Purpose: With the increasing range of potent medicines available for sale `over-the-counter' (OTC) in community pharmacies, this feasibility study set out to develop and validate a method for the pharmacovigilance of OTC medicine, using ibuprofen as a model.
Method: A trained network of community pharmacies (n 61) in Grampian, Scotland, tested dierent methods for recruiting people buying ibuprofen for their own use ( pilot 1) and then used the `best' method to test two methods of follow-up ( pilot 2).
Results: Recruitment rates ร method 1 ( pharmacy sta inserted the patient information sheet and recruitment questionnaire in the shop bag of eligible subjects): 18% (41/227) of questionnaires issued; method 2 (sta explained the study and asked eligible subjects to complete the questionnaire outwith the pharmacy): 31% (61/194); method 3 (sta explained the study and asked eligible subjects to complete the questionnaire in the pharmacy): 52% (100/192). A further 200 subjects were recruited in pilot 2. The majority of recruits (n 402) were female (75%), mean age 43 years (range 18ยฑ84 years), 73% drank alcohol, 72% were non-smokers, and 56% were in the two most auent socio-economic categories. There was a strong association between the drug dose data collected prospectively and that collected retrospectively. The average response to postal follow-up was 80% (315/392) at 1 week and 79% (308/390) at 2 months.
Conclusion:
The study has conยฎrmed the support of pharmacy personnel in undertaking research and indicated the feasibility of a major pharmacovigilance project of OTC medicines.