Friday, September 15, 2017

Illicit Drugs?

A state pharmacy inspector made a surprising discovery last year while conducting a routine records review at a Westside facility that compounded drugs for patients at UCLA medical centers. More than 1,000 IV bags of sterile medications for heart patients and others with serious health issues had been made with expired and potentially dangerous ingredients, according to state Board of Pharmacy records. At least 350 bags of the adulterated medications were delivered to patients in the sprawling UCLA Health system, which includes Ronald Reagan UCLA Medical Center and UCLA Medical Center in Santa Monica, the records show.

Whether any patients were harmed is unknown, and UCLA, which owned and operated the compounding pharmacy, has refused to comment. It’s unclear if the university attempted to warn patients who might be at risk or to recall the adulterated medications that were sent to them. UCLA quietly closed the pharmacy within days of the inspection. By then, pharmacist-in-charge Richard C. Graul had already abruptly quit his $173,000-a-year job and declared his license “inactive.”

The inspection triggered an investigation by the pharmacy board, which in July filed an accusation, a formal action seeking disciplinary sanctions against Graul and the off-campus facility, UCLA Medical Center Pharmaceutical Technology. Possible sanctions include license revocation, suspension or “further action as deemed necessary and proper,” according to the board. The accusation, which is pending, alleges that the pharmacy lacked the proper licensing, used expired drugs in compounding sterile medications, and failed to meet state standards for quality assurance and product testing.

Graul, who had been the chief pharmacist since 2005, declined to comment on the inspection results when contacted at his home in Arcadia earlier this year. “No thanks,” he said, then closed his front door. He has not responded to repeated telephone and email messages since then.

Compounding pharmacies combine, mix or alter ingredients of a drug to create prescription medication suited to individual patients. The UCLA facility compounded large quantities of antibiotics, intravenous nutritional products and sterile solutions administered during heart surgeries and other procedures. The expired drugs cited by regulators in the UCLA case include monosodium glutamate monohydrate (MSG) and monosodium aspartate monohydrate (MSA), both of which are used in cardiac surgery and other surgical procedures; clopidogrel, which is used to prevent blood clotting; mexiletine, used to treat arrhythmia; and the hormone estradiol, which in intravenous solutions is sometimes used to treat heavy uterine bleeding.

The expiration dates on those drugs ranged from November 2015 to September 2016, a month before the inspection. Using expired ingredients is potentially dangerous because they can become tainted, lose their potency or change the efficacy of the compounded medication...

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