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State's pharmacy board jumping ahead of proposed bill

New Hampshire Sunday News

February 16. 2013 10:53PM

Last October, even as state public health officials were dealing with the hepatitis C crisis, the first reports came in that patients who had received injectable drugs were being diagnosed with fungal meningitis.

The rare and potentially fatal illness was linked to contaminated drugs made by New England Compounding Center (NECC) of Framingham, Mass.

According to the Centers for Disease Control and Prevention, there were 14 cases of illness in New Hampshire linked to the contaminated drugs. Nine patients had meningitis and five developed joint infections.

The CDC reports 704 cases and 46 deaths linked to the outbreak nationwide. There have been no deaths reported in New Hampshire.

In response to the meningitis outbreak, Rep. Daniel Sullivan, D-Manchester, agreed to sponsor a bill to regulate compounding pharmacies, at the request of the state Board of Pharmacy. "It's an industry that's kind of run amok," he said. "There just wasn't enough oversight."

Robert Stout, a commissioner on the pharmacy board, said the board is already working on new regulations for compounding pharmacies rather than wait for passage of legislation.

There are 40 pharmacies in New Hampshire that do what's known as "high-risk," or sterile, compounding, and an additional 153 out-of-state pharmacies that ship sterile products here, Stout said.

State inspectors visit every pharmacy in New Hampshire, unannounced, every year, he said. But for now, the state has to rely on other states to watch over companies there.

In the NECC case, Stout said, "If Massachusetts had only done some routine inspections, they probably would have noticed this a long time ago."

New Hampshire's actions coincide with a push by the federal Food and Drug Administration, Stout said, to more clearly distinguish between a compounding pharmacy and a drug manufacturer.

NECC, he said, was shipping volumes of drugs to hospitals and clinics that were not patient-specific. "They were manufacturing, and someone should have seen that," he said.

House Bill 313 would require compounding pharmacies to label each drug with the names of the prescribing doctor and individual patient.

At a public hearing on Feb. 5, representatives from the New Hampshire Medical Society and New Hampshire Society of Eye Physicians & Surgeons said they supported the intent of HB 313, but have concerns about that provision in it.

Dr. Tim Blake is an ophthalmologist at Nashua Eye Associates and president of the NHSEPS. "From a patient safety standpoint, we're in favor of oversight and regulation of the compounding process," he said.

However, he said, ophthalmologists frequently keep certain compounded medications on hand for "office use," for patients who have macular degeneration, for instance. Requiring an individual prescription would mean patients would have to leave the office, get their prescriptions filled and then return later for treatment. It would also be more costly for the patient, he said.

Stout said he expects House Bill 313 can be amended to address the concerns of doctors. But he said, "We want to make sure, if you're going to administer a high-risk product to a patient, that it's made to the highest standards and we can assure the people of New Hampshire that it's going to be safe when they go to their doctor's office."

The House Health, Human Services and Elderly Affairs will vote on the bill on Thursday.

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