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Drug Safety

, Volume 35, Issue 10, pp 807–818 | Cite as

Patient versus Healthcare Professional Spontaneous Adverse Drug Reaction Reporting

A Systematic Review
  • Jackie Inch
  • Margaret C. Watson
  • Stella Anakwe-Umeh
  • Yellow Card Study Collaboration
Systematic Review

Abstract

Background: Increasing numbers of national pharmacovigilance schemes are accepting adverse drug reaction (ADR) reports from patients. The extent to which patient ADR reports contribute to pharmacovigilance requires comparisons to be made with reports from healthcare professionals (HCPs).

Objective: This systematic review was conducted to identify all comparative studies of patient and HCP ADR reports to national pharmacovigilance schemes.

Methods: We conducted a systematic review (which complied with the PRISMA statement) and a narrative synthesis of the results. Electronic databases (1996–2011) were searched, including MEDLINE, EMBASE and PHARM-Line, and supplementary searching of reference lists of included studies, authors’ personal reference lists and internet searches was carried out. Studies that compared patient and HCP ADR reports submitted to national reporting schemes were considered for inclusion. Independent, duplicate data extraction, quality assessment and risk of bias were undertaken.

Results: Of the 949 hits generated, three comparative studies were identified and included in this review. These studies were conducted on the national pharmacovigilance schemes in the Netherlands, Denmark and the UK.

Considerable variation was observed across the national schemes in terms of the proportion of total ADR reports submitted by patients. Some of this variation may be explained by the duration that the schemes have been in operation. The number of serious ADR reports as a percentage of total reports was similar for patients compared with HCPs within each study, but varied across studies. Similarities were shown with the Netherlands and the UK in terms of drugs reported. Both studies featured statins and proton pump inhibitors in the top five drugs.

Clear differences were shown between patients and HCPs in the body systems affected by ADRs as well as the therapeutic categories reported in both the UK and Danish studies. There was considerable similarity when considering the nature of ADRs reported. The Dutch study also showed similarities between patients and physicians in terms of the types of drugs for which ADRs were reported.

Conclusions: Despite the large and increasing number of national pharmacovigilance schemes that accept ADR reports from patients, few comparative studies have been undertaken of patient and HCP reporting. Comparison across schemes is challenging because of differences in reporting processes, the inclusion criteria of schemes and different reporter types. The true value of patient ADR reports to pharmacovigilance will remain unknown unless more comparative evaluations are undertaken. This systematic review has highlighted both similarities and differences between reporter behaviour, the implications of which, in terms of signal generation, require further exploration.

Keywords

Adverse Drug Reaction Patient Report Adverse Drug Reaction Report Reporting Scheme Yellow Card Scheme 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

The authors would like to thank the Yellow Card Study Collaboration, which includes A.J. Avery, C. Anderson, C.M. Bond, H. Fortnum, A. Gifford, P.C. Hannaford, L. Hazell, J. Krska, A.J. Lee, D.J. McLernon, E. Murphy, T. Payne and S. Shakir. We also thank the Royal Pharmaceutical Society librarian for performing the search of the PHARM-Line database on our behalf.

The original literature review was conducted as part of a project funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme (project number 06/92/03) and was published in full in Health Technology Assessment Vol. 15, No. 20 (www.hta.ac.uk/1628). However, the systematic review reported here was conducted following this programme and was unfunded. All researchers were independent from the funder. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health. The original study sponsor did not participate in the study design; collection, analysis or interpretation of data; writing the report; or the decision to submit the paper for publication. © Crown copyright 2012. Reproduced with the permission of the Controller of Her Majesty’s Stationery Office and the Department of Health.

References

  1. 1.
    George C. Reporting adverse drug reactions: a guide for healthcare professionals. London: British Medical Association, 2006Google Scholar
  2. 2.
    Golomb BA, McGraw JJ, Evans MA, et al. Physician response to patient reports of adverse drug effects: implications for patient-targeted adverse effect surveillance. Drug Saf 2007; 30(8): 669–75PubMedCrossRefGoogle Scholar
  3. 3.
    World Health Organization. Consumer reporting of adverse drug reactions. WHO Drug Inf 2000; 14(4): 211–5Google Scholar
  4. 4.
    Avery AJ, Anderson C, Bond CM, et al. Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess 2011; 15(20): 1–234, iii-ivPubMedGoogle Scholar
  5. 5.
    The PRISMA statement [online]. Available from URL: www.prisma-statement.org [Accessed 2012 Jul 30]
  6. 6.
    Ekins-Daukes S, Irvine D, Wise L. The Yellow Card Scheme: evaluation of patient reporting of suspected adverse drug reactions [abstract no. 223]. Pharmacoepidemiol Drug Saf 2006; 15: S105Google Scholar
  7. 7.
    Barrow PL, Foy M, Gandhi S, et al. The Yellow Card Scheme: experience of patient reporting of adverse drug reaction since nationwide launch [abstract no. 221]. Drug Saf 2009; 32(10): 968Google Scholar
  8. 8.
    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(9): 775–88PubMedCrossRefGoogle Scholar
  9. 9.
    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(11): 1067–74PubMedCrossRefGoogle Scholar
  10. 10.
    de Langen J, van Hunsel F, Passier A, et al. Adverse drug reaction reporting by patients in the Netherlands. Drug Saf 2008; 31(6): 515–24PubMedCrossRefGoogle Scholar
  11. 11.
    Health Canada. Adverse reaction and incident reporting — 2010. Can Adverse Reaction Newsl 2011; 21(3): 2–5Google Scholar
  12. 12.
    Health Canada. Canada vigilance adverse reaction online database [online]. Available from URL: http://www.hc-sc.gc.ca/dhp-mps/medeff/databasdon/index-eng.php [Accessed 2011 Jul 29]
  13. 13.
    US FDA. AERS reporting by healthcare providers and consumers by year [online]. Available from URL: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070456.htm [Accessed 2011 Jul 29]
  14. 14.
    Danish Medicines Agency. The Danish Medicines Agency’s annual pharmacovigilance report 2010 [online]. Available from URL: www.laegemiddelstyrelsen.dk/~/media/BAC4DA2950FF4AE1BC6D559EC35AFB3B.ashx [Accessed 2012 Jul 31]
  15. 15.
    Danish Medicines Agency [online]. Available from URL: www.laegemiddelstyrelsen.dk [Accessed 2011 Aug 5]
  16. 16.
    Netherlands Pharmacovigilance Centre [online]. Available from URL: http://www.lareb.nl/kennis/signalen.asp [Accessed 2011 Aug 9]
  17. 17.
    US FDA. MedWatch: The FDA safety information and adverse event reporting program [online]. Available from URL: http://www.fda.gov/Safety/MedWatch/default.htm [Accessed 2010 Apr 20]
  18. 18.
    Metters J. Report of an independent review of access to the Yellow Care Scheme. London: The Stationery Office, 2004Google Scholar
  19. 19.
    van Grootheest K, de Jong-van den Berg L. Patients’ role in reporting adverse drug reactions. Expert Opin Drug Saf 2004; 3(4): 363–8PubMedCrossRefGoogle Scholar
  20. 20.
    Commission of the European Communities. Proposal for a regulation of the European Parliament and of the Council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Brussels: European Medicines Agency, 2008 [online]. Available from URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF [Accessed 2012 Aug 1]Google Scholar
  21. 21.
    Moore N, Begaud B. Improving pharmacovigilance in Europe. BMJ 2010; 340: c1694PubMedCrossRefGoogle Scholar
  22. 22.
    Pirmohamed M, Atuah KN, Dodoo ANO, et al. Pharmacovigilance in developing countries. BMJ 2007; 33(462): 1233–4Google Scholar

Copyright information

© Springer International Publishing AG 2012

Authors and Affiliations

  • Jackie Inch
    • 1
  • Margaret C. Watson
    • 1
  • Stella Anakwe-Umeh
    • 2
  • Yellow Card Study Collaboration
  1. 1.Centre of Academic Primary CareUniversity of AberdeenForesterhill, AberdeenScotland
  2. 2.MSc Public Health and Health Services Research, Department of Public HealthUniversity of AberdeenAberdeenScotland

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