title: The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective.
abstract: OBJECTIVE
  To explore the opinions of patient reporters to the UK Yellow Card Scheme (YCS) on the importance of the scheme.
  
  
  METHODS
  Postal questionnaires were distributed on our behalf to all patient reporters submitting a Yellow Card to the Medicines and Healthcare Regulatory Agency (MHRA) between March and December 2008, with one follow-up reminder to non-responders. Qualitative analysis was undertaken of responses to an open question asking why respondents felt patient reporting was important. This was followed up by telephone interviews with a purposive sample of selected respondents.
  
  
  RESULTS
  There were 1362 evaluable questionnaires returned from 2008 distributed (68%) and 1238 (91%) respondents provided a total of 1802 comments. Twenty-seven interviews were conducted, which supported and expanded the views expressed in the questionnaire. Four main themes emerged, indicating views that the YCS was of importance to pharmacovigilance in general, manufacturers and licensing authorities, patients and the public and health professionals. Reporters viewed the YCS as an important opportunity to describe their experiences for the benefit of others and to contribute to pharmacovigilance. The scheme's independence from health professionals was regarded as important, in part to provide the patient perspective to manufacturers and regulators, but also because of dismissive attitudes and under-reporting by health professionals.
  
  
  CONCLUSIONS
  Direct patient reporting through the YCS is viewed as important by those who have used the scheme, in order to provide the patient experience for the benefit of pharmacovigilance, as an independent perspective from those of health professionals.
authors.affiliation: University of Nottingham, Nottingham, UK. claire.anderson@nottingham.ac.uk
authors.forename: Claire
authors.initials: C
authors.lastname: Anderson
authors.forename: Janet
authors.initials: J
authors.lastname: Krska
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Murphy
authors.forename: Anthony
authors.initials: A
authors.lastname: Avery
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration* / Q000706:statistics & numerical data; D000368:Aged; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000523:psychology; D010358:Patient Participation / Q000379:methods / Q000706:statistics & numerical data; D010361:Patients / Q000523:psychology*; D060735:Pharmacovigilance; D012923:Social Class; D011795:Surveys and Questionnaires; D006113:United Kingdom