Massachusetts regulators have ordered all pharmacists and pharmacy technicians who worked at the Framingham company linked to the national fungal meningitis outbreak to immediately stop working in the drug-
compounding industry, a sign that state officials are concerned that its front-line workers might not have followed proper procedures.
An Oct. 31 letter from the Massachusetts Board of Registration in Pharmacy obtained by the Globe states that the investigation of the outbreak had determined that pharmacists and pharmacy technicians employed by the New England Compounding Center “may present an immediate or serious threat to the public health, safety, and welfare and should immediately cease.”
The board previously voted to seek the permanent surrender of New England Compounding’s pharmacy license, as well as permanent revocation of the licenses of the company’s three primary pharmacists, including Barry Cadden, a co-owner, and his wife, Lisa Conigliaro Cadden.
New England Compounding closed early last month and recalled all of its products. A steroid produced at the company has been linked to 419 fungal meningitis cases and joint infections and 30 deaths, the Centers for Disease Control and Prevention said Monday.
A spokesman for the state health agency, which includes the pharmacy board, said the letter was sent to pharmacists and technicians working at New England Compounding when it closed, but declined to say how many employees received letters.
‘I am troubled by the potential for technicians who had no idea that [problems were] going on to be adversely impacted.’
Todd Brown — executive director of the Massachusetts Independent Pharmacists Association, a group that represents most compounders — said he believes the board’s actions are too sweeping.
“While I understand the board has to take every precaution to ensure something like New England Compounding doesn’t happen again, I am troubled by the potential for technicians who had no idea that [problems were] going on to be adversely impacted,” Brown said.
Pharmacy technicians, who typically are the ones who mix the drugs in a compounding facility, may learn the craft on the job, Brown said. State rules require technicians to be at least 18 years old, have a high school or equivalent diploma, and have no drug-related felony convictions. The rules also require technicians to complete 500 hours of on-the-job training or a board-approved training course and pass a board-
approved exam that may be given by their employer.
State officials have said that New England Compounding was illegally mass producing drugs, operating more like a manufacturing facility subject to licensing by the US Food and Drug Administration.
The FDA said its preliminary investigation has found widespread contamination in New England Compounding’s clean rooms, where the sterile injectable drugs linked to the fungal meningitis outbreak were produced.
Brown said it is possible New England Compounding’s pharmacy technicians were unaware of state laws that prohibit compounders from mass production without proper federal oversight and may not have been told by company leaders that sterility tests showed repeated contamination.
“I can’t think of any rational reason why these technicians couldn’t work in pharmacies that had appropriate practices and procedures,” Brown said. “If a New England Compounding technician didn’t have good techniques, that would be caught in a good compounder.”
The Oct. 31 letter says that “failure to immediately cease and desist compounding-
related practice may warrant suspension” of the pharmacists’ and technicians’ licenses.
The letter also said the preliminary investigation had determined that staff members had violated specific sections of the state’s pharmacy regulations, including ones that govern codes of conduct and others that specify actions that are subject to discipline. Among those actions are “conduct that has the capacity or potential to place the public health, safety, or welfare at risk” and “engaging in conduct that has the capacity or potential to deceive or defraud.”
The letter, signed by board president James T. DeVita, informed the pharmacists and technicians that the cease-and-desist order is considered a nondisciplinary action and that they have a right to contest it. The letter said the order will stand until the board “takes final action on any pending investigation or complaint and/or the board issues written approval” for each individual to resume compounding.
Patrick administration spokesman Alec Loftus referred questions about the board’s action to DeVita, who could not be reached for comment.
As state and federal health officials continue to investigate, Congress has launched its own inquiry. The House Energy and Commerce Committee announced Monday that it is convening public hearings Nov. 14 on the matter, and FDA Commissioner Margaret Hamburg has agreed to testify. Invited but not confirmed to appear are Cadden and James Coffey, director of the Massachusetts pharmacy board.