SEARCH

SEARCH BY CITATION

Keywords:

  • adverse drug reactions;
  • direct patient reporting;
  • pharmacovigilance

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT

• Little is known about why patients actually report suspected adverse drug reactions to schemes like the Yellow Card Scheme. Greater understanding of the reasons for reporting could be of benefit in marketing strategies aiming to increase the number of reports.

WHAT THIS STUDY ADDS

• Direct patient reporting through the Yellow Card Scheme 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.

• Reporters viewed the Yellow Card Scheme as an important opportunity to describe their experiences for the benefit of others and to contribute to pharmacovigilance.

• The Yellow Card 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.

AIM 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.

CONCLUSION 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.