Tighter restrictions were proposed in reaction to the multi-state meningitis outbreak caused by contaminated steroids produced by a Massachusetts compounding pharmacy.
New legislation proposed by Massachusetts Governor Deval Patrick would provide for increased oversight over compounding pharmacies that operate or distribute medications in the state. The legislation, filed on January 4, 2013, is designed to help prevent future incidents such as the multi-state fungal meningitis outbreak caused by contaminated steroids produced by a Massachusetts compounding pharmacy. The steroids, produced by the New England Compounding Center (NECC), have been associated with at least 44 deaths.
The proposed legislation would:
require pharmacies that engage in sterile compounding to hold a special license;
empower the Massachusetts Board of Pharmacy to levy fines on pharmacies licensed in the state for violations;
set up whistleblower protections for pharmacists and other pharmacy staffers;
require out-of-state pharmacies that deliver and dispense medications in Massachusetts to be licensed by the state’s board of pharmacy;
and increase non-industry representation on the board of pharmacy, so the board would include 4 pharmacists, 1 nurse, 1 physician, 1 pharmacy technician, 1 quality improvement expert, and 3 members of the public.
The proposed reorganization of the board of pharmacy was included in response to the fact that its then-director failed to pass on a complaint about the NECC received from the Colorado pharmacy board in June 2012, before the third of 3 batches of contaminated steroids was shipped.
“There is no action that we in government can take to prevent all abuses in all industries—but we must do what we can,” Gov. Patrick said in a press release
In addition, Gov. Patrick announced support for a previously filed bill that would increase the fine for corporate manslaughter to $250,000 from $1,000, where it has stood for almost 200 years. The governor also directed the state public health department to increase the number of inspectors at the pharmacy board, to require all inspectors to be pharmacists with at least 5 years of clinical experience, and to require additional training and specific expertise in sterile compounding for inspectors in that area.
Previous changes made in the wake of the NECC fiasco include requiring sterile compounding pharmacies to report details of their volume and distribution to the state, which will indicate to regulators when compounders are behaving like manufacturers, and requiring licensed pharmacies and pharmacists to report to the pharmacy board whenever they are the subject of disciplinary action by any state or federal agency, allowing it to keep tabs on pharmacies doing business out of state.
Around the time the legislation was introduced, a letter sent by the NECC demanding that its cleaning company, UniFirst Corp, take responsibility for the contaminated steroids came to light. UniFirst, which provided monthly cleaning services to the pharmacy, rejected the demand.