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.
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...e equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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WHO has published the first-ever guidance on the clinical management of diphtheria. The only previously available guidance was an operational protocol. The new guidance followed the rigorous process for developing guidance at WHO.
It addresses the use of Diphtheria Antitoxin (DAT) in the treatmen...t of diphtheria. There is a worldwide shortage of DAT and evidence based recommendations on the use of DAT were requested by many Member States.
The guidance also includes new recommendations on antibiotics. In patients with suspected or confirmed diphtheria, WHO recommends using macrolide antibiotics (azithromycin, erythromycin) rather than penicillin antibiotics.
This clinical practice guideline has been rapidly developed recognizing the global increase in diphtheria outbreaks. Outbreaks of diphtheria in Nigeria, Guinea and neighbouring countries in 2023 have highlighted the urgent need for evidence-based clinical practice guidelines for the treatment of diphtheria. Given the sporadic nature of outbreaks, many clinicians in the affected regions have never managed acute diphtheria and its related complications. Diphtheria remains a neglected disease and vaccination is the top priority. At the same time, for patients with diphtheria, access to antibiotics, DAT and supportive care can be lifesaving.
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The document provides detailed guidelines for the production, formulation, and implementation of oral rehydration salts (ORS) to combat dehydration caused by diarrhoea, particularly in children. It focuses on the composition, quality standards, and packaging requirements of ORS, aiming to support na...tional authorities and healthcare providers in ensuring effective and accessible treatment. It also highlights strategies for manufacturing ORS locally while adhering to international health and safety standards.
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Guidelines for the treatment of human African trypanosomiasis. Web Annex A. Commissioned by WHO Cochrane Response
WHO Guidelines for the Treatment of Human African Trypanosomiasis. Web Annex B
This document provides a generic model that can be used for risk assessment of exposure to insecticide products applied as indoor residual sprays. It aims to harmonize the risk assessment of such insecticides for public health use in order to generate comparable data for their registering and labell...ing by national regulatory authorities. The assessment considers both adults and children (all age groups) as well as people in the following specific categories:
- those preparing the spray;
- those applying the spray;
- residents living in the treated houses;
- residents who participate in preparing and applying insecticides.
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The frequency of infectious disease epidemics is increasing, and the role of the health sector in the management of epidemics is crucial in terms of response. In the context of infectious disease epidemics, the use of climate-informed early warning systems (EWS) has the potential to increase the eff...ectiveness of disease control by intervening before or at the beginning of the epidemic curve, instead of during the downward slope.
Currently, the initiation of interventions is heavily reliant on routine disease surveillance systems – data that often arrive too late for preventative response. However, forecasting of disease outbreaks using surveillance and weather information shows promising potential – there also remains further scope to examine seasonal climate forecasts. By combining these elements in new EWS based on computational models, it will be possible to improve both the timeliness and impact of disease control. The World Health Organization (WHO) is strengthening existing surveillance systems for infectious diseases to enable the development of more robust and timely EWS, which has resulted in the rapid development and innovation of EWS for disease outbreaks.
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Amélioration de la santé des populations en Afrique
This document outlines the evaluation process that WHO undertakes to assess novel tools and strategies targeted at VBDs. Its aim is to articulate the linkage between the generation of evidence that demonstrates public health impact of novel interventions, and the development of policy recommendation...s based on the generated data. The document defines standards for the evaluation process, as well as the steps that an applicant needs to undertake, along with some guiding principles that aim to support applicants in the development of submissions with WHO.
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HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the current low disease prevalence, the positive predicti...ve value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care. Confirmation of Tbg infection requires microscopic examination of body fluids necessitating specific training. The best performing methods are laborious and reach 85–95% diagnostic sensitivity when performed by skilled personnel.
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HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the current low disease prevalence, the positive predicti...ve value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care.
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Cyclone in Mozambique and Zimbabwe
Ebola virus disease in Democratic Republic of the Congo
Humanitarian crisis in Mali
Humanitarian crisis in Central African Republic.
Prevention, early diagnosis, and effective treatment are essential for the control and elimination of Neisseria gonorrhoeae as a public health problem. Currently, in Latin America and the Caribbean, treatment for gonorrhea infection is largely empiric and based on clinical diagnosis. In the Americas..., the high burden of new N. gonorrhoeae infections (estimated at 11 million new cases a year), the complexity of the disease epidemiology, and in many countries the limited resources, make it difficult to fully understand the burden of disease and the burden of antimicrobial resistance (AMR) in N. gonorrhoeae.
PAHO has developed this document to facilitate the navigation of available guidance and recommendations for N. gonorrhoeae AMR surveillance by public health and health care professionals, at the national and subnational levels, involved in designing, implementing, and/or strengthening AMR surveillance of N. gonorrhoeae and overall surveillance of sexually transmitted infections.
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