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, refused for months to comment or say if it attempted to warn patients who might be at risk.
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 pharmacist-in-charge 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.
Virginia Herold, the pharmacy board’s executive officer who signed the accusation, declined to comment on it, citing pending legal action. A hearing before an administrative law judge has yet to be scheduled.
For the last six months, UCLA officials had refused to answer any questions about the board’s findings or release inspection reports and other public records.
The Times this week submitted written questions about UCLA’s responses to the findings, including whether patients or their doctors were notified and whether any of the adulterated medications sent out by the pharmacy were recalled, as often happens in such cases. Only when drugs are recalled are compounding pharmacies required by state law to notify patients or doctors who received them.
UCLA responded Tuesday with a brief statement that acknowledged it closed the pharmacy after the inspection in October, but it did not address the board’s allegations or answer any of the questions.
“It was a business decision that does not affect UCLA Health’s other pharmacies or ability to provide exceptional patient care,” it said of the closure. “UCLA Health is committed to compliance with pharmacy board regulations designed to ensure high-quality care.”
On Friday, after The Times posted its story online, UCLA spokeswoman Tami Dennis sent an email stating that a “retrospective review” had “revealed no evidence of outdated compounds being administered to patients” and that “no adulterated ingredients were identified.”
In a second email Friday, she said that the outdated medications that inspectors found at the pharmacy in October were removed and destroyed; products that had been made there are now purchased from outside suppliers.
The Times has asked for inspection reports or other documentation of the retrospective review, in addition to previous inspection reports and other documents related to the pharmacy requested last spring.
Eric Kastango, a New Jersey pharmacist who testified as an expert for the prosecution in a federal criminal case against a Massachusetts compounding pharmacy charged in a fatal meningitis outbreak in 2012, said the California board’s action raises two major issues.
The first, he said, is that the UCLA pharmacy provided compounded sterile medications to other pharmacies without the appropriate license to do that. The second is that it produced “misbranded and adulterated drugs” by using expired ingredients.
The board’s allegations represent “major violations of pharmacy regulations and patient safety principles,” said Kastango, who reviewed the accusation at The Times’ request.
Herold, the state pharmacy board executive, did address one of the causes for discipline – that the pharmacy lacked the proper license to manufacture and distribute compounded medications throughout the UCLA system.
“A specialty license is required to operate as a centralized hospital packaging pharmacy, which [UCLA and Graul] failed to obtain from the board,” the accusation states.
Although last year’s inspection revealed the lack of a specialty license, the requirement to have one had been in place since 2013, Herold said. She could not explain why inspectors had missed the deficiency in previous inspections but said they should have caught it.
3:35 p.m.: Updated with comments from UCLA.
This article was originally published at 10:05 a.m.