Standard Operating Procedure
West Africa is experiencing the largest, most severe, most complex outbreak of Ebola virus disease in history. On 11 August 2014, WHO convened a consultation where the participants concluded that in the particular context of the current Ebola outbreak in West Africa, it is ethically acceptable to of...fer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluat-
ed for safety and efficacy in humans as potential treatment or prevention
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This interim guidance to national health authorities and blood transfusion services outlines the steps required to collect convalescent whole blood (CWB) or plasma (CP) from Ebola virus disease (EVD) recovered patients for transfusion to patients with early EVD, as an empirical treatment modality.
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Document contents:
Guidance on donor selection, screening, donation and handling of blood and plasma units;
guidance on transfusion of convalescent whole blood or plasma;
other considerations.
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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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You can download the handbook, worksheets and quick reference cards from the website!
The HHEAT is an ethical analysis tool designed to help humanitarian healthcare workers make ethical decisions. It consists of 3 components: (1) a summary card highlighting key questions, (2) a handbook providing a...n overview of the tool, and (3) a worksheet for recording the decision-making process. The tool was inspired by research examining ethical challenges and moral distress experienced by humanitarian workers. The HHEAT has been tested and validated by humanitarian workers and experts from the fields of humanitarian medicine and nursing, as well as applied ethics.
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Antimicrobial Resistance and Infection Control 2014,3 :31
Plos Neglected Tropical Diseases 8(11): e3229 (20 November 2014)
Sub-Saharan African Journal of Medicine: Year : 2014 | Volume : 1 | Issue : 1 | Page : 1-14
PLOS ONE | www.plosone.org 1
January 2014 | Volume 9 | Issue 1 | e86616
This guide is a resource for physicians and other health care professionals who provide care and treatment to patients with drug-resistant tuberculosis.
There is no guarantee that a successful pilot program introducing a reproductive health innovation can also be expanded successfully to the national or regional level, because the scaling-up process is complex and multilayered. This article describes how a successful pilot program to integrate the S...tandard Days Method (SDM) of family planning into existing Ministry of Health services was scaled up nationally in Rwanda.
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These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M...edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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