CHPA Rolls Out Pediatric Cough/Cold Education Campaign

An industry education campaign on proper use of cough/cold products in children will target decision-making points in consumers' lives, with a particular focus on reaching new mothers.

Consumer Healthcare Products Association President Linda Suydam outlined the group's education program and other elements of its proposed risk minimization plan during testimony at the Nonprescription Drugs and Pediatric joint advisory committee meeting Oct. 18.

Aimed at caregivers and health care professionals, the plan will be a "multi-year, multi-media campaign with elements distributed through multiple channels including public service announcements and paid advertising," Suydam said.

Elements of the campaign will start now and through March 2008 and will "continue through the life of the multi-year program," Suydam said.

The campaign targets consumers "at tactical decision-making points in their lives, such as in stores, on the Internet, in doctors' offices, daycare centers and maternity wards, and with 4 million births each year, there will be a particular focus on new mothers," she said.

The plan will be "managed by an expert steering committee composed of members of top medical, government and consumer organizations," Suydam said.

CHPA is partnering with organizations including the American Academy of Family Physicians, American Pharmacists Association and FDA to develop the campaign materials.

The group also plans on conducting consumer surveys to track awareness and effectiveness of the programs, Suydam said.

CHPA will start the process in November with a baseline survey "to determine parent and caregiver attitudes and behaviors regarding pediatric dosing with over-the-counter cough and cold medicines," followed by establishing three pilot markets "in which we will conduct additional advertising and partner with local poison control centers to monitor outcomes and provide direct interventions to help reduce misuse where needed," she said.

Discussing other elements of CHPA's risk minimization plan, Suydam noted members intend to complete their plan to change labels for all pediatric cough/cold medications within one year.

The group concurrently announced its plans for pediatric pharmacokinetic studies in children ages 2 through 12 on the ingredients dextromethorphan, phenylephrine, guaifenesin, brompheniramine, diphenhydramine and doxylamine (¹ (Also see "CHPA Plans Pharmacokinetic Trials On Pediatric OTC Cough/Cold Drugs" - Pink Sheet, 8 Oct, 2007.), p. 8).

According to CHPA, the goals of the overall program are to "build awareness of correct use," "change caregivers' attitudes about risk and more importantly, caregivers' behaviors about the use of over-the-counter cough and cold medicines," and to "significantly reduce misuse and overdose" of the products, Suydam said.

The group formulated the plan in response to issues raised in a citizen petition about the products' safety in children under 6 years of age.

After hearing testimony from the petitioners as well as industry, the joint advisory committee decided in split votes Oct. 19 to recommend immediately that all OTC cough/cold medicines should not be used for 2-to 5-year-old children, but are safe for 6- to 12-year-olds (² (Also see "FDA Panel Narrowly Votes Against Cough/Cold Drugs For Children Up To Age 6" - Pink Sheet, 22 Oct, 2007.), p. 3).

Suydam said data show the products are safe when used as directed and most serious adverse events are associated with overdose and misuse, particularly in children under the age of 2.

"We also know that accidental ingestion appears to be a major factor in children 2 years and older. These are areas where new labeling and education can make the difference. As for efficacy, we know it is well-established in adults and we have additional work to do to confirm or refine dosage levels in children," she said.

Prior to the advisory committee meeting, the group proposed changing pediatric cough/cold product labels from "Ask a Doctor" to "Do Not Use" in children under 2, and adding "Do not use to sedate children" or similar language for OTC monographed antihistamines as well as announced its member companies would cease marketing OTC cough/cold preparations for infants (³ (Also see "Firms Stop Cough/Cold Product Promotions For Use By Infants – CHPA" - Pink Sheet, 8 Oct, 2007.), p. 9).

- Jessica Lake ([email protected])