Patients views and experiences in online reporting adverse drug reactions

Findings of a national pilot study in Japan

Michiko Yamamoto, Kiyoshi Kubota, Mitsuhiro Okazaki, Akira Dobashi, Masayuki Hashiguchi, Hirohisa Doi, Machi Suka, Mayumi Mochizuki

Research output: Contribution to journalArticle

12 Citations (Scopus)

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 of220 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.

Original languageEnglish
Pages (from-to)173-184
Number of pages12
JournalPatient Preference and Adherence
Volume9
DOIs
Publication statusPublished - 2015 Jan 23

Fingerprint

Drug-Related Side Effects and Adverse Reactions
Japan
reporter
drug
experience
questionnaire
Surveys and Questionnaires
Pharmacovigilance
Internet

Keywords

  • Adverse drug reaction reporting system
  • Patient experience
  • Patient safety
  • Pharmacovigilance

ASJC Scopus subject areas

  • Social Sciences (miscellaneous)
  • Medicine (miscellaneous)
  • Health Policy
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Cite this

Patients views and experiences in online reporting adverse drug reactions : Findings of a national pilot study in Japan. / Yamamoto, Michiko; Kubota, Kiyoshi; Okazaki, Mitsuhiro; Dobashi, Akira; Hashiguchi, Masayuki; Doi, Hirohisa; Suka, Machi; Mochizuki, Mayumi.

In: Patient Preference and Adherence, Vol. 9, 23.01.2015, p. 173-184.

Research output: Contribution to journalArticle

Yamamoto, Michiko ; Kubota, Kiyoshi ; Okazaki, Mitsuhiro ; Dobashi, Akira ; Hashiguchi, Masayuki ; Doi, Hirohisa ; Suka, Machi ; Mochizuki, Mayumi. / Patients views and experiences in online reporting adverse drug reactions : Findings of a national pilot study in Japan. In: Patient Preference and Adherence. 2015 ; Vol. 9. pp. 173-184.
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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 of220 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.",
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