ALEXANDRIA, Va. — The National Association of Chain Drug Stores delivered on Tuesday testimony on the safe usage of pediatric acetaminophen products before a joint meeting of the Food and Drug Administration Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee.
"As [the] FDA has recognized in the past, acetaminophen is an extremely safe medication when used at recommended doses. In addition, it is one of the most commonly used medications in the United States. With this in mind, it is important to ensure that any new policies or regulations affecting availability of acetaminophen products are workable considering the great consumer need for, and widespread use of, these products," stated Kevin Nicholson, VP pharmacy adviser, government affairs and public policy with NACDS.
In the testimony, NACDS also expressed its support for the recent announcement that all single-ingredient pediatric acetaminophen products will be converted to one concentration.
"We are pleased that the makers of single-ingredient pediatric acetaminophen products have announced that they are converting all pediatric liquid acetaminophen formulations to one concentration. This, as well as other improvements and initiatives they have announced, will help patients and caregivers accurately dose pediatric acetaminophen products and help prevent medication errors," Nicholson added.
NACDS also highlighted its support for weight-based dosing instructions for all children's single-ingredient liquid acetaminophen medicines.
"We believe that it will allow for more accurate dosing and help to reduce adverse incidents," Nicholson stated.
NACDS has been engaged in review of pediatric liquid acetaminophen formulations. In 2009, NACDS testified before an FDA advisory group detailing its recommendation to include dosing instructions for children younger than 2 years of age on labels of over-the-counter single-ingredient acetaminophen products intended for children.
The association also is a member of the Acetaminophen Awareness Coalition, spearheaded by the Consumer Healthcare Products Association and the American Pharmacists Association to address acetaminophen-related issues and educational needs. The coalition will soon be launching a campaign to educate consumers about the importance of following directions on labels and how to properly use products containing acetaminophen.