title: Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors: Education Center for Clinical Pharmacy Practice, Showa Pharmaceutical University, Tokyo, Japan.
authors: Michiko
authors: M
authors: Yamamoto
authors: Department of Pharmacoepidemiology, Graduate School of Medicine, University of Tokyo, Japan.
authors: Kiyoshi
authors: K
authors: Kubota
authors: Education and Research Institute of Information Science, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.
authors: Mitsuhiro
authors: M
authors: Okazaki
authors: Education and Research Institute of Information Science, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.
authors: Akira
authors: A
authors: Dobashi
authors: Division for Evaluation and Analysis of Drug Information, Faculty of Pharmacy, Keio University, Tokyo, Japan.
authors: Masayuki
authors: M
authors: Hashiguchi
authors: Education Center for Clinical Pharmacy Practice, Showa Pharmaceutical University, Tokyo, Japan.
authors: Hirohisa
authors: H
authors: Doi
authors: Department of Public Health and Environmental Medicine, The Jikei University School of Medicine, Tokyo, Japan.
authors: Machi
authors: M
authors: Suka
authors: Division for Evaluation and Analysis of Drug Information, Faculty of Pharmacy, Keio University, Tokyo, Japan.
authors: Mayumi
authors: M
authors: Mochizuki
keywords: adverse drug reaction reporting system; patient experience; patient safety; pharmacovigilance