Current oral contraceptive use instructions: an analysis of patient package inserts
Williams-Deane, M.; Potter, L.S.
Family Planning Perspectives 24(3): 111-115
1992
ISSN/ISBN: 0014-7354 PMID: 1628713 DOI: 10.2307/2135540Document Number: 319674
The patient package inserts (PPIs) for 56 brands of combined and triphasic oral contraceptives made by 9 U.S. Manufacturers were analyzed for content, completeness, consistency, format and readability. PPIs for oral contraceptives are required by the Food and Drug Administration (FDA) to be standardized and to include instructions on how to take pills properly and what to do if pills are missed. Most manufacturers used the same PPI for all their brands, so that users must scan the pamphlet to find start directions for their brand. Most makers offered at least 2 choices for start day, Day 1, 5, and/or Sunday. Directions for 1 missed pill were fairly consistent. Directions for missing 2 pills, and especially 3 or more missed, varied widely, and were even omitted in some cases, but generally posed no added risk of pregnancy. Instructions for using a back-up contraceptive method when starting or when pills were missed also varied greatly. There was potential for confusion because of the number of options, and potential for contraceptive failure because of the long periods, up to 3 weeks, during which the user would be expected to use an additional method. A more serious criticism was the format of the PPIs. Most were printed in extremely small type, often in pale colors, without headings or paragraphing, so the user would need to scan the whole insert, and in many cases the directions for physicians also, to find needed information. When the text was analyzed for readability the PPIs were found to be at 10th grade level, and the physician's section at 12th grade level. Family Health International recommended that all pill PPIs be standardized to avoid confusion for women switching brands, and that format, type size, and readability be improved for use by those with lower reading skills. Furthermore it was suggested that diagrams be included showing what direction to take pills from the package, and that a summary card be provided in the packet.