I have written about this topic before here but readers will want to read this information. Maybe the Florida Board of Pharmacy will finally take action about Royal Palm Compounding Pharmacy, LLC and Mark Rubin. Here is more information to be considered.
Mark Rubin had a small community pharmacy in Boca Raton (Express Care Pharmacy) that did everything (regular drugs, durable medical equipment (bedside commodes, etc) and some limited compounding. He sold that pharmacy (and transferred the patient account info) to either a CVS or a Publix pharmacy.
- Mark Rubin then started the 1st Royal Palm Specialty Pharmacy in Wellington, FL (a part of Palm Beach County known as Royal Palm Beach). This pharmacy was located in a non-descript "office building" with no obvious sign that it was a pharmacy, no direct patient walkthrough (they did exclusive mail orders to physician and veterinarian office and/or patient homes). This is the modus operandi of a rogue compounding pharmacy (e.g. KRS Global Biotechnology d/b/a GBTRx Pharmacy). The pharmacy will use aggressive sales tactics by holding exhibiting booths at national conferences such as the American Academy of Anti-Aging Medicine (A4M); employ sales reps on a national basis whose income is based almost exclusively on commission; will tout to prescribers (doctors, veterinarians, etc) the "profit-making potential" of prescribing/dispensing/
... 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
Vote to restrict pharmacy from compounding drugs (pages 6-7 of PDF) http://www.mass.gov/eohhs/
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Mark Rubin had a small community pharmacy in Boca Raton (Express Care Pharmacy) that did everything (regular drugs, durable medical equipment (bedside commodes, etc) and some limited compounding. He sold that pharmacy (and transferred the patient account info) to either a CVS or a Publix pharmacy.
| PH24074 | ROYAL PALM COMPOUNDING PHARMACY, LLC | 117 S STATE RD 7 | PHARMACY | ROYAL PLM BEACH | |
| PH21594 | ROYAL PALM PHARMACY LLC | EXPRESS CARE PHARMACY | 117 SOUTH STATE RD 7 | PHARMACY | ROYAL PALM BEACH |
| PH25743 | ROYAL PALM SPECIALTY PHARMACY LLC | ROYAL PALM SPECIALTY PHARMACY LLC | 118 MAIN STREET | PHARMACY | WEBSTER |
| PH26863 | WELLINGTON PHARMACY INC. | Royal Palm Pharmacy | 11328 OKEECHOBEE BLVD | PHARMACY | ROYAL PALM BEACH |
| ROYAL PALM COMPOUNDING PHARMACY, LLC | ||
| LICENSE NUMBER: PH24074 | Printer Friendly Version  | |
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| ROYAL PALM PHARMACY LLC | ||
| LICENSE NUMBER: PH21594 | Printer Friendly Version | |
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| ROYAL PALM SPECIALTY PHARMACY LLC | ||
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Notice, the Webster, MA pharmacy has a FLORIDA NON-RESIDENT PHARMACY LICENSE, and since Massachusetts has "dragged it's feet in disciplining this pharmacy", and Royal Palm has not self-reported this compounding pharmacy error (resulting in significant patient harm (i.e. A teenager getting a heart attack), the Florida Department of Health Bureau of Enforcement has not even become aware of the danger posed by this rogue compounding pharmacy, a complaint has never been filed against this pharmacy, and the Florida Board of Pharmacy has not been presented with anything it could act upon to protect the Florida public from this pharmacy making further compounding errors and/or exploiting patients through split-fee/patient brokering arrangements.
MARK JAYRUBIN | ||
| LICENSE NUMBER: PS32908 | Printer Friendly Version | |
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Dr. Kenneth Woliner MD, ABFM, from Holistic Family Medicine(www.holisticfamilymed.com) located in Boca Raton, Florida provides these specific tidbits of information:
So, because one state hasn't disciplined their pharmacy that ships drugs to other states (including Florida), the other states are completely oblivious to the risk posed by this rogue compounding pharmacy. Sort of makes a strong case for FEDERAL OVERSIGHT OF THE PRACTICE OF PHARMACY (when drugs are routinely shipped across state lines).
... 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.
Pharmacies are supposed to report serious errors such as this one (a medication dispensed 1,000 times as strong as it should have been, leading to a heart attack). But do they report these errors? No. Does the state boards of pharmacy discipline pharmacies for failing to self-report errors as required by law (in addition to disciplining them for the compounding/dispensing error themselves)? No.
... 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.
WITHOUT A QUORUM, Mass Board of Pharmacy votes to reverse this restriction (pages 5-6 of PDF) http://www.mass.gov/eohhs/
... 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.”
Hence, we need an investigation/audit of state DOH Bureau's of Enforcement that are "too easy" on rogue pharmacies (and other licensees).
... Health officials fired the pharmacy board’s executive director, ...
I don't want Mark Whitten fired. He's an honest broker. As for the bureaucrats in the FL Bureau of Enforcement (Lucy Gee, Susie Love, Jeanne Clynne, etc), that is a different matter, and only one the JLAC, Surgeon General, and the Governor, could decide.
... 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.
Sounds to me that the the MA Board of Pharmacy accepted the "excuse" of "I tried to call the patient's mother ..." and did not not discipline the pharmacist or pharmacy for not self-reporting a serious dispensing error.
...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.
The wheels of justice do turn slowly. This is a case from 2011. (pages 10-11) of: http://www.mass.gov/eohhs/
... 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.
5 comments:
Who can I speak to about these pharmacies?
Do you have a complaint with the pharmacy? Inside information? Let me know what type of information you have and I will try to connect you with the person to talk to.
http://www.abbyjenn.com/
his new company, he sells the ingredients to physicians, they dispense them to patients instead of send patient to pharmacy, and the physician and him split the insurance reimbursement and dispensing fee they add on. Company is tax exempt as it is on paper as being in Bermuda, sounds perfectly legitimate right?
Just looked up to see if your facts were correct. AbbyJenn is registered as an LLC in the State Of Delaware. In fact the physicians order the compounding material directly from the compound manufacturer, not AbbyJenn. I guess you can make just about any claims you want out here. Sounds like a jealous colleague who did not think of this business model first.
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