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Comprehension of a Prototype Over-the-Counter Label for an Emergency Contraceptive Pill Product

From Family Health International, Research Triangle Park, North Carolina; and Women’s Capital Corporation, Washington, District of Columbia.

Address reprint requests to: Elizabeth G. Raymond, MD, MPH, Family Health International, PO Box 13950, Research Triangle Park, NC 27709; E-mail: eraymond{at}fhi.org.

OBJECTIVE: This study was designed to evaluate comprehension of a prototype over-the-counter package label for an emergency contraceptive pill product.

METHODS: Interviews were conducted with 663 women in malls and family planning clinics in eight United States cities. The sample included many young and minority women and women of low literacy. After looking at the package, subjects were asked 30 questions that addressed 11 communication objectives about indications, contraindications, instructions, side effects, and management of serious complications. Most questions asked whether or not use of the product would be appropriate in a described situation.

RESULTS: Seven of the 11 communication objectives were each understood by more than 85% of subjects. Most women in the study understood the most important objectives: that the product is indicated for prevention of pregnancy after unprotected sex (93%), that the first pill should be taken within 72 hours or as soon as possible after intercourse (97%), that the product should not be used by women who are already pregnant (98%), and that the product does not prevent sexually transmitted diseases or human immunodeficiency virus/acquired immune deficiency syndrome (94%). More-literate women were more likely to understand the objectives than less-literate women.

CONCLUSION: These results indicate that by reading the prototype label, most women could understand key information necessary for safe and effective use of this product.

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