APhA Recommends FDA Improve Pediatric OTC Labeling

Main Category: Pediatrics / Children's Health
Also Included In: Pharmacy / Pharmacist
Article Date: 22 Oct 2007 - 1:00 PDT

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The American Pharmacists Association (APhA) told the Food and Drug Administration (FDA) that more complete, comprehensive and understandable labeling information is needed on over-the-counter products intended for pediatric patients.

Testifying before the FDA Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee on "Safety and Efficacy of Over-the-Counter (OTC) Cough and Cold Products Marketed for Pediatric Use," APhA President and community pharmacist Winnie Landis described the important role pharmacists play in helping consumers manage and improve their medication use - including the selection, dosing, and administration of OTC products.

"Pharmacists rely on the FDA to determine whether medications, including OTC products, are safe and effective. However, the number of products from which consumers must choose combined with confusing labeling can lead to unintentional misuse of these products. We encourage consumers, particularly parents trying to treat their children, to take advantage of their pharmacist's medication expertise," stated Landis.

Landis presented the following recommendations for addressing the issue of appropriate use of OTC cough and cold products in pediatric patients:

• Provide complete, comprehensive, and understandable information on product labels;
  
  
• Discontinue the use of same brand-name or brand-name line extensions when the products contain different active ingredients;
  
  
• Include the following statements on the OTC product label "Ask your doctor or pharmacist about the directions for using this product" and "Do Not Use in children under two years of age";
  
  
• Standardize OTC dosing units;
  
  
• Improve OTC drug monograph information; and
  
  
• Include pharmacist representation on FDA Advisory Committees that address OTC products.

To view the testimony, click here.

The American Pharmacists Association is dedicated to improving medication use and advancing patient care. Founded in 1852 as the American Pharmaceutical Association, APhA is the first-established and largest professional association of pharmacists in the United States. Our more than 60,000 members include pharmacists, scientists, student pharmacists, pharmacy technicians and others interested in advancing the profession.

http://www.aphanet.org