There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
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Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi...demic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
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In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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1st edition.
Unitaid’s report describes a slate of new devices that can more efficiently identify dangerously ill children so that they can be treated immediately. These tools make it easier to recognize danger signs, and support integrated approaches to reducing childhood deaths from the three ...greatest childhood killers: malaria, pneumonia and diarrhoea.
The report also highlights tests that can determine whether or not a child has an illness that can be treated with antibiotics. Viral infections are a common cause of childhood fevers, but cannot be cured with antibiotics. Although many children seeking care at clinics have fever, three-quarters by some estimates, only a small fraction of those have an illness that can be treated with an antimalarial or antibiotic drug
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The publication conveys the quantitative surveillance results focusing on tobacco use and noncommunicable disease (NCD) related behaviours among youth (13–15 years) in Member States of the WHO South-East Asia Region, namely, the Global School-based Student Health Survey (GSHS) and the Global Youth... Tobacco Survey (GYTS). This publication contains selected indicators relating to tobacco use and other related risk behaviours of youth (aged 13–15 years) in Member States of the WHO South-East Asia Region. The tobacco indicators are mainly taken from GYTS and other indicators relating to risk behaviours (dietary behaviours, physical activity, alcohol use, drug use, mental health, violence and unintentional injury, sexual behaviours, protective factors and hygiene) are taken from GSHS. The latest findings from surveys conducted in Member States are presented in the publication.
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We systematically reviewed Medline as well as the references of published review articles for relevant studies of adherence to multidrug treatment of both drug-susceptible and drug-resistant TB through February 3, 2018. We included randomized controlled trials (RCTs) as well as prospective and retro...spective cohort studies (CSs) with an internal or external control group that evaluated any adherence intervention and conducted a meta-analysis of their impact on TB treatment outcomes. Our search identified 7,729 articles, of which 129 met the inclusion criteria for quantitative analysis. Seven adherence categories were identified, including DOT offered by different providers and at various locations, reminders and tracers, incentives and enablers, patient education, digital technologies (short message services [SMSs] via mobile phones and video-observed therapy [VOT]), staff education, and combinations of these interventions.
https://doi.org/10.1371/journal.pmed.1002595
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Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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The purpose of this manual is to define a limited number of indicators that will objectively describe the management and use of antimicrobials in hospitals and to provide tools and step-by-step instructions for designing and carrying out an assessment of antibiotic use and management in hospitals. T...he indicators in this manual will complement the existing WHO (1993) indicators of outpatient antimicrobial use suggested in How to Investigate Drug Use in Health Facilities (including percentage of encounters in which an antibiotic was prescribed and percentage of medicine costs spent on antibiotics) and will address the need for antimicrobial indicators for inpatient conditions.
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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The use of Delamanid and Bedaquiline for Children with Drug-Resistant Tuberculosis.
Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr...am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
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Tuberculosis treatment failure results in increased risk of morbidity, drug resistance, transmission and mortality. There are few data about tuberculosis treatment outcomes in Burkina Faso. The current study investigated the factors associated with tuberculosis treatment failure in the central east ...health region of Burkina Faso.
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This study addresses part of the Terms of Reference for a scoping report ‘An analysis of approaches to laboratory capacity strengthening for drug resistant infections in low and middle income countries’. It has been produced as a separate report because it is also very relevant for a second stud...y ‘Supporting Surveillance Capacity for Antimicrobial Resistance: Regional Networks and Educational Resources’. This study compares antimicrobial surveillance systems in three low and middle income countries in order to describe the components of these systems and to understand which surveillance models are best suited to particular contexts. Ghana, Nigeria and Nepal were selected as study countries because they cover different continents and include one ‘fragile’ context (Nigeria). Brief information from Malawi is also included.
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Barbados currently has a rudimentary framework and capacity to address the issue of antimicrobial resistance. There however needs to be coordination of efforts and improvement in areas where gaps have been identified.Actions required include improved antibiotic stewardship in healthcare settings, pr...evention of the spread of drug-resistant organisms//bacteria, elimination of the use of medically-important antibiotics for growth promotion in food animals, and expanded surveillance for drug-resistant bacteria in humans and animals.
The National Action Plan will provide the roadmap to guide Barbados in the effort to address the urgent and serious threat of AMR and will be organized around three goals for collaborative action.
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The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, ...Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The document provides information on different aspects of care and support for TB patients. In particular, the handbook provides practical guidance on the implementation of the interventions that enable treatment adherence such as social support, treatment administration options, digital adherence technologies. The practical guidance also includes models of care for all TB patients, models of care for children and adolescents, integrated care for TB, HIV and comorbidities, engagement of private sector, managing of TB in health emergencies. This new practical handbook also includes two important chapters on health education and counselling, and palliative care for patients with TB.
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The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug... Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, ...Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The operational handbook provides practical information and tools that complement the recommendations in the guidelines. The strategies described in the operational handbook are based on the latest WHO recommendations which were formulated by Guideline Development Groups using the GRADE approach. In many cases however, the recommendations in their current form lacked sufficient clinical and programmatic detail, which is important for implementation. This operational handbook complements the guidelines with practical advice based on best practices and knowledge from the fields such as pharmacokinetics, pharmacodynamics, microbiology, pharmacovigilance and clinical and programmatic management.
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The Updated guidelines on Management of tuberculosis in children and adolescents include new recommendations that cover diagnostic approaches for TB, shorter treatment for children with non-severe drug-susceptible TB, a new option for the treatment of TB meningitis, the use of bedaquiline and delama...nid in young children with multidrug- and rifampicin-resistant TB and decentralized and family-centred, integrated models of care for TB case detection and prevention in children and adolescents.
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To support its R&D activities on Chagas disease, DNDi launched the Chagas Clinical Research Platform (CCRP). The platform brings together partners, experts, and stakeholders to provide support for evaluation and development of new treatments for Chagas disease. The patient-centred platform aims to f...acilitate clinical research, provide a forum for technical discussions, develop a critical mass of expertise, and strengthen institutional research capacities. In addition, it identifies and reviews priority needs, works towards standardization of methodology to assess drug efficacy and reviews alternatives for using current approved drugs (new schemes, doses, combination) and special scenarios (resistance).
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More than one million people each year become infected by parasites that cause the disease cutaneous leishmaniasis (CL). This disease manifests as one or more skin lesions or ulcers that are slow to heal with variable response rates to drug treatments. Thus far, little attention has been paid to how... the cultural effects of gender shape perceptions and experiences of CL. This review aims to bring together and analyse existing studies which use qualitative data to explore these differences. These studies offered insights into our specific research questions.
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