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Almost a fifth of medicines in Africa sub-standard or falsified

A study from the University of North Carolina at Chapel Hill found that sub-standard and falsified medicines, including medicines to treat malaria, are a serious problem in much of the world. In low- and middle-income countries, more than 13% of the essential medicines that satisfy the priority health care needs of the population fall in this category. When looking specifically at African countries, the portion of sub-standard and falsified medicines rises to almost 19%.

Falsified medicines are medical products that deliberately and fraudulently misrepresent their identity, composition or source. Sub-standard medicines are real medical products that fail to meet quality standards or specifications for a variety of reasons, including poor manufacturing, shipping or storage conditions, or because the drug is sold beyond its expiration date.

Researchers analysed 96 previous studies of falsified and sub-standard medicines and each of the studies tested more than 50 medications. The team found that antimalarials and antibiotics were the medicines most commonly sold in sub-standard or falsified conditions. In low- and middle-income countries, 19% of antimalarials and 12% of antibiotics are sub-standard or falsified.

Sachiko Ozawa, an associate professor at the UNC Eshelman School of Pharmacy, led the research along with collaborators.

"The prevalence of sub-standard and falsified medicines is a substantial public health problem because these medicines can be ineffective or harmful and can prolong illnesses, cause poisoning or lead to dangerous drug interactions," said Ozawa. "Our study shows that a concerted global effort is needed to improve supply chain management for medicines and to identify solutions to this understudied issue."

The researchers searched five databases for studies related to sub-standard and falsified medicines. They reviewed 256 studies and included 96 studies in their analysis.

"We need more global collaboration to implement laws on drug quality, increase quality control capacity, and improve surveillance and data sharing," said James Herrington, a professor in the UNC Gillings School of Global Public Health and a co-author of the study. "This can strengthen the global supply chain against poor quality medicines, improve health outcomes by reducing antimicrobial and anti-parasitic resistance and, ultimately, help governments, businesses and patients save money."

The team's analysis found limited information on the economic impact of poor quality medicines, with the estimates of market size ranging widely from $10bn to $200bn. Sub-standard and falsified medicines can burden health systems by diverting resources to ineffective or harmful therapies and cause additional treatment costs and reduced worker productivity due to treatable illnesses, but these effects have not been measured.

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.

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

[link url=""]University of North Carolina at Chapel Hill material[/link]
[link url=""]JAMA Network Open abstract[/link]

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