Just months before a meningitis outbreak exposed major holes in the state’s oversight of pharmacies, regulators abandoned a plan to shut down a Massachusetts pharmacy whose medication error sent a teenager to the emergency room with a heart attack. They have yet to discipline the company for the mistake.
State records obtained by the Globe show that in July 2011, Royal Palm Specialty Pharmacy of Webster accidentally gave a boy thyroid medication that was 1,000 times too strong, requiring him to be hospitalized with serious heart problems. The board found out about the incident only when the boy’s mother complained four months later, even though pharmacies are required to promptly report serious errors.
But, after initially voting to shut down Royal Palm last July, members of the Massachusetts Board of Registration in Pharmacy reversed themselves a week later and decided to negotiate a settlement with the company instead, the records show.
A year later, the board has yet to reach an agreement with the company or discipline the pharmacy. And Royal Palm has continued to operate with few restrictions, though the company has acknowledged the mistake to regulators and promised to take steps to prevent similar accidents in the future.
“This speaks to a systemic problem” with state regulators, said Sarah Sellers, a former Food and Drug Administration official who advocates more stringent regulation of compounding pharmacies, which make specialized versions of drugs that aren’t readily available from major drug manufacturers. “The states are not doing enough to identify the problems, figure out the scope of the problems, and correct the problems.”
The state pharmacy board already has come under fire for ignoring warning signs about another compounding pharmacy, New England Compounding Center, whose injections were linked last fall to an outbreak of fungal meningitis that killed 61 people and sickened 749 in 20 states. The Framingham-based company which, like Royal Palm, made specially formulated drugs, later surrendered its license.
Since then, Governor Deval Patrick has vowed to make sure nothing like the meningitis outbreak ever happens again. Health officials fired the pharmacy board’s executive director, toughened state regulations, conducted dozens of unannounced inspections of high-risk compounding pharmacies, and issued cease-and-desist orders against nearly a dozen.
Massachusetts officials also insisted they are still pursuing potential disciplinary action against Royal Palm, cautioning that it takes time to complete a thorough investigation.
“Folks who do investigations are very focused on getting it right,” said Dr. Madeleine Biondolillo, director of the Department of Public Health bureau that oversees the board staff.
In addition, the Legislature’s Joint Committee on Public Health is expected to approve a bill on Tuesday to increase the oversight of compounding pharmacies going forward.
But the state has not replaced several board members who made critical decisions about both New England Compounding and Royal Palm.
Records show that four of the seven current board members were on the board last year when the meningitis outbreak linked to New England Compounding occurred, three of whom also participated in the vote to reverse the shutdown order against Royal Palm.
All four holdover board members either declined to comment for this story or couldn’t be reached, but Biondolillo defended them, saying they seem engaged and focused on patient safety. “I see a very effective board,” she said.
The administration did try to push out one former member, Sophia Pasedis, last October after meeting minutes suggested shemay have voted on matters related to her employer, a sister company of New England Compounding. But Pasedis insisted on remaining on the board until her five-year term expired at the end of November.
Currently, there are four vacancies on the 11-member, unpaid board.
One former board member, Dr. Donald Accetta, said he stepped down earlier this year after he found the work was becoming tedious, but said he thought board members did their best to make sure companies corrected any problems.
“The board’s job is not to shut down pharmacies,” said Accetta, a Taunton physician. “It’s the board’s job to make sure it is a safe environment for the consumer.”
But some industry and government officials alike say that regulators across the country, including in Massachusetts, haven’t paid enough attention to compounding pharmacies.
In most cases, compounding pharmacies are small mom-and-pop operations, which make flavored versions of drugs for children, alter the ingredients for patients with allergies, or fill other custom orders. But, as the industry grew, many pharmacies shipped a significant proportion of their drugs across state lines, raising questions of whether they were being watched closely enough.
“Compounding pharmacies slipped under the radar,” Accetta said.
David Miller, chief executive of the International Academy of Compounding Pharmacists, an industry group, said it is clear in retrospect that Massachusetts’ oversight had a number of weaknesses, including the failure to follow up on signs that companies were violating the law.
“Massachusetts had many laws that it did not enforce,” Miller said.
Others contend that too many members of state pharmacy boards are pharmacists who might be reluctant to discipline their peers, even when inspectors find serious problems. Six of the seven Massachusetts pharmacy board members are registered pharmacists, though Patrick has recently proposed reducing the number of spots on the board reserved for pharmacists to four.
“The scenario has been repeated in many states where boards are composed of compounding pharmacies and other pharmacy interests,” said Sellers, the former FDA official. However, the public health committee’s bill is expected to reserve a majority of the seats for pharmacists to make sure they have the expertise to oversee the industry.
Pharmacist Mark Rubin originally started Royal Palm, which touts its expertise in making everything from weight loss supplements to pain treatments, in southeast Florida under the name Royal Palm Compounding Pharmacy.
His wife, Agnes, also a pharmacist, opened a second pharmacy in Webster under a similar name, Royal Palm Specialty Pharmacy, in 2011.
They also aggressively marketed their services across the country, getting licensed to sell prescription drugs in nearly every state.
But as the business expanded, it also drew complaints.
In March 2011, Colorado’s pharmacy board fined the Florida branch of the Rubins’ business $5,500 for failing to report all controlled substances it shipped to the state. A year later, North Carolina’s board suspended the company’s permit after finding that the company shipped at least 13 prescriptions into the state before it obtained a license there.
In addition, Royal Palm Compounding acknowledged it filled 30 prescriptions by a Michigan doctor for out-of-state patients he never examined, according to a consent order North Carolina reached with the company. The Florida pharmacy closed in 2012.
Massachusetts started investigating Royal Palm in Webster after receiving a complaint from the mother of a 19-year-old who received thyroid medication from Royal Palm in July 2011. Instead of providing 10 microgram capsules of a version of a thyroid hormone called T3 as the prescription called for, the pharmacy accidentally provided capsules containing about 10,000 micrograms, according to documents.
After taking the drug, the teenager had to be taken to an emergency room four times and hospitalized twice in August 2011 for heart problems. And the symptoms didn’t completely go away. A year later, investigators told board members the “patient continues to experience palpitations and generalized weakness.”
Investigators found Royal Palm did not report the overdose to the state board, despite a requirement that pharmacies report errors within 15 days that cause death or serious injuries.
A Royal Palm pharmacist, Karen Blakely, told the state she did not initially report the incident to the state because she did not know what happened to the patient. “I tried to call the patient’s mother numerous times, but never received a phone call back,” Blakely said.
She has since been reprimanded by the state for the compounding error. The mother said in the complaint that she and the son’s attorney both notified the company about the teenager’s injuries.
Royal Palm also promised the board it would double-check its calculations and better label raw ingredients, so it would be clear when pharmacists needed to dilute drugs before filling orders.
“We regret the error ever occurred and are doing everything possible to prevent future mistakes,” Blakely said in a statement to the board.
But in a follow-up inspection in April 2012, the board found that Royal Palm was not fully complying with its corrective plan.
The board initially ordered the pharmacy to “cease compounding” until it demonstrated that it was meeting industry standards. But just a week later, half the board members met again and voted to propose a consent agreement that would put the company on probation, according to the board’s minutes.
State officials could not point to any new information uncovered between the meetings or explain why the board voted with only five members present – one short of the quorum needed to legally conduct business. “It’s a good question and it’s a question we are paying a lot of attention to as well,” said Biondolillo, the state public health official. “That is absolutely not the way the current staff and leadership would allow the process to go.”
But most of the pharmacy board members who approved the reversal on Royal Palm remain on the board, including James DeVita, who is the board’s president, and Karen Ryle, who recently became president of the National Association of Boards of Pharmacy, giving her a role in shaping regulatory policies nationwide. DeVita could not be reached for comment, and Ryle said she could not comment without first reviewing the files.
Since the about-face on Royal Palm’s shutdown, a new inspection in January found the company was continuing to violate state rules, including failing to store drugs in ways to prevent their accidental misuse, documents show.
In February, the state ordered Royal Palm to stop making the thyroid medicine it gave to the teenager who suffered the heart problems. And board members voted in May to either prosecute Royal Palm for the violations or seek a settlement with the company. Staffers said last week they could not predict when or how the case will be resolved, and the board’s website still shows it has no record of disciplining the firm.
Royal Palm and its attorney did not return multiple calls seeking comment.
Issues at the pharmacy board are complicated by the fact that the agency releases so little information to the public. Unlike some licensing boards, the pharmacy board doesn’t issue an annual reportand only recently started posting minutes of board meetings on its website.
The board was also slow to share information about the complaints against Royal Palm, taking five months to respond to the Globe’s request for records. The agency provided a copy of the complaint against the company, inspection records, and other documents only after the Globe successfully appealed to the secretary of state. The records the state did release were heavily redacted, blacking out not only the patient’s name, but also his injuries and the name of his lawyer.
“We are very committed to transparency, but the laws are the laws,” Biondolillo said. She said the state could not disclose any details about the patient that might identify him.
This month, state lawmakers agreed to increase the board’s reporting requirements as part of the budget “so we can see how the board conducts its business,” said state Representative Jeffrey Sanchez, who cochairs the Legislature’s Joint Committee on Public Health.
If signed into law, the measure would require the board to create an annual report detailing how it handles each complaint while also dramatically boosting the board’s budget.
But the Boston Democrat said it was up to the governor, not lawmakers, to judge whether board members are doing their job. “We do not have a supervisory role over them,” Sanchez said.Todd Wallack can be reached at firstname.lastname@example.org. Follow him on Twitter @twallack.