Global Patterns of Adverse Drug Reactions Over a Decade
- 386 Downloads
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.
KeywordsAdverse Drug Reaction Anatomical Therapeutic Chemical Artesunate Therapeutic Group Adverse Drug Reaction Reporting
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.
- 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
- 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
- 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]
- 20.The World Bank Group. Country classifications 2010 [online]. Available from URL: http://data.worldbank.org/about/country-classifications [Accessed 2010 Apr 8]
- 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.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.WHO Collaboration Centre for Drug Statistics Methodology. 2007 [online]. Available from URL: http://www.whocc.no/atc_ddd_index/ [Accessed 2011 Apr 3]
- 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]
- 28.WHO. World health statistics 2010. Geneva: WHO, 2010Google Scholar
- 29.WHO. The safety of medicines in public health programmes: pharmacovigilance an essential tool. Geneva: WHO, 2006Google Scholar