in 2005 when she used a large amount of compounded numbing agent prior to laser hair removal. The victim, 22-year-old Shiri Berg, had been given the drug without the benefit of a physician-conducted physical exam or the taking of patient history.

About the ASDSA

With a membership of nearly 5,700 physicians, the American Society for Dermatologic Surgery Association, a 501(c)6 association, was created to promote the educational and professional interests of dermatologic surgeons; provide a vehicle for advocacy and public education efforts on behalf of dermatologic surgeons and their patients; and address socio-economic issues that impact the practice of dermatologic surgery as a specialty. The American Society for Dermatologic Surgery Association advocates for patient safety and access to quality care, skin cancer prevention and education, and fair and appropriate office-based surgery regulation.

[1] Claudine Hamel-Desnos, et. al. Evaluation of the efficacy of polidocanol in the form of foam compared with liquid form in sclerotherapy of the greater saphenous vein: initial results. Dermatologic Surgery, 2011, 29(12):1170-5; discussion 1175.

[2] Goldman, MP. La Jolla Spa MD. National Center for Biotechnology Information. Sodium tetradecyl sulfate for sclerotherapy treatment of veins: is compounding pharmacy solution safe? Dermatologic Surgery, 2004, Dec;30(12 Pt 1):1454-6; discussion 1456.

SOURCE American Society for Dermatologic Surgery Association



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