Public confidence in ADR identification and their views on ADRreporting: mixed methods study.

Abstract

The value of patients as potential reporters into pharmacovigilance systems is acknowledged worldwide and allowed in Thailand. However, nothing is known about the Thai public's awareness of direct patient reporting facility or their views concerning it. This study aimed to determine confidence among members of the public in identifying suspected adverse drug reactions (ADRs), information sources they use and their views towards direct ADR reporting. Mixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with members of the public recruited in primary care centres, pharmacies and public places during October 2013 to February 2015. All questionnaire respondents reporting an ADR were invited to participate in phase 2. Written informed consent was made before the start of the interview. There were 414 (17.2%) of 2400 questionnaire respondents who had experienced an ADR, almost half (46%) of whom used their own experience to identify ADRs. Having a degree, having a severe ADR and consulting a physician increased respondent confidence in the association between medicine and suspected ADR. The majority (27) of the 30 interviewees indicated general agreement with patient reporting to regulatory authorities. Four main themes emerged covering reasons for reporting ADRs including expectations of health authorities, healthcare professionals and manufacturers, and helping other people. Awareness of direct reporting was low with a desire for a range of reporting methods. Results indicate support among the Thai general public of direct ADR reporting. Greater promotion of direct reporting by all healthcare professionals is required.