New Jersey lawmakers want pharmacies that mix their own medicines to earn accreditation after mistakes by a New England company killed dozens and sickened hundreds nationwide.
The New England Compounding Center, based in Massachusetts, closed and filed for bankruptcy amid wrongful-death lawsuits filed last year after the center’s drugs were implicated in killing 44 people and infecting hundreds of others — including at least 48 patients in New Jersey.
The center manufactured and distributed steroid medication to health providers across the country, including several in Cumberland County. The medicine was contaminated with fungus that could cause meningitis in patients.
The scandal has put compounding pharmacies under more national scrutiny, particularly in New Jersey where pharmaceuticals remain the state’s No. 1 industry.
State Sen. Jeff Van Drew, D-Cape May, Cumberland, Atlantic, introduced a bill that would require pharmacies that mix their own medications to earn accreditation through one of several national boards.
Van Drew, a dentist from Dennis Township, said his interest is primarily with sterile compounding, not the compounding that most pharmacies in New Jersey routinely perform. He is working on the bill with the New Jersey Board of Pharmacy.
“Your regular pharmacy compounds all the time. As a dentist, they have compounded things for me,” he said. “They don’t need additional requirements thrust upon them, quite frankly. But sterile compounding does need additional oversight.”
Pharmacies for generations prepared drugs for individual patients until relatively recently, when large pharmaceutical companies took over most of those duties.
Today, pharmacies still provide this service — called compounding — for patients that are allergic to fillers such as gluten sometimes used in pills.
Pharmacist Meredith Swank, 43, of Bridgeton, offers this service for patients at Woodruff’s Drugs in Bridgeton.
“In the 1960s there wasn’t anything commercially available. That’s all we did,” she said of her pharmacy, which has served Bridgeton customers since 1887.
“When drug companies became big in the 1970s, pharmacies got away from compounding,” she said.
Some patients have trouble swallowing pills. Others are prescribed a medication in a dose not readily available from the drug manufacturer, she said.
Swank said pharmacists mix or prepare the compounds in ways that help the patients absorb the active ingredients — sometimes through the skin.
But Swank makes an important distinction between this type of common compounding and the sterile compounding for eye drops, nasal sprays and injections performed by the New England Compounding Center.
“It’s a lot more risky to do sterile compounds,” she said. “These are sterile preparations, so you need a laminar flow hood. It has to be a totally sterile environment. You could pay $100,000 for that equipment.”
For this reason, she does not perform any sterile compounding at her pharmacy.
And Swank sees another difference between the medicines she provides and those distributed by the Massachusetts center: mass distribution.
“When you compound, there is a triangle between the patient, the doctor and the pharmacist. But you’re not a manufacturer,” she said.
Compounding pharmacies have carved an important niche in South Jersey, said pharmacist Mark Taylor, owner of Jersey Shore Pharmacy Compounding & Long-Term Care in Egg Harbor Township.
His pharmacy is in the midst of expanding its compounding lab to meet the growing demand from its patients. The pharmacy consists of a small waiting room separated by glass from several compounding labs where workers make gelatin tablets that melt on the tongue or add powdered ingredients to empty pill capsules in lots of 20 at a time.
Unlike Woodruff’s Drugs, Jersey Shore also has its own sterile laboratory where pharmacists and technicians draped in full-body gowns with masks and gloves prepare solutions for injection and eye drops.
Taylor said his compounding lab relies on heavy-duty ventilation and strict lab protocols to keep patients and employees safe. These safeguards are important because the technicians are working with these medicines all day. The fine powder can become airborne.
Once the technicians prepare a batch of sterile solutions, vials are sent to testing laboratories that ensure they contain the proper medicine and dose or concentration with no contaminants, said Bill Campion, the pharmacy’s director of marketing and education.
The lab also provides veterinary compounds for customers’ dogs and cats, and for animals at zoos such as Cape May County’s.
“We have to be able to adjust the concentrations of medicines for something as small as a field mouse to as big as an elephant,” Campion said.
Even as Jersey Shore Pharmacy works on completing its expansion, it is seeking accreditation through the Pharmacy Compounding Accreditation Board, based in Washington, D.C.
States across the country are re-examining their regulation of the industry. Taylor said he thinks it’s a good idea for compounding pharmacies to seek accreditation, but not necessarily because of the Massachusetts tragedy.
“You don’t want anyone regulating you to the point where you can’t do business. But there is a public concern,” he said. “It depends on the certification the state wants you to get.”
The New England Compounding Center case put a spotlight on the entire industry, said Pharmacy Compounding Accreditation Board spokeswoman Kristin Prince. But her group sees a big difference between the mass manufacturing and distribution that company allegedly performed, which normally would be regulated by the U.S. Food and Drug Administration, compared to the small-batch compounding most small pharmacies perform for individual patients.
“There’s a gray area. It’s a dance we’re always in,” she said. “They’ve changed the whole atmosphere for compounding pharmacies.”
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