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Executive Summary

OTC PEDIATRIC DOSING SHOULD BE BASED ON PATIENT HEIGHT, Arno Zaritsky, MD, University of North Carolina at Chapel Hill, told an OTC Drug Feedback meeting on Sept. 1. "Length [or height] predicted weight is more accurate than weight determined by age," Zaritsky maintained. Zaritsky is the director of the pediatric intensive care unit of UNC. Studies were presented showing that the length of an infant, or height of a child, has a higher correlation with weight than does age. Analyses of data from the National Center for Health Statistics found that "age-based dosaging only agreed with the proper weight-based dosage 55% of the time," Zaritsky observed. "Forty-five percent of the time, we ended up giving a dose that was most often smaller than what would be optimal." Age-based dosing had been recommended by the FDA Advisory Review Panel on OTC Cold, Cough, Allergy, Bronchodilator, and Asthmatic Drug Products as a standard for pediatric dosaging. The panel made an age-based recommendation while recognizing that determination of "children's dosages based on age, although convenient, may be the least reliable method because of the large variation in weight of patients at a specific age." Studies submitted at the OTC Drug Feedback meeting were in response to a June 20 Federal Register notice on FDA's intent of proposed rule-making and request for information on pediatric dosing. At the Sept. 1 meeting, Deputy Director Division of OTC Drug Evaluation Gerald Rachanow called for a consensus of the medical and scientific community on weight-based dosing emphasizing that the issue must be resolved "before proceeding" to a proposal. In addition, he said, "we want a chart that will either be weight-based, length-based or both if we can get an agreement on the numbers." Rachanow indicated that there is still a question as to whether FDA will require changes in labeling to conform with pediatric dosing recommendations or allow the manufacturers comply on a voluntary basis. The meeting was attended by representatives of the Proprietary Association, and six companies: Burroughs Wellcome; Bristol-Myers; A. H. Robins; ICI Pharmaceuticals; Merrell Dow; and Sandoz. To date, only one other comment has been elicited by the June federal Register notice. That comment supported "changing pediatric labeling to include both weight and age schedules." Jacksonville University Assistant Professor of Nursing Carole Cayer, RN, contended that often families do not know the weights of their children or are not capable of understanding complex dosing schedules.

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