Massachusetts public health regulators Wednesday adopted emergency regulations that will allow hospitals to share medications to address drug shortages worsened by the closure of two specialty pharmacies following a national outbreak of fungal meningitis.
The rules adopted by the state’s Public Health Council, an appointed board of professors, clinicians, and public health advocates, will go into effect Dec. 1.
Injectable steroids produced at New England Compounding Center have been blamed for 490 illnesses — mostly meningitis cases but also joint infections — and 34 deaths in 19 states. The Framingham pharmacy supplied drugs to most hospitals in the state and hundreds across the country before it closed in October. Its larger sister company, Ameridose in Westborough, was a major supplier to hospitals nationwide; it was temporarily shuttered last month while authorities investigate its sterility practices. All products from both pharmacies were recalled in September and October.
Iyah Romm, policy and health planning director at the Department of Public Health, told the council Wednesday that hospitals were reporting shortages of certain medications before the outbreak and the shortages have grown more serious with the closures.
An information packet given to council members by Romm’s staff said that cardiovascular, anesthetic, analgesic, and anti-infective drugs were in short supply, and that the health department had received “numerous requests from hospitals and hospital pharmacies” to waive requirements that bar hospitals from sharing medications.
Romm said in an interview that while the new rules allow the department to grant waivers allowing sharing of any drug, the agency’s intent is to primarily grant the requests for compounded medications, which are specially prepared to meet the specific needs of a patient.
The rules are mainly intended to enable hospitals to share drugs within their health care systems. But Romm said the state could consider special requests to distribute them outside those organizations.
“We will consider every request on a case-by-case basis,” Romm said.
An e-mailed statement from the Massachusetts Hospital Association called the change “a significant and positive step toward easing the medication shortage,” but the group said it will not solve the issue over the long term.
The Globe reported earlier that hospitals have been working to develop long-term plans for ensuring an uninterrupted supply of critical medications in the wake of the meningitis outbreak, because they are wary of depending on the re-opening of Ameridose. Partners HealthCare has begun to examine the possibility of creating a central compounding facility that would seek approval from the US Food and Drug Administration to prepare medications for the hospitals within Partners, the state’s largest health care system.
Margaret Clapp, chief pharmacy officer at Partners’ Massachusetts General Hospital, said the regulations will help and are “heading in the right direction,” but Partners will still need a longer-term solution.
Council member Dr. Alan Woodward suggested that the state health department consider a more lasting remedy that would allow smaller hospitals within a health care system to continue receiving compounded medications from its larger counterparts because, he said, quality concerns at compounding companies are likely to persist. The emergency regulations stipulate that waivers granted to hospitals will be temporary and “time-limited” and are only intended to ease a facility’s specific drug shortage.
Romm said the department will forward Woodward’s proposal to a special commission, appointed by Governor Deval Patrick, that will study potential changes to laws and regulations to fill the regulatory gray area between state and federal oversight of compounding pharmacies. The commission held its first meeting Tuesday.
Regulators have said that New England Compounding was mass-producing drugs, acting more like a manufacturer, in violation of its state license. The FDA regulates manufacturers and state pharmacy boards have typically overseen compounders, but critics say an increasing number of large-scale compounding companies have used that patchwork system to escape oversight.