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 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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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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Am. J. Trop. Med. Hyg., 106 (Suppl 5), 2022, pp. 56–60. Lymphatic filariasis (LF) is a parasitic disease that is a major cause of chronic disability in the developing world. According to the 2021–2030 road map for neglected tropical diseases (NTDs) published by the World Health Organization (WHO...), the global goal for LF is elimination as a public health problem by 2030 through repeated rounds of mass drug administration (MDA). Critical components of any elimination program are monitoring and surveillance. Appropriate assessment tools and methods are needed for each stage of an elimination program; mapping to identify which areas require intervention, monitoring to assess the impact of interventions, and post-intervention surveillance to validate elimination or detect recrudescence.
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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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Improvements in water sanitation and hygiene (WASH) and wastewater management in all sectors are critical elements of preventing infections and reducing the spread of antimicrobial resistance (AMR) as identified in the Global Action Plan to combat AMR. Yet, at present, WASH and wastewater management... actors and improvement actions are under-represented in AMR multi-stakeholder platforms and national action plans (NAPs). This WHO/FAO/OIE technical brief on WASH and wastewater management to reduce the spread of AMR provides a summary of evidence and rationale for WASH and wastewater actions within AMR NAPs and sector specific policy to combat AMR. Evidence and actions are presented in the domains of; coordination and leadership, households and communities, health care facilities, animal and plant production, manufacturing of antimicrobials, and surveillance and research.
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The Global Programme on Tuberculosis & Lung Health of the World Health Organization (WHO/GTB) is now combining all current recommendations into one overall set of consolidated guidelines on TB. The guidelines contain recommendations pertaining to all areas related to the programmatic management of T...B (e.g. screening, preventive treatment, diagnostics, patient support, and the treatment of drug-susceptible TB and DR-TB). The consolidated guidelines contain modules specific to each programmatic area.
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Drugs and medical supplies are dispensed at the cutting edge level of the interface between the public health system and the people. Availability or lack of it brings either credit or discredit to the public health system. The primary reason for holding stocks of medicines and medical supplies in a ...proper scientific manner is to ensure continuous and uninterrupted availability to prevent stock-outs, especially of critical items of supply while at the same time ensuring that stocks of medicines do not get expired. An efficient inventory management is a pre-requisite for optimal stock management. It enables the management of health facilities to know the current pattern of consumption of drug trends over a period of time and also variances. The environmental control of the drugs and other medical supplies play an important role to keep the products' efficacy intact. Some medicines and vaccines need special storage temperature, otherwise, there may be wastage. The quality of the medicines can be adversely affected by poor storage, transportation and distribution. Thus, maintaining proper storage condition for health commodities is vital for ensuring their quality. So, by this training, CDMU wants to educate different people dealing with medicines and equip them for the roles they have to perform efficiently so that the wastage does not take place or can be minimized.
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The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of noncommunicable diseases (NCDs). This report examines the effect of the COVID-19 pandemic on access to NCD medicines, and the policies and strategies implemented by countries and health sys...tems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
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The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of noncommunicable diseases (NCDs). This report examines the effect of the COVID-19 pandemic on access to NCD medicines, and the policies and strategies implemented by countries and health sys...tems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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This report provides an update on the key facets of HIV treatment access, including the latest HIV treatment guidelines from World Health Organization (WHO), an overview on pricing for first-line, second-line, and salvage regimens, and a summary of the opportunities for – and threats to – expand...ing access to affordable antiretroviral therapy (ART).
The report is supplemented by 11 drug profiles that contain more detailed information on pricing trends and patent barriers for key antiretroviral drugs and fixed-dose combinations. Also included is an annex of conditions that define eligibility for reduced prices from 15 pharmaceutical companies.
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The extensive use of antimicrobials in human and veterinary medicine in recent years has accelerated the emergence and spread of resistant microorganisms. This situation has been worsened by the lack of investment in developing new effective antibiotics. The severity of the consequences is clear to ...see: it is estimated that each year, drug-resistant infections result in at least 25 000 patient deaths and cost the EU EUR 1,5 billion in healthcare costs and through loss of productivity
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Long-term polio vaccine security – the timely, sustained, and uninterrupted supply of suitable types of affordable, quality-assured polio vaccines – is essential in the global effort to achieve and maintain a polio free world. However, fragmented approaches and short-term planning pose considera...ble challenges to securing long-term polio vaccine security.
This framework is designed to enhance the efforts of existing structures and workstreams within the Global Polio Eradication Initiative (GPEI) and other stakeholders by improving communication and coordination on vaccine security. Ensuring vaccine security is crucial for maintaining a timely, sustained, and uninterrupted supply of affordable, quality-assured polio vaccines in the global fight to achieve and sustain a polio-free world. However, challenges such as fragmented approaches, short-term planning, a dynamic policy environment, and a diverse product pipeline present significant risks to long-term vaccine security. This framework emphasizes the need for alignment and coordination across key polio operational domains, including Poliovirus Containment, Research and Development, and Vaccine Manufacturing and Supply. It also underscores the critical role of normative frameworks and policies in shaping long-term vaccine strategies that guide these operational areas. Additionally, it highlights the importance of cross-cutting elements such as financing and access to resources, along with the integration of communication, coordination, and advocacy efforts, as essential enablers for achieving vaccine security. To secure long-term vaccine supply, it is imperative to enhance alignment and strengthen coordinated efforts across workstreams and with stakeholders, including vaccine manufacturers.
Recognizing that vaccine security is an ongoing endeavor, requiring continuous monitoring and adaptation, this framework will undergo regular updates and revisions. Initially, the management of the framework will be carried out by the GPEI Vaccine Supply Group (VSG).
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To support its R&D activities on Chagas disease, DNDi launched the Chagas Clinical Research Platform (CCRP). The platform brings together partners, experts, and stakeholders to provide support for evaluation and development of new treatments for Chagas disease. The patient-centred platform aims to f...acilitate clinical research, provide a forum for technical discussions, develop a critical mass of expertise, and strengthen institutional research capacities. In addition, it identifies and reviews priority needs, works towards standardization of methodology to assess drug efficacy and reviews alternatives for using current approved drugs (new schemes, doses, combination) and special scenarios (resistance).
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An Act to repeal the Dangerous Medicines Act of 1973,to ensure the availability of certain drugs for exclusive medical, scientific and related purposes, while preventing their abuse; to prevent the diversion from lawful trade of controlled chemicals, controlled equipment and controlled materials for... use in the unlawful manufacture of such drugs; to render drug trafficking and related conduct as serious criminal offences and to ensure that trafficking and related conducted as serious criminal offences and to ensure that offenders or suspects are brought to justice; to render certain conduct by drug users as criminal offences, to provide for the treatment and rehabilitation of drug abusing or dependent offenders; to establish the Lesotho Narcotics Bureau; and for related matters.
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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.
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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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Ahead of World Malaria Day, the WHO Global Malaria Programme published a new operational strategy outlining its priorities and key activities up to 2030 to help change the trajectory of malaria trends, with a view to achieving the global malaria targets. The strategy outlines 4 strategic objectives ...where WHO will focus its efforts, including developing norms and standards, introducing new tools and innovation, promoting strategic information for impact, and providing technical leadership of the global malaria response.
In recent years, progress towards critical targets of the WHO Global technical strategy for malaria 2016-2030 has stalled, particularly in countries that carry a high burden of the disease. In 2022 there were an estimated 608 000 malaria-related deaths and 249 million new malaria cases globally, with young children in Africa bearing the brunt of the disease.
Millions of people continue to miss out on the services they need to prevent, detect, and treat malaria. Additionally, progress in global malaria control has been hampered by resource constraints, humanitarian crises, climate change and biological threats such as drug and insecticide resistance.
“A shift in the global malaria response is urgently needed across the entire malaria ecosystem to prevent avoidable deaths and achieve the targets of the WHO global malaria strategy,” notes Dr Daniel Ngamije, Director of the Global Malaria Programme. “This shift should seek to address the root causes of the disease and be centred around accessibility, efficiency, sustainability, equity and integration.”
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