By Matt Murphy
State House News Service
---- — BOSTON — As the state’s pharmacy board considers final regulations to improve oversight of retail and compounding pharmacies, some in the industry believe it was the lack of enforcement of existing rules that led to a deadly fungal meningitis outbreak.
“In retrospect, we feel this situation could have been prevented if either the FDA or the Board of Pharmacy enforced the regulations already on the books,” Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, told the News Service yesterday after testifying before the board.
Brown and David Miller, of the International Academy of Compounding Pharmacists, offered feedback yesterday to the Board of Registration in Pharmacy on emergency regulations put in place Nov. 1 following the linkage of the meningitis outbreak to tainted steroids produced by the New England Compounding Center in Framingham.
Only three people testified on the regulations that apply to an industry that has come under scrutiny in Massachusetts and at the federal level in the wake of the outbreak.
Brown called it “ironic” that a Massachusetts pharmacy would be responsible given the relatively strict regulations already in place, and he called NECC an “outlier” that flaunted the state’s regulations and yet their violations went undetected.
Board president James DeVita and counsel Heather Engman alone were on hand to collect public comment on the regulations adopted at the direction of Gov. Deval Patrick in early November. The state at that time also permanently revoked NECC’s pharmacy license and Patrick established a special commission to report back before the end of the year on legislative steps the state could take to improve its oversight and pharmacy licensing laws and regulations.
The board also began periodic, unannounced inspections of compounding labs in the state.
While the regulations governing Massachusetts-based pharmacies are already strong, according to Brown and Miller, both said they had concerns that there was no registration process for out-of-state pharmacies doing business in Massachusetts. Georgia and Pennsylvania are the only other two states that don’t require out-of-state registration.
“It is a concern to us whenever we see a board that doesn’t have the same type of protections for citizens of pharmacies and compounding pharmacies outside its borders,” Miller said.
Brown said he has been in contact with legislators who have agreed to file legislation regarding the registration of out-of-state pharmacies in Massachusetts, though he declined to name lawmakers with whom he has been working.
Miller also raised concerns about the amount of time allowed before a pharmacy shut down by the board can have a hearing. The emergency regulations specify that a pharmacy is entitled to a hearing within 21 days of receiving a cease-and-desist order, but Miller said that could be very detrimental to both the business and patients looking to get their prescriptions filled. He recommended holding a hearing within five days.
“We’re placing our patients at risk with not being able to obtain their medications,” Miller said.
The emergency regulations adopted by the board require compounding pharmacies to report to the state the volume and distribution of drugs to determine whether they are acting more like a manufacturing facility that would be subject to Food and Drug Administration oversight.
The regulations also require pharmacies to report to the state when they are the subject of an investigation by another state or federal authority, and create stiffer penalties if pharmacies fail to comply with rules and regulations.
Brown suggested clarifying the definition of compounding, and limiting the requirement that pharmacies report “adverse events” to the state to those associated with compounding or when compounding products cause serious harm attributed to the accuracy, potency or sterility of the product.
Paul Garbarini, a pharmacist and attorney who represents pharmacies sanctioned by the board, also took issue with the requirement that pharmacists report pending criminal charges to the board.
“I think it flies in the face of common sense and fair play,” he said, suggesting convictions would be more relevant.