Paula Wolfson, wtop.com
WASHINGTON – Compounding pharmacies can be a godsend for people with special medical needs. But a controversy surrounding a Massachusetts drug maker is creating image problems for the industry.
The New England Compounding Center, which says it’s a compounder, mass-produced steroid injections that have been linked to an outbreak of fungal meningitis.
“It is just mind-boggling,” says Ron Keech, a compounding pharmacist at Village Green Apothecary in Bethesda, Md.
He says the New England Compounding Center “hijacked a compounding pharmacy and turned it into a manufacturing thing.”
Compounding pharmacies traditionally mix custom medication based on a doctor’s prescription for an individual.
Most, like Village Green Apothecary, are small, locally owned businesses that thrive on a personal approach.
They do not create new medicines as much as they adapt existing formulas to meet special needs. Many customers have allergies to substances used as fillers or coatings in mass-produced medications. Others need a specific strength that is not mass-manufactured, or they need to take the medicine in a different form, say a liquid, instead of a pill.
“We basically make an individual product for an individual patient,” says Keech.
What happened at the New England Compounding Center was just the opposite. It mass-produced medications and then sent them off for resale.
In so doing, it broke existing laws. Keech says he’s sad for those affected by the meningitis outbreak, but also angry.
“It gives a black eye to the vast majority of pharmacies that are compounding under the laws and doing things appropriately.”
Keech says there are strong industry and government guidelines for compounding, but they apparently were not enforced in this case. He also notes that by operating under the guise of a pharmacy, the Massachusetts company managed to avoid inspection by the Food and Drug Administration as a mass drug manufacturer.
Keech says a true compounding pharmacy is a throwback to the old-fashioned neighborhood drugstore. In fact, compounding is the way all medications were made until the mass manufacturing of drugs started in the 1950s.
Although some compounding pharmacists are employed by clinics and hospitals, many like Keech work in independent drug stores with a small-town feel.
“The majority of our customers are long-term customers. People we know by name, and they know us,” says Keech.
“And that, basically, is how compounding should be done.”