Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

OTC PEDIATRIC DOSING SHOULD BE BASED ON PATIENT HEIGHT

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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth
UsernamePublicRestriction

Register

PS014243

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel