More uniform, readable labels for OTC drugs

September 1, 1997

Pharmaceutical Representative

The American Pharmaceutical Association recommended that the FDA follow through on its proposal to improve readability and uniformly format labels for all over-the-counter products.

The American Pharmaceutical Association recommended that the FDA follow through on its proposal to improve readability and uniformly format labels for all over-the-counter products.

"…FDA's initiative to improve consumer labeling of OTC drugs is necessary and substantively on target," said Janet Engle, Pharm.D., a member of the board of trustees for APhA, during her presentation of APhA's formal comments in Washington last July.

The association based its recommendations on results of a study conducted by professors at the College of Pharmacy at Idaho State University.

Specifically, APhA recommended enlarging over-the-counter packaging to accommodate more information in larger font types. As the nation's population ages, more readable labels will be increasingly relevant for the elderly. Larger packaging and fonts are immediate alterations that would assist these consumers. To improve readability, labels could also avoid hyphenated text and unnecessary capitalization. Important warnings could be written in bolded typefaces.

APhA proposed that labels refer consumers to physicians, nurses or pharmacists when they have questions. Vague references to "health care professionals" may suggest to some consumers that anyone in a white coat is a knowledgeable source, Engle said.

Instead, labels should explicitly direct consumers to the most appropriate health care professional who will be most accessible at the time of product purchase or use. Commonly, Engle said, this turns out to be the pharmacist.

In response to the FDA's question of whether poison control center information simply cluttered labels or provided a valuable resource to consumers, Engle responded: "…The poison control center network offers valuable and timely services to patients and family members when there has been a poisoning incident. These centers prevent deaths and are likely to reduce avoidable costly health care utilization." PR

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