Are Pharmacists Liable for OTC Advice?

This month, we look at a pharmacist’s responsibility regarding Over-the-Counter (OTC) medications.  

As with many cases, there was a dispute as to the facts of the case, with each side presenting a different scenario. The plaintiff, Mrs. W, claimed that she telephoned Ms. S, a pharmacist employed by her regular pharmacy, Rite Aid, to ask advice about whether her husband, Mr. W, could safely take the OTC decongestant, Sudafed. Mrs. W alleged that she had a conversation with the pharmacist regarding her husband’s medical history, and that the pharmacist approved Mr. W’s use of Sudafed. Mrs. W did not mention that her husband had suffered from “a little bit of prostate trouble,” to the pharmacist during this conversation.

The pharmacist, Ms. S, denied that this phone conversation had ever taken place, and denied that she ever had a conversation with Mrs. W about whether Mr. W could take a Sudafed. In fact, Ms. S stated in her deposition that even if the conversation did occur, which she claims it did not, she would not have recommended Sudafed. In addition, Rite Aid noted that there was no evidence of Mr. W’s prostate problem in Rite Aid’s prescription records.

Mrs. W claimed that based on the advice of the pharmacist, she gave her husband a Sudafed pill. The medication allegedly exacerbated Mr. W’s prostate symptoms, and he suffered from difficulty urinating, bladder distension, and burst blood vessels in his bladder. Treatment required the use of catheters, causing frequent hospital visits for many weeks, as well as two operations to close the blood vessels. Mrs. W alleged that her husband suffered permanent nerve injury from the bladder distension, causing pain and disability for two years until he died from an unrelated illness.

After his death, Mrs. W sued Rite Aid alleging medical malpractice. Rite Aid moved for summary judgment, asking the court to dismiss the case based on two issues: 1) that Rite Aid cannot be held liable because a pharmacist has no duty regarding nonprescription drugs, and 2) that even if such a duty does exist, Rite Aid is protected from liability based on the learned intermediary doctrine. [The learned intermediary doctrine was discussed in an earlier column – see: https://www.managedhealthcareconnect.com/blog/when-does-pharmacist-have-duty-warn-patient].

The Court’s Decision

The United States District Court in Utah looked at two questions when deciding whether to dismiss the case against Rite Aid: 1) do a pharmacist’s professional duties include counseling patients on OTC medications? 2) does the learned intermediary doctrine protect pharmacists from liability for giving incorrect advice about OTCs?

The court answered the first question in the affirmative, holding that “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 non-negligent manner consistent with a reasonably prudent pharmacist's response to a customer's question about the safety of a nonprescription drug.” Whether the pharmacist met that duty can only be established by expert testimony as to what a reasonably prudent pharmacist in the same situation would do.

As to the second question, the court held that the learned intermediary doctrine does not apply to non-prescription medications. It only shields pharmacists from liability for failure to warn of the risks associated with prescription drugs. According to the court, “adoption of the learned intermediary doctrine with respect to pharmacists was based in part on the ‘unique set of relationships’ among pharmacists, physicians, customers, and drug manufacturers in the prescription drug context.” The court held that it has no application to non-prescription medications, which are sold in a completely different manner.

The court refused to dismiss the case against Rite Aid.

The Takeaway

While you can’t always protect yourself from being sued, you can take some steps to avoid being found liable. Avoid giving advice on the telephone – medication education is best given in the pharmacy. If it is necessary to give advice via the phone, keep a record. Do not give OTC advice lightly – consider referring the patient to his/her physician’s office for advice instead. Many health insurance companies offer access to a nurse for questions, and patients can be referred to online sources of information. If you are counseling a patient on OTCs, use the actual drug labeling for the product as the basis of your education.

Ann W. Latner, JD, is a freelance writer and attorney based in New York. She was formerly Director of Periodicals at the American Pharmacists Association.