Computers, OBRA 90 and the pharmacist's duty to warn.
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Biomedical subjects
Publications and source records attributed to G G Cacciatore.
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Patients who suffer harm from a prescription drug often sue both the prescribing physician and the drug manufacturer, seeking recovery for failure to warn of the drug's potential harm. In many of these cases, the drug manufacturer is relieved of liability under the "learned intermediary" doctrine. If, however, a drug manufacturer misrepresents information or fails to adequately warn a physician about a drug's potential dangers, it may be possible for a physician to maintain a legal cause of action against the manufacturer. This article discusses the legal basis for such a lawsuit and describes two legal cases involving physicians who sued pharmaceutical manufacturers based on inadequate warnings regarding their products.
Arbor Drugs, Inc., advertised that its computer could detect dangerous drug interactions. A pharmacist failed to warn a patient accordingly and the patient suffered a stroke as a result of an interaction between tranylcypromine and a decongestant. The Michigan Court of Appeals held that this failure to warn was actionable under the theories of negligence and fraud as well as under the Michigan Consumer Protection Act. The court's basic message is that pharmacies may be held legally responsible for preventing harm when they represent themselves as being capable of doing so.
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Many professions are highly regulated, yet few are regulated to the degree pharmacy is. Not only are there large numbers of regulations, but the regulations are so detailed they dictate precisely how pharmacists are to perform both dispensing and clinical services. As a result, pharmacists end up trying to meet the requirements of the regulations rather than exercising professional judgment and providing true pharmaceutical care. Many of the regulations are unnecessary intrusions into the practice of pharmacy and tend to diminish its professionalism.