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Court rules that pharmacy information sheets fulfill duty to warn
James Keagy 41

Court rules that pharmacy information sheets fulfill duty to warn

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On the Docket

David B. Brushwood, BSPharm, JD

A Connecticut court recently issued a ruling that places an otherwise “ordinary” pharmacist duty to warn case into the category of “interesting.”

Background

A patient’s dentist prescribed ondansetron, clarithromycin, and meclizine after the patient complained of vertigo. These prescriptions were accurately processed at the pharmacy. The pharmacy provided no verbal counseling related to a drug–drug interaction between ondansetron and clarithromycin. The pharmacy did, however, provide the patient with written information about the drugs.

The patient used the medications as directed for 4 days, after which he was found to be “unresponsive, sweating, and having difficulty breathing.” The patient was transported to a hospital where he was pronounced dead. The patient’s estate filed a lawsuit claiming that alleged negligence by the dentist and the pharmacy resulted in the patient’s death due to the interaction of ondansetron and clarithromycin.

The pharmacy moved for dismissal of the case, arguing that there was no duty to warn the patient of the drug–drug interaction. Alternatively, the pharmacy argued that even if a duty to warn existed, that duty had been fulfilled by providing information sheets to the patient describing the possible drug–drug interaction.

Court gavel

Rationale

The court first referred to the established legal precedent that there is “no generalized duty” for pharmacists to warn every patient of every possible risk of every medication. The court then considered 3 commonly recognized exceptions to this precedent of “no generalized duty” to warn.

The first exception applies when a pharmacist has “specific knowledge of potential harm to specific persons in a particular case.” This exception most frequently arises when a patient has a drug allergy that is known to a pharmacist and the pharmacist dispenses medication without addressing the allergy. The court held that this drug–drug interaction case did not qualify for the first exception.

The second exception occurs when a pharmacist “makes a representation that they will engage in a process of evaluation of the possible side effects caused by the administration of a drug or a combination of drugs.” There was evidence that the dispensing pharmacist had contacted the dentist to discuss the prescribed medications. The plaintiffs contended that this consultation triggered the second exception to the “no generalized duty” to warn rule. The court disagreed, ruling that “communication by a pharmacist with a physician does not create a duty for the pharmacist to provide information to the patient.”

The third exception is recognized by courts when “there is something patently and obviously wrong with the prescription itself,” such as a “fatal dose” or an “absolute contraindication.” The court noted that there were no allegations of any such facts in the drug–drug interaction case, and the third exception was rejected.

The court then turned to the pharmacy’s alternative argument that the duty to warn, if there was a duty, had been fulfilled. The court said that the information sheets provided by the pharmacy to the patient with both ondansetron and clarithromycin stated that the medications “may cause a condition that affects the heart rhythm (QT prolongation)” and that “the risk of QT prolongation may be increased if you have certain medical conditions or are taking other medications that may cause QT prolongation.”

The court ruled that “the warnings provided by [the pharmacy] were more than adequate to satisfy a duty to warn.”

The case against the pharmacy was dismissed.

Takeaways

As a matter of practice, the best approach may be for pharmacists to both verbally counsel patients and to provide patients with a drug information leaflet. As a matter of law, this case suggests that the information leaflet, by itself, may meet the pharmacist’s duty to warn.

Providing patients with drug information leaflets (what FDA calls “Written Consumer Medication Information” or “CMI”) is not only effective patient care, but also a useful risk management tool. ■

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