Monday, August 12, 2013

American Society for Dermatologic Surgery Association's Position on Compounding


Compounding Pharmacy Position Statement

To view compounding pharmacy legislation ASDSA is tracking, click here

 Support: 
  • Safeguards to ensure that drugs made in compounding pharmacies are uncontaminated, and at consistent, appropriate dosage levels 
  • Appropriate regulations requiring licensure and inspection of compounding pharmacies 
Oppose:  
  • Regulation which restricts physician access to non-sterile compounded pharmaceuticals by prohibiting the purchase of these materials in bulk for in-office use 
  • Prescription of controlled compounded pharmaceuticals by non-physicians 
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 compounded drugs are the appropriate strength and makeup to avoid placing patients in harm’s way. The meningitis outbreak tragedy attributed to a contaminated batch of steroid injections made in a compounding pharmacy has drawn public attention to the real and critical nature of public safety concerns a failure to properly regulate and monitor compounding pharmacies. 

Providing uncontaminated drugs at consistent, appropriate dosage levels must be of paramount concern. A 2011 study published in the scientific journal Dermatologic Surgery 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.[1] Such discrepancies put patients at risk of inappropriate dosage and infection. According to a 2004 study published in the same journal, 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]  

Compounded pharmacies should be licensed and regularly inspected to make certain appropriate sterility safeguards are in place. According to an April 2013 U.S. Food and Drug Administration (FDA) inspection report of 29 compounding pharmacies, “Select FDA observations during the inspections include:  incomplete and/or inadequate drug product batch failure investigations, inappropriate and/or inadequate clothing for sterile processing, lack of appropriate air filtration systems, insufficient microbiological testing, and other practices that create risk of contamination.”[3]  

Any topical or injectable medication made in a compounded pharmacy should be ordered  by a physician and administered according to the physician’s instructions. In 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 re-sold the drug for use outside of a medical setting without the benefit of a physician prescription, physician-conducted physical exam or the taking of patient history.[4] 

Physician access to bulk purchase of drugs made in compounding pharmacies should be preserved for the purpose of in-office use. Most dermatologic surgeons practice in office-based settings and do not have the ready access to hospital pharmacies that many inpatient or hospital outpatient providers have. Regulations which prohibit physicians from purchasing drugs made in compounding pharmacies in bulk for the purpose of in-office use delay patient treatment and increase the cost of healthcare overall. These products made for purchase by physicians for in-office use should be clearly marked “for office use” and should not be re-sold to patients for use outside of the office.  



[1]Weiss, R., et al. Absence of Concentration Congruity in Six Compounded Polidocanol Samples Obtained for Leg Sclerotherapy. Dermatol Surg 2011;37:812–815  
[2]Goldman, M. Sodium Tetradecyl Sulfate for Sclerotherapy Treatment of Veins: Is Compounding Pharmacy Solution Safe? Dermatol Surg 2004;30:1454–1456 
[3]2013, April 11. U.S. Food and Drug Administration. Summary: 2013 FDA Pharmacy Inspection Assignment. Retrieved April 25, 2013 from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm347722.htm 
[4]North Carolina Medical Board v Ira David Uretsky, MD. Retrieved April 18, 2013 fromhttps://glsuite.ncmedboard.org/DataTier/Documents/Repository/0/0/3/9/94ceb2f9-42a0-49b6-8444-7242067a09f5.pdf            

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