Evidence map›Paper›PMID 27314405›Full record

ArticleDrug safety2016

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

Marita Mann, Assegid Mengistu, Johannes Gaeseb, Evans Sagwa, Greatjoy Mazibuko, Joseph B Babigumira, Louis P Garrison, Andy Stergachis

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.8field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 2 countries.

Marita MannDepartment of Pharmacy, University of Washington, 1959 NE Pacific Ave, H-375, Box 357630, Seattle, WA, 98195-7630, USA. mm97@uw.edu.
Assegid MengistuTherapeutics Information and Pharmacovigilance Centre, Namibia Medicines Regulatory Council, Windhoek, Namibia.
Johannes GaesebNamibia Medicines Regulatory Council, Ministry of Health and Social Services, Windhoek, Namibia.
Evans SagwaSystems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), Management Sciences for Health, Windhoek, Namibia.
Greatjoy MazibukoSystems for Improved Access to Pharmaceutical and Services (SIAPS/Namibia), Management Sciences for Health, Windhoek, Namibia.
Joseph B BabigumiraDepartment of Global Health, University of Washington, Seattle, WA, USA.
Louis P GarrisonDepartment of Pharmacy, University of Washington, 1959 NE Pacific Ave, H-375, Box 357630, Seattle, WA, 98195-7630, USA.
Andy StergachisDepartment of Pharmacy, University of Washington, 1959 NE Pacific Ave, H-375, Box 357630, Seattle, WA, 98195-7630, USA.
University of Washington · USMinistry of Health and Social Services · NA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionActive 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.

methodsA 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.

resultsFor 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.

conclusionActive 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.

Indexed as

PharmacovigilanceAdultAdverse Drug Reaction Reporting SystemsAnti-HIV AgentsAntiretroviral Therapy, Highly ActiveCohort StudiesCost-Benefit AnalysisFemaleHealth Care CostsHIV InfectionsHumansMaleMiddle AgedNamibiaQuality-Adjusted Life YearsSentinel SurveillanceAnti-HIV Agents

Identifiers

PMID27314405
OpenAlexW2443247320

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.