Add a commentWEBSTER — Even after a local compounding pharmacy told the state that corrective measures were in place to prevent a recurrence of a serious medication error in 2011 that allegedly caused a teen to have a heart attack, the company failed to comply with its plan of correction.
The state Board of Registration in Pharmacy in April completed its investigation of a complaint that Royal Palm Specialty Pharmacy, 118 Main St., mistakenly filled a prescription in July 2011 for the thyroid hormone liothyronine, also known as T3, that was 1,000 times too strong. The state would not release information about the patient, but according to The Boston Globe, the 19-year-old male suffered a heart attack. According to state records, Royal Palm staff determined two days later that a mistake had been made with the prescription because bottles of liothyronine were mislabeled. But the company did not report the error to the patient or the state board, state officials said.
Pharmacies are required to report improper dispensing of a prescription drug within 15 business days of discovering or being informed of the mistake. The state found out about it four months later in a complaint from the teen's mother. Royal Palm submitted a plan of correction to the board that included labeling all containers of liothyronine “For Trituration Only,” and ensuring that all compounding calculations were checked by a second staff member. But state inspectors found bottles of the powerful thyroid medication not labeled in April 2012, resulting in the company's submitting a further plan of correction, according to records provided by the state Department of Public Health.
During an unannounced inspection in January 2013, a container of the drug was again found not labeled, as well as other violations. That prompted the state Board of Registration in Pharmacy to order Royal Palm to immediately stop the compounding and preparation of liothyronine sodium. The company was also ordered to not remove any of the drug from its premises.
“Royal Palm's failure on at least two occasions to comply with its plan of correction(s) … constitutes an immediate threat to public health and safety,” the board counsel wrote in the February cease and desist order. David Kibbe, a spokesman for the state Department of Public Health, last week said a show-cause hearing for Royal Palm has not yet been scheduled. The board is proposing to suspend, revoke or impose other discipline against the company's registration to practice as a pharmacy.
“The complaints against Royal Palm are troubling and that's why the Board took action to issue a cease and desist order …” Mr. Kibbe wrote in an email. “The Board also launched an investigation into the pharmacy's practices, and a Board prosecutor is currently reviewing complaints against Royal Palm, pharmacist Mark Rubin, and his wife, Agnes Rubin, who is the pharmacy's manager-of-record.”
Mr. and Mrs. Rubin, through their attorney, have denied many of the allegations from the state. Mrs. Rubin has been a licensed pharmacist in the state since 2001. She established the business in Webster in 2011 and is listed as the sole owner. The state says that as manager, she was responsible for making sure staff had the appropriate experience and training. Her husband has been practicing pharmacy in the state since April 2011. Mr. Rubin was not at the business when the improper compounding occurred, but according to state records, he was called by another Royal Palm pharmacist to assist her with compounding the prescription. The state says he also did not make sure that the preparation was checked for accuracy by another Royal Palm pharmacist.
This is not the first serious pharmacy violation for Mr. Rubin. Last year, the North Carolina Board of Pharmacy suspended the license of Royal Palm Compounding Pharmacy, a company Mr. Rubin owned in Florida, after learning that the company had shipped at least 13 prescriptions into the state before it had a permit. In the consent order of discipline, the North Carolina board also noted that Mr. Rubin's company on several occasions sold compounded medications to patients in North Carolina prescribed by physicians in other states. Another violation was that the Florida company filled prescriptions for a doctor in Florida and one in Michigan for patients in other states.
In some of the cases, the prescriptions were issued “without a physical examination of the patients and in the absence of prior prescriber-patient relationships,” according to the North Carolina Board of Pharmacy. Mr. Rubin has since closed the Florida pharmacy.
Staff at the Webster pharmacy last week said the couple is out on maternity leave. No one answered the door at their home at 2 Blueberry Terrace. Ursula Kokocinski of Webster, who visited the pharmacy one day last week, said the allegations will not stop her from being a loyal customer. She said she transferred to Royal Palm when a former Walgreens pharmacist she was pleased with took a job at Royal Palm.
“I think they follow the rules. It must have only been human error,” Ms. Kokocinski said.
The error at Royal Palm happened a couple of months before steroid injections from Framingham-based New England Compounding Center resulted in a fungal meningitis outbreak that killed 61 people and sickened 749 other people in 20 states. The state has since stepped up measures to better monitor compounding pharmacies.
On July 9, the Legislature's Joint Committee on Public Health voted favorable action on a bill aimed at strengthening oversight of compounding pharmacies, after months of review. The bill, which is an expansion of a similar bill filed by Gov. Deval L. Patrick, is expected to go to the House Committee on Ways and Means.
Contact Elaine Thompson at ethompson@telegram.com.
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