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Pharmacovigilance in developing countries (part II): a path forward

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Abstract

In recent years, attention to pharmacovigilance has gained momentum in developing countries, however awareness of, and policies or systems for pharmacovigilance in most developing countries still lags sharply behind developed countries. This article proposes different strategies to encourage the introduction and sustain the advancement of robust pharmacovigilance systems in developing countries. To this end, this article seeks to accomplish the ultimate goal of pharmacovigilance in a developing country context; ensuring patient safety and promoting safe and rational use of drugs.

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References

  1. World Health Organization. Minimum requirements for a functional pharmacovigilance system. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/PV_Minimum_Requirements_2010_2.pdf. Accessed April 2016.

  2. Gonzalez-Gonzalez C, Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Strategies to improve adverse drug reaction reporting: a critical and systematic review. Drug Saf. 2013;36(5):317–28.

    Article  CAS  Google Scholar 

  3. 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 

  4. Pagotto C, Varallo F, Mastroianni P. Impact of educational interventions on adverse drug events reporting. Int J Technol Assess Health Care. 2013;29(4):410–7.

    Article  Google Scholar 

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

    Article  CAS  Google Scholar 

  6. Shankar PR, Subish P, Mishra P, Dubey AK. Teaching pharmacovigilance to medical students and doctors. Ind J Pharmacol. 2006;38(5):316–9.

    Article  Google Scholar 

  7. Van Hunsel F, Härmark L, Pal S, Olsson S, van Grootheest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012;35(1):45–60.

    Article  Google Scholar 

  8. Jha N, Rathore DS, Shankar PR, Thapa BB, Bhuju G, Alshakka M. Need for involving consumers in Nepal’s pharmacovigilance system. Aust Med J. 2014;7(4):191–5.

    Article  Google Scholar 

  9. Uppsala Monitoring Centre. The form of the form: examples and good practice in designing an ADR reporting form. https://www.who-umc.org/media/1481/creating-adr-report.pdf. Accessed March 2016.

  10. Therapeutic Goods Administration. Blue card adverse reaction reporting form. https://www.tga.gov.au/form/blue-card-adverse-reaction-reporting-form. Accessed April 2016.

  11. Kuchya S, Kalaiselvan V, Kaur I, Singh GN. Mobile application an approach to enhance easy adverse drug reactions reporting in India. Health Technol. 2016;6(2):157–8.

    Article  Google Scholar 

  12. Appiah B. Africa struggles to improve drug safety. CMAJ. 2012. https://doi.org/10.1503/cmaj.109-4199.

    Article  PubMed  PubMed Central  Google Scholar 

  13. National Agency for Food and Drug Administration and Control (NAFDAC) official website, Nigeria. Regulations. http://www.nafdac.gov.ng/index.php/regulation/161-faqs. Accessed March 2016.

  14. Edwards IR, Lindquist M. Social media and networks in pharmacovigilance: boon or bane? Drug Saf. 2011;34(4):267–71.

    Article  Google Scholar 

  15. WHO Collaborating Center for International Drug Monitoring: Uppsala Monitoring Centre. VigiFlow. https://www.who-umc.org/global-pharmacovigilance/vigiflow/vigiflow/. Accessed Nov 2016.

  16. Ahmad SR. Pharmacovigilance bolstered in the Arab world. Lancet. 2014. https://doi.org/10.1016/S0140-6736(14)62375-8.

    Article  PubMed  Google Scholar 

  17. Strengthening Pharmaceutical Systems (SPS). Supporting pharmacovigilance in developing countries: the systems perspective. 2009. http://apps.who.int/medicinedocs/documents/s18813en/s18813en.pdf. Accessed March 2016.

  18. Egyptian Pharmaceutical Vigilance Center. EPVC newsletters. http://epvc.gov.eg/viewpage.aspx?Pid=6. Accessed Nov 2015.

  19. World Health Organization. WHO pharmaceuticals newsletter No. 6. 2012. http://www.who.int/medicines/publications/NewsletterNo62012.pdf?ua=1. Accessed April 2016.

  20. World Health Organization. WHO pharmaceuticals newsletter No. 6. 2015. http://www.who.int/medicines/publications/pharmnewsletter6-2015.pdf?ua=1. Accessed April 2016.

  21. Jeetu G, Anusha G. Pharmacovigilance: a worldwide master key for drug safety monitoring. J Young Pharm. 2010;2(3):315–20.

    Article  CAS  Google Scholar 

  22. 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.

  23. Kovacs S, Hawes SE, Maley SN, Mosites E, Wong L, Stergachis A. Technologies for detecting falsified and substandard drugs in low and middle income countries. PLoS ONE. 2014. https://doi.org/10.1371/journal.pone.0090601.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Preston C, Valdez ML, Bond K. Strengthening medical product regulation in low- and middle-income countries. PLoS Med. 2012. https://doi.org/10.1371/journal.pmed.1001327.

    Article  PubMed  PubMed Central  Google Scholar 

  25. Riviere JE, Buckley GJ. Ensuring safe foods and medical products through stronger regulatory systems abroad. Washington (DC): Institute of Medicine of the National Academies Press (2012). Accessed Oct 2016.

  26. Attaran A, Barry D, Basheer S, Bate R, Benton D, Chauvin J, Garrett L, Kickbusch I, Kohler JC, Midha K, Newton PN, Nishtar S, Orhii P, Martin M. How to achieve international action on falsified and substandard medicines. BMJ. 2012. https://doi.org/10.1136/bmj.e7381.

    Article  PubMed  Google Scholar 

  27. Council of Europe. The MEDICRIME convention. http://www.coe.int/en/web/medicrime/home. Accessed Sept 2017.

  28. Pirmohamed M, Atuah KN, Dodoo AN, Winstanley P. Pharmacovigilance in developing countries. BMJ. 2007;335(7618):462.

    Article  Google Scholar 

  29. Babigumira JB, Stergachis A, Choi HL, Dodoo A, Nwokike J, Garrison LP Jr. A framework for assessing the economic value of pharmacovigilance in low- and middle-income countries. Drug Saf. 2014;37(3):127–34.

    Article  Google Scholar 

  30. The Global Fund. The global fund to fight AIDS, Tuberculosis and Malaria. http://www.theglobalfund.org/en/. Accessed Nov 2016.

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Acknowledgements

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.

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The authors declare that they have no competing interests.

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Correspondence to Shaimaa Elshafie.

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Elshafie, S., Roberti, A.M. & Zaghloul, I. Pharmacovigilance in developing countries (part II): a path forward. Int J Clin Pharm 40, 764–768 (2018). https://doi.org/10.1007/s11096-017-0588-2

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