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Study: Pediatric Drug Labeling Tough to Understand

Child taking medicine from parent (U.S. Food and Drug Administration)

(U.S. Food and Drug Administration)

Instructions on over-the-counter (OTC) medicines for children in the U.S. are confusing and hard for parents to understand and follow, according to a study in the 1 December issue of the Journal of the American Medical Association (JAMA). Researchers at New York University’s School of Medicine, Emory University School of Medicine in Atlanta, University of Miami in Florida, and Northwestern University in Evanston, Illinois conducted the study.

The researchers reviewed 200 top-selling pediatric oral liquid OTC medications categorized as analgesics, cough/cold, allergy, or gastrointestinal medicines, which represent 99 percent of the U. S. market of these products. They found that a quarter (25%) of these products did not include dosing devices, such as a cup or dropper for giving the medicine, and that nearly all (99%) had directions on the bottle’s label and dose markings on the device that do not match. More than half the products also did not use standard abbreviations for terms such as teaspoon or milliliter.

The study authors believe that when dosing instructions and devices match, and standard abbreviations are used, parents will be less confused and better able to give the proper dose of medication to their child. The authors also recommend that terms such as “cc” and “drams”, which are not commonly understood, not be used in labeling. Tablespoon instructions, they note, should also not be used because they are often confused with teaspoon instructions which can lead to a 3-fold underdose or overdose.

The study was undertaken after the U.S. Food and Drug Administration issued voluntary guidelines last year recommending greater consistency in dosing directions and accompanying measuring devices, following numerous reports of accidental overdosing in children attributed in part to these issues.

Related: Study: Youth Prescriptions Nearly Double Since 1994

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