Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte...d with the Ebola virus:
BCX4430 (Biocryst);
Brincidofovir (Chimerix);
Favipiravir (Fujifilm Corporation/Toyama);
TKM-100802 (Tekmira);
AVI-7537 (Sarepta);
ZMapp (Leafbio Inc.);
Anti-Ebola F(ab’)2 (Fab’entech).
The amount of information available for the seven treatments is highly variable. For some compounds there is no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans, albeit for the treatment of other viral diseases.
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More than 40% of the world population is 24 years old or younger, the vast majority of whom live in low- and lower middle–income countries. Globally, a quarter of disability-adjusted life years (DALYs) for mental disorders and substance abuse is borne by this age group and about 75% of mental diso...rders diagnosed in adulthood have their onset before the age of
24 years . Most children and young people in developing countries, however, do not have access to mental health care.
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Anema et al. AIDS Research and Therapy 2011, 8:13 http://www.aidsrestherapy.com/content/8/1/13
Cardiovascular diseases, principally ischemic heart disease (IHD), are the most important cause of death and disability in the majority of low- and lower-middle-income countries (LLMICs). In these countries, IHD mortality rates are significantly greater in individuals of a low socioeconomic status (...SES).
Three important focus areas for decreasing IHD mortality among those of low SES in LLMICs are (1) acute coronary care; (2) cardiac rehabilitation and secondary prevention; and (3) primary prevention. Greater mortality in low SES patients with acute coronary syndrome is due to lack of awareness of symptoms in patients and primary care physicians, delay in reaching healthcare facilities, non-availability of thrombolysis and coronary revascularization, and the non-affordability of expensive medicines (statins, dual anti-platelets, renin-angiotensin system blockers). Facilities for rapid diagnosis and accessible and affordable long-term care at secondary and tertiary care hospitals for IHD care are needed. A strong focus on the social determinants of health (low education, poverty, working and living conditions), greater healthcare financing, and efficient primary care is required. The quality of primary prevention needs to be improved with initiatives to eliminate tobacco and trans-fats and to reduce the consumption of alcohol, refined carbohydrates, and salt along with the promotion of healthy foods and physical activity. Efficient primary care with a focus on management of blood pressure, lipids and diabetes is needed. Task sharing with community health workers, electronic decision support systems, and use of fixed-dose combinations of blood pressure-lowering drugs and statins can substantially reduce risk factors and potentially lead to large reductions in IHD. Finally, training of physicians, nurses, and health workers in IHD prevention should be strengthened.
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Background
Low- and middle-income countries now experience the highest prevalence and mortality rates of cardiovascular disease.
Main text
While improving the availability and delivery of proven, effective therapies will no doubt mitigate this burden, we posit that studies evaluating cardiovasc...ular disease risk factors, management strategies and service delivery, in diverse settings and diverse populations, are equally critical to improving outcomes in low- and middle-income countries. Focusing on examples drawn from four cardiovascular diseases — coronary artery disease, stroke, diabetes and kidney disease — we argue that ethnicity, culture and context matter in determining the risk factors for disease as well as the comparative effectiveness of medications and other interventions, particularly diet and lifestyle interventions.
Conclusion
We believe that a host of cohort studies and randomized control trials currently being conducted or planned in low- and middle-income countries, focusing on previously understudied race/ethnic groups, have the potential to increase knowledge about the cause(s) and management of cardiovascular diseases across the world.
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The Zimbabwe National Pharmacovigilance Policy Handbook, 2nd Edition updates the November 2013 version to indicate the Zimbabwe National Pharmacovigilance (PV) Centre’s compliance with the WHO Pharmacovigilance Indicators Handbook 2015.
Neurological, Psychiatric, and Developmental Disorders: Meeting the Challenge in the Developing World
Institute of Medicine (US) Committee on Nervous System Disorders in Developing Countries.
Washington (DC): National Academies Press (US); 2001.
The MSF qualification scheme is concerned with the pharmaceutical quality assessment for drugs. This procedure is applicable to products for international supply, i.e. products supplied through the MSF procurement centres. This qualification procedure is not applicable for local purchase, i.e. purch...ase of drugs within the project countries. For quality assurance principles and assessment of drugs for local purchase refer to the guideline for local pharmaceutical market assessment.
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Dans certaines parties d’Afrique, la transmission du paludisme a lieu principalement pendant les trois ou quatre mois de la saison des pluies. Environ 39 millions d’enfants de moins de cinq ans vivent dans les zones de transmission saisonnière, où on dénombre environ 34 millions de cas et où... plus de 150.000 enfants meurent chaque année. La CPS est une intervention préventive ciblant spécifiquement les enfants vivant dans ces régions. La CPS, appelée autrefois traitement préventif intermittent chez l’enfant, est « l’administration intermittente d’un traitement complet par un médicament antipaludique pendant la saison du paludisme afin de prévenir la
maladie, avec pour objectif de maintenir les concentrations sanguines du médicament antipaludique à des taux thérapeutiques pendant toute la période où le risque de paludisme est le plus élevé. »
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This curriculum was designed to train newly recruited health care workers (HCW) in the basic knowledge and skills needed to improve different HIV services within the health facility including identification, linkage, retention and support. In addition to HIV basics, the training has supplementary un...its focused on PMTCT, psychosocial support, opportunistic infections, tuberculosis and HIV, nutrition and family planning in order to give a more well-rounded and comprehensive training of related topics.
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PLOS Medicine | https://doi.org/10.1371/journal.pmed.1002514 March 1, 2018
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
Research Article
PLOS Medicine | https://doi.org/10.1371/journal.pmed.1002625 July 31, 2018 / 1-19
Reproductive health needs are particularly acute in countries affected by armed conflict. Reliable information
on aid investment for reproductive health in these countries is essential for improving the efficiency and effectiveness of
aid. The purpose of this study was to analyse official developm...ent assistance (ODA) for reproductive health activities in
conflict-affected countries from 2003 to 2006.
Methods and Findings: The Creditor Reporting Syst
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