October 29, 2012
DAYTON — Ohio reported two more illnesses in a deadly fungal meningitis outbreak linked to a Massachusetts compounding company, bringing the state’s total to 13 cases as it cracks down on pharmacies that custom-mix prescriptions.
Cases involving a 39-year-old Clermont County man and a 56-year-old Warren County woman were added to those previously reported in Crawford, Franklin, Hamilton, Marion and Morrow counties, the Ohio Department of Health said Monday. Federal officials have listed 25 deaths and more than 330 illnesses in the outbreak linked to back injections made by a specialty pharmacy.
Jesse L. Wimberly, pharmacy inspector for the Ohio State Board of Pharmacy, said Ohio has 17 specially designated compounding pharmacies statewide. They’re usually inspected at least once every three years, though inspectors will go more often if there are complaints or reported violations.
“Now we’re going to every one of these pharmacies that are designated for compounding,” Wimberly told the Dayton Daily News for a story published Monday.
Wimberly said the state now requires pharmacies to specify how much of their business is strictly retail sales and how much is mixing up custom preparations. And they have to be able to demonstrate that they meet cleanliness standards and show that their products are being prepared for specific patients — not mixed up in advance and set aside to fill future orders.
“The issue we’re having now is, are you doing patient-specific compounding,” Wimberly said. “We don’t do manufacturing. We do compounding for specific patients. We check the records and make sure that they’re in compliance so that when you get a prescription it’s for a specific person and you’re compounding that prescription for that person and giving that prescription to that person.”
Not being able to link prescriptions to specific patients is one of the issues officials are finding in the investigation of the New England Compounding Center in Framingham, Mass., he said.
Since news broke of the problems at the Massachusetts pharmacy, Ohio has ordered the closure of a compounding pharmacy in Piqua, north of Dayton. On Oct. 19, the state ordered JAH Pharmacies Inc. to close after issuing 29 citations, most for failure to meet cleanliness standards or for having outdated drug stock.
In Massachusetts, state pharmacy regulators started to conduct surprise inspections at compounding pharmacies last week. State officials announced over the weekend they had shut down one such pharmacy over sterility concerns.