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NH eyes better drug safety one year after meningitis outbreak

New Hampshire Sunday News

September 14. 2013 11:23PM

On Sept. 21, 2012, the Tennessee Department of Health notified the Centers for Disease Control and Prevention that a patient there had developed meningitis after receiving a steroid injection at a surgical center.

It was the first sign of a deadly, multistate outbreak linked to a Massachusetts compounding pharmacy that would sicken 750 people in 20 states, including 14 patients in New Hampshire. There have been 64 deaths tied to the outbreak, but none in the Granite State.

Now, New Hampshire is poised to adopt regulations on compounding pharmacies and the products they dispense in the state. And health experts say folks here are safer because of the lessons learned from what happened a year ago.

Never before

It was an unprecedented public health threat. Contaminated drugs made by New England Compounding Center (NECC) in Framingham, Mass., were injected into patients, exposing them to fungal infections in a way health providers had never before encountered.

"There was no data. There were no studies. There was really no literature, other incidents to draw on," recalled Chris Adamski, chief of the Infectious Disease Bureau at the state Department of Health. "How scary is that for someone, to say we really don't know how this is going to be?"

The state and CDC continue to monitor patients for long-term symptoms; Adamski said the 14 patients diagnosed with fungal meningitis or joint infections here have all recovered.

NECC closed after the contamination was discovered, and the company filed for bankruptcy late last year.

On June 27, Gov. Maggie Hassan signed into law House Bill 313, which regulates the compounding of drugs or devices. The law requires new labeling and record keeping for compounded drugs, limits the quantities of such drugs that can be sent to providers and requires the Board of Pharmacy to adopt new rules for compounding pharmacies.

And it defines "compounding" as the "preparation, mixing, assembling, packaging or labeling of a drug or device" as a result of a practitioner's prescription drug order or "in anticipation of prescription drug orders based on routine ... prescribing patterns."

The latter wording was included after medical providers testified that they often keep small quantities of compounded drugs on hand to treat patients, such as some eye medications.

Robert Stout, a Candia pharmacist who is a commissioner on the pharmacy board, said it was already working on new regulations for compounders even before the new law passed.

Draft ready

A draft of the proposed rules will be discussed at the board's meeting on Wednesday at 9 a.m.

After that, Stout said, the board will accept public comment before submitting the proposed regulations to the Joint Legislative Committee on Administrative Rules for possible approval. "What we'd ideally like to see happen is to have the rules go into effect when the law goes into effect in January," Stout said.

The board proposes inspection not only of the compounding pharmacies in the state, but also of all compounded medications sent here, Stout said. The board plans to hire a third full-time inspector and add a part-time technician to conduct such inspections.

Stout said the plan is to inspect all medications at providers' offices, including surgical centers, doctors' offices, even veterinary clinics - "any place that holds drugs that will be administered to patients."

It's a tall order, he acknowledged.

But Stout noted compounders have been "self-policing" since the NECC crisis, and he said the state is "in a much better position today" as a result of what happened.

Adamski said the meningitis outbreak heightened awareness about the potential dangers of contaminated compounds. "I think it has changed the landscape," she said.

Regular notices

The federal Food and Drug Administration puts out frequent notices of recalls by out-of-state compounding pharmacies, and Adamski views that as a favorable development. "I think it's a good thing because they're on high alert for anything that may potentially impact the integrity of the product," she said.

The state Division of Public Health works closely with the Board of Pharmacy to determine whether any such recalled products were sent to providers here or administered to patients, Adamski said, noting there have been no instances of illness tied to recalled products since the NECC outbreak.

Although health officials cannot assure the public that such a problem will never again occur, Adamski said, "the processes and the regulations are being crafted to bring us to a place where we can be as safe as possible and patient harm is minimized."

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