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Proposal to Tighten Regs on Maine Compounding Pharmacies Gets Little Support
04/22/2013   Reported By: Patty B. Wight

Last year, an outbreak of fungal meningitis that killed 53 people and sickened nearly 700 others was traced to what's known as a "compounding pharmacy" in Massachusetts. Maine is one of many states considering tighter regulations for compounding pharmacies, where ingredients are mixed to make medications. But as Patty Wight reports, a proposal presented to lawmakers today is apparently not what the doctor ordered, with no health care providers stepping forward in support.

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Pharmacists compound drugs all the time. It can be something as basic as adding fruit flavor to a children's medication, to the more complex, such as mixing intravenous drugs. The compounding pharmacy in Massachusetts where the meningitis outbreak originated - the New England Compounding Center - manufactured medications in bulk that it then shipped them across the U.S.

Maine pharmacies tend to be more boutique-style, customizing medications for individual patients. While the state has good regulations in place, says Democratic Rep. Sharon Treat, she still wonders: "Does the Maine Board of Pharmacy have the tools it needs to make sure that a similar situation could never occur in Maine?"

Treat doesn't think so. At a hearing today, she said there are gaps in the existing law, and her proposed bill would close them. Treat has a list of proposed changes: create more oversight and authority over compounding pharmacies; establish a separate license for pharmacies that do so-called "sterile" compounding - those are the ones that mix things like intravenous drugs or antibiotics.

"When something goes wrong, people die," Treat said. "And we want to make sure that doesn't happen here."

While others agree with that sentiment, no one spoke in support of Treat's bill. Opponents took a similar line of reasoning that is often heard in the gun control debate - that is, what happened with the Massachusetts pharmacy was horrible, but no law can prevent bad behavior.

Joseph Bruno is a pharmacist and president of the Maine Board of Pharmacy. "We're very aware of the problem," he said. "We're putting new rules in place. But if someone's going to violate the law like New England Compounding Center, nothing could have prevented that."

Bruno says the Maine Board of Pharmacy is already updating rules about sterile compounding. He says the board is fully capable of the task, and pharmacist Bob Morrissette agrees. He spoke on behalf of the Maine Pharmacy Association, which is opposed to the bill because it would restructure the Board of Pharmacy - replacing two of its pharmacists with a doctor and nurse to avoid potential conflicts of interest.

"The Board is made up of five pharmacists from various practice areas and two members of the public. And it has protected the citizens of Maine for many, many years," Morrissette said. "So why would we want to upset this well-balanced, effective group?"

Even the Maine Medical Association's Gordon Smith, who testified neither for nor against Treat's bill, worries that the legislation would do more harm to than good.

"While we need to make sure that the product is safe, we also need to make sure that it doesn't go so far in moving that needle that there is no product," Smith said.

The Labor, Commerce, Research, and Economic Development Committee will hold a work session on the bill to determine whether it will go to the full Legislature.

Earlier this month, the FDA announced it found potential safety problems at 30 of 31 sterile compounding pharmacies it inspected since the meningitis outbreak. The pharmacies were across 18 states. None were in Maine.


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