IMPACT OF BENEFIT MESSAGES IN PATIENT PACKAGE INSERTS ON SUBJECTIVE DRUG PERCEPTION

Objective: To explore the impact of the inclusion of a benefit message in a patient package insert on knowledge about medicines and on subjective benefithisk perception. Setting: Female members of community social organizations, female relatives of psychology stu-dents, and caregivers to psychotic patients. Nature of the study: Randomized, controlled healthy human volunteer study with three parallel experiments, involving the inserts of cisapride, itraconazol, and risperidon. Design: Subjects were recruited in a convenience sample and randomized to one control and two intervention groups (one with a normal insert and one with an insert with a benefit message). Material and methods: Subjects were asked to read the inserts (using mock text in the control group) in 5 to 15 minutes. Knowledge of the medication was tested with 20 simple questions (to be answered Yes/ No/Don k know) and benefithisk perception with a five-point bipolar Likert scale. Results: In the three experiments respectively 89, 102, and 83 subjects were recruited. The provision of inserts increased the knowledge about medication in all the intervention groups. Thirty-one percent, 41 %, and 54 % of the subjects who read a normal insert agreed that the benefit of the medicine was greater than its risks. compared to 62%, 64%, and 70 % of subjects who read an insert with a benefit message included ( P < 0.05 in all 3 experiments). Discussion: A hypothesis for further research is formulated: adding a section on benefit information within a patient package insert helps to integrate increased knowledge about medication into a more balanced benefit/risk perception