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Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan

Authors Yamamoto M, Kubota K, Okazaki M, Dobashi A, Hashiguchi M, Doi H, Suka M, Mochizuki M

Received 14 October 2014

Accepted for publication 13 December 2014

Published 23 January 2015 Volume 2015:9 Pages 173—184


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 4

Editor who approved publication: Dr Johnny Chen

Michiko Yamamoto,1 Kiyoshi Kubota,2 Mitsuhiro Okazaki,3 Akira Dobashi,3 Masayuki Hashiguchi,4 Hirohisa Doi,1 Machi Suka,5 Mayumi Mochizuki4

1Education Center for Clinical Pharmacy Practice, Showa Pharmaceutical University, Tokyo, Japan; 2Department of Pharmacoepidemiology, Graduate School of Medicine, University of Tokyo, Japan; 3Education and Research Institute of Information Science, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan; 4Division for Evaluation and Analysis of Drug Information, Faculty of Pharmacy, Keio University, Tokyo, Japan; 5Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, Tokyo, Japan

Background: Patients have been allowed to report adverse drug reactions (ADRs) directly to the government in some countries, which would contribute to pharmacovigilance.
Objective: We started a pilot study to determine whether web-based patient ADR reporting would work in Japan. This article aims to describe the characteristics of the patient reporters, and to clarify patient views and experiences of reporting.
Methods: Patients who submitted online ADR reports were contacted to respond to an ADR reporting questionnaire; only consenting reporters were included. Subjects with multiple responses were excluded from analysis. The questionnaire consisted of both closed and open questions. Questionnaire responses were examined using Pearson’s chi-squared test.
Results: A total of 220 web-based ADR reports were collected from January to December 2011; questionnaires were sent to 190 reporters, excluding those who gave multiple reports and those that refused to be contacted. Responses were obtained from 94 individuals (effective response rate: 49.5%). The median respondent age was 46.0 years. Sixty-three respondents found out about this pilot study on the Internet (67.0%). The numbers of respondents claiming that they had difficulty recalling the time/date of ADR occurrence were 16 patient reporters and three non-patient reporters. The number of reporters who found it difficult to complete the online reporting form was 22 patients (26.2%) and one non-patient (10%). Fifty-seven respondents (60.6%) expected feedback after reporting and many respondents wanted to know the process of ADR data collection and related information. Seventy-three respondents (77.7%) stated that they would report ADRs again in future.
Conclusion: Throughout the entire questionnaire, online patient ADR reporting was received with a forward-looking, positive approach. To facilitate smoother web-based reporting experiences in future, some improvements may be required in online ADR reporting forms, particularly with regard to respondent feedback.

Keywords: adverse drug reaction reporting system, patient safety, patient experience, pharmacovigilance

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