Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries

Sachiko Ozawa,Tatenda T Yemeke,James E Herrington,Sarah K Laing,Daniel R Evans,Deson G Haynie,Sophia Bessias

doi:10.1001/jamanetworkopen.2018.1662

Abstract

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. 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. Five databases (PubMed, EconLit, Global Health, Embase, and Scopus) were searched from inception until November 3, 2017. 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. 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. Prevalence and/or estimated economic impact of substandard and falsified medicines. 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. 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. PROSPERO Identifier: CRD42017080266.

Highlights

Increasing access to essential medicines is integral to the effort to reduce global morbidity and mortality.[1]
Of studies included in the meta-analysis, 19.1% of antimalarials and 12.4% of antibiotics were substandard or falsified
We identified 265 primary data collection studies that sought to determine the prevalence of substandard and falsified (SF) essential medicines in low- and middle-income countries (LMICs) (Figure 1)

Summary

Introduction

Increasing access to essential medicines is integral to the effort to reduce global morbidity and mortality.[1] While access and health outcomes have generally improved in recent decades, these efforts face a serious obstacle from the threat of substandard and falsified (SF) medicines.[2,3,4] Poorquality medicines increase risks of morbidity and mortality by prolonging illnesses and heighten the risk of treatment failure, poisoning, and adverse drug interactions.[5,6] Circulation of SF medicines with little clinical effectiveness places entire communities at risk of drug resistance, posing a threat to global treatment effectiveness, as well as undermining people’s overall trust in the health system and its legitimate health care professionals.[5,6,7,8,9] Over time, diminished trust in licensed health care professionals may further encourage informal care-seeking and self-medication.[10] Poor health outcomes can erode trust in the manufacturers of genuine pharmaceutical products, which are often challenging to distinguish from SF ones without the use of verification technologies.[11]

Methods

Results

Discussion

Conclusion