Over 10.4 million women in the United States use oral contraceptives (OCs). The FDA requires that OC packages contain a Patient Package Insert (PPI) to provide information directly to patients about the use and safety of OCs. The current PPI is written at a 10-12th grade reading level, uses unfamiliar terminology, small typeface, and indistinct section headings, making it difficult for patients to find and understand specific information. This project was conducted to improve the PPI so information can be found, read, understood and applied safely and effectively by OC users, and also to assess the revised PPI’s utility as an educational tool for providers of reproductive health care. Following two focus groups, different versions of the PPI were developed and field-tested with 94 family planning clients at three Philadelphia area clinics. Clients were interviewed one-on-one to determine how well they understood the information, their opinions about it, as well as the wording they would use in explaining specific points to a friend. Additionally, 40 experts from the fields of health communications, literacy, and oral contraceptives, as well as pharmaceutical manufacturers and clinic staff, reviewed and provided input on PPI revisions. Finally, a survey of family planning clinic staff examined their current use of the PPI and their opinions on the utility of the revised PPI as an educational and training tool. Feedback from all groups was incorporated into the final document, now written at below a 6th grade reading level. The final PPI was submitted to FDA for consideration.
Learning Objectives: At the conclusion of the presentation, participants will: (1) be familiar with the oral contraceptive Patient Package Insert (PPI); (2) understand the process of improving readability and utility of the PPI; (3) be more aware of the importance of the PPI as an educational tool for patients
Keywords: Contraceptives, Education
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: Family Planning Council
Philadelphia, PA
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.