Improving patient educational literature: an understandable patient package insert for "the pill"

The objective of this project was to develop a simpler, more understandable, and accurate patient package insert (PPI) for inclusion in all packs of oral contraceptives (OCs). The project involved field-testing, using focus groups and semistructured cognitive interviews with family planning patients, a self-administered survey of clinic staff, and written recommendations from oral contraceptive and readability experts. The revision and field-testing of the PPI reduced its length by one third, lowered its reading level from the 10th to 1 2th grade down to 6th grade, included lay as well as medical terminology, and reorganized the information to make it easier to find and easier to use. The revised PPI, as submitted to the FDA in February 2001, could increase patient knowledge of safe and effective pill use and would be a valuable educational tool for providers of oral contraceptives. The FDA is currently updating the OC product labeling to reflect the most recent safety data and will then issue the labeling, including the field-tested patient package insert, for public comment.