Evaluating the educational content of direct-to-consumer fulfillment materials

Purpose. The educational content of direct-to-consumer (DTC) fulfillment materials was evaluated. Methods. A list of prescription drug products advertised to consumers via broadcast media from August 1997 through April 20, 2002, was obtained from the Food and Drug Administration (FDA). The prescription products were categorized by disease state on the basis of their FDA-approved indications. Eight disease states were selected for analysis purposes and included acne, allergic rhinitis, depression, diabetes, hypercholesterolemia, migraine, overactive bladder, and osteoporosis. A total of 31 products were advertised directly to consumers for the eight targeted disease states, 26 of which met the inclusion criteria. The educational content of the advertisements for these 26 products was assessed by analyzing the materials' consistency, instructiveness, and consumer orientation. Results. Two of the 26 materials analyzed contained claims that potentially broadened a drug's indication from that listed in the FDA-approved labeling. The majority of materials listed the condition name (92%), symptom information (77%), the drug's mechanism of action (65%), the drug's time to onset of action (54%), and supportive behaviors (62%). Twenty of 24 DTC fulfillment materials (83%) were not written at the reading level of eight grade lower. Fifteen of the 26 mailings contained educational diagrams, 52% of which met the criteria for necessity, and a greater percentage met the criteria for suitability (905), familiarity (86%), overall layout (88%), single concept (86%), and lack of distracting elements (100%). Conclusion. DTC fulfillment materials appear to have more educational content than DTC print advertisements but are still overwhelmingly deficient in meeting the recommended sixth to eight-grade reading level.