Nonpharmacy OTC Sales: Patients Lose

Joshua J. Pray, Pharm.D. Candidate, W.Steven Pray, Ph.D., R.Ph.

In This Article


Free enterprise (the freedom of private business to organize and operate for profit in a competitive system without interference by government beyond regulation necessary to protect public interest and keep the national economy in balance) does not always serve the best interests of the patient. The methods by which nonprescription products are sold in the United States are designed specifically to promote manufacturers' marketing plans. This column explores the issue of pharmacist-only sales of nonprescription products and devices.

Before prescribers write an order for a prescription product, they must interpret the body of information concerning the product, weighing its potential benefits against its risks. This concept, known as the learned intermediary doctrine, states that a manufacturer has a duty to warn the prescriber, not the patient, about a prescription product's potential hazards.[1] The consumer is not deemed capable of making an informed decision about the suitability of a specific prescription product.

However, when an item is sold directly to the consumer, the manufacturer has a duty to warn the consumer of any hazards or recommended precautions associated with the use of the product.

The advent of direct-to-consumer (DTC) advertising in the mid-1980s and its rapid acceleration in the late 1990s brought about a major change in the physician/patient relationship. Patients began making prescriber appointments to request specific medications they had seen advertised. In 1999, the New Jersey Supreme Court ruled that DTC advertising in a 1991 contraceptive implant advertising campaign was an exception to the learned intermediary doctrine because the pharmaceutical had been marketed directly to the consumer.[2,3] According to the court, the manufacturer that used DTC advertising assumed a duty to warn the patient about potential risks involved in using the product.