Pharmacovigilance in India, Uganda and South Africa with Reference to WHO’s Minimum Requirements

Document Type : Original Article

Authors

1 Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland

2 University of Basel, Basel, Switzerland

3 Queen Mary University of London, Global Public Health Unit, London, UK

4 The Foundation for Research in Community Health, Pune, India

5 School of Pharmacy, University of the Western Cape, Bellville, South Africa

6 Swiss Tropical and Public Health Institute, Basel, Switzerland

Abstract

Background
Pharmacovigilance (PV) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI) interviews and compares them with the World Health Organization’s (WHO’s) minimum PV requirements for a Functional National PV System.
 
Methods
A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs), members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO’s minimum requirements.
 
Results
All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO.
 
Conclusion
A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory bodies in regulating the market ensuring the safety and effectiveness of medications. National PV systems in the study countries needed strengthening. Greater attention to funding is needed to coordinate and sustain PV activities. Our study highlights a need for developing more systematic approaches to regularly monitoring and evaluating PV policy and practices.

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  1. World Health Organization (WHO). The Importance of Pharmacovigilance: Safety Monitoring of Medicinal Products. Geneva: WHO; 2002.
  2. Lalvani P, Milstein J. Access to New Health Products in Low Income Countries and the Challenge of Pharmacovigilance. [cited 16 Feb 2013]. Available from: http://pdpaccess.org/downloads/projects/full-papers/            PharmacovigilanceDiscussionPaper.pdf
  3. World Health Organization (WHO). The Safety of Medicines in Public Health Programmes: Pharmacovigilance an Essential Tool. Geneva: WHO; 2006.
  4. Ghosh AK. Current problems and future aspects of pharmacovigilance in India. Int J Pharm Bio Sci 2011; 2: 15-9.
  5. Vaidya SS, Bpharm JJ, Heaton PC, Steinbach M. Overview and comparison of postmarketing drug safety surveillance in selected developing and well-developed countries. Drug Inf J2010; 44: 519-33.  doi: 10.1177/009286151004400501
  6. 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. doi: 10.2165/11536390-000000000-00000
  7. World Health Organization (WHO). Minimum Requirements for a Functional Pharmacovigilance System. [cited12 Aug 2013]. Available from: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/            PV_Minimum_Requirements_2010_2.pdf  
  8. World Health Organization (WHO). Pharmacovigilance Toolkit, version 2.0, 24 January 2012. [cited 25 Apr 2013]. Available from: http://apps.who.int/medicinedocs/en/d/Js19107en/ 
  9. WHO Uppsala Monitoring Centre (UMC). The WHO Programme [internet]. [cited 25 Apr 2013]. Available from: http://www.who-umc.org 
  10. Strengthening Pharmaceutical Systems (SPS) Program. Safety of Medicines in Sub-Saharan Africa: Assessment of Pharmacovigilance Systems and their Performance. Arlington, VA: Management Sciences for Health; 2011.
  11. Central Drugs Standard Control Organization (CDSCO). Schedule Y (amended version) Drugs and Cosmetic Rules. [cited 8 Aug 2013]. Available from: http://cdsco.nic.in/html/          schedule-y%28amendedversion-2005%29original.htm
  12. Central Drugs Standard Control Organization (CDSCO). Pharmacovigilance Programme of India (PvPI) for Assuring Drug Safety. Government of India; 2013.  
  13. Gupta YK. Pharmacovigilance Programme for India [internet]. 2010. [cited 8 Aug 2013]. Available from: http://pharmabiz.com/NewsDetails.aspx?aid=57406&sid=9
  14. Bandekar MS, Anwikar SR, Kshirsagar NA. Quality check of spontaneous adverse drug reaction reporting forms of different countries. Pharmacoepidemiol Drug Saf 2010; 19: 1181-5. doi: 10.1002/pds.2004
  15. Adithan C, Dkhar SA. Drug Alert Regional Pharmacovigilance Center. Drug Alert 2012; 6: 2-3.
  16. Subhashini DK. Proactive pharmacovigilance vital for drug safety [internet]. [cited 7 Aug 2013]. Available from:   http://saffron.pharmabiz.com/article/detnews.asp?            articleid=53054&sectionid=50
  17. Central Drugs Standard Control Organization (CDSCO). Four Years’ Achievements 2009-2013. [cited 30 Aug 2013]. Available from: http://cdsco.nic.in/writereaddata/       FouryearsachievementsofCDSCO (2009-2013).pdf
  18. Ndagije HB. What is Current Practice of Pharmacovigilance in Uganda? [cited 18 Apr 2013]. Available from: http://africapv2012.files.wordpress.com/2012/04/day-2_5_country-presentations-nras_h-ngadije            -uganda-compatibility-mode.pdf
  19. Ndagije HB. Working together with the Public Health Programmes: a regulator’s perspective for addressing the minimum requirements for Pharmacovigilance.  [cited 13 Aug 2013]. Available from: http://www.nda.or.ug
  20. National Drug Authority Uganda. Structure of NDA/Departments/Drug Information. [cited 26 Apr 2013]. Available from: http://www.nda.or.ug/
  21. United Nations Statistics Division. UNdata Uganda. [cited 20 Aug 2013].  Available from: http://data.un.org/Search.aspx?q=uganda
  22. Medicines Control Council SA. Medicines and Related Substances Control Act 101 of 1965 after Amendment by the Medicines and Related Substances Control Amendment Act (Act 90 of 1097) Regulations 34 and 37; 1997.
  23. Uppsala Monitoring Center (UMC) VigiBase. Numbers of Reports per year in South Africa between 2002 and 2012. Uppsala: Uppsala Monitoring Center; 2013.
  24. United Nations Statistics Division. UN data South Africa. [cited 20 Aug 2013]. Available from: http://data.un.org/Search.aspx?q=south+africa
  25. South Africa Government. Census 2011 Statistical release - P0301.4 /Statistics South Africa. [cited 15 Aug 2013]. Available from: http://www.statssa.gov.za
  26. Systems for Improved Access to Pharmaceutical Services (SIAPS). Pharmacovigilance Systems in Five Asian Countries. Arlington, VA: Management Sciences for Health: 2013.