Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance

Tabernero, Patricia; Newton, Paul N.

doi:10.1136/bmjgh-2023-012039

Cited by 3 publications

(1 citation statement)

References 65 publications

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“…This scourge is also affecting the socioeconomic aspect of many countries. 2,[5][6][7][8] Detection is an essential cornerstone for the identification of SF medicines and therefore for their quarantine and withdrawal from the supply chain. This detection has traditionally been possible thanks to pharmacopeial methods.…”

Section: Introductionmentioning

confidence: 99%

In-Field Implementation of Near-Infrared Quantitative Methods for Analysis of Medicines in Tropical Environments

Waffo Tchounga,

Marini,

Nnanga Nga

et al. 2023

Appl Spectrosc

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Near-infrared (NIR) spectroscopy is actually a well-established technique that demonstrates its performance in the frame of detection of poor-quality medicines. The use of low-cost handheld NIR spectrophotometers in low-resource contexts can allow an inexpensive and more rapid detection compared to laboratory methods. Considering these points, it was decided to develop, validate, and transfer methods for the quantification of ciprofloxacin and metronidazole tablet samples using a NIR handheld spectrophotometer in transmission mode (NIR-M-T1) coupled to chemometrics such as partial least squares regression (PLSR) algorithm. All of the models were validated with the total error approach using an accuracy profile as a decision tool, with ±10% specifications and a risk α set at 5%. Quantitative PLSR models were first validated in Belgium, which is a temperate oceanic climate zone. Second, they were transferred to Cameroon, a tropical climate zone, where issues regarding the prediction of new validation series with the initial models were highlighted. Two augmentation strategies were then envisaged to make the predictive models robust to environmental conditions, incorporating the potential variability linked to environmental effects in the initial calibration sets. The resulting models were then used for in-field analysis of ciprofloxacin and metronidazole tablet samples collected in three cities in Cameroon. The contents results obtained for each sample with the two strategies were close and not statistically different. Nevertheless, the first one is easier to implement and the second is the best regarding model diagnostic measures and accuracy profiles. Two samples were found to be noncompliant in terms of content, and these results were confirmed using high-performance liquid chromatography taken as the reference method.

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Section: Introductionmentioning

confidence: 99%

In-Field Implementation of Near-Infrared Quantitative Methods for Analysis of Medicines in Tropical Environments

Waffo Tchounga,

Marini,

Nnanga Nga

et al. 2023

Appl Spectrosc

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Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance

Tabernero

Newton

2023

BMJ Glob Health

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ObjectivesTuberculosis (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/methodsWe 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.ResultsOf 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).ConclusionsSF, 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.

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Effect of Different Levofloxacin Doses on QTc Interval Prolongation in Multidrug-Resistant Tuberculosis Patients Treated with the 9-Month All-Oral Regimen

Soedarsono,

Rampengan,

Agustiyanto

et al. 2024

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Introduction: The World Health Organization (WHO) has recommended the 9-month all-oral regimen for multidrug-resistant tuberculosis (MDR-TB) treatment. This regimen is expected to increase the treatment success rate. Bedaquiline, levofloxacin, and clofazimine are QT-prolonging drugs included in the 9-month all-oral regimen. Bedaquiline and clofazimine are given at the same dose for all patients, while levofloxacine dose is given in 750 mg and 1,000 mg based on the body weight. This study analyzed the correlation between different levofloxacin doses and certain factors on QTc interval prolongation. Methods: This observational retrospective study used the medical records of MDR-TB patients who underwent the 9-month all-oral regimen. Electrocardiography (ECG) for QTc interval measurement was recorded at the baseline before and 2 weeks after treatment. The measured variables included patient demographic data, body mass index (BMI), electrolyte levels, and comorbidities. Results: Thirty MDR-TB patients were included in this study. Gender, diabetes mellitus (DM), and levofloxacin dose did not correlate with QTc interval prolongation at 2 weeks after drug administration (p-values of 0.558, 0.197, and 0.134, respectively). Age, potassium level, magnesium level, calcium level, and baseline QTc interval also did not correlate with QTc interval prolongation at 2 weeks after drug administration (p-values of 0.433, 0.479, 0.705, 0.746, and 0.333, respectively). Multivariate analysis showed that the risk factor associated with QTc interval prolongation at 2 weeks after drug administration was a BMI of 0.013. Conclusion: Different levofloxacin doses did not correlate with QTc interval prolongation in MDR-TB patients treated with the 9-month all-oral regimen. The incidence of QTc interval prolongation was significantly associated with the lower BMI level.

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Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance

Cited by 3 publications

References 65 publications

In-Field Implementation of Near-Infrared Quantitative Methods for Analysis of Medicines in Tropical Environments

In-Field Implementation of Near-Infrared Quantitative Methods for Analysis of Medicines in Tropical Environments

Estimating the prevalence of poor-quality anti-TB medicines: a neglected risk for global TB control and resistance

Effect of Different Levofloxacin Doses on QTc Interval Prolongation in Multidrug-Resistant Tuberculosis Patients Treated with the 9-Month All-Oral Regimen

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