RT Journal Article SR Electronic T1 The quality of antiretroviral medicines: an uncertain problem JF BMJ Global Health JO BMJ Global Health FD BMJ Publishing Group Ltd SP e011423 DO 10.1136/bmjgh-2022-011423 VO 8 IS 3 A1 Ngan Thi Do A1 Phonepasith Boupha A1 Paul N Newton A1 Céline Caillet YR 2023 UL http://gh.bmj.com/content/8/3/e011423.abstract AB Objectives Substandard and falsified (SF) antiretrovirals (ARVs) risk poor outcomes and drug resistance, potentially affecting millions of people in need of treatment and prevention. We assessed the available evidence on SF ARV and related medical devices to discuss their potential public health impact.Methods Searches were conducted in Embase, PubMed, Google, Google Scholar, Web of Science and websites with interest in ARV quality in English and French up to 30 November 2021. Publications reporting on the prevalence of SF ARV were assessed in a quantitative analysis using the Medicine Quality Assessment Reporting Guidelines (MEDQUARG).Results We included 205 publications on SF ARV and 11 on SF medical devices. Nineteen prevalence surveys of SF ARV, published between 2003 and 2021, were included, with no surveys relevant to SF medical devices. The prevalence survey sample size ranged from 3 to 2630 samples (median (Q1–Q3): 16.0 (10.5–44.5); 3 (15.8%) used random outlet sampling methods. Of the 3713 samples included in the prevalence surveys, 1.4% (n=51) failed at least one test. Efavirenz, nevirapine and lamivudine-nevirapine-stavudine combination were the most surveyed ARV with failure frequencies of 3.6% (7/193), 2.6% (5/192) and 2.8% (5/177), respectively. The median (Q1%–Q3%) concordance with the MEDQUARG criteria was 42.3% (34.6%–55.8%).Conclusion These results suggest that there are few data in the public domain of the quality of ARV in supply chains; the proportion of SF ARV is relatively low in comparison to other classes of essential medicines. Even a low proportion of the ARV supply chain being poor quality could make a large difference in the HIV/AIDS international landscape. The 95-95-95 target for 2026 and other international targets could be greatly hampered if even 1% of the millions of people taking ARV (for both prevention and prophylaxis) receive medicines that do not meet quality standards. More surveillance of SF ARV is needed to ensure issues are detected.All data relevant to the study are included in the article or uploaded as online supplemental information. All data are mapped and can be downloaded on the Infectious Diseases Data Observatory Medicine Quality Surveyor system(https://www.iddo.org/mqsurveyor/%23antiretrovirals).