Patient views and experiences of making adverse drug reaction reports to the Yellow Card Scheme in the UK

Pharmacoepidemiology and Drug Safety

Volumn 20, Issue 5, 2011, Pages 523-531

  Mclernon, David J ^a   Bond, Christine M ^a   Lee, Amanda J ^a   Watson, Margaret C ^a   Hannaford, Philip C ^a   Fortnum, Heather ^b   Krska, Janet ^c   Anderson, Claire ^b   Murphy, Elizabeth ^d   Avery, Anthony ^b  

^a UNIVERSITY OF ABERDEEN   (United Kingdom)

^b UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^c LIVERPOOL JOHN MOORES UNIVERSITY   (United Kingdom)

^d UNIVERSITY OF LEICESTER   (United Kingdom)

Author keywords

Adverse drug reaction reporting system; Patient; Personal narratives; Questionnaire

Indexed keywords

ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; ANTIPARASITIC AGENT; CARDIOVASCULAR AGENT; CENTRAL NERVOUS SYSTEM AGENTS; DERMATOLOGICAL AGENT; GASTROINTESTINAL AGENT; HEMATOLOGIC AGENT; INSULIN; SEX HORMONE;

ADULT; ADVERSE DRUG REACTION; AGED; ARTICLE; DRUG INDUCED DISEASE; DRUG SURVEILLANCE PROGRAM; EDUCATION; EXPERIENCE; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; ONLINE MONITORING; PRIORITY JOURNAL; QUESTIONNAIRE; UNITED KINGDOM; UNSPECIFIED SIDE EFFECT;

ADULT; ADVERSE DRUG REACTION REPORTING SYSTEMS; AGED; GREAT BRITAIN; HUMANS; MALE; MIDDLE AGED; PATIENT PARTICIPATION; PHARMACEUTICAL PREPARATIONS; PILOT PROJECTS; QUESTIONNAIRES; SEX FACTORS; SOCIOECONOMIC FACTORS;

EID: 79955148466     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2117     Document Type: Article

References (24)

1. Metters J.Report of an Independent Review of Access to the Yellow Card scheme.The Stationery Office: London, 2004.
2. Medicines and Healthcare products Regulatory Agency (MHRA). Evaluation of patient reporting to the yellow card system. (Accessed 30 June 2010).
3. Medicines and Healthcare products Regulatory Agency (MHRA). Download reporting forms and promotional material for the Yellow Card Scheme. (Accessed 30 June 2010).
4. House of Commons Health Committee.The influence of the pharmaceutical industry. Fourth report of session 2004-2005.The Stationery Office: London, April2005.
5. Medicines and Healthcare products Regulatory Agency (MHRA). Patient reporting of suspected adverse drug reactions. (Accessed 30 June2010).
6. Medicines and Healthcare products Regulatory Agency (MHRA). Welcome to the on-line reporting site for the Yellow Card Scheme. (Accessed 30 June 2010).
7. McLernon DJ, Bond CM, Hannaford PC, et al.Adverse drug reaction reporting in the UK: a retrospective observational comparison of Yellow Card reports submitted by patients and healthcare professionals.Drug Saf 2010;33:775-788.
8. Health Action International. Patients' reporting of adverse reactions. Outcomes of a seminar organised by Health Action International Europe 26 May 2005. (Accessed 30 June 2010).
9. McGuire T, Moses G. What do consumers contribute to pharmacovigilance? Lessons from the AME line. Conference Proceedings, National Medicines Symposium. Canberra 2006.
10. AERS Reporting by Healthcare Providers and Consumers by Year. (Accessed 30 June 2010).
11. van Grootheest K, de Graaf L, de Jong-van den Berg LTW.Consumer adverse drug reaction reporting: a new step in pharmacovigilance?Drug Saf 2003;26:211-217.
12. Blenkinsopp A, Wilkie P, Wang M, et al.Patient reporting of suspected adverse drug reactions: a review of published literature and international experience.Br J Clin Pharmacol 2006;63:148-156. DOI:10.1111/j.1365-2125.2006.02746.x.
13. Anonymous.UK call for patient ADR reporting. Script 2001; 2634:4.
14. Aagaard L, Nielsen LH, Hansen EH.Consumer reporting of adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004 to 2006.Drug Saf 2009;32:1067-1074. DOI:10.2165/11316680-0-00000.
15. de Langen J, van Hunsel F, Passier A, et al.Adverse drug reaction reporting by patients in the Netherlands: three years of experience.Drug Saf 2008;31:515-524.
16. Hazell L, Shakir SAW.Under-reporting of adverse drug reactions. A systematic review.Drug Saf 2006;29:385-396.
17. Hammond IW, Rich D.Consumers usurp spontaneous adverse event reporting in the United States.Pharmacoepidemiol Drug Saf 2005;14 (S2):S8-S9.
18. Herxheimer A, Crombag M-R, Alves TL. Direct patient reporting of adverse drug reactions: a fifteen-country survey and literature review. Health Action International (HAI) Europe: Netherlands, 2010. (Accessed 30 June 2010).
19. WHO Collaborating Centre for Drug Statistics Methodology. ATC Structure and Principles. Available at: (Accessed 30 June 2010).
20. Medicines and Healthcare products Regulatory Agency (MHRA). Promotion of the Yellow Card Scheme. (Accessed 30 June 2010).
21. Golomb BA, McGraw JJ, Evans MA, et al.Physician response to patient reports of adverse drug effects.Drug Saf 2007;30:669-675.
22. Foster JM, van der Molen T, de Jong-van den Berg L.Patient-reporting of side effects may provide an important source of information in clinical practice.Eur J Clin Pharmacol 2007;63:979-980. DOI:10.1007/s00228-007-0339-8.
23. Jarernsiripornkul N, Krska J, Richards RME, et al.Patient reporting of adverse drug reactions: useful information for pain management?Eur J Pain 2003;7:219-224. DOI:10.1016/S1090-3801(02)00114-3.
24. Cox AR.Patient reporting of adverse drug reactions.Pharmacovigilance Rev 2009;3(2):18-21.