Over-the-counter ibuprofen: how and why is it used?

Abstract

Abstract Objectives To pilot an over-the-counter (OTC) medicine pharmacovigilance project, using ibuprofen as a model. Method All users of any tablet or capsule form of ibuprofen (excluding compound products) purchased from 61 participating community pharmacies, aged ≥18 years and able to give informed consent, were eligible to join the study. A postal questionnaire one week after the index purchase monitored the follow-up rate, drug usage, past medical history, concurrent medication, symptoms and health service utilisation. Setting Primary care: community pharmacies in Grampian, Scotland. Key findings A total of 443/544 (81 per cent) questionnaires were completed. The recommended daily dose of OTC ibuprofen (1,200mg) was exceeded by 35 customers (8 per cent) on at least one day and the recommended maximum daily dose that can be prescribed by a physician (2,400mg) was exceeded on five occasions. During the seven days after the index purchase, ibuprofen was used by 15 customers (4 per cent) with an active or past history of peptic ulcer, and 30 (7 per cent) with an active or past history of asthma. Thirty-eight per cent had purchased ibuprofen for a chronic condition and 32 per cent were still taking it at the end of the initial seven-day period. Twenty-eight of 412 customers (7 per cent) sought advice during the seven-day period about at least one symptom: 13 consulted their general practitioner, 12 consulted a pharmacist, two consulted both their GP and a pharmacist, and one consulted a hospital doctor. Some of these consultations (23/28, 82 per cent) might have related to an adverse reaction to ibuprofen: 11 customers (3 per cent) consulted about lower abdominal symptoms, nine about gastric symptoms and three about wheeziness. Conclusions This pilot study identifies instances of contraindicated and excessive use of OTC ibuprofen, indicating a need for pharmacovigilance studies of OTC medicines; it also demonstrates the feasibility of a major study.