Healthcare decisions and product labeling: Results of a consumer comprehension study of prototype labeling for proposed over-the-counter cholestyramine

This study was designed to determine whether randomly selected subjects could comprehend prototype consumer-oriented package labeling and inserts for over-the-counter cholestyramine, a nonsystemic lipid-lowering agent. The primary messages communicated in the label were that consumers should see their doctor before taking cholestyramine and should read the full package insert. In addition, the label communicated indication, dosage, and preparation, as well as key warnings about use with other medications. The insert reinforced the message about seeing the doctor before taking cholestyramine and before taking concurrent medications, further explained the purpose of the drug and its correct use, and provided information about the two types of cholesterol, risk factors for heart disease, and the importance of diet and exercise. A total of 1,806 randomly selected subjects were interviewed in their homes in 40 geographic regions. After examining the product container with one of the three labels being tested, they were given a questionnaire to test their understanding of the label communication points. They were then asked to read the package insert and tested on their understanding of the messages it communicated. Responses were analyzed by gender, age, and education level, as well as by label format. For the education-level subgroup analysis, the high-school-nongraduate group was supplemented by 419 subjects, for a total of 2,225 subjects. Statistical analyses were performed on completed questionnaires by an independent data analysis company. The net correct response to the two primary communication objectives was 99% among the total population. Responses to questions addressing the use of concurrent medications; types of cholesterol; purpose, dosage, and preparation of the medication; and diet and exercise were also clearly understood. This study showed a high level of comprehension of the purpose and correct use of cholestyramine among both high-school graduates and nongraduates.