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Section 4: Clinical pharmacy services
4CPS-059 Seventeen drugs, one sample: analysing multiple anti-tuberculosis drugs simultaneously using one method
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  1. M Bolhuis1,
  2. E Jongedijk1,
  3. O Akkerman2,
  4. D Touw3,
  5. M Sturkenboom1
  1. 1University Medical Center Groningen, Clinical Pharmacy and Pharmacology, Groningen, The Netherlands
  2. 2University Medical Center Groningen, Pulmonary Diseases and Tuberculosis- Tb Center Beatrixoord, Groningen, The Netherlands
  3. 3University Medical Center Groningen, Clinical Pharmacy and Pharmacology- University of Groningen- Department of Pharmaceutical Analysis- Groningen Research Institute of Pharmacy, Groningen, The Netherlands

Abstract

Background and Importance In 2021, a total of 1.6M people died from tuberculosis (TB), although it is a preventable and curable disease. Depending on susceptibility, TB is treated with a combination of several of 20 anti-TB drugs from the World Health Organization (WHO) treatment guidelines. Interindividual variability may result in toxicity or ineffective treatment. Therapeutic drug monitoring (TDM) can be used to optimise dosing and treatment. However, several analyses may be needed, which is time consuming, expensive, and may result in needing multiple samples from a patient.

Aim and Objectives Therefore, we aimed to develop a simple method to analyse all anti-TB drugs in one analysis.

Material and Methods We developed a liquid chromatography tandem mass spectrometry (LC-MS/MS) method in plasma, serum or saliva, allowing simultaneous analysis of 17 anti-TB drugs and 6 metabolites. The runtime of any combination of these 17 drugs only takes 1.7 minutes. We checked all standard parameters assuring the quality of our analysis and checked the expiry of the samples at different temperatures, allowing extrapolation to low-income countries.

Results With this method, we are able to analyse all first-line and most second-line anti-TB drugs, if processed immediately (e.g. pretomanid, delamanid, levofloxacin, moxifloxacin, gatifloxacin, bedaquiline, linezolid, tedizolid, clofazimine, ethionamide, prothionamide, rifapentine, and rifabutin) using a method that was validated according to the EMA Guidance.

Conclusion and Relevance In conclusion, we developed a method to analyse 17 anti-TB drugs simultaneously in one sample of plasma, serum or saliva: all first-line, BPaLM (bedaquiline, pretomanid, linezolid, and moxifloxacin), and 9m all oral regimen for multidrug-resistant/rifampicin resistant (MDR/RR-TB) drugs, and 63% of the longer MDR-TB regimen drugs. This method will save time and will further optimise therapeutic drug monitoring.

References and/or Acknowledgements N/A

Conflict of Interest No conflict of interest.

https://doi.org/10.1136/ejhpharm-2024-eahp.163

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