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Instructions on over-the-counter medications for children are found to be confusing
Date:11/30/2010

Instructions on boxes and bottles of over-the-counter (OTC) medicines for children in the United States are confusing and hard for parents to understand and follow, according to a study in the December 1 issue of JAMA.

"There is an unacceptable amount of inconsistency in labels and measuring devices of OTC liquid medications for children," said H. Shonna Yin, MD, assistant professor of pediatrics at NYU School of Medicine who co-led the study. "These types of inconsistencies are likely to be a source of confusion for parents and can lead to errors in dosing, placing children at risk."

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.

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

"This is an issue of patient safety and needs urgent attention," said Ruth Parker, MD, professor of medicine at Emory University School of Medicine, who co-led the study. "Given how many products are affected, it seems unlikely that the voluntary guidelines alone set by the FDA and industry will fix this problem. The current guidance does not contain a timeline for compliance or specify consequences for non-compliance. Standards and regulatory oversight will likely be needed to
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Contact: Dorie Klissas
dorie.klissas@nyumc.org
212-404-3555
NYU Langone Medical Center / New York University School of Medicine
Source:Eurekalert

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