One big mistake: 36 people dead.
Their deaths have triggered a renewed debate on regulating the pharmacies that create specially compounded medications. At issue is whether states continue to regulate what are called “compounding” pharmacies and manufacturers — or whether the federal Food and Drug Administration gets more power to oversee the industry.
“Some states will revise their regulations,” said David Ball, spokesman for the International Academy of Compounding Pharmacists. It is a trade group with offices in Texas and Washington, D.C., and represents 2,700 members in the industry. Said Ball, “The FDA may have broader authority over large-scale operations. It’s hard to say what will happen.”
The cause of the deaths was an outbreak of meningitis linked to the New England Compounding Center, one of the specialty pharmacies that create medications that are specially prescribed for individual patients. The center shipped 16,676 vials of a contaminated steroid to 23 states. That contaminated steroid — methylprednisolone — caused an outbreak of meningitis that has struck 510 people.
The New England Compounding Center is licensed to compound prescriptions for individuals. But in this case, it was mass-producing the steroid, which requires an additional license.
The deaths have raised questions about gaps in regulation and the possibility of more lapses. In New York, pharmacists downplay the likelihood of such mistakes here.
“This would never have happened in New York,” said Selig Corman, the director of professional affairs for the Pharmacists Society of the State of New York headquartered in Albany. It is the largest trade group for pharmacists in the state.
He used to own a pharmacy, Corman said. Inspectors made unscheduled visits at least once a year, he said. And New York pharmacies meet strict standards, he said.
“They have clean rooms,” said Corman. “Very sterile atmosphere. One locally here in the Albany area, if you wish to go in the compounding area they have to wear proper clothing: hats, special booties, and garments to maintain the sterility of the atmosphere.”
In New York, more than 20,000 pharmacists are licensed by the state, Corman said, along with 4,000 registered pharmacies.
Brewerton Pharmacy is the closest compounding pharmacy to Syracuse. Brewerton Pharmacy and all other pharmacies in New York are regulated by the State Board of Pharmacy.
“I think that’s where the regulation still needs to be,” said Nick Chervinsky, owner of the Brewerton Pharmacy and a licensed pharmacist.
Corman of the Pharmacists Society is confident the regulation of compounding pharmacies will remain at the state-level and the federal FDA will continue to enforce compounding manufacturing. The chance of the FDA gaining more regulatory power over compounding pharmacies is unlikely, he said.
“There would be a lot of pressure to not allow that to happen,” said Corman.
(Chet Davis is a senior with dual majors in broadcast journalism and political science.)
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