Pharmacovigilance of over-the-counter products based in community pharmacy: a feasible option?

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 different 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-method 1 (pharmacy staff inserted the patient information sheet and recruitment questionnaire in the shop bag of eligible subjects): 18% (41/227) of questionnaires issued; method 2 (staff explained the study and asked eligible subjects to complete the questionnaire outwith the pharmacy): 31% (61/194); method 3 (staff 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 18-84 years), 73% drank alcohol, 72% were non-smokers, and 56% were in the two most affluent 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 confirmed the support of pharmacy personnel in undertaking research and indicated the feasibility of a major pharmacovigilance project of OTC medicines.