April 22, 2013

Maine lawmaker seeks tighter pharmacy regulation

Rep. Sharon Anglin Treat says Maine should learn from the 2012 meningitis outbreak linked to Massachusetts.

By Susan M. Cover scover@mainetoday.com
State House Bureau

AUGUSTA — The deaths of 53 people after a nationwide meningitis outbreak linked to a compounding pharmacy in Massachusetts has prompted a local lawmaker to submit a bill to strengthen regulations in Maine.

click image to enlarge

Pharmacy technician Suzanne Goddard works under a hood preparing bags of intravenous medicines in the sterile room at Kennebec Pharmacy & Home Care in Augusta.

Joe Phelan/Kennebec Journal

"We need to make sure what happened at that Massachusetts pharmacy could never happen in Maine," said Rep. Sharon Anglin Treat, D-Hallowell. "One of the reasons we have these issues is we have no unified federal law to deal with compounding pharmacies."

Treat, an attorney who works as executive director of the National Legislative Association on Prescription Drug Prices, said she began researching Maine law with regard to compounding pharmacies after the incident last fall at New England Compounding Center in Framingham. A contaminated steroid sent across the country from the pharmacy sparked a meningitis outbreak, killing 53 and sickening more than 700 in nearly 20 states.

No cases of illness or death were reported in Maine, according to the Centers for Disease Control and Prevention.

Since then, state lawmakers in more than 10 states have proposed tighter restrictions, according to the National Conference of State Legislatures. Treat's bill would require all compounding pharmacies that fill prescriptions for those who live in Maine to be licensed by Maine. It also would create a new type of license for compounding pharmacies, removes two pharmacists from the state Board of Pharmacy and replaces them with a physician and a nurse, and require pharmacy board members to file an annual statement disclosing conflicts of interest.

In addition, L.D. 1315 would require the board to participate in a national data reporting system and institute a $25,000 fine for out-of-state pharmacies that fail to comply with Maine's rules.

Treat's bill also calls for better public disclosure by requiring the board to post on its website all enforcement actions related to pharmacies, pharmacists and pharmacy technicians and information regarding pharmacy inspection results.

"There's public disclosure to make sure members of the public can find out if there's malpractice or malfeasance," she said.

Kennebec Pharmacy & Home Care on Leighton Road in Augusta, one of the state's handful of compounding pharmacies, fills both sterile and nonsterile prescriptions, General Manager Joe McVety said. Despite the ready availability of prescription drugs, compounding pharmacies still are needed to mix drugs for specific patients that address their particular needs, he said.

His pharmacy mixes creams and ointments and can make capsules without dyes that may be problematic for some patients, he said. It also makes intravenous solutions for patients who need care at home. He estimates the pharmacy fills 15 compounded prescriptions a day.

On Friday, pharmacy technician Suzanne Goddard worked in the sterile laboratory, where she mixed chemotherapy drugs that would be administered by IV. The drugs would be used by a patient later that day or the following day.

McVety said the pharmacy is inspected once a year by the state and has received Home Care Services Accreditation, which is completed every three years. It sends out samples of its products to be tested throughout the year and follows federal guidelines.

"There's all kinds of regulations for us," he said. "They have been looking at us and they will continue to look at us."

Unlike what happened in Massachusetts, compounding pharmacies in Maine fill only specific prescriptions for individual patients. They do not produce compounds in mass quantities.

McVety said he's not opposed to making improvements to the current system and probably will attend the public hearing on Treat's bill to learn more about what she's hoping to accomplish.

"Certainly we should be looking at our practice in the state of Maine," he said. "As far as I know, we all have legitimate practices here."

(Continued on page 2)

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