US FDA Info Leaflet Plan Slammed

4 March 1996

US pharmacists and doctors are opposing a Food and Drug Adm-inistration plan for them to give out leaflets with every prescription to explain, in simple language, the product's risks and how to take it safely. The plan would prevent many of the thousands of drug-related ailments each year, the FDA said, but pharmacists and doctors say consumers will only throw the leaflets away.

45% of patients receive no written data other than dosage instructions, while others get instructions of varying thoroughness with some not even giving a drug's dangerous side effects, says the government. The FDA "will not rest until consumers get good patient information," says Commissioner David Kessler, who wants pharmacists to give information on every drug that poses a "serious and significant" risk, plus similar guides to less dangerous drugs, to at least 75% of pat-ients by the year 2000. if the deadline is not met, it would mandate leaflets for all drugs. The gap between the information patients need and that which they receive "is fast becoming intolerable," he said.

Patients "Throw Leaflets Away Immediately" Druggists want to get more data to pati-ents but the FDA plan would stifle innovative ways to provide it, said John Gans of the American Pharmaceutical Associat-ion. The elderly would be bombarded with paper, and doctors fear patients who do read will be so scared by lists of rare side effects that they will stop taking their medicine. Patients often forget a doctor's oral information, he said, and about $75 billion a year goes on treating drug side effects. Pharmacists say patients throw leaflets away immediately, and 41% do not understand instructions as simple as "take pills on an empty stomach."

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