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.
Subject(s)
Antitubercular Agents/standards , Public-Private Sector Partnerships/standards , Quality Control , Sustainable Development , Tuberculosis/drug therapy , Antitubercular Agents/chemistry , Antitubercular Agents/therapeutic use , Chemistry, Pharmaceutical/economics , Chemistry, Pharmaceutical/methods , Chemistry, Pharmaceutical/standards , Costs and Cost Analysis , Humans , Retrospective Studies , SolubilityABSTRACT
Республика Молдова входит в число 18 приоритетных стран для борьбы с туберкулезом (ТБ) в Европейском регионе ВОЗ и 27 стран мира с высоким бременем ТБ с множественной лекарственной устойчивостью (МЛУ-ТБ). Согласно классификации Глобального фонда для борьбы со СПИДом, туберкулезом и малярией, Республика Молдова занимает второе место среди 110 стран по уровню средств, выделяемых на душу населения. Вторая фаза реализации консолидированного гранта в рамках раундов 8 и 9 была одобрена в декабре 2012 года с условием представления на следующем этапе обзорной оценки Национальной программы по туберкулезу и стратегического плана (на основе этой обзорной оценки) по усилению приверженности лечению и снижению числа пациентов, результаты лечения которых неизвестны. Серьезную озабоченность вызывал тот факт, что, как показала оценка, осуществление мер вмешательства и поддержка оказали лишь ограниченное воздействие на улучшение результатов лечения. В октябре 2012 года Министерство здравоохранения обратилось в Европейское региональное бюро ВОЗ с просьбой обеспечить координацию обзорной оценки Национальной программы по туберкулезу.
Subject(s)
Epidemiology , Health Care Economics and Organizations , National Health Programs , Tuberculosis , Tuberculosis, Multidrug-Resistant , Tuberculosis, PulmonaryABSTRACT
The Republic of Moldova is among the WHO European Region’s 18 high-priority countries for tuberculosis (TB) control and among the world’s 27 high multidrug-resistant TB (MDR-TB) burden countries. The Global Fund to Fight AIDS, Tuberculosis and Malaria ranks the Republic of Moldova second among 110 countries by level of funds provided per capita. The second phase of implementation of its consolidated Round 8 and 9 TB grant was approved in December 2012 with a request to submit, at a later stage, a review of the National TB Programme and a strategic plan (based on the review) to improve treatment compliance and reduce loss to treatment follow up. A major concern highlighted was that supported interventions have shown only a limited impact in improving treatment success. In October 2012 the Ministry of Health asked the WHO Regional Office for Europe to coordinate the review of the National TB Programme.The review took place from 4 to 15 February 2013. Twelve international and seven national experts participated, visiting 18 districts and three municipalities, the autonomous region of Gagauzia and the Transnistria region. The review team developed a strategic plan to improve treatment compliance and reduce loss to treatment follow up immediately after the review; this appears as part of the roadmap attached to this report (Annex 1). The team members conveyed their key findings and recommendations at the end of the mission to the Minister of Health.