scholarly journals Quality Assessment of Solid Pharmaceuticals and Intravenous Fluid Manufacturing in Sub-Saharan Africa

Author(s):  
Adedibu C. ◽  
Musa O. ◽  
Lyabo M. ◽  
Ojeyemi M. ◽  
George O.
2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
D Macquart De Terline ◽  
P Zabsonre ◽  
D Balde ◽  
S Ikama ◽  
R N Guetta ◽  
...  

Abstract Introduction Hypertension results in more deaths than any other risk factor and has been on the rise in Sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. Purpose We performed a quality assessment of five commonly used antihypertensive generic drugs in ten Sub-Saharan African countries and studied the impact of price on quality. Methods Drug samples were prospectively collected using standardized methods between 2012 and 2014. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Quality was defined based on the percentage ratio of measured to expected dosage of active ingredient. Results A total of 1185 samples were assessed, of which 70.0% were generic (n=830). Among the generic drugs, the percentage of poor quality drugs was 24.3% (n=202/830). The percentage ratio of measured to expected dosage of active ingredient ranged from 49.2% to 111.3%; the majority (81.7%) of the poor quality samples had insufficient quantity of the active ingredient. Moreover, poor quality was not associated with purchase price of the drug. Conclusion In this study from ten Sub-Saharan African countries, nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality. Concerted measures to improve the quality of antihypertensive drugs could lead to major improvements in hypertension control with attendant reduction of its deleterious consequences in low and middle income countries. Figure 1. Percentage of poor quality in generic antihypertensive drugs according to the country of purchase. Acknowledgement/Funding Grant AAP-2014-042, ANSM (Agence Nationale Sécurité du Médicament


2020 ◽  
Author(s):  
Benjamin Peter Silberberg ◽  
Stephen Aston ◽  
Selda Boztepe ◽  
Jamie Rylance

Abstract Background Sepsis guidelines are widely used in High Income Countries and intravenous fluids are an important supportive treatment modality. However, fluids have been harmful in intervention trials in Low-Income Countries, most notably in sub-Saharan Africa. We assessed the relevance, quality and applicability of available guidelines for the fluid management of adult patients with sepsis in this region. Methods We identified sepsis guidelines by systematic review with broad search terms, duplicate screening and data extraction. We included peer-reviewed publications with explicit relevance to sepsis and fluid therapy. We excluded those designed for specific medical conditions, for limited geographic locations, or for non-adult populations. We used the AGREE II tool to assess the quality of guideline development, performed a narrative synthesis and using theoretical case scenarios to assess practical applicability to everyday clinical practice in resource-constrained settings. Results Published sepsis guidelines are heterogeneous in sepsis definition and in quality: 8/10 guidelines had significant deficits in applicability, particularly with reference to resource considerations in low-income settings. Indications for intravenous fluid were: hypotension (8/10); clinical markers of hypoperfusion (6/10); lactataemia (3/10). Crystalloids were overwhelmingly recommended (9/10). Suggested volumes varied; 5/10 explicitly recommended “fluid challenges” with reassessment, totalling between 1L and 4L during initial resuscitation. Fluid balance, including later de-escalation of therapy was not specifically described in any. Norepinephrine was the preferred initial vasopressor (5/10), specifically targeted to MAP >65mmHg (3/10), with higher values suggested in pre-existing hypertension (1/10). Recommendations for guidelines were almost universally derived from evidence in High Income Countries. None of the guidelines suggested any refinement for patients with malnutrition. Conclusions Widely used international guidelines contain disparate recommendations on intravenous fluid use, lack specificity and are largely unattainable in Low-Income Countries given available resources. A relative lack of high-quality evidence from sub-Saharan Africa increases reliance on recommendations which may not be relevant or implementable.


2021 ◽  
Author(s):  
Ryan Ruff

The Jomtien World Conference and the Dakar World Education Forum declared Education for All (EFA) as a primary policy goal of countries in sub-Saharan Africa. Malawi, a participant of both Jomtien and Dakar, first achieved EFA through its Free Primary Education policy of 1994. However, this early effort resulted in a number of unintended consequences typical of EFA, including negative impacts on educational system quality. In this paper, a quality assessment framework is used to evaluate whether Malawian EFA policies were designed with the necessary support for an effective universal primary educational system as defined by planning, social barriers, budgetary limitations, and educational quality. Two policy phases were evaluated, each a ten year period following Jomtien (1990-2000) and Dakar (2000-2010). Results indicate that EFA polices in the Jomtien phase often failed to consider social and structural considerations necessary to improve the educational experience, which belied a quantitative achievement of universal primary education. While policies in the Dakar phase addressed many of the quality deficiencies of the previous era, lingering issues such as enrollment and retention remained.


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e036988
Author(s):  
Kelechi Elizabeth Oladimeji ◽  
Armstrong Dzomba ◽  
Olatunji Adetokunboh ◽  
Lindiwe Zungu ◽  
Sanni Yaya ◽  
...  

IntroductionSub-Saharan Africa remains the epicentre of the HIV pandemic, yet enormous knowledge gaps still exist to elicit a comprehensive portrait of multimorbidity and HIV linkage. This study aims to conduct a systematic meta-analysis of peer-reviewed literature to investigate the current status of multimorbidity epidemiology among people living with HIV (PLHIV) in sub-Saharan Africa.Methods and analysisOur review will assess observational studies (ie, cohort, case–control and cross-sectional) on multimorbidity associated with HIV/AIDS between 1 January 2005 and 31 October 2020 from sub-Saharan Africa. Databases to be searched include PubMed/MEDLINE, Scopus, Web of Science, Cochrane library, African Index Medicus and African Journals Online. We will also search the WHO clinical trial registry and databases for systematic reviews. The search strategy will involve the use of medical subject headings and key terms to obtain studies on the phenomena of HIV and multimorbidity at high precision. Quality assessment of eligible studies will be ascertained using a validated quality assessment tool for observational studies and risk of bias through sensitivity analysis to identify publication bias. Further, data on characteristics of the study population, multimorbid conditions, epidemiological rates and spatial distribution of multimorbid conditions in PLHIV will be extracted. Heterogeneity of individual studies will be evaluated using the I2 statistic from combined effect size estimates. The statistical analysis will be performed using STATA statistical software V.15 and results will be graphically represented on a forest plot.Ethics and disseminationEthical approval is not applicable in this study as it is a systematic review of published literature. The review findings may also be presented at conferences or before other relevant stakeholders.PROSPERO registration numberCRD42020148668.


2018 ◽  
Vol 12 (48) ◽  
pp. 1067-1072
Author(s):  
Ahua René KOFFI ◽  
Nadège KOUADIO-N’GBESSO ◽  
Timothée OUASSA ◽  
Koua ATOBLA ◽  
N’Zébo Désiré KOUAME ◽  
...  

2017 ◽  
Vol 1 (6) ◽  
pp. 533-537
Author(s):  
Lorenz von Seidlein ◽  
Borimas Hanboonkunupakarn ◽  
Podjanee Jittmala ◽  
Sasithon Pukrittayakamee

RTS,S/AS01 is the most advanced vaccine to prevent malaria. It is safe and moderately effective. A large pivotal phase III trial in over 15 000 young children in sub-Saharan Africa completed in 2014 showed that the vaccine could protect around one-third of children (aged 5–17 months) and one-fourth of infants (aged 6–12 weeks) from uncomplicated falciparum malaria. The European Medicines Agency approved licensing and programmatic roll-out of the RTSS vaccine in malaria endemic countries in sub-Saharan Africa. WHO is planning further studies in a large Malaria Vaccine Implementation Programme, in more than 400 000 young African children. With the changing malaria epidemiology in Africa resulting in older children at risk, alternative modes of employment are under evaluation, for example the use of RTS,S/AS01 in older children as part of seasonal malaria prophylaxis. Another strategy is combining mass drug administrations with mass vaccine campaigns for all age groups in regional malaria elimination campaigns. A phase II trial is ongoing to evaluate the safety and immunogenicity of the RTSS in combination with antimalarial drugs in Thailand. Such novel approaches aim to extract the maximum benefit from the well-documented, short-lasting protective efficacy of RTS,S/AS01.


1993 ◽  
Vol 47 (3) ◽  
pp. 555-556
Author(s):  
Lado Ruzicka

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