Meningitis outbreak prompts state board to scrutinize drug-compounding operations
By Ben Sutherly
The Ohio State Board of Pharmacy plans to get a better handle on the size of the state’s compounding-pharmacy industry in the wake of a deadly outbreak of fungal meningitis, which apparently originated at a compounding pharmacy in Massachusetts.
On Friday, the board suspended the license of a compounding pharmacy in Piqua.
The board said that JAH Pharmacies, overseen by Jeff Hogrefe, failed to properly separate a compounding pharmacy from a retail Medicine Shoppe; fell short of sterility standards; used outdated drug stock; and illegally manufactured drugs that weren’t compounded for a “ patient-specific legitimate prescription."
Hogrefe disputed those allegations and said JAH tested all products for sterility and potency.
“I’m excited to move forward with them and get the problems rectified,” Hogrefe said. The Medicine Shoppe will remain open “and has nothing to do with JAH Pharmacies.”
The nationwide outbreak of fungal meningitis has renewed a debate over how best to balance the need for custom-made prescriptions with regulations meant to ensure the safety of such products. As of yesterday, 23 deaths had been reported. There have been reports of 284 infections in 16 states, 11 of them in Ohio.
About 430 Ohioans have received steroid injections that might have been tainted, according to the pharmacy board.
The International Academy of Compounding Pharmacists estimates that 7,500 U.S. pharmacies specialize in pharmacy compounding, and an additional 8,200 pharmacies associated with hospitals and other health-care providers use the practice daily.
It’s unclear how many Ohio pharmacies specialize in compounding, the process of making custom medications that can’t be obtained commercially, or dividing those medications into dosages appropriate for individual consumption by humans and animals.
The pharmacy board issues only wholesaling and retailing licenses for drugs, but it does try to keep track of those pharmacies that get more than half of their business from compounding, said board spokesman Jesse Wimberly.
In Ohio, as few as 17 pharmacies get the bulk of their business from compounding, Wimberly said.
The pharmacy board typically learns through inspections whether pharmacies primarily focus on compounding, but it will start asking pharmacies for that information through license applications and renewals, Wimberly said.
He said the pharmacy board is taking other steps to see whether Ohio has adequate regulations concerning compounding pharmacies. He did not elaborate.
The state has 17 agents who inspect pharmacies, plus eight pharmacists who specialize in inspecting compounding pharmacies. The board strives to inspect each pharmacy at least every three years, Wimberly said. Most of those visits are unannounced, he said.
Punitive action against Ohio’s compounding pharmacies is infrequent. Aside from the Piqua pharmacy’s license suspension, one other pharmacy that currently focuses primarily on compounding has been fined by the state during the past decade, a Dispatch review found.
Teregen Labs in Willoughby was fined $31,000 in 2004 for various violations, including compounding products for physicians and clinics to keep as stock.
“It had to do with the method of how we filled the prescription,” said George Fiderio, the pharmacy’s president and owner. “It had nothing to do with patient safety.”
The pharmacy board on Oct. 9 suspended the Ohio license of the compounding pharmacy in Massachusetts, New England Compounding Center (NECC).
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