The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective

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.