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

Anderson, Claire and Krska, Janet and Murphy, Elizabeth and Avery, Anthony (2011) The importance of direct patient reporting of suspected adverse drug reactions: A patient perspective. British Journal of Clinical Pharmacology, 72 (5). pp. 806-822. ISSN 03065251 (ISSN) . (The full text of this publication is not currently available from this repository. You may be able to access a copy if URLs are provided)

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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. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

Item Type: Article
Additional information: Unmapped bibliographic data: PY - 2011/// [EPrints field already has value set] AD - University of Nottingham, Nottingham, United Kingdom [Field not mapped to EPrints] AD - Liverpool John Moores University, Liverpool, United Kingdom [Field not mapped to EPrints] AD - University of Leicester, Leicester, United Kingdom [Field not mapped to EPrints] JA - Br. J. Clin. Pharmacol. [Field not mapped to EPrints]
Uncontrolled keywords: Adverse drug reactions, Direct patient reporting, Pharmacovigilance,
Subjects: R Medicine > RS Pharmacy and materia medica
Divisions: Faculties > Science Technology and Medical Studies > Medway School of Pharmacy
Depositing User: Janet Krska
Date Deposited: 19 Oct 2012 10:57
Last Modified: 11 Apr 2014 13:49
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