This report presents an analysis of antibacterial agents in preclinical (third annual review) and clinical (fifth annual review) development. The analysis covers traditional (direct-acting small molecules) and non-traditional antibacterial agents in development worldwide. It evaluates to what extent... the present pipeline addresses infections caused by WHO Priority Pathogens, Mycobacterium tuberculosis and Clostridioides difficile. The report also provides an assessment of the traditional agents with respect to whether they meet a set of predefined criteria for innovation, namely absence of known cross-resistance, new target, mode of action and/or class. It also includes an overview of the agents that obtained authorization since 1 July 2017.
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Cryptococcal disease, particularly cryptococcal meningitis is a significant cause of morbidity and mortality among people living with HIV with advanced HIV disease. It is estimated that it is responsible for nearly 19% of AIDS-related mortality, second only to tuberculosis. Rapid screening, diagnosi...s and linking to appropriate treatment are critical actions national programs must take to reduce the burden of disease.
WHO in 2022 introduced updated guidelines for diagnosing, preventing, and managing cryptococcal disease among adults, adolescents and children living with HIV. This policy brief provides a summary of the key recommendations, clinical considerations, and also stresses the importance of ensuring access to life-saving antifungals. There is an urgent need for countries to scale-up management for not just cryptococcal meningitis, but address cryptococcal disease in the context of a package of care for advanced HIV disease as recommended by WHO.
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his first edition describes the standard operating procedures for health products for NTDs amenable to preventive chemotherapy and the medicines donated to treat them. These include albendazole for lymphatic filariasis and soil-transmitted helminthiases; azithromycin for trachoma and yaws; diethylca...rbamazine citrate for lymphatic filariasis; ivermectin for onchocerciasis and lymphatic filariasis; mebendazole for soil-transmitted helminthiases; praziquantel for schistosomiasis; and triclabendazole for foodborne trematodiases. Standard operating procedures for diseases amenable to case management will be covered in subsequent editions, including the application process for requesting medicines (Chapter 1). In the meantime, the procedures described in the rest of the document apply for both case management and preventive chemotherapy NTD health products.
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The pandemic has emphasized the high risk of avoidable harm to patients, health workers, and the general public, and has identified a range of safety gaps across all core components of health systems at all levels.
The rapid review ‘Implications of the COVID-19 pandemic for patient safety’ ex...plores impacts that the COVID-19 pandemic did have on patient safety in terms of risks and avoidable harm, specifically in terms of diagnostic, treatment and care management related issues as well as highlights the main patterns of these implications within the broader health system context.
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The WHO Ebola Virus Disease (EVD) Clinical management: living guidance contains the Organization’s most up-to-date recommendations for the clinical management of people with EVD. Providing guidance that is comprehensive and holistic for the optimal care of patients with EVD throughout their il...lness is important.
The living guidance is available in both pdf format (via the ‘Download’ button) and via an online platform in both French and English, and is updated regularly as new evidence emerges.
This first version of the Clinical management for EVD living guidance contains four new recommendations regarding use of therapeutics for EVD, this includes two strong recommendations for the use of monoclonal antibody therapies. This new living guideline is written to accompany the optimized supportive care (oSoC) for EVD standard operating procedures (5, 6). The living guideline aims to summarize high quality evidence for EVD therapeutics and make recommendations for their use.
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Tools and practical guidance for achieving high uptake
Infectious disease outbreaks and epidemics are increasing in frequency, scale and impact. Health care facilities can amplify the transmission of emerging infectious diseases or multidrug-resistant organisms (MDRO) within their settings and communities. Therefore, evidence-based infection prevention ...and control (IPC) measures in health care facilities are critical for preventing and containing outbreaks, while still delivering safe, effective and quality health care. This toolkit is intended to support IPC improvements for outbreak management in all such facilities, both public and private throughout the health system. Specifically, this document systematically describes a framework of overarching principles to approach the preparedness, readiness and response outbreak management phases. The document also provides a toolkit of resource links to guide specific actions for each infectious disease and/or MDRO outbreak management phase at any health facility. This document is specifically tailored to an audience of stakeholders who establish and monitor health care facility-level IPC programs including: IPC focal points, epidemiologists, public health experts, outbreak response incident managers, facility-level IPC committee(s), safety and quality leads and managers, and other facility level IPC stakeholders.
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The Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (the framework) aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-u...se research.
The framework adopts the One health approach and focuses on the role that responsible life sciences research can play in preventing and mitigating risks caused by accidents, inadvertent or deliberate misuse with the intention to cause harm to humans, nonhuman animals, plants and agriculture, and the environment.
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Quarta Edição.
Esta quarta edição do manual se baseia no esquema de avaliação de risco apresentado na terceira edição. Uma avaliação completa, baseada em evidências e transparente dos riscos permite que as medidas de segurança sejam equilibradas com o risco real de trabalhar com agentes... biológicos, caso a caso. Isso permitirá que os países implementem políticas e práticas de biossegurança e biosseguridade laboratoriais economicamente viáveis e sustentáveis que sejam relevantes para suas circunstâncias e prioridades individuais.A necessidade de atualizar as diretrizes de biossegurança de laboratórios internacionais faz parte de uma iniciativa mais ampla para globalizar a biossegurança e enfatizar os princípios e as abordagens que são acessíveis a países que tenham ampla gama de recursos financeiros, técnicos e regulatórios
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Implementation guide for national, district and facility levels.
This implementation guide contains practical guidance for policy-makers,
programme managers, health practitioners and other actors working to
establish and implement quality of care (QoC) programmes for maternal,
newborn and child ...health (MNCH) at national, district and facility levels.
It is intended to help anyone, throughout the health system, who wants
to take action to improve the QoC for MNCH.
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This document sets out, therefore, to explain the socioeconomic value of investing in the fight against NTDs and highlights priorities for global investment attention. Our work was guided by the need not only for
additional funding and funders but also for the need to understand the current funding... climate, in which value for money and the efficient use of resources to fill the most critical of gaps are more relevant than ever.
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This policy brief aims to provide a review of the current progress on implementing the Malawi national action plan on AMR, identifies critical gaps, and highlights findings to accelerate further progress in the human health sector. The target audience includes all those concerned with implementing a...ctions to combat antimicrobial resistance in Malawi.
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The primary audience for these recommendations includes health professionals who are responsible for developing national and local health-care guidelines and protocols and health workers involved in the provision of care to women and their newborns during pregnancy, labour and childbirth; this inclu...des midwives, nurses, general medical practitioners and obstetricians. The primary audience also includes managers of maternal and child health programmes, and relevant staff in ministries of health and educational and training institutions, in all settings.
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The primary audience for these recommendations includes health professionals who are responsible for developing national and local health-care guidelines and protocols and health workers involved in the provision of care to women and their newborns during pregnancy, labour and childbirth; this inclu...des midwives, nurses, general medical practitioners and obstetricians. The primary audience also includes managers of maternal and child health programmes, and relevant staff in ministries of health and educational and training institutions, in all settings.
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The primary audience for these recommendations includes health professionals who are responsible for developing national and local health-care guidelines and protocols and health workers involved in the provision of care to women and their newborns during pregnancy, labour and childbirth; this inclu...des midwives, nurses, general medical practitioners and obstetricians. The primary audience also includes managers of maternal and child health programmes, and relevant staff in ministries of health and educational and training institutions, in all settings.
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This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...nd rapid diagnostic providers.
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The WHO BioHub Biosafety & Biosecurity: criteria and operational modalities sets out the requirements to which laboratories wishing to receive biological materials as part of this international exchange system should abide, to ensure safe and secure operations. These provisions are in accordance wit...h the recommendations of the WHO Laboratory Biosafety Manual 4th edition (LBM4), adopting an evidence- and risk-based approach to enable scalable and adaptable biosafety provisions and actions, proportionate to the assessed risk
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These guidelines provide updated evidence-based recommendations on the priority HCV-related topics from the 2018 WHO Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C infection and the 2017 WHO Guidelines on hepatitis B and C testing. These priority areas are:
... direct-acting antiviral (DAA) treatment of adolescents and children ages ≥3 years of age
simplified HCV service delivery (decentralization, integration and task sharing)
HCV diagnostics – use of point-of-care (POC) HCV ribonucleic acid (RNA) assays and reflex HCV RNA testing.
These guidelines also update existing chapters without new recommendations, such as the inclusion of new manufacturers’ protocols on the use of dried blood spot (DBS) for HCV RNA testing and new data to inform the limit of detection for HCV RNA assays as a test of cure, in addition to their use for diagnosis.
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In 2013, WHO and the Foundation for Innovative New Diagnostics convened a meeting of Buruli ulcer experts in Geneva, Switzerland (9) at which two priority unmet needs in diagnosis were identified:
a diagnostic test for early detection of Buruli ulcer in symptomatic patients with sufficient positive... predictive value to put patients on appropriate treatment; and
a screening test at the primary health care or community level for symptomatic patients with ulcer
In March 2018, they convened a global meeting with the aim of establishing an action plan to develop new diagnostic solutions for Buruli ulcer and to create a framework of collaboration to address unmet needs in diagnostics for the disease. The participants agreed to develop a target product profile (TPP) to address the need for a rapid diagnostic test for use at the primary health-care level.
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