Liability for advice on OTC use

On the Docket


One of the many services pharmacists provide is advice on OTC products. Patients expect this service to be provided at no cost. In a recent case from a federal court in Utah, the wife of a patient, alleging that a pharmacist’s free advice was inaccurate and harmful, sued the pharmacy.

Background

The patient’s wife alleged that she called her regular pharmacy and asked whether her husband could safely use phenylpropanolamine. She stated that she discussed her husband’s medical history with a pharmacist, who allegedly said her husband could safely use the OTC drug. During the conversation, the wife did not mention that her husband had previously suffered from “a little bit of prostate trouble.” The pharmacist denied that the conversation ever occurred and insisted that she would not have recommended phenylpropanolamine even if the conversation had occurred.

In her lawsuit, the wife alleged that her husband’s use of phenylpropanolamine exacerbated his “prostate trouble,” leading to several surgeries and hospitalizations prior to his death 2 years later from an unrelated illness.

The lawsuit alleged malpractice based on the pharmacist’s negligence and bad advice. The pharmacy filed a motion to dismiss the case, citing two arguments:

  • A pharmacist’s duty of care does not require giving adequate advice about OTC drugs.
  • The learned intermediary doctrine shields pharmacists from liability for failure to warn.

Rationale

The court said, “It appears that [the pharmacy] argues that a pharmacist is exempt from any and all liability when giving advice about nonprescription drugs, even when the pharmacist dispenses bad advice.” However, the court said, “Pharmacists in Utah clearly have duties regarding nonprescription drugs. If a pharmacist answers a customer’s question and offers advice about nonprescription drugs, the pharmacist must advise and act in a nonnegligent manner consistent with a reasonably prudent pharmacist’s response to a customer’s question about the safety of a nonprescription drug.”

  • The court also rejected the pharmacy’s learned intermediary defense. That defense assigns responsibility to the physician for patient education and immunizes pharmacists from some failure-to-warn claims. The court ruled that the learned intermediary defense applies only to prescription drugs.
  • The court refused to dismiss the case, but the pharmacy may still have a strong defense based on the facts as they become established.

Risk management strategies

Malpractice liability for inaccurate advice on OTC drugs has always been a possibility in pharmacy. Pharmacists accept responsibility for the consequences of their mistakes. This is one characteristic of professional status. On the other hand, it is important for pharmacists to use effective risk-management strategies that address this liability exposure, such as the following:

  • Pharmacists should never answer drug safety questions over the telephone. Patients should be required to visit the pharmacy for education related to drug safety. Otherwise, patients can be referred to the Internet (e.g., WebMD), to their health insurance company (many have nurses on call to answer enrollee questions), or to their primary care physician.
  • An interactive video stream discussion between the pharmacist and patient may substitute for a physical visit to the pharmacy.
  • If patients choose to visit the pharmacy for advice on drug safety matters, pharmacists should use the product’s official drug labeling (DrugFacts for OTC products) as the foundation for patient education.
  • Any consultation that requires discussion of a patient’s medical condition should occur in the patient education area of the pharmacy.
  • Patient education should be routinely and briefly documented so that the absence of documentation clearly means a discussion did not occur.

Based on: Whiting v Rite Aid Pharmacy, 2014 U.S.Dist. LEXIS 87354 (June 24, 2014)