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Review of National Spontaneous Reporting Schemes

Strengths and Weaknesses

  • Original Research Article
  • Published:
Adverse Drug Reactions and Toxicological Reviews

Abstract

Objective: To investigate and compare the operation of different national spontaneous reporting schemes for adverse drug reactions.

Design: Drug safety agencies in 18 countries were contacted by letter to request information about their spontaneous reporting scheme for adverse drug reactions. This information related to the background of the scheme, operational aspects of the scheme and numbers of reports received.

Results: Replies were received from 12 countries. Many differences were found between the schemes operating in different countries. Some schemes had been in operation for over 30 years, while others were more recently established. While most schemes rely on voluntary reports, in two countries (France and Spain), reporting is a legal requirement for healthcare professionals. Reports are accepted from doctors, dentists and pharmacists in all of the countries surveyed; however the role of other health professionals and the general public was found to vary. There were also differences in the types of reactions for which reports are requested, and the products covered by the schemes. In some countries (e.g. Denmark) reports of all reactions are sought, while other countries focus on only serious reactions or reactions to newly marketed products. In Australia, there is a separate scheme for drug-induced congenital malformations and Canada, South Africa and the US run separate schemes for reactions to vaccines. However, other countries include these reactions in the general spontaneous reporting schemes. The numbers of reports received by the countries also varies considerably — from a few hundred each year in South Africa to over 20 000 in the US.

Conclusions: While the schemes all operate on the basic principle of collecting reports of adverse reactions to identify potential hazards, they showed many different approaches to the spontaneous reporting of adverse drug reactions. Features of one scheme may serve to improve reporting rates for another. In addition, all 12 countries participate in the World Health Organization International Drug Monitoring Programme, thus helping to inform the whole international community of drug safety problems.

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References

  1. Griffin JP. Survey of the spontaneous adverse drug reaction reporting schemes in fifteen countries. Br J Clin Pharmacol 1986; 22: 83S–100S

    Article  PubMed  Google Scholar 

  2. Edwards IR. Spontaneous reporting: of what?: clinical concerns about drugs. Br J Clin Pharmacol 1999; 48: 138–41

    Article  PubMed  CAS  Google Scholar 

  3. McGettigan P, Feely J. Adverse drug reaction reporting: opinions and attitudes of medical practitioners in Ireland. Pharmacoepidemiol Drug Saf 1995; 4: 355–8

    Article  Google Scholar 

  4. World Health Organization. WHO Programme [online]. Available from URL: http://www.who.pharmasoft.se/umc.html [Accessed 2000 Aug 31]

  5. Van Boxtel CJ. Strategies for PMS of new drugs in the EC. Pharmacoepidemiol Drug Saf 1993; 2: S7–S10

    Article  Google Scholar 

  6. World Health Organization. About UMC [online]. Available from URL: http://www.who.pharmasoft.se/umc.html [Accessed 2000 Aug 31]

  7. Rawlins MD. Spontaneous reporting of adverse drug reactions. I: the data. Br J Clin Pharmacol 1988; 26: 1–5

    Article  PubMed  CAS  Google Scholar 

  8. Better ADR alerting needed in the UK. Scrip 1999; 2482: 7

  9. Roeser HP, Rohan AP. Post-marketing surveillance of drugs. The spontaneous reporting scheme: role of the Adverse Drug Reactions Advisory Committee. Med J Aust 1990; 153: 720–6

    PubMed  CAS  Google Scholar 

  10. Bem JL, Wood SM, West L, et al. 25 years of the Committee on Safety of Medicines: an international perspective of the benefits. Drug Saf 1990; 5: 161–7

    Article  PubMed  CAS  Google Scholar 

  11. ‘Yellow card’ reporting now allowed for all community pharmacists. Pharm J 1999; 263: 776

    Google Scholar 

  12. Davis S, Coulson R. Community pharmacist reporting of suspected ADRs: (1) the first year of the yellow card demonstration scheme. Pharm J 1999; 263: 786–8

    Google Scholar 

  13. Royer RJ. Pharmacovigilance: the French system. Drug Saf 1990; 5Suppl. 1: 137–40

    Article  PubMed  Google Scholar 

  14. Wood SM, Coulson R. Adverse drug reactions on-line information tracking (ADROIT). Pharm Med 1993; 7: 203–13

    Google Scholar 

  15. Mann RD. Prescription event monitoring: recent progress and future horizons. Br J Clin Pharmacol 1998; 46: 195–201

    Article  PubMed  CAS  Google Scholar 

  16. Committee on Safety of Medicines, Medicines Control Agency. HIV adverse drug reactions reporting scheme. Curr Probl Pharmacovigil 1998 Mar; 24: 3

    Google Scholar 

  17. Committee on Safety of Medicines, Medicines Control Agency. A new reporting initiative for paediatric adverse drug reactions in the Trent region. Curr Probl Pharmacovigil 1999 Feb; 25: 4

    Google Scholar 

  18. Committee on Safety of Medicines. Welcome to the yellow card adverse drug reactions reporting scheme pages [online]. Available from URL: http://ftp.open.gov.uk/mca/csmhome.htm [Accessed 2000 Apr 13]

  19. United Nations. Estimates of mid-year population 1986–1995. In: demographic yearbook 1995. New York: United Nations, 1997; 47: 152–9

    Google Scholar 

  20. Koch-Weser J, Sellers EM, Zacest R. The ambiguity of adverse drug reactions. Eur J Clin Pharmacol 1977; 11: 75–8

    Article  PubMed  CAS  Google Scholar 

  21. Wilholm BE, Olsson S, Moore N, et al. Spontaneous reporting schemes outside the United States. In: Strom BL, editor. Pharmacoepidemiology. 3rd rev. ed. Chichester: John Wiley and Sons Ltd, 2000: 175–92

    Chapter  Google Scholar 

  22. Health Canada. Adverse drug reaction reporting: 1999. Can Adverse Drug React News 2000; 10: 1

    Google Scholar 

  23. Sills JM, Tanner LA, Milstein JB. Food and drug administration monitoring of adverse drug reactions. Am J Hosp Pharm 1986; 43: 2764–70

    PubMed  CAS  Google Scholar 

  24. Edwards C, Smith JM, Bateman DN, et al. Adverse drug reaction monitoring in hospitals: a study of a pharmacy (green card) monitoring scheme in the Northern region [abstract]. Pharm J 1989; 243: R48

    Google Scholar 

  25. Hall M, McCormack P, Arthurs N, et al. The spontaneous reporting of adverse drug reactions by nurses. Br J Clin Pharmacol 1995; 40: 173–5

    Article  PubMed  CAS  Google Scholar 

  26. Egberts TCG, Smulders M, de Konig FHP, et al. Can adverse drug reactions be detected earlier?: a comparison of reports by patients and professionals. BMJ 1996; 313: 530–1

    Article  PubMed  CAS  Google Scholar 

  27. Mitchell AS, Henry DA, Hennrikus D, et al. Adverse drug reactions: can consumers provide early warning? Pharmacoepidemiol Drug Saf 1994; 3: 257–64

    Article  Google Scholar 

  28. Fisher S, Bryant SG. Postmarketing surveillance: accuracy of patient drug attribution judgements. Clin Pharmacol Ther 1990; 48: 102–7

    Article  PubMed  CAS  Google Scholar 

  29. Fisher S, Bryant SG, Kent TA, et al. Patient drug attributions and postmarketing surveillance. Pharmacotherapy 1994; 14: 202–9

    PubMed  CAS  Google Scholar 

  30. Kennedy DL, Goldman SA, Lillie RB. Spontaneous reporting in the United States. In: Strom BL, editor. Pharmacoepidemiology. 3rd rev. ed. Chichester: John Wiley and Sons Ltd, 2000: 151-74

    Google Scholar 

  31. Department of Health. The expert patient: a new approach to chronic disease management for the 21st century. London: Department of Health, 2001

    Google Scholar 

  32. Inman WHW, Weber JCP. The United Kingdom. In: Inman WHW, editor. Monitoring for drug safety. 2nd ed. Lancaster: MTP, 1986: 37

    Google Scholar 

  33. Rogers AS, Israel E, Smith CR, et al. Physician knowledge, attitudes and behaviour related to reporting adverse drug events. Arch Intern Med 1988; 148: 1596–600

    Article  PubMed  CAS  Google Scholar 

  34. Randhawa HK, Smith JC, Irvin LE. Hospital doctors’ attitudes to adverse drug reactions and their reporting. Pharm J 1987; 238: 739–95

    Google Scholar 

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Acknowledgements

The authors would like to thank the staff of the following pharmacovigilance agencies for their response: Adverse Drug Reactions Advisory Committee (Australia), Centre National de Pharmacovigilance (Belgium), Health Canada, Danish Medicines Agency, Agence du Medicament (France), Arzneimittelkommission der Deutschen Ärzteschaft (Germany), Irish Medicines Board, Medicines Evaluation Board (Netherlands), Centre for Adverse Reactions Monitoring (New Zealand), Medicines Control Council (South Africa), Centro Nacional de Farmacobiologia (Spain) and the Food and Drug Administration (US). The authors also wish to thank the Committee on Safety of Medicines (UK) and Sten Olsson of the World Health Organization. There is no conflict of interest between the authors and the drug safety agencies through funding or employment. Funding was through the Welsh School of Pharmacy.

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  1. The Welsh School of Pharmacy, Cathays Park, Redwood Building, King Edward VII Avenue, Cardiff, CF10 3XF, Wales, UK

    M. Louise Hughes, Cate M. C. Whittlesea & David K. Luscombe

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  1. M. Louise Hughes
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  2. Cate M. C. Whittlesea
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  3. David K. Luscombe
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Correspondence to M. Louise Hughes.

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Hughes, M.L., Whittlesea, C.M.C. & Luscombe, D.K. Review of National Spontaneous Reporting Schemes. Adv Drug React Toxicol Rev 21, 231–241 (2002). https://doi.org/10.1007/BF03256199

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