Public healthMassachusetts moves against unscrupulous compounding pharmas
State regulators in Massachusetts have shut down or cited thirty-two of the state’s forty compounding pharmacies as a result of a nationwide fungal meningitis outbreak. The outbreak killed forty-five people and sickened 696, who required hospitalization.
State regulators in Massachusetts have shut down or cited 80 percent of the state’s compounding pharmacies as a result of a nationwide fungal meningitis outbreak.
The USA Today reports that only eight of the state’s compounding pharmacies were not cited or shut down. The penalties were a result of tainted spinal steroids produced at the New England Compounding Center in Farmingham, Massachusetts. The contaminated drugs have resulted in forty-five deaths and the center has been shut down.
PharMerica, one of the firms which was part of the crackdown, was ordered to stop its sterile compounding operations in Massachusetts late last year after the facility was found “non-compliant with facility design and controls and in its preparation of sterile medications,” the Massachusetts Health Department said in a statement
The unannounced inspections which led to the citations and shut downs started last fall, when the first death were reported. In total, 696 people across the nation have fallen ill due to the fungus-infested steroids.
PharMerica has offices in Franklin, Knoxville, and Memphis, according to Tennessee health licensing records. The company is based in Kentucky and has a license to ship drugs into Tennessee from Kentucky and Indiana.
A cease-and-desist order was given against the company’s offices in Brockton, but PharMerica has submitted a plan of correction, according to department spokeswoman Anne Roach.
USA Todaynotes that officials in Rhode Island inspected a PharMerica facility after they found out about the Massachusetts operation being shut down, and found unsterile conditions as well as unlicensed personnel performing duties designated for licensed technicians only. In addition, the compounding operations were transferred to the Rhodes Island office without proper documentation. As a result, a cease-and-desist order on all sterile compounding was issued last month.
Massachusetts Health Commissioner Lauren Smith said the results of the inspection were “troubling,” but that the citations have led to “significant corrective measures and increased compliance among sterile compounders.”
In total, eleven of the forty compounding pharmacies have been issued either partial or complete cease-and-desist orders, and another twenty-one were cited for various violations but were allowed to continue operations as long as the problems were addressed.
The preliminary results of a recent survey in Tennessee stated at least 352 pharmacies in the state practice sterile drug compounding, but state regulators have not initiated any special on-site inspections of those pharmacies.
The state has just five inspectors to regulate 1,905 licensed pharmacies and 352 compounders and the Tennessee Board of Pharmacy said additional inspectors will be needed.
