Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries : A Systematic Review and Meta-analysis

Key Points

Question

What are the prevalence and estimated economic burden of substandard and falsified medicines in low- and middle-income countries?

Findings

In this systematic review of 265 studies comprising 400 647 drug samples and meta-analysis of 96 studies comprising 67 839 drug samples, the prevalence of substandard and falsified medicines in low- and middle-income countries was 13.6% overall (19.1% for antimalarials and 12.4% for antibiotics). Data on the estimated economic impact were limited primarily to market size and ranged widely from $10 billion to $200 billion.

Meaning

Substandard and falsified medicines are a substantial health and economic problem; a concerted global effort is needed to secure the global supply chain, increase quality control capacity, and improve surveillance to better assess the problem and identify solutions.

Abstract

This systematic review and meta-analysis examines 96 studies of substandard and falsified medicines in low- and middle-income countries to determine the prevalence and estimated economic burden of these medicines.

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.

Trial Registration

PROSPERO Identifier: CRD42017080266