When it comes to pharmaceuticals, dates matter. Medications past their expiration date not only lose their potency, but they can bring harm to patients.
When it comes to investigations, dates matter, too. The one-year mark of a pivotal California pharmacy inspection centering around expired drugs is fast approaching, although that anniversary date won’t mark a resolution to action that is currently pending.
Last October, an inspection of a Westside pharmacy owned by UCLA revealed that the facility had been compounding medications using drugs past their use-by dates. According to state Board of Pharmacy reports, UCLA Medical Center Pharmaceutical Technology prepared as many as 1,000 IV bags for patients at UCLA medical centers (including UCLA Medical Center in Santa Monica and Ronald Reagan UCLA Medical Center in Los Angeles), patients battling cardiac disease and other grave conditions.
Hundreds of possibly tainted IV bags sent to medical centers
Of the 1,000 allegedly contaminated or compromised IV sterile bags identified by regulators, the board estimates that around a third of them found their way to medical facilities. However, it is not known whether any of the medications were administered to patients, and whether patients were harmed.
Compounded medications are used when particular patient needs are better met with combinations, syntheses, or alterations of traditional prescription drugs. For instance, if a child needs a medication for which no pediatric dosage is available, the drug might be compounded to produce a dose a small body could tolerate. Or, if a patient has an allergy to an ingredient in a necessary medication for which there is no ready substitute, a drug might be compounded swapping out the problematic element for a safe one.
The UCLA pharmacy under fire compounded products administered intravenously to patients during surgery (including cardiac surgery), for example, antibiotics, sterile solutions, and nutritive substances.
Pharmacist-in-charge makes a quick exit
Richard Graul of Arcadia was the pharmacist-in-charge at the time of the inspection (and had been for 12 years), reportedly earning $173,000 per year. He quit immediately after the inspection, and just a few days later, UCLA closed the off-campus facility altogether. The inspection allegations were serious enough that the pharmacy board launched an investigation, leading up to a formal accusation filed by the board last July.
The board’s action seeks punitive measures against UCLA Medical Center Pharmaceutical Technology, as well as Graul. Potential sanctions may involve the suspension or revocation of licenses, and, more broadly, “further action as deemed necessary and proper” as the board sees fit.
Improper licensing also at issue
The board’s formal accusation claims that UCLA Medical Center Pharmaceutical Technology, under Graul’s management, not only used expired ingredients when compounding sterile medications, but also alleges that the pharmacy did not possess the specific license required for providing compounded sterile medications to other facilities in the first place.
Clopidogrel is a drug that prevents blood clotting, mexiletine treats irregular heartbeat, estradiol is a hormone that alleviates uterine hemorrhaging. State inspectors reported that those were among the expired drugs they found in use in the pharmacy in October of 2016, along with monosodium aspartate monohydrate (MSA) and monosodium glutamate monohydrate (MSG), drugs often used during heart surgeries. Expiration dates ranged from November of 2015 to September of 2016.
UCLA hasn’t had much to say about the pending action
According to The Los Angeles Times, UCLA representatives have not been forthcoming in answering queries or releasing reports to the public. Although the newspaper recently sent questions — including whether patients and doctors were notified about the potentially dangerous compounded medications that had been dispensed — UCLA limited its response to a statement addressing its decision to shutter the facility:
“It was a business decision that does not affect UCLA Health’s other pharmacies or ability to provide exceptional patient care. UCLA Health is committed to compliance with pharmacy board regulations designed to ensure high-quality care.”
However, following the online appearance of a Times piece, the paper reports that it received an email from Tami Dennis, UCLA spokesperson, who cited a “retrospective review” that had “revealed no evidence of outdated compounds being administered to patients” and that “no adulterated ingredients were identified.” And in a subsequent email, Dennis told the Times that all expired meds unearthed by state inspectors went on to be destroyed.
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