Pharmacy Times, Volume 0, 0

Responding to concerns raised by thenation's pharmacists, an FDA nonprescriptiondrug advisory committee calledfor new restrictions on the use of OTCcough and cold medicines by childrenaged 6 and under.

The group's recommendation came onthe heels of testimony by the AmericanPharmacists Association (APhA) whichcalled on the FDA to require more complete,comprehensive, and understandablelabeling information on OTCs intendedfor pediatric patients.

"Pharmacists rely on the FDA to determinewhether medications, including OTCproducts, are safe and effective," communitypharmacist Winnie Landis said on behalfof APhA."However, the number of productsfrom which consumers must choose combinedwith confusing labeling can lead tounintentional misuse of these products."

Landis advisedparents trying totreat their childrenfor coughsand colds to"take advantageof their pharmacist's medication expertise."

The APhA witness also recommendeda series of additional steps to promotethe safer use of pediatric medicines,including requiring standardized dosageunits, improved OTC drug monographinformation, and a ban on the "use ofsame brand name or brand name lineextensions when the products containdifferent active ingredients."

Additionally, Landis called for new OTCdrug labeling instructing patients to: "Askyour doctor or pharmacist about thedirections for using this product."