Two Compounding Pharmacists Plead Guilty Over Outbreak
Alabama residents David Allen, a former pharmacist-in-charge of the now-defunct compounding pharmacy Advanced Specialty Pharmacy doing business as Meds IV, and William Timothy Rogers, a pharmacist and former president of Meds IV, have agreed to plead guilty to charges for their role in distributing adulterated drugs to Birmingham-area hospitals in 2011. The Department of Justice (DOJ) says both have agreed to plead guilty to two misdemeanor violations of the federal Food, Drug and Cosmetic Act.
The government alleges that the pharmacy’s Total Parenteral Nutrition (TPN), a liquid nutrition administered intravenously to patients who cannot or should not receive their nutrition through eating, was made using their own compounded amino acid solution. The solution, DoJ says, was “adulterated in the following ways: it consisted in whole or in part of a filthy, putrid, or decomposed substance, namely Serratia marcescens (S. marcescens) and it was prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. S. marcescens is gram-negative bacteria that can cause bloodstream infections if introduced into the bloodstream through contaminated medications. These infections can cause serious medical complications, including death, because S. marcescens is resistant to many antibiotics.”
According to the charging document, the amino acid was prepared by Meds IV outside a laminar airflow workbench and was kept unrefrigerated, in a room that was not sterile, in a large pot sitting on the floor, sometimes overnight, before it was sterilized and used. Nine patients at various Birmingham-area hospitals who developed bloodstream infections caused by S. marcescens died, and several other hospital patients developed S. marcescens bloodstream infections but survived, according to DoJ.
“Americans expect and deserve drugs that are safe, effective, and that meet appropriate standards for quality, yet Meds IV contaminated and distributed drug products that resulted in serious harm to patients,” acting FDA commissioner Stephen Ostroff was quoted in the DoJ release as saying. “Such conduct cannot be tolerated, and the FDA will continue to work with the Department of Justice to pursue aggressive enforcement actions against those who place American patients at risk.”
For each count, the defendants face a statutory maximum sentence of up to one year in prison, a fine of up to $250,000, or both, and a term of supervised release after any imprisonment for up to one year.