White Coat Notes

Bill to increase pharmacy oversight in Mass. passes House

Patients would be able to go online to check the safety record of Massachusetts compounding pharmacies that custom-mix medications and the businesses would be subject to surprise inspections under legislation unanimously approved by the House Wednesday and aimed at preventing a repeat of the deadly fungal meningitis outbreak blamed on steroid injections made by a Framingham speciality pharmacy.

The bill, which moves to the state Senate, would require pharmacists who prepare injectable and other medications that must be sterile to take continuing education classes. State health officials also would have to alert federal regulators about any adverse side effects patients suffer while taking medications made by compounding pharmacies, which make drugs for patients who need doses or preparations that are not available off the shelf.

The bill is aimed at closing a yawning gap between state and federal oversight of compounding pharmacies that came to light in the wake of the meningitis outbreak.

Advertisement—Continue Reading Below

More than 740 people in 20 states were sickened last year, including 64 who died, from tainted steroids produced at New England Compounding Center in Framingham.

The company was operating essentially like a manufacturer, mixing large batches of drugs, but it wasn’t regulated by the US Food and Drug Administration like other drug manufacturers and received only infrequent inspections from the state pharmacy board.

“This is, first and foremost, about fixing where we were deficient in state oversight and enforcement,” said Representative Jeffrey Sánchez, a Jamaica Plain Democrat who sponsored the bill.

After the meningitis outbreak, Governor Deval Patrick directed state regulators to conduct surprise inspections of compounding pharmacies that make sterile medications, and the bill would make those inspections permanent. Sánchez said he wants to ensure that oversight continues after the Patrick administration.

The measure also would require that compounding pharmacies at hospitals be visited by state pharmacy inspectors, not just during routine hospital inspections.

“We want to sure that we got everyone under the umbrella so nobody is out of the reach of our oversight,” Sánchez said.

New England Compounding had a record of violations of state pharmacy regulations in the years leading up to the outbreak, but the Pharmacy Board has not routinely made violations public. Sánchez said his bill would correct that. “It’s also about transparency so patients can know, in real time, the quality and safety of the compounding pharmacy that is putting together that drug product for them,” he said.

Massachusetts Senator Edward Markey said in a statement that the legislation will help restore patients’ confidence in compounding pharmacies.

“This new legislation means Massachusetts will have the strongest state regulations in the country overseeing the compounding pharmacy industry,” Markey said.

Share