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 for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
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Expert Consensus Validation 2018.
This innovative approach aimed at improving and facilitating the screening, prescribing and monitoring of drug therapy for older patients, is currently being further developed in the area of Clinical Pharmacology at the University of Heidelberg in Mannheim. This ap...proach represents another advance in worldwide research efforts aimed at adding a new dimension to already-existing classification systems and negative listings of potentially inappropriate medications for the elderly.
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Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi...demic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
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Q3: In individuals with a first psychotic episode with full remission, how long should antipsychotic drug treatment be continued after remission in order to allow for the best outcomes?
In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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This guide is a resource for physicians and other health care professionals who provide care and treatment to patients with drug-resistant tuberculosis.
Q1: Are brief psychosocial interventions for people using cannabis or psychostimulants effective in reducing drug use, dependence and harm from drug use?
Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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The purpose of this manual is to define a limited number of indicators that will objectively describe the management and use of antimicrobials in hospitals and to provide tools and step-by-step instructions for designing and carrying out an assessment of antibiotic use and management in hospitals. T...he indicators in this manual will complement the existing WHO (1993) indicators of outpatient antimicrobial use suggested in How to Investigate Drug Use in Health Facilities (including percentage of encounters in which an antibiotic was prescribed and percentage of medicine costs spent on antibiotics) and will address the need for antimicrobial indicators for inpatient conditions.
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Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr...am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
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Africa Centers for Disease Control and Prevention (Africa CDC) is aware of the media releases of the preliminary results of a large randomized clinical trial conducted in the United Kingdom, which included dexamethasone, a corticosteroid, as one of the drugs used for the treatment of COVID-19 patien...ts. The investigators reported that administration of oral or injectable dexamethasone resulted in about one-third reduction in mortality among COVID-19 patientsi that required mechanical ventilation and about one-fifth for patients requiring oxygen.
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The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, ...Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The document provides information on different aspects of care and support for TB patients. In particular, the handbook provides practical guidance on the implementation of the interventions that enable treatment adherence such as social support, treatment administration options, digital adherence technologies. The practical guidance also includes models of care for all TB patients, models of care for children and adolescents, integrated care for TB, HIV and comorbidities, engagement of private sector, managing of TB in health emergencies. This new practical handbook also includes two important chapters on health education and counselling, and palliative care for patients with TB.
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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 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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The purpose of this document is to stop to irrational use/ over prescription of this reserve/
experimental/ emergency use authorisation drug Remdesivir. For this reason, Joint
Monitoring Group under Chairmanship of DGHS took into consideration findings of the
followi...ng studies to issue this advisory:
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N Engl J Med 2022; 386:911-922, DOI: 10.1056/NEJMoa2104535
Four months of antituberculosis treatment was noninferior to 6 months of treatment in children with drug-susceptible, nonsevere, smear-negative tuberculosis (SHINE Study)
WHO’s sentinel surveys of acquired HIV resistance to dolutegravir among people receiving dolutegravir-containing antiretroviral therapy is intended for easy and frequent implementation. Results from sentinel surveys provide insight into the prevalence and year-over-year trends of dolutegravir resi...stance in adults, children and adolescents receiving dolutegravir-based ART.
This sentinel method is implemented complementary to WHO-recommended methods for estimating nationally representative levels of acquired HIV drug resistance.
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A wide spectrum of disease severity has been described for Human African Trypanosomiasis (HAT) due to
Trypanosoma brucei rhodesiense (T.b. rhodesiense), ranging from chronic disease patterns in southern countries of East Africa to an increase in virulence towards the north. However, only limited d...ata on the clinical presentation of T.b. rhodesiense HAT is available. From 2006-2009 we conducted the first clinical trial program (I MPAMEL III) in T.b. rhodesiense endemic areas of
Tanzania and Uganda in accordance with international standards (ICH-GCP). The primary and secondary outcome measures were safety and efficacy of an abridged melarsoprol schedule for treatment of second stage disease. Based on diagnostic findings and clinical examinations at baseline we describe the clinical presentation of T.b. rhodesiense HAT in second stage patients from two distinct geographical settings in East Africa.
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Arsenical monotherapies were previously very successful for treating human African trypanosomiasis (HAT).
Melarsoprol resistance emerged as early as the 1970s and was widespread by the late 1990s.
Melarsoprol resistance represents the only example of widespread drug resistance in HAT patients wher...e the genetic mechanism has been established.
The current goal of elimination of HAT as a public health problem by 2020 may be undermined by the emergence and spread of resistance to current or new drugs.
Insights into potential resistance mechanisms for current and new drugs will facilitate predictions of the likelihood of resistance and will also facilitate rational approaches to minimizing, monitoring, and tackling the future emergence of resistance.
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Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however, inaccuracies associated with current serological tests makes it difficu...lt to fully assess the need for and impact of eradication campaigns using these tools. Under the recommendation of the WHO Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases(NTDs), a working group was assembled and tasked with agreeing on priority use cases for developing target product profiles (TPPs) for new diagnostics tools.
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In 2014, an estimated 40 million women of reproductive age were infected with Schistosoma haematobium, S. japonicum and/or S. mansoni. In both 2003 and 2006, the World Health Organization (WHO) recommended that all schistosome-infected pregnant and breastfeeding women be offered treatment, with praz...iquantel, either individually or during treatment campaigns. In 2006, WHO also stated the need for randomized controlled trials to assess the safety and efficacy of such treatment. Some countries have yet to follow the recommendation on treatment and many programme managers and pregnant women in other countries remain reluctant to follow the recommended approach.
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