Legal Q & A: June 19, 2006

A frequent area of potential liability is the duty to warn. For example, suppose that in filling a valid Rx for Desyrel for a male patient you did not counsel him on the possibility of priaprism. Should you be liable for any injuries? Should you thus counsel patients on the possibility of every known adverse effect?

Traditionally, pharmacists were afforded protection from liability via the learned intermediary doctrine, which states that a drug manufacturer has a duty to warn the physician of the potential dangers and adverse effects of a drug. The physician, in turn, has a duty to so warn the patient during the course of treatment. A major premise of the doctrine is that only the physician has adequate knowledge of the patient's medical condition during the course of treatment/evaluation. Earlier courts held that (1) pharmacists lacked an understanding of, and access to, patients' medical history; (2) pharmacists had no duty to monitor and intervene with a patient's treatment; and (3) requiring pharmacists to warn would cause them to second-guess and interfere with the doctor-patient relationship.

Some courts have recently abandoned the rationale of the learned intermediary doctrine, holding that pharmacists do have a duty to warn. The theories under which courts may impose a duty to warn include: (1) obvious inadequacies on the face of the prescription; (2) expert testimony indicating the pharmacist violated a standard of due care; (3) violation of OBRA-'90 requirements; (4) the pharmacist's personal knowledge that a patient is taking medication more quickly than prescribed; (5) the pharmacist's personal knowledge of a patient's unique medical problems; or (6) known contraindications that would alert a reasonably prudent pharmacist to a potential problem.

Most pharmacists would agree that the OBRA-'90 requirements, and similar state board regulations, foster a strong pharmacist-patient relationship and improved patient drug therapy. But some courts may construe OBRA-'90 as defining the standard of care of pharmacy and defining the offer to counsel as an assumption of the duty to warn. As such, a pharmacist may be subject to liability for failing to adhere to these requirements if a patient is injured during therapy. The requirements do serve as a solid foundation to the practice of pharmacy, but most pharmacists would agree that they should not be the determinative factor of potential liability.

Prudent pharmacists would be well advised to comply with OBRA-'90, their state board's rules and regulations, and their company's policies and procedures. Document all actions and decisions in a manner that demonstrates your professional mindset and rationale, particularly discussions with the physician, office personnel, and the patient. Log what was discussed and why, including patient counseling in appropriate situations, the result of the discussion, and any other relevant factors. Always err on the side of caution. It is not only in the patient's best interest but may also prevent liability when you fill that next prescription correctly.