Pharmacy Law: Duty to Warn Waived When Patient Refuses Counseling

Larry M. Simonsmeier, JD, RPh
Published Online: Thursday, December 1, 2005
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Issue of the Case A California appellate court was asked in this month's case whether a pharmacist has a duty to warn of a medication's side effects when the patient refuses to be counseled.

Facts of the Case

The plaintiff presented 2 prescriptions to the defendant pharmacy. One was a new prescription for trazodone (Desyrel) as a sleep aid, and the other was for an increased dosage of sertraline (Zoloft). When the pharmacy clerk noted that the patient had already been taking Zoloft, she asked if he wished to speak to the pharmacist about the trazodone.

The patient admitted in his deposition that he responded, "Oh, I don't need to talk to him about a sleeping pill." He also testified that he thought that the sleep aid was not a powerful drug. The plaintiff also signed a form that stated, "I do not wish to be counseled by the pharmacist and do not have any questions."

Although not a corporate requirement, the pharmacy typically provides a printed handout that includes warnings of any side effects with each new prescription. The plaintiff did not get such a handout.

After the plaintiff took the trazodone at bedtime for several days, he developed priapism, which occurs in less than 1% of men taking the drug. The pharmacy's printed handout warns male patients to contact their physician immediately, should the condition develop. The plaintiff was not treated for 3 days and sustained permanent injury. The plaintiff sued both the prescribing psychiatrist and the pharmacy.

The Court's Ruling

The trial court awarded summary judgment in favor of the pharmacy. The appellate court affirmed. (Note: In a separate action, a jury returned a $3-million verdict against the psychiatrist.)

The Court's Reasoning

The trial court concluded that the pharmacy had complied with its regulatory requirement because the plaintiff had been offered the opportunity to speak to a pharmacist. The appellate court went on to note that the state regulation and the federal statute upon which it was based expressly contemplated the possibility of a waiver by the patient, in which case a pharmacist has no duty to provide a consultation.

Even though the record was clear that the plaintiff refused any consultation, he argued that the pharmacy's offer to consult was ineffective. He claimed that the pharmacist was busy at the time of dispensing the medication, that he had waited for some time to get the prescription filled, and that there were people in line in front of and behind him.

The court did not accept this argument, because there was nothing in the exchange between the pharmacy clerk and the plaintiff that indicated that there would be any delay.

Next, the plaintiff contended that his refusal was invalid because "no actual pharmacist" ever spoke to him, as he claimed was promised in a Board of Pharmacy newsletter. The court found no evidence that the board had ever disciplined pharmacies in which an employee other than the pharmacist made the offer to consult. The court concluded that any interpretation of the regulation must comply with common sense. In the court's opinion, it served no purpose and was unrealistic to expect a pharmacist to greet every patient, and to interpret the regulation to require the pharmacist to do so would delay the filling of prescriptions and result in more impatient customers.

Not giving up, the plaintiff then took the position that a mere offer to consult was not enough and that the pharmacist must provide consultation, no matter what. The court recognized that no one could physically require a patient to listen to an oral consultation. The court went on to state that it would be absurd to suggest that a pharmacist or clerk could not first ask the patient whether he or she would like the consultation.

Finally, the court looked at the effectiveness of the plaintiff's waiver. Whether there has been a waiver generally is a question of fact, except where the underlying facts are undisputed and only one inference may reasonably be drawn. In a somewhat circuitous argument, the plaintiff maintained that someone should have told him that the sleeping medication had serious side effects so that he knew what he was waiving.

The court concluded that waiver of consultation does not require notice of the substance or dangers of what was waived. Otherwise, no waiver would be effective until the relinquishing parties learned in whole or in part what they were relinquishing, which, would obviate the need for the waiver.

Larry M. Simonsmeier is Emeritus Professor of Pharmacy Law at Washington State University College of Pharmacy.




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