Abstract
BackgroundQuality-assured medicines are a principal means of achieving health-related Sustainable Development Goals. An example of quality assurance/quality control (QA/QC) procedures in drug procurement is provided by the operation of the Global Drug Facility (GDF) of the Stop TB Partnership, the largest provider of tuberculosis (TB) medicines to the public sector worldwide.MethodsProcedures 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 in the laboratories of GDF’s external quality control agent (QCA). Assay and dissolution results determined by the manufacturers and by the external QCA were compared using Bland-Altman analysis.ResultsAll investigated batches of medicines were in specifications at the time of shipment. The costs for QA/QC were 0.8% of purchase costs. The median time required for chemical analysis was 10 working days. Comparison of the medicine quality analysis results showed for the poorly water-soluble compound rifampicin a bias of 4.4%, with the manufacturers reporting higher values than the external QCA, most likely due to different methods employed for the analysis. Overall 95% limits of agreement (LOAs) were -6.7 to +8.0% for assay, and -10.1 to +11.8% for dissolution. In case of kanamycin injections, 95% LOAs for assay reached -14.5 to +13.2%, largely attributable to samples from one manufacturer who had used a microbiological assay while the external QCA had used an HPLC assay.ConclusionsGDF’s procedures represent a useful benchmark when evaluating QA/QC procedures of other medicine procurement operations. Inter-laboratory comparison using Bland-Altman plots allows to investigate bias and variability in medicine quality control and should be considered as a routine procedure by drug procurement agencies, to identify priorities for further improvements.
Highlights
Improving access to quality-assured medicines is a principal means of achieving health-related Sustainable Development Goals and Universal Health Coverage [1]
Comparison of the medicine quality analysis results showed for the poorly water-soluble compound rifampicin a bias of 4.4%, with the manufacturers reporting higher values than the external quality control agent (QCA), most likely due to different methods employed for the analysis
Global Drug Facility (GDF)’s quality assurance/quality control (QA/quality control (QC)) procedures have proven to represent a very successful model to ensure uninterrupted access to quality-assured medicines at low prices. These procedures should be used as a benchmark when evaluating and improving quality assurance (QA)/QC procedures of other medicine procurement operations, both within and beyond the area of anti-TB medicines
Summary
Improving access to quality-assured medicines is a principal means of achieving health-related Sustainable Development Goals and Universal Health Coverage [1]. The scientific literature is virtually devoid of detailed empirical data on procedures, costs and time requirements of quality assurance/ quality control (QA/QC) in drug procurement Such data are needed especially at present, since stagnating donor health funding forces many countries to expand their national procurement processes, including medicine procurement for AIDS, tuberculosis (TB) and malaria [7]. This can introduce the risk of purchasing medicines of unknown quality, and thereby exacerbate the growing global health challenge of serious drug-resistant infections [7, 8]. An example of quality assurance/quality control (QA/QC) procedures in drug procurement is provided by the operation of the Global Drug Facility (GDF) of the Stop TB Partnership, the largest provider of tuberculosis (TB) medicines to the public sector worldwide
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