Building on our decades of commitment to human rights in medicine and healthcare, we have published a new report on emerging threats in health-related human rights both globally and in the UK.
'H...ealth and human rights in the new world (dis)order' outlines a shifting rights landscape in which new technologies, environmental change and geopolitical reconfigurations are putting renewed and at times intense stress on human rights, both in medicine and healthcare more broadly.
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Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusde...dit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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Antimicrobials are medicines, including antibiotics, antivirals, antifungals, and antiparasitics, that are used to prevent and treat infections in humans, animals, and plants. Antimicrobial Resistance (AMR) arises when bacteria, viruses, fungi, and ...parasites no longer respond to these medicines, rendering them ineffective and making infections more difficult to treat. This resistance increases the risk of disease spread, severe illness, disability, and death. Although AMR is a natural phenomenon driven by genetic
changes in pathogens, it is significantly accelerated by human activities such as the misuse and overuse of antimicrobials in healthcare, agriculture, and animal husbandry.
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The era of effective antibiotics is coming to a close. In just a few generations, many “miracle medicines”have been beaten into ineffectiveness by the bacteria they were i...ntended to eradicate. Bacteria quickly adapt to the presence of antibacterial agents in order to survive. The misuse of antibiotics,which is an international problem, only exacerbates the steady evolution of resistance. In August 2010, the journal Lancet Infectious Diseases posed the question "Is this the end of antibiotics?" documentingthe rapid spread of multidrug-resistant bacteriaand predicting that 10 years remain in the useful life of many agents.
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This document provides interim guidance on the management of the blood supply in response to the pandemic outbreak of coronavirus disease (COVID-19...). It emphasizes the importance of being prepared and responding quickly and outlines key actions and measures that the blood services should take to mitigate the potential risk to the safety and sufficiency of the blood supplies during the pandemic.
It should be read in conjunction with WHO Guidance for National Blood Services on Protecting the Blood Supply During Infectious Disease Outbreaks, which provides general guidance on the development of national plans to respond to any emerging infectious threats to the sufficiency or safety of the blood supply.
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This document provides interim guidance on the management of the blood supply in response to the pandemic outbreak of coronavirus disease (COVID-19...). It emphasizes the importance of being prepared and responding quickly and outlines key actions and measures that the blood services should take to mitigate the potential risk to the safety and sufficiency of the blood supplies during the pandemic.
It should be read in conjunction with WHO Guidance for National Blood Services on Protecting the Blood Supply During Infectious Disease Outbreaks, which provides general guidance on the development of national plans to respond to any emerging infectious threats to the sufficiency or safety of the blood supply.
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Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of ...medicines in Nigeria.
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Inequality of access to palliative care and symptom relief is one of the greatest disparities in global health care (1). Currently, there is avoidable suffering on a massive scale due to lack ...class="attribute-to-highlight medbox">of access to palliative care and symptom relief in low- and middle-income countries (LMICs) (1). Yet basic palliative care that can prevent or relieve most suffering due to serious or life-threatening health conditions can be taught easily to generalist clinicians, can be provided in the community and requires only simple, inexpensive medicines and equipment. For these reasons, the World Health Assembly (WHA) resolved that palliative care is "an ethical responsibility of health systems"(2). Further, most patients who need palliative care are at home and prefer to remain there. Thus, it is imperative that palliative care be provided in the community as part of primary care. This document was written to assist ministries of health and health care planners, implementers and managers to integrate palliative care and symptom control into primary health care (PHC).
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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 h...ospitals and to provide tools and step-by-step instructions for designing and carrying out an assessment of antibiotic use and management in hospitals. The 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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An estimated 59 000 people die from rabies each year. That’s one person every nine minutes of every day, 40% of whom are children living in Asia and Africa. As dog bites cause almost all human cas...es, we can prevent rabies deaths by increasing awareness, vaccinating dogs to prevent the disease at its source and administering life-saving treatment after people have been bitten. We have the vaccines, medicines, tools and technologies to prevent people from dying from dog-mediated rabies. For a relatively low cost it is possible to break the disease cycle and save lives
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in develop...ing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
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The goal of the draft global action plan is to ensure, for as long as possible, continuity of successful treatment and prevention of infectious dis...eases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them.
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For thousands of years, humans have been using wildlife for commercial and subsistence purposes. Wildlife trade takes place at local, national and international levels, with different forms of wildl...ife, such as live animals, partly processed products and finished products. Wildlife is a vital source of safe and nutritious food, clothing, medicine, and other products, in addition to having religious and cultural value. Wildlife trade also contributes to livelihoods, income generation and overall economic development.
However, wildlife trade can have detrimental effects on species conservation, depleting natural resources, impoverishing biodiversity and degrading ecosystems (Morton et al., 2021). Wildlife trade, whether legal or illegal, regulated or unregulated, can pose threats to animal health and welfare. It also presents opportunities for zoonotic pathogens to spill over between wildlife and domestic animals, and for diseases to emerge with serious consequences for public or animal health and profound economic impacts (IPBES, 2020; Swift et al., 2007; Smith et al., 2009; Gortazar et al., 2014; Stephen, 2021; Stephen et al., 2022; FAO, 2020). The risk of pathogen spillover and disease emergence is amplified with increased interaction between humans, wildlife and domestic animals. The risk of pathogen spillover has also been exacerbated by climate change, intensified agriculture and livestock production, deforestation, and other land-use changes. Wildlife trade is also a risk to ecosystem biodiversity via the introduction of invasive species (Wikramanayake et al., 2021). Therefore, increased effort must be put into understanding the potential consequences of the wildlife trade, mapping and analysing the adjacent risks, and implementing strategies to manage those risks. Reducing wildlife-trade risks not only helps to limit disease but also minimises the negative effects of invasive species. Between 1960 and 2021, invasive alien species caused estimated cumulative damage of around 116 billion euros across 39 countries in the European Union alone, despite strict import regulations (Haubrock et al., 2021). The effect of invasive species is extremely apparent.
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Exciting new treatment approaches make the management of hepatitic C one of the most rapidly developing areas of ...t medbox">medicine. The Flying Publisher short Guide to Hepatitis C is an up-to-date source of information for physicians, residents and advanced medical students.
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Evidence for improving community health supply chains from Ethiopia, Malawi and Rwanda. Journal of Global Health vol. 4 No.2 (2014)
The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal med...icines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP... shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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At least half of the world’s population does not have full coverage of essential health services. Health expenses push more than 100 million people into extreme poverty each and every year, forcin...g them into terrible choices that no one should ever have to make: Buy medicine or food? Education or health care? These stark statistics make the case for universal health coverage compelling.
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For 50 SAM children with medical complications and for a paediatric ward of 10-15 beds for 3 months
The PED/SAM kit is especially designed to provide medicines, renewables and equipment suitable ...for children and to treat the common childhood illness including severe acute malnutrition with medical complications.
This kit does NOT contain any food supplements, TB, HIV medicines or vaccines.
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The global pandemic has highlighted fragility in international supply chains and the dependency of many African countries on imported personal protective equipment (PPE). Market pressures have also ...increased prices for imported supplies and put additional pressure on areas with limited resources for procurement. There is an urgent operational need to develop the domestic capacity to supply PPE from within the African continent. There is huge variation in Member
States industrial manufacturing capacity and the regulatory and testing capacity of government agencies at present. Growing number of companies, including micro- and small-medium enterprises, have responded by repurposing, albeit temporarily, to manufacture an assortment of PPEs. This workshop aims to bring together government representatives, industry, and subject matter experts on material testing and standards to promote the development of domestic production of safe and effective PPE made in Africa.
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