On The Docket
David B. Brushwood, BSPharm, JD
A pharmacy may be held liable for malpractice if a pharmacist breaches a duty to warn a patient of potential medication risks. In a recent failure to warn lawsuit, the Supreme Court of Utah refused to apply what it called the “learned intermediary exception” to the pharmacist’s general duty of due care.
According to the court, a patient had for many years been using oxycodone to treat “severe chronic pain.” The patient’s physician diagnosed the patient with “anxiety and depression,” and the physician prescribed clonazepam. The defendant pharmacy’s computer system alerted the pharmacist to an interaction between oxycodone and clonazepam, and the pharmacist overrode the warning.
The pharmacist allegedly failed to consult with the physician. Whether the pharmacist provided warnings to the patient was a matter of dispute. The patient’s wife testified that if the pharmacist had warned the patient of the risk of combining the two drugs, the patient would have told her, which he did not do. The patient died and an autopsy determined that the “cause of death was oxycodone clonazepam toxicity.”
The patient’s estate sued the pharmacy for failure to warn. The pharmacy moved for dismissal of the lawsuit. The pharmacy contended that any duty to warn rests with the physician and not the pharmacist, based on the learned intermediary rule. The trial judge denied the pharmacy’s motion, and the pharmacy appealed.
Rationale
On appeal, the Utah Supreme Court explained, “It is important to understand that, despite its moniker, the learned intermediary rule functions more like an exception to a rule.” The court clarified that “in negligence cases, it is the general rule that a pharmacist has a duty to possess and exercise the reasonable degree of skill, care, and knowledge that would be exercised by a reasonably prudent pharmacist in the same situation.”
The court noted that the learned intermediary rule was initially adopted to avoid pharmacist interference with the physician–patient relationship. Yet the court recognized inapplicability of the rule when “a pharmacist has knowledge of a patient-specific risk or observes an obvious error on the face of the prescription.”
The court concluded that “the dangers of combining clonazepam and oxycodone are well known” and the pharmacist in this case “was aware that the prescription posed serious risks that were specific to [the patient].” The court ruled that the learned intermediary exception to the pharmacist’s general duty of care did not apply in this case.
The pharmacy also moved for dismissal because the prescriber testified that he would not have changed the order even if the pharmacist had contacted him. This argument is sometimes referred to as decisional causation. An allegedly negligent actor generally cannot be held liable for failing to perform an action if that action would have been futile. The court disagreed with this argument, ruling that it was based on speculation of what might have happened, rather than on evidence of what did happen.
The trial judge’s order refusing dismissal of the estate’s lawsuit against the pharmacy was affirmed.
Takeaways
The management of drug–drug interaction alerts is a significant challenge for pharmacy. This is particularly the case with the opioid–benzodiazepine interaction because many patients use these two drugs together and do not experience adverse effects.
The message of this case is that prescribers should always be consulted by a pharmacist when there is an opioid–benzodiazepine computer alert. Patients should always be counseled about the potential for harm from this drug–drug interaction, and they should be referred to their prescriber for additional information that is specific to their medical condition.
This may be a lengthy process, but it is worth the time that it takes. It is not an emergency. Pharmacy practice site policies and procedures should specify where and how enduring documentation can be made to memorialize actions taken to protect a patient from a drug–drug interaction. ■