Background: We evaluated female adolescents' comprehension of a prototype over-the-counter package label for an emergency contraceptive pill product.
Study design: Volunteers aged 12-17 years who could read English were recruited at malls and clinics in six United States metropolitan areas. After completing a literacy assessment, subjects examined the prototype package and answered 20 questions that assessed understanding of six key concepts related to appropriate use of the product.
Results: The analysis population included 335 subjects, 54 to 59 of each year of age between 12 and 17 years. When asked what the product is used for, 264 respondents (79%) specifically indicated contraception. The six key concepts were each understood by 83-96% of subjects. In all 24 population subgroups examined, each key concept was understood by at least 72% of subjects.
Conclusion: Female adolescents aged 17 years and younger understand the prototype package label well enough to enable safe and effective use without assistance from a clinician.