Pharmacists may soon have less say over their profession under proposed compounding pharmacy legislation filed by Gov. Deval Patrick of Massachusetts on January 4.
In a break with the recommendations of the state Special Commission on the Oversight of Compounding Pharmacies, which called for 6 pharmacists on an 11-member board of pharmacy, the proposed legislation seeks to limit the number of pharmacists to 4. “The Board will include more members not practicing in the industry they are responsible for regulating,” Patrick said in a news release.
But Christian A. Hartman, PharmD, MBA, FSMSO, named to chair the commission by the governor on November 1, 2012, backed the commission’s recommendations and disagreed with the governor in an interview with Pharmacy Today. “Part of the issue of how we got here is: We didn’t have the expertise on the board of pharmacy, and the proposed governor’s legislation makes it even worse.” Hartman is Director of Clinical Quality and Patient Safety at Wolters Kluwer; Principal and Director, Patient Safety and Quality, at Lucian Health; and founder and President of the American Society of Medication Safety Officers.
Currently, according to the Massachusetts Board of Registration in Pharmacy website, 7 members of the 11-member board are pharmacists; there’s also 1 physician, 1 nurse, and 2 public members. Carmen Catizone, MS, BSPharm, DPh, Executive Director of the National Association of Boards of Pharmacy, provided national context. “The typical board of pharmacy usually consists of six to eight members,” Catizone said. “The members include pharmacists from various practice settings, such as community pharmacy and hospital pharmacy, as well as at least one consumer, nonpharmacist member.”
Massachusetts was home to the now-closed New England Compounding Center (NECC) facility linked to the fungal meningitis outbreak. As Today went to press, 44 people had died and 678 people had been sickened in 19 states because of the outbreak of fungal meningitis and other infections, according to CDC. CDC, in collaboration with state and local health departments and FDA, is investigating the outbreak. Rep. Ed Markey (D-MA) introduced proposed federal legislation on November 2, 2012; NECC was in Markey’s district. Congress held two related hearings on November 14 and 15, 2012; at the first hearing, the widow of an early victim testified, without notes.
The Massachusetts state board of pharmacy approved emergency regulations on November 1, 2012. According to Hartman, every pharmacy manager in the state has signed an attestation making known their pharmacy’s level of compounding and level of quality. (For more information on state-related actions related to compounding pharmacy, see page 53 of January Today.)
Patrick’s proposed legislation also requires a special license for sterile compounding; authorizes the board of pharmacy to assess fines; establishes whistleblower protections; requires licensure for out-of-state pharmacies that deliver and dispense medications in the state, according to a news release.
Hartman predicted that Patrick’s legislation would pass because of the level of public interest around the world, but hoped that appropriate amendments will be in place to increase the expertise at the board of pharmacy, not decrease it. “I believe the governor is reacting [to] a tragedy that has occurred on a national scale,” Hartman said. “From a pharmacy point of view, this tragic event has unfortunately placed pharmacists and pharmacies in a negative light. And reality is most pharmacists and pharmacies are doing great things.”
In the national discussion of factors that led to the tragedy, many have pointed to a regulatory gray area in which the evolving compounding pharmacy industry fell between FDA’s jurisdiction over traditional manufacturing and the state’s jurisdiction over pharmacy practice. The last of the special commission’s 25 recommendations stated: “The Commonwealth of Massachusetts should advocate for the FDA to exert its current authorities under federal regulation. The Board of Pharmacy should exert authority where the FDA does not.”
Hartman explained to Today that the commission was not necessarily coming down on the other side of the argument that says that FDA’s existing powers are enough. “We didn’t go into that level of detail,” he said. “If a pharmacy is behaving in such a way that they are moving beyond the practice of pharmacy and moving into manufacturing, we would expect that the federal government would come in and apply whatever authority they have over manufacturing. And if they don’t, then it’s back to the board of pharmacy to come in and exert any authorities that we may have over pharmacy.”