E-DRUG: Prevalence and Estimated Economic Burden of Substandard and Falsified
Medicines in Low- and Middle-Income Countries
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A Systematic Review and Meta-analysis
Ozawa S, Evans D, Bessias S, Haynie D, Yemeke T, Laing S, Herrington J.
JAMA Network Open
Open Access. PDF available at:
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2696509
Abstract
Importance: Substandard and falsified medicines burden health systems by
diverting resources to ineffective or harmful therapies, causing medical
complications and prolonging illnesses. However, the prevalence and
economic impact of poor-quality medicines is unclear.
Objective: To conduct a systematic review and meta-analysis to assess the
prevalence and estimated economic burden of substandard and falsified
essential medicines in low- and middle-income countries.
Data Sources: Five databases (PubMed, EconLit, Global Health, Embase, and
Scopus) were searched from inception until November 3, 2017.
Study Selection: Publications were assessed to determine whether they
examined medicine quality and the prevalence and/or economic burden of
substandard and falsified medicines in low- and middle-income countries.
Studies with a sample size of 50 or more were included in the meta-analysis.
Data Extraction and Synthesis: The study is registered in PROSPERO and
reported via the Preferred Reporting Items for Systematic Reviews and
Meta-analyses (PRISMA) reporting guidelines. Study quality was assessed
using an adapted Medicine Quality Assessment Reporting Guidelines scoring
metric. Multiple reviewers conducted the data extraction and quality
assessment independently.
Main Outcomes and Measures: Prevalence and/or estimated economic impact
of substandard and falsified medicines.
Results: Two hundred sixty-five studies that estimated the prevalence of
poor-quality essential medicines in low- and middle-income countries were
identified. Among 96 studies that tested 50 samples or more (67 839 total
drug samples), overall prevalence of poor-quality medicines was 13.6% (95%
CI, 11.0%-16.3%), with regional prevalence of 18.7% in Africa (95% CI,
12.9%-24.5%) and 13.7% in Asia (95% CI, 8.2%-19.1%). Of studies included in
the meta-analysis, 19.1% (95% CI, 15.0%-23.3%) of antimalarials and 12.4%
(95% CI, 7.1%-17.7%) of antibiotics were substandard or falsified. Eight
approximations of the economic impact, focused primarily on market size,
with poor or undisclosed methods in estimation were identified, ranging
from $10 billion to $200 billion.
Conclusions and Relevance: Poor-quality essential medicines are a
substantial and understudied problem. Methodological standards for
prevalence and rigorous economic studies estimating the burden beyond
market size are needed to accurately assess the scope of the issue and
inform efforts to address it. Global collaborative efforts are needed to
improve supply-chain management, surveillance, and regulatory capacity in
low- and middle-income countries to reduce the threat of poor-quality
medicines.
Posted by Sachi Ozawa
Associate Professor
Division of Practice Advancement and Clinical Education
Eshelman School of Pharmacy
University of North Carolina
Sachi Ozawa <sachi.ozawa@gmail.com>