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Drug Safety

, Volume 39, Issue 9, pp 859–872 | Cite as

Active Surveillance versus Spontaneous Reporting for First-Line Antiretroviral Medicines in Namibia: A Cost–Utility Analysis

  • Marita MannEmail author
  • Assegid Mengistu
  • Johannes Gaeseb
  • Evans Sagwa
  • Greatjoy Mazibuko
  • Joseph B. Babigumira
  • Louis P. GarrisonJr
  • Andy Stergachis
Original Research Article

Abstract

Introduction

Active surveillance pharmacovigilance is a systematic approach to medicine safety assessment and health systems strengthening, but has not been widely implemented in low- and middle-income countries. This study aimed to assess the cost effectiveness of a national active surveillance pharmacovigilance system for highly active antiretroviral therapy (HAART) compared with the existing spontaneous reporting system in Namibia.

Methods

A cost–utility analysis from a governmental perspective compared active surveillance pharmacovigilance to spontaneous reporting. Data from a sentinel site active surveillance program in Namibia from August 2012 to April 2013 was projected to all HIV-infected adults initiating HAART in Namibia. Costs (pharmacovigilance program, HAART, adverse event [AE] treatment), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs, dollars/QALY) were evaluated. Analysis was completed for (i) cohort analysis: a single cohort beginning HAART in 1 year in Namibia followed over their remaining lifetime, and (ii) population analysis: patients continued to enter and leave care and treatment over 10 years.

Results

For the cohort analysis, totals were US$21,267,902 (2015 US dollars) and 116,224 QALYs for care and treatment under active surveillance pharmacovigilance versus US$15,257,381 and 116,122 QALYs for care and treatment under spontaneous reporting pharmacovigilance, resulting in an ICER of US$58,867/QALY for active surveillance compared with spontaneous reporting pharmacovigilance. The population analysis ICER was US$4989/QALY. Results were sensitive to quality of life associated with AEs.

Conclusion

Active surveillance pharmacovigilance was projected to be highly cost effective to improve treatment for HIV in Namibia. Active surveillance pharmacovigilance may be valuable to improve lives of HIV patients and more efficiently allocate health resources in Namibia.

Keywords

Gross Domestic Product Active Surveillance Spontaneous Reporting Spontaneous Reporting System Pharmacovigilance System 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Compliance with Ethical Standards

Funding

This report was made possible by the generous support of the American people through the US Agency for International Development (USAID), under the terms of cooperative Agreement Number AID-OAA-A-11-00021. The contents are the responsibility of Management Sciences for Health and do not necessarily reflect the views of USAID or the United States Government.

Conflict of interest

Marita Mann, Assegid Mengistu, Johannes Gaeseb, Evans Sagwa, Greatjoy Mazibuko, Joseph B. Babigumira, Louis P. Garrison, Jr., and Andy Stergachis have no conflicts of interest that are directly relevant to the content of this study.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • Marita Mann
    • 1
    Email author
  • Assegid Mengistu
    • 2
  • Johannes Gaeseb
    • 3
  • Evans Sagwa
    • 4
  • Greatjoy Mazibuko
    • 4
  • Joseph B. Babigumira
    • 5
  • Louis P. GarrisonJr
    • 1
  • Andy Stergachis
    • 1
    • 5
  1. 1.Department of PharmacyUniversity of WashingtonSeattleUSA
  2. 2.Therapeutics Information and Pharmacovigilance Centre, Namibia Medicines Regulatory CouncilWindhoekNamibia
  3. 3.Namibia Medicines Regulatory Council, Ministry of Health and Social ServicesWindhoekNamibia
  4. 4.Systems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), Management Sciences for HealthWindhoekNamibia
  5. 5.Department of Global HealthUniversity of WashingtonSeattleUSA

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