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 Royal Palm down 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.”
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