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Metro

Mass. board was lenient on drug maker

Took harsh steps with many other pharmacists

Massachusetts regulators have yanked the licenses of scores of pharmacists in recent years, according to a Globe analysis of national disciplinary data, giving them a track record not out of line with other states, even as they repeatedly failed to discipline the Framingham compounding pharmacy now blamed for a deadly US outbreak of fungal meningitis.

The Massachusetts Board of Registration in Pharmacy revoked or suspended the licenses of 138 of the more than 11,000 licensed pharmacists in the state during the six years preceding June 2011. That is more than many other states, according to data collected by the ­National Association of Boards of Pharmacy.

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Overall, Massachusetts ranked in the middle of states in terms of the number of such actions it took per 1,000 pharmacists during that period, though some years it ranked higher or lower.

A review of how the board compares with its counterparts nationally also shows that it is significantly less transparent, failing to provide on its website the most basic information about its members and does not routinely announce board discipline and other actions. It does not produce an annual ­report as do many other states.

It also failed, until this week, to conduct unannounced ­inspections, something at least 10 other states have routinely done. But many of the board’s regulations are similar to those in other states, requiring pharmacies to comply with industry safety standards.

Carmen Catizone, executive director of the national association, said Massachusetts does not have a reputation for being either particularly stringent or lax about enforcement.

“Massachusetts did not stand out as a board that was not taking actions or taking more actions than other states,” Catizone said. “They seemed ­active and responsive, but did not stand out.”

State officials defended the pharmacy board this week against suggestions it could have done more to prevent the deadly outbreak of meningitis that has been linked to New England Compounding Center.

But Dr. Michael Carome of Public Citizen, a watchdog group that has often been critical of state medical boards for not doing enough to discipline doctors, said: “It seems like the evidence of recurrent problems was just overwhelming. Why both state and federal officials failed to take action is just inexplicable.”

In particular, he and others questioned the board’s decision six years ago to ignore its own staff’s recommendations to formally sanction New England Compounding.

So far, 24 people have died, and 317 people in 17 states have been diagnosed with fungal meningitis or joint infections after receiving steroid injections made by New England Compounding, according to the US Centers for Disease Control and Prevention.

State records released this week show the board’s staff proposed an official reprimand and a three-year probation for New England Compounding and its chief pharmacist, Barry ­Cadden, after receiving a series of complaints that the company was shipping drugs in bulk without individual prescriptions. The board also received other complaints, including one reporting an adverse ­patient reaction to the same ­injectable steroid involved in the current outbreak.

But the board agreed to drop the reprimand and reduce the probation period to a single year in 2006, after the company’s lawyer complained it could potentially put the company out of business. Ultimately, the board waived even that more modest penalty.

“It’s certainly a concern,” said state Senator Richard T. Moore, chairman of the Joint Committee on Health Care ­Financing.

Governor Deval Patrick and administration officials said they are investigating why the board decided not to take more serious action against New England Compounding in 2006. Seven of the 10 current board members were on the board then and have since been reappointed by Patrick, state ­records show. Alec Loftus, an administration spokesman, ­declined to say whether the governor will ask any board members to resign, but said “all options are on the table.”

“We will take the necessary and appropriate actions at the conclusion of our comprehensive review,” Loftus said.

A senior Patrick administration official defended the board at a press conference Tuesday.

“There is no indication at this moment in our investigatory process that the Board of Pharmacy has done anything wrong,” said Dr. Madeleine ­Biondolillo, director of the ­Bureau of Health Care Safety and Quality.

The Patrick administration has taken steps to tighten the requirements for compounding pharmacies, which custom-mix prescriptions for individuals. Patrick said the state would ­immediately begin annual, unannounced inspections of compounding pharmacies.

Some states have gone further after patients were harmed by compounded drugs. In 2003, the Missouri pharmacy board started testing compounders’ medications for potency and sterility. In June 2010, the most recent data available, out of 225 potency tests performed in Missouri, 15 percent failed to meet standards. The concentrations ranged from less than a third to nearly double the proper levels.

The state board plays a critical, yet often overlooked role in making sure medication ­patients receive is safe. The Massachusetts board oversees more than 1,100 pharmacies and more than 11,000 pharmacists.

In fiscal 2011, it conducted 271 inspections and investigated 336 complaints, the state said. That year, the agency reported to the national association that it suspended or ­revoked the licenses of 33 pharmacists.

Like most pharmacy boards, it is made up primarily of pharmacists, including one who works for New England Compounding’s sister company Ameridose. State officials have said she recused herself from votes involving the companies.

Carome of Public Citizen said that while he does not know why board members failed to sanction New England Compounding or its pharmacists, licensing boards often shy away from taking disciplinary action because they are too close to the industry they regulate or do not have the resources to crack down, particularly when licensees hire lawyers to fight the charges (as New England Compounding did).

The Massachusetts licensing board does not disclose where its members work, making it difficult for outsiders to spot a potential conflict. One member is an executive with CVS Caremark, and another is a pharmacist at Walgreens, two of the largest chains in the state.

The members are also exempt from a state law requiring members of many other boards to file financial disclosure forms with the State Ethics Commission because they are not paid for the work.

Moore said he thought the law may need to be revised to require board members to disclose more information.

“Their decisions have a ­financial impact on the industry,” said Moore. “We ought to know more about them.”

Matt Carroll of the Globe staff contributed to this story. Todd Wallack can be reached at
twallack@globe.com; Kay
Lazar at klazar@globe.com.

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