The state Senate passed a bill Wednesday requiring compounding pharmacies that custom-mix sterile drugs to obtain a special license from the state pharmacy board, submit to annual inspections, and report more information about their operations. But, unlike the plan approved last month by the House, it temporarily exempts a large segment of the industry: hospital pharmacies.
Instead, the bill would create a commission to review oversight of hospital pharmacies and make recommendations by July 2015. If no change is made by then, the hospitals would become subject to the same rules as other compounding pharmacies.
“A hospital is a very different setting from a manufacturer's setting,” said Anuj Goel, vice president of legal and regulatory affairs at the Massachusetts Hospital Association. He noted that hospitals monitor their drug quality and are subject to outside reviews conducted by accreditation boards and the Centers for Medicare & Medicaid Services, which are not done at wholesale drugmakers. “Hospitals have always been and continue to be regulated.”
But federal site visits to hospital pharmacies happen irregularly, and state inspections are done as part of overall hospital licensing. The state pharmacy board now has no role in inspecting the hospital pharmacies, though it does license their pharmacists.
The bill comes after tainted drugs produced last year at a Massachusetts commercial compounding pharmacy, New England Compounding Center, sickened 751 people, killing 64. The change in the Senate bill undermined the state’s response to the tragedy, said Senator Mark Montigny, a New Bedford Democrat who proposed an amendment to subject hospital pharmacies to the new licensing rules, as the House requires. The amendment failed.
Montigny said hospitals warrant oversight because they do much of the drug compounding in Massachusetts and their products are used on some of the most vulnerable patients. He said the hospital industry lobbied to have the exemption added to the bill, which is now headed to a conference committee to iron out differences between the Senate and House versions.
“The hospitals employed their friends and did their work, and it needs to be reversed in conference,” he said. “The exemption is dangerous. ... We have put the industry first and the patient second.”
Representative Jeffrey Sánchez, a Jamaica Plain Democrat and House chairman of the Joint Committee on Public Health who has led an investigation of pharmacy oversight in the state, declined to speak specifically about the Senate bill, saying he would save his comments for the conference committee.
He said the final bill must “hold pharmacists and our own bureaucracy accountable so that this doesn’t happen again.”
Whatever new requirements are made of compounding pharmacists in Massachusetts, they should be applied to everyone working in the field, said David Miller, chief executive of the International Academy of Compounding Pharmacists.
“Regardless of where the patient is, that patient should be assured of the same equal protection under the law,” he said. “As pharmacists, we don’t believe that any practice setting or any patient should be treated either favorably or unfavorably.”
But Bill Churchill, chief of pharmacy services at Brigham and Women’s Hospital, said the hospital setting is different. Pharmacists have more information about the patients for whom they customize drugs, including about what other medications they may be taking. Many drugs they make are used immediately. While hospitals often make large batches of drugs, they don’t ship them to outside facilities, as commercial pharmacies do.
Churchill said he would welcome regulations requiring regular state inspections and reporting, but he wants the regulations to be tailored to hospital operations.
“I just want to make sure it is completely applicable to what we do,” he said.