Skip to main content
SpringerLink
Log in

Pharmacovigilance Systems in Developing Countries: An Evaluative Case Study in Burkina Faso

  • Original Research Article
  • Published:
Drug Safety Aims and scope Submit manuscript

Abstract

Background

Burkina Faso, like other Sub-Saharan African countries, has recently experienced a large-scale deployment of new medicines for the prevention and treatment of notable diseases of public health interest, including malaria, HIV/AIDS and meningitis. This new context rendered the implementation of pharmacovigilance necessary in order to monitor and establish the safety and effectiveness of these medicines. In 2008, the Ministry of Health of Burkina Faso, West Africa, launched a formal pharmacovigilance system to respond to this need.

Objective

The aim of this study was to evaluate the early-stage pharmacovigilance system of Burkina Faso through a comprehensive and system-based approach with the prospect of identifying areas for improvements.

Methods

We conducted a descriptive cross-sectional study in Burkina Faso. Sixteen key informants from the National Drug Authority (NDA), public health programmes (PHPs) and hospitals were interviewed. Study participants were selected based on a convenience sampling in the NDA, three teaching hospitals, two regional hospitals and six PHPs. Data were collected using the Indicator-based Pharmacovigilance Assessment Tool (IPAT), a metric instrument recently designed and validated by ‘Management Sciences for Health’, a US non-profit organization. The evaluation also involved the collection and review of relevant pharmacovigilance-related documentation in the institutions assessed. A scoring system was used for the quantification of assessment results.

Results

The NDA of Burkina Faso, the institution statutorily in charge of pharmacovigilance, achieved a performance score of 70 %. The basic structures for pharmacovigilance activities were in place; however, the lack of specific laws dedicated to pharmacovigilance, the lack of national guidelines and standard operating procedures on pharmacovigilance, and the insufficient coordination of pharmacovigilance stakeholders in the country were identified as the main weaknesses. Safety data collected thus far have not led to the identification of local drug-related risks; yet, relevant external safety alerts are monitored and acted upon. In 2010, 31 marketing authorizations were modified to include new safety information; seven others were suspended and the corresponding medicines were withdrawn from the national market.

In PHPs, pharmacovigilance activities were not formalized, and in hospitals, pharmacovigilance structures were still under development.

Conclusion

Relevant interventions aimed at strengthening the legal framework and structures for pharmacovigilance activities, and improving the coordination of stakeholders countrywide, should be undertaken as soon as possible. Such an investment is necessary before the national pharmacovigilance system is able to collect its own data, generate signals, evaluate and manage local medicine-related risks and then become a genuine tool for public health.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. WHO. The importance of pharmacovigilance: safety monitoring of medicinal products. WHO, 2002. Available from URL: http://whqlibdoc.who.int/hq/2002/a75646.pdf. Accessed 3 May 2011.

  2. Martin K, Bégaud B, Latry P, et al. Differences between clinical trials and postmarketing use. Br J Clin Pharmacol. 2004;57(1):86–92.

    Article  PubMed  Google Scholar 

  3. Ray WA, Griffin MR, Avorn J. Evaluating drugs after their approval for clinical use. N Engl J Med. 1993;329(27):2029–32.

    Article  PubMed  CAS  Google Scholar 

  4. Okie S. Safety in numbers-monitoring risk in approved drugs. N Engl J Med. 2005;352(12):1173–6.

    Article  PubMed  CAS  Google Scholar 

  5. Barker KN, Flynn EA, Pepper GA, et al. Medication errors observed in 36 health care facilities. Arch Intern Med. 2002;162(16):1897–903.

    Article  PubMed  Google Scholar 

  6. US FDA, Consumer Health Information. Medication errors. Feb 20, 2009. Available from URL: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM143038.pdf. Accessed 6 May 2011.

  7. Rajakannan T, Mallayasamy S, Guddattu V, et al. Cost of adverse drug reactions in a South Indian tertiary care teaching cospital. J Clin Pharmacol. 2012;52(4):559–65.

    Article  PubMed  Google Scholar 

  8. Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group. JAMA. 1997;277(4):307–11.

    Article  PubMed  CAS  Google Scholar 

  9. Rottenkolber D, Schmiedl S, Rottenkolber M, et al. Adverse drug reactions in Germany: direct costs of internal medicine hospitalizations. Pharmacoepidemiol Drug Saf. 2011;20(6):626–34.

    Article  PubMed  Google Scholar 

  10. WHO. Pharmacovigilance: ensuring the safe use of medicines. Oct 2004; Available from URL: http://whqlibdoc.who.int/hq/2004/WHO_EDM_2004.8.pdf. Accessed 3 May 2011.

  11. Meyboom RH, Egberts AC, Gribnau FW, et al. Pharmacovigilance in perspective. Drug Saf. 1999;21(6):429–47.

    Article  PubMed  CAS  Google Scholar 

  12. Mayor S. New meningococcal A vaccine is being introduced into Africa. BMJ. 2010;341:c6736.

    Article  PubMed  Google Scholar 

  13. Huff-Rousselle M, Simooya O, Kabwe V, Hollander I, et al. Pharmacovigilance and new essential drugs in Africa: Zambia draws lessons from its own experiences and beyond. Glob Public Health. 2007;2(2):184–203.

    Article  PubMed  CAS  Google Scholar 

  14. Strenthening Pharmaceutical Systems in Developing Countries (SPS), USAID. Supporting pharmacovigilance in developing countries: the systems perspective. Sep 2009. Available from URL: http://www.msh.org/projects/sps/SPS-Documents/upload/SPS_PV_Paper.pdf. Accessed 1 Mar 2011.

  15. Simooya O, The WHO. ‘Roll Back Malaria Project’: planning for adverse event monitoring in Africa. Drug Saf. 2005;28(4):277–86.

    Article  PubMed  Google Scholar 

  16. Pirmohamed M, Atuah KN, Dodoo ANO, et al. Pharmacovigilance in developing countries. BMJ. 2007;335(7618):462.

    Article  PubMed  Google Scholar 

  17. Amin AA, Kokwaro GO. Antimalarial drug quality in Africa. J Clin Pharm Ther. 2007;32(5):429–40.

    Article  PubMed  CAS  Google Scholar 

  18. United States Pharmacopeia Drug Quality and Information Program. 2010. Survey of the quality of selected antimalarial medicines circulating in Madagascar, Senegal, and Uganda: November 2009. Rockville: The United States Pharmacopeial Convention. Available from URL: http://www.usp.org/sites/default/files/usp_pdf/EN/PQM/QAMSAReport.pdf. Accessed 17 Mar 2013.

  19. Onwujekwe O, Kaur H, Dike N, et al. Quality of anti-malarial drugs provided by public and private healthcare providers in south-east Nigeria. Malar J. 2009;8:22.

    Article  PubMed  Google Scholar 

  20. Ministère de la Santé. 2011 annual statistics report. Burkina Faso: Ministère de la Santé; 2012.

    Google Scholar 

  21. Strengthening Pharmaceutical Systems (SPS) Program. Indicator-based Pharmacovigilance Assessment Tool: manual for conducting assessments in developing countries. Dec 2009. Available from URL: http://pdf.usaid.gov/pdf_docs/PNADS167.pdf. Accessed 15 Jan 2011.

  22. Zongo F, Nikiema JB. Contrôle national postmarketing de la qualité des produits pharmaceutiques. Direction de l’Approvisionnement Pharmaceutique. Service Contrôle Qualité. Ministère de la Santé (Burkina Faso), 2010 annual report.

  23. World Health Organization. A practical handbook on the pharmacovigilance of antiretroviral medicines. Available from URL: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/HIVhandbook.pdf. Accessed 17 Mar 2013.

  24. Mullard A. Mediator scandal rocks French medical community. Lancet. 2011;377(9769):890–2.

    Article  PubMed  Google Scholar 

  25. WHO. The safety of medicines in public health programmes: pharmacovigilance an essential tool. Geneva: WHO, 2006. Available from URL: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.pdf. Accessed 17 Mar 2013.

  26. Dodoo A, Adjei S, Couper M, et al. When rumours derail a mass deworming exercise. Lancet. 2007;370(9586):465–6.

    Article  PubMed  Google Scholar 

  27. WHO, the Uppsala Monitoring Centre. Safety monitoring of medicinal products: guidelines for setting up and running a pharmacovigilance center. Available from URL: http://apps.who.int/medicinedocs/en/d/Jh2934e/. Accessed 17 Mar 2013.

  28. Vallano A, Cereza G, Pedròs C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol. 2005;60(6):653–8.

    Article  PubMed  CAS  Google Scholar 

  29. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19–31.

    Article  PubMed  CAS  Google Scholar 

  30. Sevene E, Mariano A, Mehta U, et al. Spontaneous adverse drug reaction reporting in rural districts of Mozambique. Drug Saf. 2008;31(10):867–76.

    Article  PubMed  Google Scholar 

  31. Mehta U, Durrheim D, Mabuza A, et al. Malaria pharmacovigilance in Africa: lessons from a pilot project in Mpumalanga Province, South Africa. Drug Saf. 2007;30(10):899–910.

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

This study was conducted in collaboration with the United States Agency for International Development (USAID)-funded SPS programme implemented by Management Sciences for Health in the framework of a broader study on ‘Safety of Medicines in sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance’. Lassane Kabore held a French government scholarship to study the tropEd Erasmus Mundus Master programme in International Health. We are very grateful to Jude Nwokike and Hye Lynn Choi from the SPS programme for their valuable advice during the design of the study and data collection.

Lassane Kabore, Caroline Adam, Pascal Millet, Driss Berdai and Françoise Haramburu designed the study. Lassane Kabore and Souleymane Fofana collected data in Burkina Faso. Lassane Kabore, Souleymane Fofana and Pascal Millet wrote the manuscript. Françoise Haramburu and Driss Berdai reviewed the manuscript.

Funding No sources of funding were used to conduct this study or prepare this manuscript.

Conflicts of interest Lassane Kabore received financial support from the MSH for a field trip.

Author information

Authors and Affiliations

  1. Ministry of Health, Ouagadougou, Burkina Faso

    Lassane Kabore & Souleymane Fofana

  2. Développements Analytiques et Pharmaceutiques Appliqués aux Maladies Négligées et aux Contrefaçons, Université Bordeaux Segalen, Bordeaux, France

    Pascal Millet

  3. CHU de Bordeaux, Bordeaux, France

    Pascal Millet, Driss Berdai & Françoise Haramburu

  4. Paris, France

    Caroline Adam

  5. INSERM U657, Bordeaux, France

    Françoise Haramburu

  6. Département de Pharmacologie, Hôpital Pellegrin, 33076, Bordeaux Cedex, France

    Françoise Haramburu

Authors
  1. Lassane Kabore
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Pascal Millet
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Souleymane Fofana
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Driss Berdai
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Caroline Adam
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Françoise Haramburu
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Françoise Haramburu.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Kabore, L., Millet, P., Fofana, S. et al. Pharmacovigilance Systems in Developing Countries: An Evaluative Case Study in Burkina Faso. Drug Saf 36, 349–358 (2013). https://doi.org/10.1007/s40264-013-0043-9

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40264-013-0043-9

Keywords

Search

Navigation