The quality of antiretroviral medicines: an uncertain problem
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 imp...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-03-01
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| Series: | BMJ Global Health |
| Online Access: | https://gh.bmj.com/content/8/3/e011423.full |
| _version_ | 1797869112490196992 |
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| author | Paul N Newton Céline Caillet Ngan Thi Do Phonepasith Boupha |
| author_facet | Paul N Newton Céline Caillet Ngan Thi Do Phonepasith Boupha |
| author_sort | Paul N Newton |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-10T00:07:32Z |
| format | Article |
| id | doaj.art-346e49b96f7145fc9aa8e721bc0b9cda |
| institution | Directory Open Access Journal |
| issn | 2059-7908 |
| language | English |
| last_indexed | 2024-04-10T00:07:32Z |
| publishDate | 2023-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Global Health |
| spelling | doaj.art-346e49b96f7145fc9aa8e721bc0b9cda2023-03-16T18:30:06ZengBMJ Publishing GroupBMJ Global Health2059-79082023-03-018310.1136/bmjgh-2022-011423The quality of antiretroviral medicines: an uncertain problemPaul N Newton0Céline Caillet1Ngan Thi Do2Phonepasith Boupha31 Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Medicine Quality Research Group, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao People`s Democratic Republic3 Nuffield Department of Medicine, Medicine Quality Research Group, Oxford University Centre for Tropical Medicine and Global Health, Oxford, UKInfectious Diseases Data Observatory/WorldWide Antimalarial Resistance Network, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UKLao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Medicine Quality Research Group, Laboratory of Microbiology, Mahosot Hospital, Vientiane, Lao People`s Democratic RepublicObjectives 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.https://gh.bmj.com/content/8/3/e011423.full |
| spellingShingle | Paul N Newton Céline Caillet Ngan Thi Do Phonepasith Boupha The quality of antiretroviral medicines: an uncertain problem BMJ Global Health |
| title | The quality of antiretroviral medicines: an uncertain problem |
| title_full | The quality of antiretroviral medicines: an uncertain problem |
| title_fullStr | The quality of antiretroviral medicines: an uncertain problem |
| title_full_unstemmed | The quality of antiretroviral medicines: an uncertain problem |
| title_short | The quality of antiretroviral medicines: an uncertain problem |
| title_sort | quality of antiretroviral medicines an uncertain problem |
| url | https://gh.bmj.com/content/8/3/e011423.full |
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