Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance
Objectives Tuberculosis (TB) remains a major global public health problem, especially with the recent emergence of multidrug-resistant TB and extensively drug-resistant TB. There has been little consideration of the extent of substandard and falsified (SF) TB medicines as drivers of resistance. We a...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-07-01
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| Series: | BMJ Global Health |
| Online Access: | https://gh.bmj.com/content/8/7/e012039.full |
| _version_ | 1797749183045697536 |
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| author | Paul N Newton Patricia Tabernero |
| author_facet | Paul N Newton Patricia Tabernero |
| author_sort | Paul N Newton |
| collection | DOAJ |
| description | Objectives Tuberculosis (TB) remains a major global public health problem, especially with the recent emergence of multidrug-resistant TB and extensively drug-resistant TB. There has been little consideration of the extent of substandard and falsified (SF) TB medicines as drivers of resistance. We assessed the evidence on the prevalence of SF anti-TB medicines and discussed their public health impact.Materials/methods We searched Web of Science, Medline, Pubmed, Google Scholar, WHO, US Pharmacopeia and Medicines Regulatory Agencies websites for publications on anti-TB medicines quality up to 31 October 2021. Publications reporting on the prevalence of SF anti-TB drugs were evaluated for quantitative analysis.Results Of the 530 screened publications, 162 (30.6%) were relevant to anti-TB medicines quality; of those, 65 (40.1%) described one or more TB quality surveys in a specific location or region with enough information to yield an estimate of the local prevalence of poor-quality TB medicines. 7682 samples were collected in 22 countries and of those, 1170 (15.2%) failed at least one quality test. 14.1% (879/6255) of samples failed in quality surveys, 12.5% (136/1086) in bioequivalence studies and 36.9% (87/236) in accelerated biostability studies. The most frequently assessed were rifampicin monotherapy (45 studies, 19.5%) and isoniazid monotherapy (33, 14.3%), rifampicin-isoniazid-pyrazinamide-ethambutol fixed dose combinations (28, 12.1%) and rifampicin-isoniazid (20, 8.6%). The median (IQR) number of samples collected per study was 12 (1–478).Conclusions SF, especially substandard, anti-TB medicines are present worldwide. However, TB medicine quality data are few and are therefore not generalisable that 15.2% of global anti-TB medicine supply is SF. The evidence available suggests that the surveillance of the quality of TB medicines needs to be an integral part of treatment programmes. More research is needed on the development and evaluation of rapid, affordable and accurate portable devices to empower pharmacy inspectors to screen for anti-TB medicines. |
| first_indexed | 2024-03-12T16:16:32Z |
| format | Article |
| id | doaj.art-896382447f8b47f29b44b6c3bba53b94 |
| institution | Directory Open Access Journal |
| issn | 2059-7908 |
| language | English |
| last_indexed | 2024-03-12T16:16:32Z |
| publishDate | 2023-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Global Health |
| spelling | doaj.art-896382447f8b47f29b44b6c3bba53b942023-08-09T03:25:06ZengBMJ Publishing GroupBMJ Global Health2059-79082023-07-018710.1136/bmjgh-2023-012039Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistancePaul N Newton0Patricia Tabernero1Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Vientiane, Lao People`s Democratic RepublicPublic Health Unit, Faculty of Medicine, Universidad de Alcalá, Alcalá de Henares, SpainObjectives Tuberculosis (TB) remains a major global public health problem, especially with the recent emergence of multidrug-resistant TB and extensively drug-resistant TB. There has been little consideration of the extent of substandard and falsified (SF) TB medicines as drivers of resistance. We assessed the evidence on the prevalence of SF anti-TB medicines and discussed their public health impact.Materials/methods We searched Web of Science, Medline, Pubmed, Google Scholar, WHO, US Pharmacopeia and Medicines Regulatory Agencies websites for publications on anti-TB medicines quality up to 31 October 2021. Publications reporting on the prevalence of SF anti-TB drugs were evaluated for quantitative analysis.Results Of the 530 screened publications, 162 (30.6%) were relevant to anti-TB medicines quality; of those, 65 (40.1%) described one or more TB quality surveys in a specific location or region with enough information to yield an estimate of the local prevalence of poor-quality TB medicines. 7682 samples were collected in 22 countries and of those, 1170 (15.2%) failed at least one quality test. 14.1% (879/6255) of samples failed in quality surveys, 12.5% (136/1086) in bioequivalence studies and 36.9% (87/236) in accelerated biostability studies. The most frequently assessed were rifampicin monotherapy (45 studies, 19.5%) and isoniazid monotherapy (33, 14.3%), rifampicin-isoniazid-pyrazinamide-ethambutol fixed dose combinations (28, 12.1%) and rifampicin-isoniazid (20, 8.6%). The median (IQR) number of samples collected per study was 12 (1–478).Conclusions SF, especially substandard, anti-TB medicines are present worldwide. However, TB medicine quality data are few and are therefore not generalisable that 15.2% of global anti-TB medicine supply is SF. The evidence available suggests that the surveillance of the quality of TB medicines needs to be an integral part of treatment programmes. More research is needed on the development and evaluation of rapid, affordable and accurate portable devices to empower pharmacy inspectors to screen for anti-TB medicines.https://gh.bmj.com/content/8/7/e012039.full |
| spellingShingle | Paul N Newton Patricia Tabernero Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance BMJ Global Health |
| title | Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance |
| title_full | Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance |
| title_fullStr | Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance |
| title_full_unstemmed | Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance |
| title_short | Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance |
| title_sort | estimating the prevalence of poor quality anti tb medicines a neglected risk for global tb control and resistance |
| url | https://gh.bmj.com/content/8/7/e012039.full |
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