These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data.
The purpose of such research should be: i. directed towards enhancing knowledge about the human condition while ...maintaining sensitivity to the Indian cultural, social and natural environment; ii. conducted under conditions such that no person or persons become mere means for the betterment of others and that human beings who are participating in any biomedical and/or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; and iii. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of the results thereof.
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BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3379
Rapid Recommendation and visual graph. This is the fifth version (update 4) of the living guideline (BMJ 2020;370:m3379). When citing this article, please consider adding the update number and date of access for clarity. The publication of the RE...COVERY and REMAP-CAP randomised controlled trials triggered this guideline update, resulting in a strong recommendation for interleukin-6 (IL-6) receptor blockers (tocilizumab or sarilumab) in patients with severe or critical covid-19.
Prior recommendations: (a) A recommendation not to use ivermectin in patients with covid-19, regardless of disease severity, except in the context of a clinical trial; (b) a strong recommendation against the use of hydroxychloroquine in patients with covid-19, regardless of disease severity; (c) a strong recommendation against the use of lopinavir-ritonavir in patients with covid-19, regardless of disease severity; (d) a strong recommendation for systemic corticosteroids in patients with severe and critical covid-19; (e) a conditional recommendation against systemic corticosteroids in patients with non-severe covid-19; and (f) a conditional recommendation against remdesivir in hospitalised patients with covid-19.
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Heart failure with a reduced ejection fraction (HFrEF) is a condition frequently encountered by healthcare professionals and, in order to achieve the best outcomes for patients, needs to be managed optimally. This guideline document is based on the European Society of Cardiology Guidelines for the t...reatment of acute and chronic heart failure published in 2016, and summarises what is considered the best current management of patients with the condition. It provides information on the definition, diagnosis and epidemiology of HFrEF in the African context. The best evidence-based treatments for HFrEF are discussed, including established therapies (beta-blockers, ACE-i/ARBs, mineralocorticoid receptor antagonists (MRAs), diuretics) that form the cornerstone of heart failure management as well as therapies that have only recently entered clinical use (angiotensin receptor-neprilysin inhibitor (ARNI), sodium/glucose cotransporter-2 (SGLT2) inhibitors). Guidance is offered in terms of more invasive therapies (revascularisation, implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy (CRT) by implantation of a biventricular pacemaker with (CRT-D) or without (CRT-P) an ICD, left ventricular assist device (LVAD) use and heart transplantation) in order to ensure efficient use of these expensive treatment modalities in a resourcelimited environment. Furthermore, additional therapies (digoxin, hydralazine and nitrates, ivabradine, iron supplementation) are discussed and advice is provided on general preventive strategies (vaccinations). Sections to discuss conditions that are particularly prevalent in sub-Saharan Africa (HIV-associated cardiomyopathy (CMO), peripartum CMO, rheumatic heart disease, atrial fibrillation) have been added to further improve clinical care for these commonly encountered disease processes.
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Version 1.1. The WHO protocol has been adapted to resource-limited settings and builds on existing methodologies from the European Centre for Disease Prevention and Control (ECDC), the Global PPS project from University of Antwerp, the US Centers for Disease Control and Prevention (CDC), and the Med...icines Utilisation Research in Africa (MURIA).
Point Prevalence Surveys collects information on prescribing practices of antibiotics and other information relevant to treatment and management of infectious diseases in hospitalized patients, and complements surveillance of antimicrobial consumption.
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The authors conduct an integrated survey of Antimicrobial Resistant Organisms (AMR) in drinking water, wastewater and surface water in three settings in Bangladesh: rural households, rural poultry farms, and urban food markets. Results show that untreated water discharged from rural households, poul...try farms and urban markets are major contributors to surface water pollution and antibiotic resistant bacteria genes, calling for increased surveillance and monitoring.
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WHO Model Formulary for children based on the Second Model List of Essential Medicines for Children 2009.
In 2007, the World Health Assembly passed a Resolution titled ‘Better Medicines for Children’. This resolution recognized the need for research and development into medicines for children,... including better dosage forms, better evidence and better information about how to ensure that medicines for treating the common childhood diseases are given at the right dose for children of all ages.
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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 diseases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them.
WHO guidelines on the pharmacological treatment of persisting pain in children with medical illnesses
The threat posed by antimicrobial resistance (AMR) to public health as well as global health security has been reiterated in umerous World Health Assembly (WHA) resolutions. AMR is also prioritized under the Global Health Security Agenda (GHSA), and India is one of the contributing countries. The Mi...nistry of Health & Family Welfare (MoHFW) identified AMR as one of the top 10 priorities for the ministry’s collaborative work with WHO. The National Health Policy 2017 identifies antimicrobial resistance as a problem and calls for effective action to address it. An international conference on AMR – “Combating Antimicrobial Resistance: A
Public Health Challenge and Priority”, was jointly organized by the Government of India and World Health Organization (WHO) in February 2016, which was attended by more than 350 participants. The Hon’ble Prime Minister, Shri Narendra Modi, and the Hon’ble Union Minister for Health, Shri J.P. Nadda have reiterated government’s commitment to tackle AMR.
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The WHO CIA List should be used as a reference to help formulate and prioritize risk assessment and risk management strategies for containing antimicrobial resistance. The WHO CIA List supports strategies to mitigate the human health risks associated with antimicrobial use in ...food-producing animals and has been used by both public and private sector organizations. The list helps regulators and stakeholders know which types of antimicrobials used in animals present potentially higher risks to human populations and how use of antimicrobials might be managed to minimize antimicrobial resistance of medical importance. The use of the WHO CIA List, in conjunction with the OIE list of antimicrobials of veterinary importance (1) and the WHO Model Lists of Essential Medicines (2) , will allow for prioritization of risk management strategies in the human sector, the food animal sector, inagriculture (crops) and horticulture, through a coordinated multisectoral One Health approach.
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9th edition; 4th English edition 2020
Millennium Development Goal 8E aims for affordable access to essential medicines. Essential medicines, as defined by WHO, are those that “satisfy the health-care needs of the majority of the population” and that should therefore “be available at all times in adequate amounts”. However, there... is a category of medicines that faces a unique challenge in terms of availability. These are the medicines governed by the international conventions on narcotic and psychotropic substances. “Controlled medicines” is the common definition for pharmaceuticals whose active principles are listed under the 1961 United Nations Single Convention on Narcotic Drugs as amended by the 1972 Protocol, such as morphine and methadone; the 1971 United Nations Convention on Psychotropic Substances, such as diazepam and buprenorphine; and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, such as ergometrine and ephedrine. The conventions list substances in “Schedules” according to their different levels of potential for abuse and harm, and the commensurate severity of control measures to be applied by countries.
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This document was prepared in response to a need to review and potentially update the current recommendations for the antibiotic treatment of both inpatient and outpatient management of severe acute malnutrition (SAM). The current recommendations (Table 1) are based on guidelines published in 2013 i...n the WHO Pocketbook for Hospital Care for Children, and the 2013 update on SAM (outpatient management). The global threat of increasing antimicrobial resistance and new data on efficacy and safety profiles requires a re-review of the current evidence to ensure recommendations are the most appropriate. The evidence base for the use of antibiotics in children presenting with uncomplicated SAM has been recently enlarged.
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2016-2018 Early implementation,
This report presents 2015 data on the consumption of systemic antibiotics from 65 countries and areas, contributing to our understanding of how antibiotics are used in these countries. In addition, the report documents early efforts of the World Health Organization (...WHO) and participating countries to monitor antimicrobial consumption, describes the WHO global methodology for data collection, and highlights the challenges and future steps in monitoring antimicrobial consumption.
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The Mapping Antimicrobial Resistance and Antimicrobial Use Partnership (MAAP) project has conducted a multi-year, multi-country study that provides stark insights on the under-reported depth of the antimicrobial resistance (AMR) crisis across Africa and lays out urgent policy recommendations to addr...ess the emergency.
MAAP reviewed 819,584 AMR records from 2016-2019, from 205 laboratories across Burkina Faso, Cameroon, Eswatini, Gabon, Ghana, Kenya, Malawi, Nigeria, Senegal, Sierra Leone, Tanzania, Uganda, Zambia, and Zimbabwe. MAAP also reviewed data from 327 hospital and community pharmacies and 16 national-level AMC datasets.
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Myocardial infarctions are generally clinically classified into ST elevation MI (STEMI) and non-ST elevation MI (NSTEMI), based on changes in ECG. When blood flow to a part of the heart stops or the heart is injured and fails to receive enough oxygen required for its adequate functioning the conditi...on is termed as STEMI or the ‘heart-attack’ in laymen language. Patients with elevated cardiac troponin levels but negative CK-MB who were formerly diagnosed with unstable angina or minor myocardial injury are now reclassified as non-ST-segment elevation Myocardial Infarction (non-STEMI) even in the absence of diagnostic changes.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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Investigación original / Original research
Rev Panam Salud Publica 35(1), 2014
Antibiotics use with care