The importance of direct patient reporting of suspected adverse drug reactions

a patient perspective

Claire Anderson, Janet Krska, Elizabeth Murphy, Anthony Avery, Yellow Card Study Collaboration, Amanda Jane Lee

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

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.
Original languageEnglish
Pages (from-to)806-822
Number of pages17
JournalBritish Journal of Clinical Pharmacology
Volume72
Issue number5
Early online date11 Oct 2011
DOIs
Publication statusPublished - Nov 2011

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Drug-Related Side Effects and Adverse Reactions
Pharmacovigilance
Health
Interviews
Licensure
Public Health
Medicine
Surveys and Questionnaires

Keywords

  • adverse drug reactions
  • direct patient reporting
  • pharmacovigilance

Cite this

The importance of direct patient reporting of suspected adverse drug reactions : a patient perspective. / Anderson, Claire; Krska, Janet; Murphy, Elizabeth; Avery, Anthony; Yellow Card Study Collaboration ; Lee, Amanda Jane.

In: British Journal of Clinical Pharmacology, Vol. 72, No. 5, 11.2011, p. 806-822.

Research output: Contribution to journalArticle

Anderson, Claire ; Krska, Janet ; Murphy, Elizabeth ; Avery, Anthony ; Yellow Card Study Collaboration ; Lee, Amanda Jane. / The importance of direct patient reporting of suspected adverse drug reactions : a patient perspective. In: British Journal of Clinical Pharmacology. 2011 ; Vol. 72, No. 5. pp. 806-822.
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abstract = "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.",
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N2 - 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.

AB - 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.

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