E-DRUG: Quality assurance in anti-tuberculosis drug procurement by the Stop TB Partnership - Global Drug Facility
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Dear E-druggers,
I am happy to share with you our recently published article “Quality
assurance in anti-tuberculosis drug procurement by the Stop TB
Partnership - Global Drug Facility
We hope that our description of the procedures and outcomes of GDF's
quality assurance/quality control (QA/QC) efforts may provide a
benchmark for other organisations to evaluate and improve their
procedures in the assurance of medicine quality in drug procurement.
Also, our comparison of the analytical results provided by the
manufacturers and by the external quality control agent may encourage
other organisations to systematically record and analyse such data in
future, which may expand and improve the basis for the evaluation of
QA/QC data within and between organisations.
The article can be accessed using the following link:
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0243428
Abstract
Background: Quality-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.
Methods: 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 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.
Results: All 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.
Conclusions: GDF'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.
Kind regards,
Cathrin Hauk
Cathrin Hauk
Apothekerin, Doktorandin
Eberhard Karls Universitat Tuebingen
Pharmazeutische Biologie, Pharmazeutisches Institut
Auf der Morgenstelle 8, 72076 Tuebingen
Email: cathrin.hauk@uni-tuebingen.de