title: Public confidence in ADR identification and their views on ADRreporting: mixed methods study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Results indicate support among the Thai general public of direct ADR reporting. Greater promotion of direct reporting by all healthcare professionals is required.
authors.affiliation: Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, 40002, Thailand. narumol@kku.ac.th.
authors.forename: Narumol
authors.initials: N
authors.lastname: Jarernsiripornkul
authors.affiliation: Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, 40002, Thailand.
authors.forename: Arunrot
authors.initials: A
authors.lastname: Patsuree
authors.affiliation: Medway School of Pharmacy, Universities of Greenwich and Kent, Chatham Maritime, Kent, UK. j.krska@kent.ac.uk.
authors.forename: Janet
authors.initials: J
authors.lastname: Krska
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D011795:Surveys and Questionnaires; D013785:Thailand / Q000453:epidemiology; D055815:Young Adult
keywords: ADR identification; ADR reporting; Adverse drug reactions; Mixed methods; Public’s confidence