Mind the gaps - the epidemiology of poor-quality anti-malarials in the malarious world - analysis of the WorldWide Antimalarial Resistance Network database

Abstract

BackgroundPoor quality medicines threaten the lives of millions of patients and are alarmingly common in many parts of the world. Nevertheless, the global extent of the problem remains unknown. Accurate estimates of the epidemiology of poor quality medicines are sparse and are influenced by sampling methodology and diverse chemical analysis techniques. In order to understand the existing data, the Antimalarial Quality Scientific Group at WWARN built a comprehensive, open-access, global database and linked Antimalarial Quality Surveyor, an online visualization tool. Analysis of the database is described here, the limitations of the studies and data reported, and their public health implications discussed.MethodsThe database collates customized summaries of 251 published anti-malarial quality reports in English, French and Spanish by time and location since 1946. It also includes information on assays to determine quality, sampling and medicine regulation.ResultsNo publicly available reports for 60.6% (63) of the 104 malaria-endemic countries were found. Out of 9,348 anti-malarials sampled, 30.1% (2,813) failed chemical/packaging quality tests with 39.3% classified as falsified, 2.3% as substandard and 58.3% as poor quality without evidence available to categorize them as either substandard or falsified. Only 32.3% of the reports explicitly described their definitions of medicine quality and just 9.1% (855) of the samples collected in 4.6% (six) surveys were conducted using random sampling techniques. Packaging analysis was only described in 21.5% of publications and up to twenty wrong active ingredients were found in falsified anti-malarials.ConclusionsThere are severe neglected problems with anti-malarial quality but there are important caveats to accurately estimate the prevalence and distribution of poor quality anti-malarials. The lack of reports in many malaria-endemic areas, inadequate sampling techniques and inadequate chemical analytical methods and instrumental procedures emphasizes the need to interpret medicine quality results with caution. The available evidence demonstrates the need for more investment to improve both sampling and analytical methodology and to achieve consensus in defining different types of poor quality medicines.

The path to longer and healthier lives for all Africans by 2030: the Lancet Commission on the future of health in sub-Saharan Africa

“…For example, a 2014 review of the Worldwide Antimalarial Resistance Network's antimalarial quality database found no information for 17 of the 44 malaria-endemic sub-Saharan countries. 216 NGO initiatives such as the Ghanaian-born mPedigree Network (panel 8) empower patients and health professionals to identify falsified drugs and are an excellent example of health-care innovation in practice. They cannot substitute the functions of central regulators, rather they are an additional tool to enhance regulatory effectiveness.…”

Tackling the Problems Associated with Antimalarial Medicines of Poor Quality

“…systematic literature search from 1946 to March 2013 identiied 251 published antimalarial reports, of which 130 had suicient information to estimate the frequency of poor-quality antimalarials [15]. Out of 9348 antimalarials sampled, 30.1% 2813) failed chemical or packaging quality tests.…”

“…The survey found that 60.6% 63) of the 104 malaria-endemic countries had no publicly available reports on antimalarial drug quality. Further investigation of the quality of antimalarials is required in the "mericas, and in central and southern "frican regions, as there have been very few studies conducted in these malarious areas [15].…”

“…The World-Wide "ntimalarial Resistance Network WW"RN) has developed a comprehensive, open-access, global database, with a linked "ntimalarial Quality Surveyor an online visualization tool) in order to more fully understand the evidence relating to poor-quality antimalarials [15]. " systematic literature search from 1946 to March 2013 identiied 251 published antimalarial reports, of which 130 had suicient information to estimate the frequency of poor-quality antimalarials [15].…”

Poor-quality medicines: from knowledge to control and prevention

“…This is the first freely available global repository compiling the existing quality reports, which were scattered across regulators' websites, policy documents, peerreviewed medical journals and lay press. Tabernero and colleagues recently published in the Malaria Journal an in-depth analysis of this database, 3 showing that 30.1% of more than 9300 samples tested between 1946 and 2013 failed to pass the quality tests. Their paper also revealed significant gaps in the existing reports.…”