FDA, NCPIE promote new informational OTC labels - OTC/Natural Health - Brief Article

NEW YORK -- The National Council on Patient Information and Education and the Food and Drug Administration are banding to ether to promote new labels set to adorn OTC medications. The labels are the end result of the 1997 label debate that originally sought larger print and clearer writing.

NCPIE and the FDA launched the Be MedWise campaign here May 16 to alert consumers to the new OTC labels.

Manufacturers must begin producing the labels, May 16, and by May 16, 2005, every OTC sold in the United States must have the labels. Key features of the label include large print identifying the product's active ingredient, purpose, uses, warnings, directions, inactive ingredients and storage information. The labels also prompt consumers to consult a doctor, pharmacist or health care professional.

The labels will apply to more than 100,000 OTC drugs--excluding dietary supplements, which are regulated as food products.

"The drug pacts label makes it easier to understand the drug's benefit, risk and proper usage," said Dr. Jonca Bull, acting director of the Office of Drug Evaluation V for the FDA. "Consumers can make a far more informed decision when shopping for OTC medications."

The FDA also is trying t position literature in retail pharmacies. "The labels are clearly better," said Ellen Shapiro, director of the division of public affairs, training and communication for the FDA. "But it's only good I consumers know it exists an use it." According to the FDA some retailers already are on board to get the word out t consumers. Raley's, Big Foods and Kroger have ordered brochures, and Unified Western Grocers featured diagram of the new OTC label in its free 2002 calendar.

What's in the pill?

A survey commissioned by NCPIE from Harris Interactive found that Americans are confident in their use of OTC medications, but they do not have extensive knowledge of use or ingredients. The survey noted t at 36 percent of Americans are likely to combine non-prescription medications when they experience multiple symptoms, such as a headache and sore throat; 59 percent of Americans have taken at least one OTC medication in the past six months, but only 34 percent of the public could identify the active ingredient on their brand of pain reliever; and 9-out-of-10 Americans who exceed the recommended dose of OTC medications do so because they think it will increase efficacy.

The Be MedWise campaign is designed to alert consumers to new labels and to encourage the discussion of OTC usage with health care professionals. Be MedWise is being promoted with a multimedia campaign, including TV and radio spots, as well as ads in Time, Family Circle and Woman's Day magazines. NCPIE also has launched www.bemedwise.com to provide additional information.

"We often take more care in buying a VCR than buying an OTC medication," noted Linda Bernstein, Pharm.D. She noted that many consumers are jeopardizing treatment and creating new problems by taking their medications incorrectly.

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