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Long Term Follow-Up Studies of Users of Nonprescription Medicines Purchased from Community Pharmacies

Some Methodological Issues

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Abstract

Background: Despite the wider availability of medicines to the general public, little is known about their safety when supplied without prescription. Pilot work has already tested 4 methods of recruiting users of ibuprofen purchased from community pharmacies. This paper describes the piloting of a fifth method (a shortened questionnaire), long term follow-up rates of all methods, consistency of reporting of ibuprofen use, and issues relating to possible comparison groups in pharmacovigilance studies.

Methods: A shortened version of a previously tested recruitment questionnaire was used. Eligible study participants were all users, aged over 17 years, purchasing ibuprofen from a research network of community pharmacies (n = 61) in Grampian, Scotland. Postal questionnaires were sent at 1 week and 2, 6 and 12 months irrespective of the method of recruitment. The follow-up questionnaires collected information about ibuprofen and other drug usage, symptoms and associated health service utilisation.

Results: The shortened form recruited 67% of people issued with a questionnaire. The overall 12-month follow-up rate was 67%, although there were important differences in the rates by method of recruitment. There was reasonable consistency in the reporting of use or non-use of ibuprofen at different follow-up times. In the 12 months after the index purchase, 17% of participants never used any ibuprofen (non-users) and 28% used it for more than 8 weeks in total (long term users). At 12 months, long term users were significantly more likely than short term users (≤8 weeks total use) or non-users to have experienced dizziness, skin rash, itchy skin and wheeziness in the previous week.

Conclusions: Our pilot work has confirmed the feasibility of recruiting, and following-up over prolonged periods, users of nonprescription medicines. Evidence of long term use of ibuprofen confirms the need for pharmacovigilance studies of this drug, although further work is required to identify a suitable comparison group in order to inform the interpretation of such investigations.

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Acknowledgements

We are grateful to Grampian Health Board for initial funding of the Grampian Community Pharmacy Network and the University of Aberdeen for funding this pilot study. Particular thanks go to the community pharmacy personnel in the Network who contributed to the design and implementation of the project, and the many users of over-the-counter ibuprofen who participated in the study. We also wish to thank Dr Julie Simpson for statistical advice.

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Authors and Affiliations

  1. University Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen, AB25 2AY, Scotland

    Hazel K. Sinclair, Christine M. Bond & Philip C. Hannaford

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  1. Hazel K. Sinclair
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  2. Christine M. Bond
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  3. Philip C. Hannaford
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Correspondence to Hazel K. Sinclair.

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Sinclair, H.K., Bond, C.M. & Hannaford, P.C. Long Term Follow-Up Studies of Users of Nonprescription Medicines Purchased from Community Pharmacies. Drug-Safety 24, 929–938 (2001). https://doi.org/10.2165/00002018-200124120-00006

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