Today, patient harm due to unsafe care is a large and growing global public health challenge and is one of the
leading causes of death and disability worldwide. Most of this patient harm is avoidab
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le. As countries strive to
achieve universal health coverage and the Sustainable Development Goals, the beneficial effects of improved
access to health services can be undermined by unsafe care. Patient safety incidents can cause death and
disability, and suffering for victims and their families. The financial and economic costs of safety lapses are high.
There is often reduced public confidence and trust in local health systems when such incidents are publicized.
Health workers involved in serious incidents involving death or serious harm to a patient can also suffer lasting
psychological harm and deep-seated feelings of guilt and self-criticism.
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Against this background of nearly 20 years of experience of research, development and
improvement in patient safety, the role of incident and adverse event reporting, as well as the
benefits that
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derive from it, is still a work in progress.This document has two main purposes:
• to provide an up-to-date perspective on patient safety incident reporting and
learning systems currently in place, including how to fill in existing gaps in these
systems;
• to provide practical guidance on the establishment and effective use of patient
safety incident reporting and learning systems.
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Therapeutics Information and Pharmacovigilance Centre | TIPC
22 December 2020
The COVID-19 vaccine safety guidance manual has been developed upon recommendation and guidance of GACVS members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vac
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cines will be introduced.
For ease of use, the manual is available in a compiled form and in several separate modules that can be consulted individually. For each module, specific training material is also available to facilitate implementation.
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The objective of this document is to guide the preparation and implementation of national preparedness plans for the safety of substances of human origin during outbreaks of Zika virus infection, bo
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th in affected and non-affected areas.
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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
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for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regimen characteristics corresponding to the needs of end-users.
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The HEARTS technical package provides a strategic approach to improving cardiovascular health in countries. It comprises six modules and an implementation guide. This package supports Ministries of Health to strengthen CVD management in primary health care settings. The practical, step-by step modul
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es are supported by an overarching technical document that provides a rationale and framework for this integrated approach to the management of NCDs.
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The target audience of this document (and the associated online companion tool) includes WHO country offices
in Member States of the African Region; Member States’ ministries of health and their public health emergency
operation centres; relevant external assessment teams; and partners looking
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to identify preparedness gaps and
support interventions that help address them. In the event of a suspected or confirmed VHF case, the document also serves to provide any intervening partner with a sense of what structures should be in place, in order to guide
scale-up activities in line with regional and national plans.
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Male circumcision reduces a man’s risk of heterosexual acquisition of HIV by about 60%. This guideline provides an evidence-based recommendation on the use of adult male circumcision devices for HIV prevention in public health programmes in high H
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IV prevalence, resource-limited settings. It also presents key programmatic considerations for the introduction and use of these devices in public health HIV prevention programmes. The primary audiences are policy- and decision-makers, programme managers, health-care providers, donors and implementing agencies.
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Poor quality health services are holding back progress on improving health in countries at all income levels.
Today, inaccurate diagnosis, medication errors, inappropriate or unnecessary treatment, inadequate or unsafe clinical facilities or practices, or providers who lack adequate training an
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d expertise prevail in all countries.
The situation is worst in low and middle-income countries where 10 percent of hospitalized patients can expect to acquire an infection during their stay, as compared to seven percent in high income countries. This is despite hospital acquired infections being easily avoided through better hygiene, improved infection control practices and appropriate use of antimicrobials.. At the same time, one in ten patients is harmed during medical treatment in high income countries.
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The new WHO recommendations for the treatment of isoniazid-resistant, rifampicin-susceptible TB are based upon a review of evidence from patients treated with such regimens by a Guideline Development Group in conformity with WHO requirements
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for evidence-based policies.
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Building on the 2021 Interim guidance, this second version and update, incorporates the lessons and feedback from the hepatitis pilots that successfully demonstrated the feasibility of measuring hepatitis B and C impact targets to demonstrate elimination, whilst highlighting challenges caused by hig
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h disease burden in some countries, as well as delays in reaching mortality targets due to the long natural history of disease progression to liver cirrhosis and hepatocellular carcinoma.
The path to elimination provides a framework with 3 levels of achievements for which WHO certification is available. Each stepwise progression from bronze to silver to gold tiers will promote an iterative expansion of prevention, diagnosis and treatment services for viral hepatitis services and strengthen measurement systems to support attainment of the 2030 elimination goals.
This updated version also includes changes, clarifications and new guidance on alternative measurement approaches for country validation of elimination. Through the validation process, WHO and partners continue to provide country support for strengthening health system capacity and patient-centred services that respect and protect the human rights of people living with viral hepatitis and ensures meaningful engagement of communities in the national, regional and global viral hepatitis response.
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Hepatitis B (HBV) infection is a major public health problem and cause of chronic liver disease.
The 2024 HBV guidelines provide updated evidence-informed recommendations on key priority topics. These include expanded and simplified treatment criteria f
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or adults but now also for adolescents; expanded eligibility for antiviral prophylaxis for pregnant women to prevent mother-to-child transmission of HBV; improving HBV diagnostics through use of point-of-care HBV DNA viral load and reflex approaches to HBV DNA testing; who to test and how to test for HDV infection; and approaches to promote delivery of high-quality HBV services, including strategies to promote adherence to long-term antiviral therapy and retention in care.
The 2024 guidelines include 11 updated chapters with new recommendations and also update existing chapters without new recommendations, such as those on treatment monitoring and surveillance for liver cancer.
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Addressing comorbidities and risk factors for TB is a crucial component of Pillar one of the End TB Strategy, which focuses on integrated patient-centred care and prevention, including action on TB
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and comorbidities. The Framework for collaborative action on TB and comorbidities aims to support countries in the evidence-informed introduction and scale-up of holistic people-centred services for TB, comorbidities and health-related risk factors, with the goal of comprehensively addressing TB and other co-existing health conditions. It should be used in conjunction with relevant WHO guidelines. The Framework is intended for use by people working in ministries of health, other relevant line-ministries, policymakers, international technical and funding organizations, researchers, nongovernmental and civil society organizations, as well as primary care workers, specialist health practitioners, and community health workers who support the response to TB and comorbidities in both the public and private sectors.
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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
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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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A Provisional Document. The purpose of this manual is to provide guidance to public health professionals tasked with managing a response to viral hepatitis. As every country’s needs are different with respect to its epidemiology and the current level of response, people would use this manual in di
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fferent ways
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Injection practices worldwide and especially in low- and middle-income countries (LMICs) include multiple, avoidable unsafe practices that ultimately lead to the large-scale transmission of bloodborne viruses among patients, health care providers and the community at large.
Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and for rehabilitation. WHO developed guidance on medical device donation in 2011, which has been now rev
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iewed, with new evidence, new references on considerations for medical device solicitation and provision, risks associated with inappropriate donations, the responsibilities of donors and recipient, and the steps they should follow before, during and after a donation. It includes three sections: description of major problems that may be faced during the donation process, listing of best practices for donors and recipients and addressing situations requiring special attention. It also has three annexes for further reading: the criteria for the acceptability of a donation, literature review on donations of medical devices between 2010 and 2023 and a flyer. This document is intended to improve the quality of medical devices donations, including medical equipment, single-use medical devices and in-vitro diagnostics, to provide maximum benefit to all stakeholders. The considerations can be used to develop institutional or national policies and regulations for medical devices donations. This document is intended for use by any organization, expert or practitioner involved in the donation, procurement, management of medical devices, including health workers, biomedical engineers, health managers, policymakers, donors, nongovernmental organizations and academic institutions.
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