The National Council on Patient Information and Education, a not-for-profit coalition of health organizations, said television ads would begin immediately, followed up by other educational efforts -- such as brochures -- aimed at the millions of Americans who take OTC medications ranging from pain killers to cold remedies and relief for heartburn and indigestion. Funding is coming from McNeil Pharmaceuticals but NCPIE has total control over the program content.
"Most Americans use over-the-counter medications routinely," said W. Ray Bullman, NCPIE executive vice president. The Be MedWise campaign is to "communicate the 3 Rs" -- respect for the value of OTC medications, understanding the risk involved in taking them and using them responsibly, he added.
Hal Quinley, group president for Harris Interactive, which conducted a public survey last fall including more than 1,100 American adults, said 33 percent of respondents admitted taking more than the recommended dosage of OTC drugs. While 59 percent said they had used an OTC medication in the past six months, 95 percent added they only read a part of the product label.
"We're dealing with problems here that are very preventable," Quinley said. "Many of these medications have the same active ingredients and consumers may not be aware of this."
For example -- and this is used in the advertising campaign -- a person taking a cold medication may also take one for pain and fever, not realizing both contain the pain killer acetaminophen -- and resulting in them taking double the recommended dosage.
The Harris survey found only 34 percent of respondents could identify correctly the active ingredient in the OTC medications they take, 36 percent admitted to taking multiple OTC products at once and 91 percent of those who said they took more than the recommended dosage added they did so thinking it would make the medication more effective.
There are more than 100,000 OTC medications on the market and they contain more than 1,000 active ingredients. More than 700 contain ingredients and dosages previously only available by prescription. The NCPIE said more than 5 billion OTC drug products are sold each year in America, making it a $19 billion industry in 2002, according to statistics from the A.C. Nielsen Co.
Still, however, the problem does not look so large based on numbers. Government statistics show in 1999 less than 1 percent of hospitalizations -- some 170,000 -- were related to OTC medication usage. No death rate was available, Bullman said.
Despite the low numbers, Thomas Menighan, president of the American Pharmaceutical Association, said the risk is real.
"Where the problems begin to arise is when people use OTC beyond brief episodic usage," he said. When people take OTC medications -- for heartburn, for example -- over a long time, they may not be taking needed prescription medication or are failing to address a more serious illness that needs medical treatment.
The Be MedWise campaign also is embracing the Food and Drug Administration's new regulation requiring conformity and standardization of OTC drug labels. The FDA issued the regulation in 1999, giving most of the industry until May this year to comply. The FDA's campaign began more than a decade ago with consumer complaints OTC labels were not consistent, were difficult to read or understand or were absent from some packages.
"But we can't do it ourselves," said Ellen Shapiro director of the Division of Public Affairs for FDA's Center for Drug Evaluation and Research. "There are just too many people to reach and the message is too important."
The new FDA regulation requires labels to include the active ingredient of the drug and warnings about potential interactions, adverse events and situations in which certain people should not take the product.
For more information, see NCPIE's new Web site at bemedwise.org.