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“MedWise Prescription” Education Campaign Targets Rx-OTC Interactions

This article was originally published in The Tan Sheet

Executive Summary

The latest "MedWise" consumer education campaign will focus on warning patients against the potential for overdosing when mixing OTC and prescription drugs with the same active ingredients

The latest "MedWise" consumer education campaign will focus on warning patients against the potential for overdosing when mixing OTC and prescription drugs with the same active ingredients.

The launch of "Be MedWise Prescription for Taking OTC Medicines" is a cooperative effort between FDA, the National Council on Patient Information & Education, and the Surgeon General.

NCPIE released survey data on consumer use of OTC drugs to support the campaign, which kicked off on Sept. 10.

The campaign uses television, print, and its 1 website to convey the surgeon general's "prescription": a list of questions that consumers should ask their pharmacists about use of OTC drugs.

"Today six out of every 10 medications consumers buy are over the counter drugs," FDA Deputy Commissioner Lester Crawford, PhD, noted during a Sept. 10 press briefing in Washington, D.C.

"So making sure there is clear and helpful information about OTC medicines is more important than ever before."

"Communicating the facts about risks and benefits...is especially important for OTC medicines because many of these products were once prescription drugs and often contain the same active ingredient as prescription medicines," Crawford emphasized.

"Consumers need to tell their pharmacist or doctor about the prescription medicines they are taking before combining them with an [OTC] drug," he added.

The survey, prepared by Harris Interactive, showed that 51% of those polled "report having taken an OTC medicine and a prescription drug simultaneously," NCPIE reports, while 48% reported taking more than the recommended dose of an OTC.

Conducted in June 2003 on 1,009 adults, the survey also tracked the progress of consumer awareness of OTC use issues since the advent of the "Drug Facts" label and the original "Be MedWise" launch.

NCPIE released a similar survey when the campaign began in 2002 (2 (Also see "OTC Awareness “Be MedWise” Campaign To Feature Radio, Print, TV Ads" - Pink Sheet, 28 Jan, 2002.), p. 10).

The new survey "charts some encouraging trends" about consumer use of labels, NCPIE notes. For example, 23% reported reading dosage information, versus 16% in the first poll.

Forty-four percent said they looked for the active ingredient, compared to 34% in 2002, while 20% reported looking for information on side effects, versus 10% in the earlier poll.

The MedWise campaign likely has increased in importance as more Rx-to-OTC switches become "close calls," according to FDA.

Schering-Plough's Claritin entered the consumer market in December 2002, and the firm is considering a possible switch of the Rx follow-on Clarinex . AstraZeneca's Prilosec OTC , marketed by Procter & Gamble, will be available the week of Sept. 15.

Crawford said that adverse events involving OTCs lead to "a significant number of hospitalizations each year" in the U.S. He estimated OTC-related hospitalizations at 178,000 for 2001, the last year for which he had figures available.

The new campaign is supported by funding from Procter & Gamble Health Sciences Institute and McNeil Consumer & Specialty Pharmaceuticals.

A 30-second public service announcement produced by Saatchi & Saatchi (New York) focuses on the potential for overdosing when taking Rx and OTC drugs with the same active. The spot will air nationally this fall.

Brochures bearing the signature of Surgeon General Richard Carmona, MD, outline questions to ask when choosing consumer drugs, such as: "What [OTC] medicines are available for the symptoms I want to treat?" and "What other medicines (OTC and prescription), herbal products or dietary supplements should I avoid while taking this OTC medicine?"

Carmona said the script "may be the most important prescription I've ever written."

Speaking on behalf of the American Pharmacists Association, Magaly Rodriguez de Bittner noted the group is "very excited about this new prescription," adding that "pharmacists believe it's about time."

It is "important for consumers to understand that they can go to their pharmacists," she stressed, adding "Pharmacists are...probably the only health care providers that get formalized education on OTC medications."

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