The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world.
In addition, this edition includes summary and recommendations from the virtual meeting of the members of the WHO Programme f...or International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
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4th edition
The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety.
LBM encouraged countries t...o accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of biological agents in laboratories within their geographical borders.
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
This novel evidence- and risk-based approach will allow optimised resource use and sustainable laboratory biosafety and biosecurity policies and practices that are relevant to their individual circumstances and priorities, enabling equitable access to clinical and public health laboratory tests and biomedical research opportunities without compromising safety.
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The threat climate change poses to health, equity, and development has been rigorously documented. However, in an era marked by economic crisis, regional conflicts, natural disasters and growing disparities between rich and poor, the joint global actions required to address climate change have been ...vigorously debated – and critical decisions postponed.
This document, part of WHO’s Health in the Green Economy series, describes how many climate change measures can be “win-wins” for people and the planet.
These policies yield large, immediate public health benefits while reducing the upward trajectory of greenhouse gas emissions. Many of these policies can improve the health and equity of people in poor countries and assist developing countries in adapting to climate change that is already occurring, as evidenced by more extreme storms, flooding, drought and heatwaves.
WHO’s Department of Public Health and Environment launched the Health in the Green Economy initiative in 2010 to review potential health and equity “co-benefits” of proposed climate change measures – as well as relevant risks.
This review examines mitigation strategies discussed in the Fourth Assessment Report of the Intergovernmental Panel on Climate Change which constitutes the most broad-based global review of mitigation options by scientific experts.
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2016-2018 Early implementation,
This report presents 2015 data on the consumption of systemic antibiotics from 65 countries and areas, contributing to our understanding of how antibiotics are used in these countries. In addition, the report documents early efforts of the World Health Organization (...WHO) and participating countries to monitor antimicrobial consumption, describes the WHO global methodology for data collection, and highlights the challenges and future steps in monitoring antimicrobial consumption.
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The Disaster Recovery Framework (DRF) Guide for the Health Sector provides guidance on how to implement a comprehensive, integrated, and structured approach to disaster recovery. Its overarching goal is to minimize the impact of the disaster on communities and help countries to recover quickly and e...ffectively from disasters, in coordination with key stakeholders.
The DRF Guide for the Health Sector is adapted from the generic DRF Guide, and draws on the Implementation Guide For Health Systems Recovery in Emergencies, the Health Emergency and Disaster Risk Management Framework as well as the Disaster Recovery Guidance Series. The guide also makes links with multi-sectoral, government-led recovery planning processes such as the Post-Disaster Needs Assessment (PDNA), and it supports the implementation of the HDPN.
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This publication provides directions for a logical, evidence informed approach to selecting, developing, implementing and monitoring population-based interventions within the context of the double-burden of malnutrition in South-East Asia. The focus of this guide is on processed or ultra-processed p...re-packaged foods.
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About one fourth of the world’s population is estimated to have been infected with the tuberculosis (TB) bacilli, and about 5–10% of those infected develop TB disease in their lifetime. The risk for TB disease after infection depends on several factors, the most important being the person’s im...munological status. TB preventive treatment (TPT) given to people at highest risk of progressing from TB infection to disease remains a critical element to achieve the global targets of the End TB Strategy, as reiterated by the second UN High Level Meeting on TB in 2023. Delivering TPT effectively and safely necessitates a programmatic approach to implement a comprehensive package of interventions along a cascade of care: identifying individuals at highest risk, screening for TB and ruling out TB disease, testing for TB infection, and choosing the preventive treatment option that is best suited to an individual, managing adverse events, supporting medication adherence and monitoring programmatic performance.
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The toolkit's purpose is to:
improve the primary health care response for older persons.
sensitize and educate primary health care workers about the specific needs of their older clients.
provide primary care health workers with a set of tools/instruments to assess older people's hea...lth.
raise awareness among primary care health workers of the accumulation of minor/major disabilities experienced by older people.
provide guidance on how to make primary health care management procedures more responsive to the needs of older people's needs.
offer direction on how to do environmental audits to test primary health care centres for their age-friendliness.
The toolkit comprises a number of instruments (evaluation forms, slides, figures, graphs, diagrams, scale tables, country guidelines, exam sheets, screening tools, cards, checklists, etc.) that can be used by primary health care workers to assess and address older persons' health. These resources are meant to supplement and not to replace local and national materials and guidelines
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The WHO Regional Office for Europe has established the Childhood Obesity Surveillance Initiative in more than half the countries in the Region for routine monitoring of the policy response to the emerging obesity epidemic. The aim of the Initiative is to measure trends in overweight and obesity in c...hildren aged 6.0–9.9 years to get a clear understanding of the epidemic and to allow inter-country comparisons. This document outlines the common protocol agreed for use in the Initiative.
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BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3026 (Published 11 August 2020)
The BMJ "practice pointer" inlcudes a one-page visual summary of assessment and initial management of patients with persistant symptoms following acute SARS-CoV-2 infection
BMJ Open2018;8:e020423. doi:10.1136/bmjopen-2017-02042
EC has been increasingly used in the evaluation of maternal and child health programmes.12–15 For instance, Nesbitt et al compared crude coverage and EC of pregnant women with facility-based obstetric services in Ghana and estimated that alth...ough 68% of the women studied had service access only 18% received high-quality care provided by a skilled birth attendant.16 Similarly, by comparing EC of young children receiving Strengths and limitation of this study. Using multiple data sources (direct observation, vignettes, facility inventories) this study comprehensively assessed under 5-year-old child service
performance of first-line health facilities. We conducted this study in around 500 primary-level health facilities and within 7000 households
across six regions in Burkina Faso.
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In this contingency planning guidance, a set of actions to prepare for emergencies from all hazards and to help minimize their impact, is proposed. These actions include the development, implementation, simulation, monitoring and regular update of risks-based contingency plans.
The goal of this Global Action Plan is to articulate synergistic actions that will be required to prevent HIVDR from undermining efforts to achieve global targets on health and HIV, and to provide the most effective treatment to all people living with HIV including adults, key populations, pregnant ...and breastfeeding women, children and adolescents. The Global Action Plan has five strategic objectives: 1) prevention and response; 2) monitoring and surveillance; 3) research and innovation; 4) laboratory capacity; and 5) governance and enabling mechanisms.
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Based on WHO South-East Asia Regional Strategy on Autism Spectrum Disorder
The collaborative framework for implementation of the “WHO South-East Asia Regional Strategy on Autism Spectrum Disorders” articulates to Member States: the nature of autism spectrum disorder and the issues faced by ...PwASD and their caregivers; the foundation on which the Regional Strategy and the collaborative framework is based; desired outcomes against each objective of the ASD Regional Strategy; recommended actions to fulfill each objective; requisite parameters that should govern the recommended actions; and suggested guidelines for monitoring, evaluating and reporting a Member State’s progress towards fulfilling the objectives. It encourages Member States to share best practices and information for promoting cooperation and partnerships for development of effective and sustainable programmes.
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The ongoing COVID-19 pandemic has shown that public financial management (PFM) should be an integral part of the response. Effectiveness in financing the health response depends not only on the level of funding but also on the way public funds are allocated and spent, this is determined by the PFM r...ules, and how money flows to health service providers. So far, early assessments have shown that PFM systems ranged from being a fundamental enabler to acting as a roadblock in the COVID-19 health response. While service delivery mechanisms have been extensively documented throughout the pandemic, the underlying PFM mechanisms of the response also merit attention. To highlight the importance of PFM in health emergency contexts, this rapid review analyses various country PFM experiences and identifies early lessons emerging from the financing of the health response to COVID-19. The assessment is done by stages of the budget cycle: budget allocation, budget execution, and budget oversight. Identifying lessons from the varying PFM modalities used to finance the response to COVID-19 is fundamental both for health policy-makers and for finance authorities to prepare for future health emergencies.
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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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Developmental disabilities are common. Yet, children with developmental disabilities have been neglected in health systems planning and policy provisions for health and continue to experience stigmatization, institutionalization, barriers to access health care and inequalities in health and educatio...n outcomes.
Using findings from research and practice and guided by the tenets of international human rights conventions, this WHO-UNICEF Global Report on children with developmental disabilities provides principles and approaches to intentionally include the needs and aspirations of children and young people with developmental disabilities in policy, programming and public health monitoring. It makes the case for greater accountability and proposes 10 priority actions to accelerate changes towards inclusive environments and responsive multisectoral care systems for children with developmental disabilities.
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Confronted with the important issue of patient safety, in 2002 the Fifty-fifth World Health Assembly adopted a resolution urging countries to pay the closest possible attention to the problem and to strengthen safety and monitoring systems. In May 2004, the Fifty-seventh World Health Assembly approv...ed the creation of an international alliance as a global initiative to improve patient safety. The World Alliance for Patient Safety was launched in October 2004 and currently has its place in the WHO Patient Safety programme included in the Information, Evidence and Research Cluster.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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