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

• Published in: Pharmacoepidemiology and drug safety 1999-12, Vol.8 (7), p.479-491
• Main Authors: Sinclair, H. K., Bond, C. M., Hannaford, P. C.
• Format: Article
• Language: English
• Subjects: community pharmacy; ibuprofen; non-prescribed medicines; pharmacovigilance study; research network
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/(SICI)1099-1557(199912)8:7<479::AID-PDS462>3.0.CO;2-B

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. Copyright © 1999 John Wiley & Sons, Ltd.