Advertisement

Drug Safety

, Volume 35, Issue 12, pp 1171–1182 | Cite as

Global Patterns of Adverse Drug Reactions Over a Decade

Analyses of Spontaneous Reports to VigiBase™
  • Lise Aagaard
  • Johanna Strandell
  • Lars Melskens
  • Paw S. G. Petersen
  • Ebba Holme Hansen
Original Research Article

Abstract

Background: Although systems to collect information about suspected adverse drug reactions (ADRs) were established in many countries and by the WHO in the 1960s, few studies have examined reported ADRs related to national income.

Objective: The aim of the study was to characterize ADRs reported to the WHO-ADR database, VigiBase™, and to relate data to national income.

Methods: We analysed ADR reports submitted to VigiBase™ from 2000 to 2009 with respect to reporting rate, age and sex of patient, type, seriousness and medications. Reports were also analysed with respect to national income level, classified in accordance with the World Bank definition: low, lower-middle, upper-middle and high.

Results: We analysed 1 359067 ADR reports including 3 013 074 ADRs. Overall, 16% of reports were serious and 60% were reported for females. High-income countries had the highest ADR reporting rates (range 3–613 reports/million inhabitants/year) and low-income countries the lowest (range 0–21). Distribution of ADRs across income groups with respect to age group, seriousness and sex was non-significant. Overall, the majority of ADRs were reported for nervous system medications, followed by cardiovascular medicines. Low-income countries reported relatively more ADRs for anti-infectives for systemic use than high-income countries, and high-income countries reported more ADRs for antineoplastic and immunomodulating agents than lower-income groups.

Conclusion: This study showed that high-income countries had the highest ADR reporting rates and low-income countries the lowest, with large variations across countries in each group. Significant differences in ADR reporting rates were only found for ADRs of the type ‘skin and subcutaneous tissue disorders’ and for the therapeutic groups ‘antiinfectives for systemic use’ and ‘antineoplastic and immunomodulation agents’. To strengthen ADR reporting rates, especially in low-income countries, more research is needed about the impact of organizational structures and economic resources of national pharmacovigilance centres and ADR reporting practices on the large variations in ADR reporting rates within income groups.

Keywords

Adverse Drug Reaction Anatomical Therapeutic Chemical Artesunate Therapeutic Group Adverse Drug Reaction Reporting 
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

We would like to thank the WHO UMC for making data available. The authors are indebted to the national centres that contribute data. The opinions and conclusions in this study are not necessarily those of the various centres, nor of the WHO.

L. Aagaard, J. Strandell, L. Melskens, P.S.G. Petersen and E. Holme Hansen designed the study, analysed data and wrote the first version of the manuscript. L. Melskens and P.S.G. Petersen collected the data. All authors saw and approved the final version of the manuscript.

No sources of funding were used to assist in the preparation of this study, and the authors have identified no financial or other conflicts of interest with respect to the content of this article.

The MedDRA® trademark is owned by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on behalf of the ICH.

References

  1. 1.
    Stricker B, Psaty BM. Detecting, verification and quantification of ADRs. BMJ 2004; 329: 44–7PubMedCentralPubMedCrossRefGoogle Scholar
  2. 2.
    Hansen EH. Technology assessment of pharmaceuticals: the necessity of user perspective. Cah Sociol Demogr Med 1990; 30: 313–27PubMedGoogle Scholar
  3. 3.
    Hansen EH. Technology assessment in a user perspective: experiences with drug technology. Int J Technol Assess Health Care 1992; 8: 150–65PubMedCrossRefGoogle Scholar
  4. 4.
    Dukes MNG. The effects of drug regulation. Lancaster: MTP Press Limited, 1985CrossRefGoogle Scholar
  5. 5.
    Hughes ML, Whittlesea CM, Luscombe DK. Review of national spontaneous reporting schemes: strengths and weaknesses. Adverse Drug React Toxicol Rev 2002; 21: 231–41PubMedCrossRefGoogle Scholar
  6. 6.
    Olsson S. The role of the WHO programme on International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Saf 1998; 19: 1–10PubMedCrossRefGoogle Scholar
  7. 7.
    Pirmohamed M, Atuah KN, Dodoo AN, et al. Pharmacovigilance in developing countries. BMJ 2007; 335: 462PubMedCentralPubMedCrossRefGoogle Scholar
  8. 8.
    Caudron JM, Ford N, Henkens M, et al. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health 2008; 13: 1062–72PubMedCrossRefGoogle 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: 1067–74PubMedCrossRefGoogle Scholar
  10. 10.
    Faich GA. US adverse drug reaction surveillance 1989–1994. Pharmacoepidemiol Drug Saf 1996; 5: 393–8PubMedCrossRefGoogle Scholar
  11. 11.
    Johann-Liang R, Wyeth J, Chen M, et al. Pediatric drug surveillance and the Food and Drug Administration’s adverse event reporting system: an overview of reports, 2003–2007. Pharmacoepidemiol Drug Saf 2009; 18: 24–7PubMedCrossRefGoogle Scholar
  12. 12.
    Figueras A, Capella D, Castel JM, et al. Spontaneous reporting of adverse drug reactions to non-steroidal anti-inflammatory drugs: a report from the Spanish System of Pharmacovigilance, including an early analysis of topical and enteric-coated formulations. Eur J Clin Pharmacol 1994; 47: 297–303PubMedCrossRefGoogle Scholar
  13. 13.
    Huff-Rousselle M, Simooya O, Kabwe V, et al. Pharmacovigilance and new essential drugs in Africa: Zambia draws lessons from its own experiences and beyond. Glob Public Health 2007; 2: 184–203PubMedCrossRefGoogle Scholar
  14. 14.
    Cheng W, Li Y-C, Fu Z, et al. The quality of analysis of adverse drug reaction reports in Shanghai during 2003–2007. Pharm Care Res 2008; 8: 276–80Google Scholar
  15. 15.
    Metha U, Allen E, Barnes Kl. Establishing pharmacovigilance programs in resource-limited settings: the example of treating malaria. Expert Rev Clin Pharmacol 2010; 3: 509–25CrossRefGoogle Scholar
  16. 16.
    Sevene E, Mariano A, Mehta U, et al. Spontaneous adverse drug reaction reporting in rural districts of Mozambique. Drug Saf 2008; 31: 867–76PubMedCrossRefGoogle Scholar
  17. 17.
    Olsson S, Pal SN, Stergachis A, et al. Pharmacovigilance activities in 55 low- and middle-income countries: a questionnaire-based analysis. Drug Saf 2010; 33: 689–703PubMedCrossRefGoogle Scholar
  18. 18.
    WHO Collaborating Centre for International Drug Monitoring. WHO programme 2010 [online]. Available from URL: http://www.who-umc.org/DynPage.aspx?id=13140&mn=1514 [Accessed 2010 Apr 21]
  19. 19.
    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: 148–56PubMedCentralCrossRefGoogle Scholar
  20. 20.
    The World Bank Group. Country classifications 2010 [online]. Available from URL: http://data.worldbank.org/about/country-classifications [Accessed 2010 Apr 8]
  21. 21.
    Medical Dictionary for Regulatory Activities Maintance and Support Services Organization (MedDRA MSSO) [online (password required)]. Available from URL: http://www.meddramsso.com [Accessed 17 Jun 2010]
  22. 22.
    WHO Collaborating Centre for International Drug Monitoring. WHO Programme for International Drug Monitoring: guide to participating countries — submission in E2B format. Geneva: WHO, 2007Google Scholar
  23. 23.
    WHO Collaboration Centre for Drug Statistics Methodology. 2007 [online]. Available from URL: http://www.whocc.no/atc_ddd_index/ [Accessed 2011 Apr 3]
  24. 24.
    United Nations. World population prospects. Annual population 1950–2010 both sexes. Department of Economic and Social Affairs (DESA), Population Division, Population Estimates and Projections Section, 2010 [online]. Available from URL: http://esa.un.org/wpp/Excel-Data/population.htm [Accessed 2011 Apr 3]
  25. 25.
    Kuemmerle A, Dodoo AN, Olsson S, et al. Assessment of global reporting of adverse drug reactions for anti-malarials, including artemisinin-based combination therapy, to the WHO Programme for International Drug Monitoring. Malar J 2011 9; 10: 57PubMedCentralPubMedCrossRefGoogle Scholar
  26. 26.
    Zoller T, Junghanss T, Kapaun A, et al. Intravenous artesunate for severe malaria in travelers, Europe. Emerg Infect Dis 2011; 17: 771–7PubMedCentralPubMedCrossRefGoogle Scholar
  27. 27.
    Mehta U, Durrheim D, Mabuza A, et al. Malaria pharmacovigilance in Africa: lessons from a pilot project in Mpuamlanga Province, South Africa. Drug Saf 2007; 30: 899–910PubMedCrossRefGoogle Scholar
  28. 28.
    WHO. World health statistics 2010. Geneva: WHO, 2010Google Scholar
  29. 29.
    WHO. The safety of medicines in public health programmes: pharmacovigilance an essential tool. Geneva: WHO, 2006Google Scholar

Copyright information

© Springer International Publishing AG 2012

Authors and Affiliations

  • Lise Aagaard
    • 1
    • 2
    • 3
  • Johanna Strandell
    • 4
    • 5
  • Lars Melskens
    • 6
  • Paw S. G. Petersen
    • 6
  • Ebba Holme Hansen
    • 2
    • 3
    • 6
  1. 1.Institute of Public Health, Clinical Pharmacology, Faculty of Health SciencesUniversity of Southern DenmarkOdense CDenmark
  2. 2.FKL-Research Centre for Quality in Medicine UseCopenhagenDenmark
  3. 3.Danish Pharmacovigilance Research Project (DANPREP)CopenhagenDenmark
  4. 4.Uppsala Monitoring CentreUppsalaSweden
  5. 5.Department of Drug Research/Clinical PharmacologyLinköping UniversityLinköpingSweden
  6. 6.Section for Social and Clinical Pharmacy, Department of Pharmacy, Faculty of Health and Medical SciencesUniversity of CopenhagenCopenhagenDenmark

Personalised recommendations