Albertsons questions bound of Washington’s pharmacy regulations

In week two of Washington’s trial against Albertsons, experts discussed “red flags” pharmacists are trained to identify.SEATTLE (CN) — The contours of Washington state’s pharmacy regulations took center stage on Wednesday in week two of the state’s trial against Albertsons over its purported role in fueling the state’s opioid crisis.“Pharmacists also have a corresponding responsibility to ensure safe and appropriate medication therapy for their patients, and they have to utilize their due diligence to make sure that they’re providing that,” said Marlee O’Neill, the 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 guidance for pharmacies, including that pharmacists should counsel patients about opioid risk when filling certain orders.Pharmacists must use their professional judgment before filling and dispensing prescriptions that exceed the prescribing limit for opioids, O’Neill said.Much of the trial has focused on “red flags” — warning signs about the customers that should have caught pharmacists’ attention. The state accused Albertsons of putting profit over patient safety and neglecting its responsibility to report suspicious orders. Albertsons has argued the “red flag” warnings the state is relying on have no meaning beyond a courtroom and that guidance on suspicious orders is nuanced and context-dependent.The retail chain took a sharp focus on that guidance, with Albertsons attorney Enu Mainigi questioning O’Neill about the commission’s specific rules for opioid dispensing.“So, just to be clear, the commission does not lay out what the standard of care is in terms of evaluating red flags in any rule or regulation of theirs, is that fair?” prodded Mainigi.“The commission cannot simply promulgate a rule for every possible situation that might arise,” O’Neill said.The commission doesn’t have what O’Neill called an “exhaustive” list of red flags, but rather has a standard of care to guide what a reasonably prudent pharmacist would do in a certain situation.“There is no law or rule to point to as what the standard of care is in each and every situation,” O’Neill said. “Pharmacists are well-educated, highly trained, skilled professionals and have to utilize their professional judgment depending on the facts that they’re presented with.”The commission is also tasked with investigating pharmacists following complaints, to protect patients and rehabilitate the pharmacist.The court also heard the video deposition from Robert Queen, a district pharmacy manager at Albertsons until 2021.Queen identified the “red flag” warnings internally relied on. Those include prescriptions from doctors outside of the immediate geographical area, a new patient only filling narcotics, patients asking to pay cash for opioids rather than use insurance, patients using slang to identify drugs or asking for a specific manufacturer and medications prescribed in high quantities.Between the years 2006 and 2022, Albertsons owned the second-largest chain of pharmacies in the state, during which time it dispensed more than 600 million opioid prescription drug pills to customers, according to the state.On a single day in 2009, one customer walked into an Albertsons pharmacy and purchased 1,440 methadone pills. Another customer was able to buy more than 4,500 oxycodone pills and more than 300 OxyContin pills in a single month, from one store.The state questioned Queen about emails from pharmacy managers who came to him with concerns about the workload. In one, a pharmacy manager said she was leaving work every day “hyperventilating with chest pains and heart palpitations from stress and fear that I made a mistake because I’m having to work in such a chaotic, messy, hostile environment.”Other emails raised concerns about labor hours being cut, explaining the pharmacy would fall below appropriate standards.Up until the 1990s, opioids were mostly prescribed to cancer patients and those dying from terminal disease. That began to change, as doctors and nurses began to treat 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 more deadly phase in the 2010s when fentanyl, a far more dangerous synthetic opioid, became available on the black market in the U.S.Washington state was one of the states hit the hardest by the opioid epidemic, suffering from the third-highest overdose death rate, after West Virginia and Alaska. And its fatal overdose death rate, though lower than in 2023, remains well above pre-pandemic levels.The trial is expected to last until September and to feature dozens of expert witnesses and former Albertsons employees.King County Superior Court Judge Janet Helson will determine whether Albertsons bears responsibility for causing or worsening the crisis in the state at the end of the trial.Categories / Health, TrialsSubscribe to our free newslettersOur weekly newsletter Closing Arguments offers the latest about ongoing trials, major litigation and rulings in courthouses around the U.S. and the world, while the monthly Under the Lights dishes the legal dirt from Hollywood, sports, Big Tech and the arts.Additional Reads