Surveillance of a recently switched non-prescription medicine (diclofenac) using a pharmacy-based approach

Gauld, Natalie J., Shaw, John P., Emmerton, Lynne M. and Pethica, B. Damien (2000) Surveillance of a recently switched non-prescription medicine (diclofenac) using a pharmacy-based approach. Pharmacoepidemiology and Drug Safety, 9 3: 207-214. doi:10.1002/1099-1557(200005/06)9:3<207::AID-PDS483>3.0.CO;2-S

Author Gauld, Natalie J.
Shaw, John P.
Emmerton, Lynne M.
Pethica, B. Damien
Title Surveillance of a recently switched non-prescription medicine (diclofenac) using a pharmacy-based approach
Journal name Pharmacoepidemiology and Drug Safety   Check publisher's open access policy
ISSN 1053-8569
Publication date 2000-05-01
Sub-type Article (original research)
DOI 10.1002/1099-1557(200005/06)9:3<207::AID-PDS483>3.0.CO;2-S
Volume 9
Issue 3
Start page 207
End page 214
Total pages 8
Place of publication West Sussex, United Kingdom
Publisher John Wiley & Sons
Language eng
Abstract Purpose - Postmarketing surveillance of prescription medicines is a routine practice, yet similar evaluation of non-prescription medicines, including those recently switched from prescription status, is uncommon. This study presents the methodologic issues and limitations of the use of pharmacies in the 'post-reclassification' surveillance of oral diclofenac potassium 25 mg which had been recently switched from physician prescription to non-prescription sale. Methods - Consenting user-purchasers were recruited from 175 New Zealand pharmacies over 4 months. Purchasers were mailed a questionnaire for completion 7 days post-purchase. Those purchasers who met criteria for being potentially 'at risk' of adverse events were re-surveyed 30 days post-purchase. A descriptive analysis was carried out using t-test and chi-square as appropriate. These results were compared to those from other types of studies in this area. Results - The 1240 recruited purchasers returned 990 valid questionnaires (80% response). Of these 557 (56%) met 'at risk' criteria and received the second questionnaire with 480 valid returns (86.2% response). Conclusions - Useful data was gathered on the 'real-life' usage of a medicine recently reclassified from prescription to non-prescription sale. The use of community pharmacies as recruiting centres was found to be effective. Copyright (C) 2000 John Wiley and Sons, Ltd.
Keyword NSAID
Reclassified medicines
Non-prescription medicines
Community pharmacies
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Unknown

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Pharmacy Publications
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Created: Thu, 16 Dec 2010, 19:39:53 EST by Lynne Emmerton on behalf of School of Pharmacy