Report of the 23rd WHO Expert Committee on the selection and use of essential medicines
This executive summary reports the recommendations made by the Expert Committee for the 2021 update of the WHO Model List of Essential Medicines (EML) and the Model List of Essential Medicine for Children (EMLc)....
The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and formulation on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines.
more
Antibiotics use with care
This module is part of the WHO series The Immunological Basis for Immunization, which was initially developed in 1993 as a set of eight modules, comprising one module on general immunology and seven modules each devoted to one of the vaccines recommended for the Expanded Programme on Immunization, i....e. vaccines against diphtheria, measles, pertussis, polio, tetanus, tuberculosis and yellow fever. Since then, this series has been updated and extended to include other vaccines of international importance. The main purpose of the modules is to provide national immunization managers and vaccination professionals with an overview of the scientific basis of vaccination against a range of important infectious diseases. The modules developed since 1993 continue to be vaccine-specific, reflecting the biological differences in immune responses to the individual pathogens and the differing strategies employed to create the best possible level of protection that can be provided by vaccination. The modules also serve as a record of the immunological basis for the WHO recommendations on vaccine use, published in the WHO vaccine position papers.*
more
3 March 2022
The WHO Therapeutics and COVID-19: living guideline contains the Organization’s most up-to-date recommendations for the use of therapeutics in the treatment of COVID-19. The latest version of this living guideline is available in pdf format (via the ‘Download’ button) and via an ...online platform, and is updated regularly as new evidence emerges.
more
Any individual that meets the suspected case definition of monkeypox should be offered testing in appropriately equipped laboratories by staff trained in the relevant technical and safety procedures. Confirmation of monkeypox virus infection is based on nucleic acid amplification testing (NAAT), usi...ng real-time or conventional polymerase chain reaction (PCR), for detection of unique sequences of viral DNA. PCR can be used alone, or in combination with sequencing. The recommended specimen type for laboratory confirmation of monkeypox is skin lesion material, including swabs of lesion surface and/or exudate, roofs from more than one lesion, or lesion crusts.
more
Interim rapid response guidance, 10 June 2022.
It includes considerations for certain populations such as patients with mild disease with considerations for community care, patients with moderate to severe disease, sexually active persons, pregnant or breastfeeding women, children and young persons.... The guidance also addresses considerations for clinical management such as the use of therapeutics, nutritional support, mental health services, and post-infection follow-up.
The document provides guidance for clinicians, health facility managers, health workers and infection prevention and control practitioners including but not limited to those working in primary care clinics, sexual health clinics, emergency departments, infectious diseases clinics, genitourinary clinics, dermatology clinics, maternity services, paediatrics, obstetrics and gynaecology and acute care facilities that provide care for patients with suspected or confirmed monkeypox
more
Minimizing risk of developing antibiotic resistance and aquatic ecotoxicity in the environment resulting from the manufacturing of human antibiotic.
The Standard, facilitated by BSI Standards Limited (BSI), provides clear guidance to manufacturers in the global antibiotic supply chain to ensure t...hat their antibiotics are made responsibly, helping to minimize the risk of AMR in the environment.
more
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.
more
Interim rapid response guidance, 10 June 2022.
It includes considerations for certain populations such as patients with mild disease with considerations for community care, patients with moderate to severe disease, sexually active persons, pregnant or breastfeeding women, children and young persons.... The guidance also addresses considerations for clinical management such as the use of therapeutics, nutritional support, mental health services, and post-infection follow-up.
The document provides guidance for clinicians, health facility managers, health workers and infection prevention and control practitioners including but not limited to those working in primary care clinics, sexual health clinics, emergency departments, infectious diseases clinics, genitourinary clinics, dermatology clinics, maternity services, paediatrics, obstetrics and gynaecology and acute care facilities that provide care for patients with suspected or confirmed monkeypox
more
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.
more
This Commission report aims to contribute to a new era of multilateral cooperation based on strong UN institutions to reduce the dangers of COVID-19, forestall the next pandemic, and enable the world to achieve the agreed goals of sustainable development, human rights, and peace that governments are... committed to pursue as members of the UN. We address this Commission report to the UN member states, the UN agencies and multilateral institutions, and multilateral processes such as the G20 and the G7.
more
This report’s central premise is that diagnostics and therapeutics, and associated test to treat strategies, are fundamental components of the pandemic response, both for COVID-19 and for future health threats. Two years into the COVID-19 pandemic, this report reflects on the main challenges and k...ey solutions on the road to equitable access to diagnostics and therapeutics.
This report draws from experience gained through the Access to COVID-19 Tools (ACT) Accelerator Diagnostics and Therapeutics pillars, and includes the perspectives of collaborating stakeholders (countries, civil society representatives and the private sector). Building on these findings, this report proposes sixteen recommended actions to address what have been identified as key structural challenges and specifies a potential owner for each action.
more
The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid diagnostic tests (RDTs) targeting the M...UL_3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
more
The report aims to capture lessons from the COVID-19 pandemic and to highlight the opportunity for more ambitious global action: expanding sustainable access to vaccines for all towards
the Immunization Agenda 2030 and pandemic prevention, preparedness and response efforts. The report is organized ...in two sections: the first section provides WHO insights on global vaccine market dynamics, drawing from data provided by Member States, which are, in turn, analysed and displayed in the second section.
more
Canadian Journal of Microbiology 25 June 2021 https://doi.org/10.1139/cjm-2020-0572
This document summarizes the results of the WHO-commissioned full value proposition for new tuberculosis (TB) vaccines. The assessment was commissioned to provide early evidence for national and global decision-makers involved in TB vaccine development and implementation, who include stakeholders in...volved in vaccine research, financing, regulation and policy-making, manufacturing, introduction and procurement. The goal is to accelerate development of effective vaccines against TB and their rapid introduction into countries.
more
PLoS Neglected Tropical diseases August 16, 2021 https://doi.org/10.1371/journal.pntd.0009697
Chagas disease, also known as American trypanosomiasis, is a neglected tropical disease transmitted by triatomine insects, first identified in 1909. Chagas disease affects approximately 6–7 million peop...le globally and is highly prevalent in Latin America where most cases are reported. However, there is increasing evidence that Chagas disease is now an important public health issue outside the “classical” endemic countries due to population migration. Our understanding of Chagas disease, including its pathologies and factors relating to progression, remains to date limited, and is also challenged by lack of diagnosis and highly effective treatment. This systematic review aims to describe studies with Chagas patients receiving antiparasitic treatment. Databases were searched for relevant studies published after 1997, and the results of these searches were screened.
more
Front Chem. 2021; 9: 622286.
Published online 2021 Mar 12. doi: 10.3389/fchem.2021.622286
Pharmaceutical News
Evaluation of Saccharide Content of the WHO 2nd International Standard for Haemophilus Influenzae Polysaccharide Polyribosyl Ribitol Phosphate (PRP) by HPAECPAD Analysis Following Acid Hydrolysis
Consultation Documents
Lamivudine and tenofovir disoproxil fumarate tablets (lami...vudini et tenofoviri disoproxili fumarati compressi)
Tenofovir disoproxil fumarate tablets (tenofoviri disoproxili fumarati compressi)
ATC/DDD Classification
Temporary
Final
more
The Food and Agriculture Organization of the United Nations (FAO) launched a new Framework for Environmental and Social Management (FESM) to ensure that both people and the environment are protected from any potential impacts of FAO programmes and projects.
“This Framework ensures that our proj...ects do both “no harm” and support the transformation to more efficient, more inclusive, more resilient and more sustainable agrifood systems by upholding the highest international standards for risk management,” FAO Director-General QU Dongyu explained during a virtual event.
The Framework, which includes key elements of a people-centered approach and establishes environmental and social performance requirements for FAO programming, is also intended to ensure that all stakeholders, including local and indigenous communities, have ample opportunities to actively participate in projects’ activities and to voice their concerns about them.
more