SEATTLE (CN) – The contours of Washington state’s pharmacy regulations took center stage Wednesday in the state’s second week court against Albertsons over its alleged role in fueling the state’s opioid crisis.
“Pharmacists also have a corresponding responsibility to provide safe and appropriate drug therapy to their patients, and they must use their due diligence to ensure they are providing it,” said Marlee O’Neill, executive director of the state’s Pharmacy Quality Assurance Commission.
The commission oversees 1,183 pharmacies and over 21,000 pharmacists and pharmacy assistants. It publishes rules and guidelines for pharmacies, including that pharmacists must advise patients of the risk of opioids when filling certain orders.
Pharmacists should use their professional judgment before filling and dispensing prescriptions that exceed the prescription limit for opioids, O’Neill said.
Much of the trial focused on “red flags” – warning signs for customers that should have attracted pharmacists’ attention. The state accused Albertsons of putting profit over patient safety and neglecting its responsibility to report suspicious orders. Albertsons has argued that the “red flag” warnings the state is relying on have no meaning beyond the courtroom and that the guidelines for questionable warrants are nuanced and context-dependent.
The retail chain took sharp focus on that guidance, with Albertsons attorney Enu Mainigi questioning O’Neill about the commission’s specific rules on opioid distribution.
“So to be clear, the commission does not set what the standard of care is in terms of evaluating red flags in any of their rules or regulations, is that correct?” urged Mainigi.
“The commission can’t just promulgate a rule for every possible situation that might arise,” O’Neill said.
The commission does not have what O’Neill called an “exhaustive” list of red flags, but instead has a standard of care to guide what a reasonably careful pharmacist would do in a given situation.
“There is no law or rule to say what the standard of care is in any situation,” O’Neill said. “Pharmacists are well-educated, highly trained, skilled professionals and must use their professional judgment depending on the facts presented to them.”
The commission also has the task of investigating pharmacists after complaints, for the protection of patients and the rehabilitation of pharmacists.
The court also heard video depositions from Robert Queen, a district pharmacy manager at Albertsons through 2021.
The Queen identified the “red flag” warnings relied on internally. They include prescriptions from doctors outside the immediate geographic area, a new patient filling only narcotics, patients seeking to pay cash for opioids instead of using insurance, patients using jargon to identify drugs or seeking a specific manufacturer, and bulk prescription medications.
Between 2006 and 2022, Albertsons owned the second-largest pharmacy chain in the state, during which time it dispensed more than 600 million prescription opioid pills to customers, according to the state.
On a single day in 2009, a customer walked into an Albertsons pharmacy and bought 1,440 methadone pills. Another customer was able to purchase more than 4,500 oxycodone pills and more than 300 OxyContin pills in a single month from one store.
The State asked the Queen about emails from pharmacy managers who came to him with concerns about workload. In one, a pharmacy manager said she was leaving work every day “hyperventilating with chest pains and palpitations from stress and fear that I made a mistake because I have to work in such a chaotic, messy and hostile environment.”
Other emails raised concerns about the reduction in hours, explaining that the pharmacy would fall below appropriate standards.
Until the 1990s, opioids were mostly given to cancer patients and those dying of terminal illness. That began to change, as doctors and nurses began treating pain as the “fifth vital sign,” asking all patients how much pain they were in on a scale of 1 to 10.
In 1995, the FDA approved OxyContin, which became widely prescribed—and widely abused. The opioid epidemic began in 1999 and hit a new and even deadlier phase in the 2010s when fentanyl, a far more dangerous synthetic opioid, became available on the US black market.
Washington state was one of the states hardest hit by the opioid epidemic, suffering the third-highest rate of overdose deaths behind West Virginia and Alaska. And its fatal overdose death rate, while lower than in 2023, remains well above pre-pandemic levels.
The trial is expected to last until September and feature dozens of expert witnesses and former Albertsons employees.
King County Superior Court Judge Janet Helson will determine whether Albertsons is responsible for causing or exacerbating the crisis in the state at the end of the trial.
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