Study and publication on quality assurance of anti-tuberculosis drugs - the Stop TB Partnership/Global Drug Facility experience

01.01.2018 bis 31.05.2018

Arguably, the most effective intervention to counter the problem of substandard and falsified medicines is to strengthen quality assurance in drug procurement. Quality-assured medicines are of particular importance in the case of anti-tuberculosis medicines since poor quality anti-TB medicines are among the drivers of the emergence of drug-resistant TB pathogens. The Global Drug Facility (GDF) of the Stop TB Partnership, founded in 2001, is the world’s largest provider of TB products for national TB control programs. In this project, carried out in a collaboration between the group of Prof. Lutz Heide at Tübingen University, Germany, and the team of GDF in Geneva, Switzerland, procedures and results of GDF’s quality assurance/quality control (QA/QC) over the five-year period 2013-2017 were analysed retrospectively. 13,999 batches of 51 different medicines had been procured and reviewed within this period. 1,388 of these batches had been analysed by an external quality control agent of GDF. This study analyzes the procedures, costs and time requirements of this operation. The reported data may provide a benchmark for other organizations to evaluate and improve their procedures in the assurance of medicine quality in drug procurement. In addition, assay and dissolution results reported by the manufacturers were compared to those reported by the external quality control agent of GDF, revealing analytical challenges in case of kanamycin assay and rifampicin dissolution testing. These observations may encourage other organizations to systematically record and analyze such data in future, which can expand and improve the basis for the evaluation of QA/QC data within and between organizations.

Hauk C, Schäfermann S, Martus P, Muzafarova N, Babaley M, Waning B, Heide L: Quality assurance in anti-tuberculosis drug procurement by the Stop TB Partnership - Global Drug Facility: Procedures, costs, time requirements, and comparison of assay and dissolution results by manufacturers and by external analysis. PLOS ONE 15(12): e0243428. https://doi.org/10.1371/journal.pone.0243428