FDA orders new "pharmacist" reference for OTC labels in Drug Facts section

Over-the-counter drugs will have to include a reference to pharmacists within the new Drug Facts label that must appear on most products by April 2001. The reference will tell consumers to ask a pharmacist or physician about potential interactions between the OTC drug in the container and other drugs, whose categories will be indicated on the label. For example, the drug label for an antihistamine might read, "Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

The American Medical Association had fought to keep pharmacists off the new OTC Drug Facts label. Pharmacy groups had been fighting hard for as broad a reference to pharmacists as possible. But in issuing its final rule on March 17, the Food and Drug Administration said pharmacists would only be mentioned in relation to helping consumers avoid interactions. The agency rejected the idea of mentioning pharmacists as a source of clinical information.

The FDA said it had "decided not to include the phrase 'or pharmacist' in the subsection dealing with pre-existing conditions because questions concerning pre-existing diagnoses or clinical symptoms are best answered by a healthcare provider who is trained and licensed to make differential diagnoses and to treat disease entities."

Robert Hannan, interim president and chief executive of the National Association of Chain Drug Stores, welcomed the OTC rule. "A readily accessible pharmacist can help the consumer determine whether the OTC product is appropriate or if the consumer has symptoms that warrant the need to see a physician," Hannan said.

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