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Wed December 12, 2012
Compounding Pharmacists In New Hampshire Brace For Change
About 20 years ago, Bob Vecchiotti developed something called foot neuropathy. It’s a neurological condition that left his feet numb. Sometimes they would tingle or burn.
“But then the pain was getting to the point that I was losing concentration and sleep, and I decided we need to do more,” says Vecchiotti. “That’s when my primary care physician, working with a compound pharmacist, was able to come up with something that worked.”
Vecchiotti is a business consultant in Peterborough. He was somewhat skeptical of compounding.
“When the physician first mentioned a compound pharmacist, I went, ‘what?’ I was thinking of potions…of brews that people concoct.”
It actually is kind of like that at Bedford Pharmacy, where pharmacist Ron Petrin has been compounding prescriptions for 30 years. This is where you come when you need a medicine flavored for a child, or a dosage fine-tuned to your individual needs.
Unlike what was happening at the troubled New England Compounding Center, there is no mass production taking place here.
“They were making incredibly large volumes of stuff for distribution throughout the country,” says Petrin. “That’s not the function of a community compounding pharmacy.”
Petrin says--and regulators agree--that NECC was acting more like a drug manufacturer than a compounder. That distinction is important, because it changes how you get regulated.
Right now, it’s up to each state’s Board of Pharmacy to oversee compounders. It’s the job of the Food and Drug Administration (FDA) to inspect the larger manufacturers.
But where do you draw the line between the two? Is it 6 pills, or 6,000?
“It is a fine line to draw, and I think individual Boards of Pharmacy have to decide how to handle that,” says Petrin.
He says the pharmacy world is so small in New Hampshire that there aren’t companies like NECC trying to pass themselves off as a compounder.
The problem is: out-of-state compounders can sell their products in New Hampshire.
The NH Board of Pharmacy grants them what’s called a ‘non-resident’ license. If they can prove that they have good standing in their home-state, they can sell their products to doctor’s offices here in New Hampshire.
Drug shortages have helped spur more inter-state business.
But what’s come out of the NECC outbreak is that not all states regulate their compounders as closely as New Hampshire regulates its own.
That’s led to calls for more FDA oversight of the industry, and legislative hearings in Washington.
But a lobbying group for compounders bristles at the idea of expanded federal oversight instead of state-level inspections.
“People who are in this profession and doing a good job, want inspection,” says IACP spokesman David Ball. “They want to be visited by state inspectors. They want good, clear consistent regulations, so there really is no issue there with making sure there’s adequate regulatory authority. Of course, what’s equally important is enforcement of authority.”
It’s that enforcement piece that Ball says needs to be stricter.
But that can be difficult for cash-strapped states. Recent budget cuts to New Hampshire’s Board of Pharmacy meant some compliance officers were laid off. There are now only two employees left to regulate the roughly 300 pharmacies and compounders in the state.
They don’t have the time or resources to also inspect out-of-state compounders.
So the Board of Pharmacy created a Task Force to look for ways the state can beef up its regulation of non-resident producers.
At Wednesday’s Board of Pharmacy meeting, they offered some ideas:
Mandate that out-of-state pharmacies prove they’ve been inspected recently. Or limit what they sell in New Hampshire to prescriptions only—not medications for use in doctor’s offices. That’s how NECC products were distributed.
“Has it given the industry a black eye? Yeah, I think acutely is has because there is a lot of sensationalism right now with this story,” says David Rochefort. He’s a compounder in Littleton, and was tapped to serve on the task force.
Such a black eye that Rochefort changed the name of his business. What used to be called Northern New England Compounding Pharmacy sounded too much like the Massachusetts company: New England Compounding Center.
On January 1st, the name changes to Eastern States Compounding.
Even though Rochefort and the half-dozen other New Hampshire compounders had nothing to do with the outbreak, they’ve obviously felt its impact.
“Ultimately, in the end, it will make the industry better because we are going to get these rogue facilities such as the place in Massachusetts, we are going to clean those folks out, and really return to the way pharmacy was meant to be and the way we practice here, which is one doctor, one patient, one prescription, and one person at a time,” says Rochefort.
The task force continues its work, with that simple equation in mind.