Summary

Background: The patient package insert, an information leaflet included by law in the packaging of prescription drugs, contains information for the user on the specific medication.

Objectives: To explore how patient information leaflets influence patient anxiety and adherence.

Methods: A prospective cohort study was conducted in the practices of 15 family physicians. All patients receiving a new prescription for antibiotics, analgesics or antihypertensives were included. Physicians completed a questionnaire containing demographic data, assessment of the patient’s anxiety, a prediction about adherence to the treatment, and response to the information leaflet. Patients were contacted by telephone for a follow-up structured interview. Patients' reactions to the information leaflet, adherence to treatment, and use of other sources of information on medication were assessed.

Results: The study group comprised 200 patients. The patient information leaflet was read by 103 of them (51.5%). A higher educational level and a chronic medication were associated with reading the leaflet (P = 0.02 and 0.01 respectively). In 36 (34.9%), an increase in anxiety was reported after reading the leaflet. Among those who read the leaflet, 9.7% had decreased adherence. Patients who stated that reading the leaflet caused anxiety were more likely to reduce their use of the medication – 7/36 (19.5%) vs. 3/67 (4.5%), P = 0.01.

Conclusions: The proportion of patients reading the drug information leaflet is about 50%, lower than that found in previous studies. Reading the leaflet did not greatly affect adherence but aroused anxiety and decreased adherence in some patients.