Quality of fixed dose artemether/lumefantrine products in Jimma Zone, Ethiopia

Background: Malaria caused by Plasmodium vivax and Plasmodium falciparum is among the major public health problems in most endemic areas of the world. Artemisinin-based combination therapy (ACT) has been recommended as a first-line treatment for uncomplicated Plasmodium falciparum malaria almost in all endemic regions. Since ineffectively regulated medicines in resource limited settings could favour infiltration of poor quality anti-malarial medicines into pharmaceutical supply chain and jeopardize a positive treatment outcome, regular monitoring of the quality of anti-malarial medicines is critical. Thus, the aim of this study was to assess the quality of fixed dose combination (FDC) artemether (ART)/lumefantrine (LUM) tablets available in Jimma zone, Ethiopia. Methods: This study was conducted in Jimma zone, Ethiopia. A total of 74 samples of FDC ART/LUM (20mg ART/120mg LUM) tablets were collected from 27 public facilities. All samples were subjected to visual inspection and the relevant information was recorded. The samples were transported to Jimma University Laboratory of Drug Quality (JuLaDQ) and stored at ambient temperature (20 degrees C to 25 degrees C) until analysis. The Pharmacopoeial conform/non-conform methods and the risk-based Derringer's desirability function approach were employed to assess the pharmaceutical quality of the investigated products. Results: The visual inspection results revealed that there were no signs of falsified in the investigated products. Identification test results of samples indicated that all samples contained the stated active pharmaceutical ingredients (APIs). The results of uniformity of mass indicated that all samples complied with International Pharmacopoeial specification limits. The assay results, expressed as percent label claim (%lc) of ART (89.8 to 108.8%, meanSD=99.1 +/- 3.9%) and LUM (90.0 to 111.9%, mean +/- SD=98.2 +/- 3.8%) revealed that, all samples complied with International Pharmacopoeia acceptance specification limits (i.e. 90-110%lc), except one generic product (IPCA Laboratories Ltd., India) which contains excessive LUM (111.9 +/- 1.7%lc). The risk priority number (RPN) results revealed that assay (RPN=392) is relatively the most critical quality attribute followed by identity (RPN=280) and mass uniformity (40). Quality evaluation based on psycho-physical Harrington's scale revealed that more than 96% of samples were within the acceptable ranges (D >= 0.7-1.0). Conclusions: Both Pharmacopoeial and risk-based desirability function approaches to quality evaluation applied to the investigated products revealed that above 96% FDC ART/LUM tablets circulating in public settings of Jimma zone are of good quality

Drug and Therapeutics Committee (DTC) evolvement and expanded scope in Ethiopia [version 2; peer review: 2 approved]

As a key partner of Ministry of Health (MOH) Ethiopia, The Clinton Health Access Initiative (CHAI) had been implementing the Child Survival Project (CSP) since October 2015. Strengthening DTC was one of its focuses to improve overall supply chain management (SCM). The objective of this study are to review the evolution of DTCs in Ethiopia from their early years to current practice and identify the major driving and hindering factors for their functionality. A descriptive mixed study design was employed. The study made use of qualitative data supplemented with quantitative data, generated from both primary and secondary sources through key informant interviews and desk review methods. DTCs were introduced in Ethiopia in the early 1980s. The mandate of DTCs has been given to four different government organizations during that time. As a result, due to a lack of coordination among these organizations, its implementation was lagging. Recently, the government and its partners have given attention to DTCs. More than 5847 professionals underwent DTC training from 2016 onwards. DTC establishment in health facilities improved from 85% to 98% between 2015 and 2019 during baseline and end-line assessments carried out by CHAI/CSP. Similarly, DTC functionality in HFs improved from 20% to 63%. The CHAI/CSP regular supervision data analysis revealed that DTC establishment improved from 83% to 100% of HFs, while its functionality improved from 5% to 72% between 2016 and 2019, respectively. A chi-square test of independence examining the relationship between facility and pharmacy head training on DTCs and functionality of DTC in the same facility revealed a significant association between the two variables at p<0.0001. Conclusions: Providing consistent capacity building and availing strong monitoring and evaluation system improves functionality of DTCs. Moreover, national coordinating bodies for DTCs and similar structures at Regional Health Bureaus and woreda health offices should be established

Estimativas de parâmetros genéticos, diversidade molecular baseada em SNPs em Coffea canephora

The objective of this work was to assess the genetic parameters in Coffea canephora (Robusta and Conilon groups) and to analyze the genetic diversity of C. canephora accessions, which were genotyped with SNPs molecular markers. The phenotypic data were analyzed using the mixed model methodology (REML/BLUP) through the Selegen software for estimation of genetic parameters. The results showed a low genetic variability (CVg%) among the clones of Robusta and Conilon for all the evaluated traits. On the other hand, relatively high residual coefficients of variation (CV%) for most of the traits were recorded implying that these traits seem to be highly influenced by the environmental variation. The estimated repeatability for most of the traits was lowest indicating the irregularity of the superiority of the individuals among the measurements for these characters in the case of both clones showing high irregularity of the performance across measurement, which demonstrate that genotype selection based on those traits is not reliable strategy. Generally, for both groups of clones, there was low interaction with year, as observed by the genotypic correlation across measurement (rgmed) for most of the characters evaluated demonstrating that selection can be performed at any of the development stages used for measurement. Genetic diversity was investigated using 46074 polymorphic SNP markers covering the entire genome of 50 C. canephora clones (24 Conilon and 26 Robusta). The genetic similarity between each pair of clones was calculated by the Jaccard coefficient and information about diversity among clones was inferred by means of the dendrogram built using UPGMA method (Unweighted Pair-Group Method with Arithmetic Mean) with the program NTSYS pc2.1. Hence, the dendrogram divided the clones into six groups. Generally, the analysis showed that the C. canephora genotypes were clearly divided into diversity groups that can be used for breeding programs.O objetivo deste trabalho foi avaliar os parâmetros genéticos e diversidade genética de Coffea canephora (grupo Robusta e Conilon) genotipados com marcadores moleculares SNPs. Os dados fenotípicos foram analisados utilizando a metodologia de modelos mistos (REML/BLUP) por meio do programa Selegen. Os resultados mostraram uma baixa variabilidade genética entre os clones de Robusta e Conilon para todas as características avaliadas. Por outro lado, coeficiente de variação relativamente elevado foi observado para a maioria das características, o que implica que estas características parecem ser altamente influenciadas pela variação ambiental. A repetibilidade estimada para a maioria das características foi menor, indicando a irregularidade da superioridade dos indivíduos entre as medições para esses caracteres no caso de ambos os clones com elevada irregularidade do desempenho por meio de medição, o que demonstra que a seleção do genótipo com base nessas características é uma estratégia não confiável. Em geral, para ambos os grupos, houve baixa interação com ano, como foi observado por meio da correlação entre genótipos de medição (rgmed) para a maioria dos caracteres avaliados. Esse resultado demonstrou que a seleção pode ser realizada em qualquer fase de desenvolvimento usada para a medição. Para estudo de diversidade genética foi utilizado 46074 marcadores SNP polimórficos que cobrem todo o genoma de 50 clones de C. canephora (24 Conilon e 26 Robusta). A estimativa de similaridade genética entre cada par de indivíduos foi calculada pelo coeficiente de Jaccard e diversidade entre clones foi obtida pela construção do dendrograma pelo método UPGMA (Unweighted Pair- Group Method with Arithmetic Mean) usando o programa NTSYS pc2.1. Por meio do dendograma, os clones form dividos em seis grupos. A análise mostrou que os genótipos de C. canephora foram divididos em grupos de diversidade que podem ser usados para outros programas de melhoramento genético

Psychoactive substance uses among people living with HIV/AIDS in Western Ethiopia: a multi-centered facility-based cross-sectional study

Background: Substance use is very prevalent among HIV-infected people. We examined psychoactive substance use and tobacco smoking among people living with HIV/AIDS in West Ethiopia. Methods: An institutional-based cross-sectional study was conducted. Bivariable and multivariable logistic regressions were done to identify the factors associated with alcohol intake, current smoking, and khat use. The variables found significant with a p-value <.2 at bivariable were treated as candidates for the multivariable regression model. P-values of <.05 and 95% CI level were used as statistically significant differences for the final models. Results A total of 418 participants were included in the study, making the response rate 88%. About 152 (36.4%) were khat chewers (36.4, 95% CI: 31.6-40.9) and 175 (41.9%) with 95% CI (37.6-46.4) of them are current smokers. Lack of formal education (AOR = 3.82, 95% CI: 1.36, 10.67), strong social support (AOR = 0.27; 95% CI: 0.12, 0.59), urban resident (AOR = 3.52, 95%CI: 1.32, 9.34), and being single (AOR = 11.84; 95% CI: 2.4, 8.57) were found to be significantly associated with psychoactive substance use among people living with HIV/AIDS. Conclusion This study found that there are higher psycho-active substance users among people infected with HIV compared to the national data level of the same group of population

Psychoactive substance uses among people living with HIV/AIDS in Western Ethiopia: a multi-centered facility-based cross-sectional study

Background: Substance use is very prevalent among HIV-infected people. We examined psychoactive substance use and tobacco smoking among people living with HIV/AIDS in West Ethiopia. Methods: An institutional-based cross-sectional study was conducted. Bivariable and multivariable logistic regressions were done to identify the factors associated with alcohol intake, current smoking, and khat use. The variables found significant with a p-value < .2 at bivariable were treated as candidates for the multivariable regression model. P-values of < .05 and 95% CI level were used as statistically significant differences for the final models. Results: A total of 418 participants were included in the study, making the response rate 88%. About 152 (36.4%) were khat chewers (36.4, 95%CI: 31.6–40.9) and 175 (41.9%) with 95% CI (37.6–46.4) of them are current smokers. Lack of formal education (AOR = 3.82, 95% CI: 1.36, 10.67), strong social support (AOR = 0.27; 95% CI: 0.12, 0.59), urban resident (AOR = 3.52, 95%CI: 1.32, 9.34), and being single (AOR = 11.84; 95% CI: 2.4, 8.57) were found to be significantly associated with psychoactive substance use among people living with HIV/AIDS. Conclusion: This study found that there are higher psycho-active substance users among people infected with HIV compared to the national data level of the same group of population