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Pharmacovigilance in developing countries (part I): importance and challenges

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Abstract

The thalidomide disaster was the significant historical event that acted as a catalyst for pharmacovigilance activity. Following this event developed countries initiated drug monitoring systems that evolved and now extend their scope to broader drug-related safety issues; however, this was not the case in developing countries. Pharmacovigilance is still a relatively new concept with low priority in developing countries although various issues are raising concerns that magnify the need for systems to monitor post marketing drug safety in these countries. This article analyzes the barriers to introducing robust pharmacovigilance systems in developing countries.

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References

  1. World Health Organization. Pharmacovigilance: Ensuring the safe use of medicines. http://www.who-umc.org/graphics/24753.pdf. Accessed Nov 2015.

  2. Campbell J, Gossell-Williams M, Lee M. A review of pharmacovigilance. West Indian Med J. 2014;63(7):771–4.

    CAS  PubMed  Google Scholar 

  3. Van Grootheest K. The dawn of pharmacovigilance: an historical perspective. Int J Pharm Med. 2003;. https://doi.org/10.2165/00124363-200317050-00006.

    Article  Google Scholar 

  4. Saito M, Hirata-Koizumi M, Miyake S, Hasegawa R. Withdrawal of cerivastatin revealed a flaw of post-marketing surveillance system in the United States. Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2005;123:41–5.

    CAS  Google Scholar 

  5. Dieppe PA, Ebrahim S, Martin RM, Jüni P. Lessons from the withdrawal of rofecoxib. BMJ. 2004;329(7471):867–8.

    Article  Google Scholar 

  6. Glasser SP, Salas M, Delzell E. Importance and challenges of studying marketed drugs: what is a phase IV study? Common clinical research designs, registries, and self-reporting systems. J Clin Pharmacol. 2007;47:1074–86.

    Article  Google Scholar 

  7. Sultana J, Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug reactions. J Pharmacol Pharmacother. 2013;4(Suppl1):S73–7.

    Article  Google Scholar 

  8. Wilbur K. Pharmacovigilance in the Middle East: a survey of 13 Arabic speaking countries. Drug Saf. 2013;36:25–30.

    Article  Google Scholar 

  9. International Conference on Harmonisation. Ethnic factors in the acceptability of foreign clinical data E5 (R1). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E5_R1/Step4/E5_R1__Guideline.pdf. Accessed Feb 2016.

  10. McDowell SE, Coleman JJ, Ferner RE. Systematic review and meta-analysis of ethnic differences in risks of adverse reactions to drugs used in cardiovascular medicine. BMJ. 2006;332:1177–81.

    Article  CAS  Google Scholar 

  11. Alomar MJ. Factors affecting the development of adverse drug reactions (Review article). Saudi Pharma J. 2014;22(2):83–94.

    Article  Google Scholar 

  12. World Health Organization. The importance of pharmacovigilance. http://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf. Accessed Nov 2015.

  13. Isah AO, Pal SN, Olsson S, Dodoo A, Bencheikh RS. Specific features of medicines safety and pharmacovigilance in Africa. Ther Adv Drug Saf. 2012;3:25–34.

    Article  Google Scholar 

  14. Olsson S, Pal SN, Dodoo A. Pharmacovigilance in resource-limited countries. Expert Rev Clin Pharmacol. 2015;8:449–60.

    Article  CAS  Google Scholar 

  15. Donald G, McNeil Jr. Curing Hepatitis C, in an experiment the size of Egypt. New York Times. 2015. https://www.nytimes.com/2015/12/16/health/hepatitis-c-treatment-egypt.html. Accessed Mar 2016.

  16. Maggie F, Ben H. Gilead offers Egypt new hepatitis C drug at 99 percent discount. Reuters. 2014. http://www.reuters.com/article/us-hepatitis-egypt-gilead-sciences-idUSBREA2K1VF20140321. Accessed Mar 2016.

  17. Kumar V. Challenges and future considerations for pharmacovigilance. J Pharmacovigil. 2013;1:1–3.

    Article  Google Scholar 

  18. Widayati A, Suryawati S, de Crespigny C, Hiller J. Self medication with antibiotics in Yogyakarta City Indonesia: a cross sectional population-based survey. BMC Res Not. 2011;4:491.

    Article  Google Scholar 

  19. World Health Organization. Fact sheet N°134: Traditional medicine. http://www.who.int/mediacentre/factsheets/2003/fs134/en/. Accessed Nov 2016.

  20. U.S. Food and Drug Administration. 50 years: The Kefauver-Harris Amendments. 2016. http://www.fda.gov/drugs/newsevents/ucm320924.htm. Accessed Feb 2016.

  21. Medicines and Healthcare products Regulatory Agency. Press release: Yellow Card Scheme looks to the future at 50th anniversary forum. 2014. https://www.gov.uk/government/news/yellow-card-scheme-looks-to-the-future-at-50th-anniversary-forum.

  22. Uppsala Monitoring Centre. Members of the WHO Programme for International Drug Monitoring. https://www.who-umc.org/global-pharmacovigilance/members/who-programme-members/. Accessed Sept 2017.

  23. Härmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol. 2008;64:743–52.

    Article  Google Scholar 

  24. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29:385–96.

    Article  Google Scholar 

  25. Uppsala Monitoring Centre. Annual Report 2015. http://www.who-umc.org/graphics/30657.pdf. Accessed Mar 2016.

  26. Aagaard L, Strandell J, Melskens L, Petersen PS, Holme Hansen E. Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase. Drug Saf. 2012;35:1171–82.

    Article  Google Scholar 

  27. Worldometers. Africa population. http://www.worldometers.info/world-population/africa-population/. Accessed Sept 2017.

  28. Ampadu HH, Hoekman J, de Bruin ML, Pal SN, Olsson S, Sartori D, Leufkens HG, Dodoo AN. Adverse drug reaction reporting in Africa and a comparison of individual case safety report characteristics between Africa and the rest of the world: analyses of spontaneous reports in VigiBase®. Drug Saf. 2016;39:335–45.

    Article  CAS  Google Scholar 

  29. Kuemmerle A, Dodoo AN, Olsson S, Van Erps J, Burri C, Lalvani PS. Assessment of global reporting of adverse drug reactions for antimalarials, including artemisinin-based combination therapy, to the WHO Programme for International Drug Monitoring. Malar J. 2011;. https://doi.org/10.1186/1475-2875-10-57.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Bawazir SA. Attitude of community pharmacists in Saudi Arabia towards adverse drug reaction reporting. Saudi Pharm J. 2006;14:75–83.

    Google Scholar 

  31. Khan TM. Community pharmacists’ knowledge and perceptions about adverse drug reactions and barriers towards their reporting in Eastern region, Alahsa, SaudiArabia. Ther Adv Drug Saf. 2013;4:45–51.

    Article  Google Scholar 

  32. Alraie NA, Saad AA, Sabry NA, Farid SF. Adverse drug reactions reporting: a questionnaire-based study on Egyptian pharmacists’ attitudes following an awareness workshop. J Eval Clin Pract. 2015;22(3):349–55.

    Article  Google Scholar 

  33. Olsson S, Pal SN, Stergachis A, Couper M. Pharmacovigilance activities in 55 low- and middle-income countries: a questionnaire-based analysis. Drug Saf. 2010;33:689–703.

    Article  Google Scholar 

  34. World Health Organization. WHO Pharmaceuticals Newsletter 2000, No. 03: Feature: Direct reporting by consumers—First international conference, Sigtuna, Sweden. http://apps.who.int/medicinedocs/fr/d/Jh1465e/4.html. Accessed Apr 2016.

  35. Margraff F, Bertram D. Adverse drug reaction reporting by patients: an overview of fifty countries. Drug Saf. 2014;37(6):409–19.

    Article  CAS  Google Scholar 

  36. Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010;362(10):865–9.

    Article  CAS  Google Scholar 

  37. Huff-Rousselle M, Simooya O, Kabwe V, Hollander I, Handema R, Mwango A, Mwape E. 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  CAS  Google Scholar 

  38. World Health Organization. Assessment of medicines regulatory systems in sub-Saharan African countries: an overview of findings from 26 assessment reports. http://apps.who.int/medicinedocs/documents/s17577en/s17577en.pdf. Accessed Jan 2016.

  39. Strengthening Pharmaceutical Systems (SPS) Program. Safety of medicines in Sub-Saharan Africa: assessment of pharmacovigilance systems and their performance. 2011. http://apps.who.int/medicinedocs/documents/s19152en/s19152en.pdf. Accessed Jan 2016.

  40. Moscou K, Kohler J, Lexchin J. Drug safety and corporate governance. Glob Health Gov. 2013;7:56–79.

    Google Scholar 

  41. Buckley GJ, Gostin LO. Countering the problem of falsified and substandard drugs. Washington (DC): Institute of Medicine of the National Academies Press (2013). Accessed Oct 2016.

  42. Polgreen L. 84 children are killed by medicine in Nigeria. New York Times. 2009. http://www.nytimes.com/2009/02/07/world/africa/07nigeria.html. Accessed Mar 2016.

  43. World Health Organization. Alert No. 125: Contaminated Isotab® (isosorbide mononitrate) incident in Lahore Pakistan. 2012. http://www.who.int/medicines/publications/drugalerts/DrugSafetyAlert125.pdf. Accessed Apr 2016.

  44. Yadav P. Health product supply chains in developing countries: diagnosis of the root causes of underperformance and an agenda for reform. Health Syst Reform. 2015;1(2):142–54.

    Article  Google Scholar 

  45. Nayyar Gaurvika ML, Breman JG, Newton PN, Herrington J. Poor-quality antimalarial drugs in Southeast Asia and sub-Saharan Africa. Lancet. 2012;12:488–96.

    Article  CAS  Google Scholar 

  46. Glass BD. Counterfeit drugs and medical devices in developing countries. Dove Press J: Res Rep Trop Med. 2014;5:11–22.

    Google Scholar 

  47. Al-Worafi YM. Pharmacy practice and its challenges in Yemen. Aust Med J. 2014;7(1):17–23.

    Article  Google Scholar 

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Acknowledgments

The author would like to thank Professor Maggie Huff-Rousselle for her contributions. Also, very special thanks go to Mahmoud Ahmed, Johannah Segarich, and all professors, staff, and colleagues at Massachusetts College of Pharmacy and Health Sciences University.

Funding

None.

Conflicts of interest

The authors declare that they have no competing interests.

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Authors and Affiliations

  1. National Organization for Drug Control and Research, Cairo, Egypt

    Shaimaa Elshafie

  2. Massachusetts College of Pharmacy and Health Sciences University, Boston, MA, USA

    Shaimaa Elshafie & Iman Zaghloul

  3. Independent Scholar, Wellesley, MA, USA

    Anne Marie Roberti

Authors
  1. Shaimaa Elshafie
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  2. Iman Zaghloul
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  3. Anne Marie Roberti
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Correspondence to Shaimaa Elshafie.

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Elshafie, S., Zaghloul, I. & Roberti, A. Pharmacovigilance in developing countries (part I): importance and challenges. Int J Clin Pharm 40, 758–763 (2018). https://doi.org/10.1007/s11096-017-0570-z

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