Nine patients at Birmingham-area hospitals developed bloodstream infections and died after receiving TPN compounded by Meds IV.
Two pharmacists from Alabama this month received federal prison sentences for distributing tainted drugs that contributed to the deaths of nine patients at Birmingham-area hospitals in 2011.
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David Allen, 60, and William Timothy Rogers, 48, both worked at the now-defunct compounding pharmacy Advanced Specialty Pharmacy in Birmingham, which did business as Meds IV. Earlier this year, both pharmacists pled guilty to misdemeanor violations of the Federal Food, Drug and Cosmetic Act.
On June 21, 2016, U.S. District Judge Virginia Hopkins sentenced Allen to 12 months in prison and fined him $5,000. Allen was the former pharmacist-in-charge at Meds IV. Hopkins sentenced Rogers, former president of the pharmacy, to 10 months and fined him $5,000.
Principal Deputy Assistant Attorney General Benjamin C. Mizer“Compounding pharmacies are entrusted with protecting the public’s health from any harm their drugs may impose and must comply with the law,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer. “These cases demonstrate that the Department of Justice will continue to work aggressively with [FDA] to protect consumers from drugs compounded under insanitary conditions.”
U.S. Attorney Joyce White Vance for the Northern District of Alabama said Meds IV compounded intravenous nutrition without taking legally required precautions while preparing the products. “As a result, a number of patients developed serious infections,” Vance said. “We are committed to prosecuting this type of practice to the fullest extent of the law provides for and protecting the safety of our citizens.”
According to prosecutors, Meds IV compounded Total Parenteral Nutrition (TPN). Starting in February 2011, the company compounded its own amino acid solution that was mixed with other ingredients to form TPN. Prosecutors alleged that amino acid used to compound the TPN was contaminated with bacteria that can cause bloodstream infections.
CDC investigators traced the bacteria to a tap-water faucet, an open container of amino acid powder, and the surface of mixing equipment at Meds IV. CDC said Meds IV prepared the amino acid outside a laminar airflow workbench, and stored it unrefrigerated in a room that was not sterile, sometimes overnight.
During March 2011, nine patients at Birmingham-area hospitals developed bloodstream infections and died after receiving TPN compounded by Meds IV. Several others developed bloodstream infections but survived.
“Producing unsafe and contaminated drugs poses a serious threat to the U.S. public health and cannot be tolerated,” said Director George Karavetsos of the FDA’s Office of Criminal Investigations. “The FDA remains fully committed to aggressively pursuing those who place unsuspecting American consumers at risk by distributing adulterated drugs.”