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Drug Safety
Published in: Drug Safety 12/2012

01-12-2012 | Original Research Article

Global Patterns of Adverse Drug Reactions Over a Decade

Analyses of Spontaneous Reports to VigiBase™

Authors: Professor Lise Aagaard, Johanna Strandell, Lars Melskens, Paw S. G. Petersen, Ebba Holme Hansen

Published in: Drug Safety | Issue 12/2012

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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.
Literature
1.
2.
Hansen EH. Technology assessment of pharmaceuticals: the necessity of user perspective. Cah Sociol Demogr Med 1990; 30: 313–27PubMed
3.
Hansen EH. Technology assessment in a user perspective: experiences with drug technology. Int J Technol Assess Health Care 1992; 8: 150–65PubMedCrossRef
4.
Dukes MNG. The effects of drug regulation. Lancaster: MTP Press Limited, 1985CrossRef
5.
Hughes ML, Whittlesea CM, Luscombe DK. Review of national spontaneous reporting schemes: strengths and weaknesses. Adverse Drug React Toxicol Rev 2002; 21: 231–41PubMedCrossRef
6.
Olsson S. The role of the WHO programme on International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Saf 1998; 19: 1–10PubMedCrossRef
7.
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: 1062–72PubMedCrossRef
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: 1067–74PubMedCrossRef
10.
Faich GA. US adverse drug reaction surveillance 1989–1994. Pharmacoepidemiol Drug Saf 1996; 5: 393–8PubMedCrossRef
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: 24–7PubMedCrossRef
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: 297–303PubMedCrossRef
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: 184–203PubMedCrossRef
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: 276–80
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: 509–25CrossRef
16.
Sevene E, Mariano A, Mehta U, et al. Spontaneous adverse drug reaction reporting in rural districts of Mozambique. Drug Saf 2008; 31: 867–76PubMedCrossRef
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: 689–703PubMedCrossRef
18.
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: 148–56PubMedCentralCrossRef
20.
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, 2007
23.
24.
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: 57PubMedCentralPubMedCrossRef
26.
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: 899–910PubMedCrossRef
28.
WHO. World health statistics 2010. Geneva: WHO, 2010
29.
WHO. The safety of medicines in public health programmes: pharmacovigilance an essential tool. Geneva: WHO, 2006
Metadata
Title
Global Patterns of Adverse Drug Reactions Over a Decade
Analyses of Spontaneous Reports to VigiBase™
Authors
Professor Lise Aagaard
Johanna Strandell
Lars Melskens
Paw S. G. Petersen
Ebba Holme Hansen
Publication date
01-12-2012
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 12/2012
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.1007/BF03262002

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