Pharmacists would have less say in regulating their profession, and the state could for the first time fine rule-breaking druggists under legislation Governor Deval Patrick proposed Friday to prevent a repeat of the fungal meningitis outbreak blamed on a Framingham specialty pharmacy.
The legislation would require a special license for pharmacies that do sterile compounding of injectable and intravenous drugs, as did New England Compounding Center, the company that produced tainted steroids linked to more than 650 illnesses and at least 39 deaths. Out-of-state pharmacies that distribute medications in Massachusetts would have to be licensed in Massachusetts, not just in their home states.
Patrick’s plan is based in part on recommendations of a special commission he appointed in October after the national outbreak came to light. But he bucked the panel in urging that pharmacists make up only a minority of the board that licenses and disciplines them and sets rules for the profession.
The commission’s proposed changes, also announced Friday, included increasing the required number of pharmacists on the 11-member board from five to six; however, Patrick would set that number at four.
Under his proposal, other members of the board would include a nurse, a physician, a pharmacy technician, a quality improvement officer, and three members of the public.
In a State House press conference, Patrick said he believes that fewer pharmacists on the board will mean stronger oversight. “This will bring a greater range of professional perspective to the board,” he said.
But the commission’s chairman — Christian Hartman, a pharmacist who specializes in clinical quality and patient safety — said in an interview that more pharmacy specialists are needed on the board because of how diverse the industry has become.
That sentiment was echoed by Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, a group that represents most compounders.
“We don’t think that four pharmacists will adequately represent and understand all practice settings, so we will take whatever action we can to make sure the board has a different make up.”
Patrick administration officials have previously suggested that a board primarily comprised of pharmacists — including one who worked for a sister company of New England Compounding — may have been hesitant to reprimand the pharmacy, despite repeated violations at the company.
In 2004, the pharmacy board proposed sanctioning New England Compounding, but after a negotiated settlement between the company and state lawyers dropped any penalties, the board accepted the change.
Brown and Hartman said the problem with board oversight has more to do with a chronic lack of funding.
“The state takes in millions of dollars from licensing fees for pharmacists and pharmacies, so I don’t know why we don’t have enough money to run the Board of Pharmacy,” Brown said.
In October, state regulators began annual, unannounced inspections of the roughly 25 other compounding pharmacies in Massachusetts that prepare sterile injectable medications such as those directly linked to the outbreak.
Patrick said Friday that he will direct the Department of Public Health, which oversees the Pharmacy Board, to increase its inspection staff to continue surprise inspections and to raise inspector training requirements, a recommendation contained in the commission’s report. But he declined to say how much money this would cost.
“We will propose an adequate budget for those additional inspectors,” Patrick said.
Lawmakers said Friday that they had not seen the governor’s bill, but pointed out that they will also be considering other legislation on the issue.
Seth Gitell, spokesman for House Speaker Robert A. DeLeo, said in a statement that the speaker had directed a review of pharmacy oversight last fall by three committee chairmen, who conducted public hearings. “The speaker will also ask these representatives to review the governor’s recommendations, as soon as they are filed, so that the House can take swift and strong action to prevent this appalling situation from occurring again,” Gitell said.
Senate President Therese Murray said in a statement, “There will be many proposals to consider, and we plan to look at all options.”
The governor’s bill allows fines of up to $25,000 for each violation of pharmacy rules, plus $1,000 a day if pharmacies delay correcting problems. The legislation leaves it up to the Pharmacy Board to determine how to oversee out-of-state companies.
Most states require out-of-state pharmacies to fill out a brief form to prove they have a current license in their home state and to pay a fee. Massachusetts is among a handful of states that have no licensing requirements for such pharmacies, relying on pharmacies’ home states to follow up on complaints and do regular inspections.
The special commission recommended a variety of policy and rules changes that would not require legislative approval, including actions the Pharmacy Board should take to increase its transparency, such as timely posting on its website of license suspensions and revocations, inspection results, cease-and-desist orders, meeting minutes, and other board actions.
“We absolutely want to carefully consider all of these,” Smith said. “We have to think about how to operationalize [the suggestions] and how can we do it with the resources we have.”