This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
Drugs, Diagnostics, Vaccines, Preventive Technologies, Research toward a cure, and immune-based and gene therapies in development
Antimicrobial resistance (AMR) has emerged as a major public health problem all over the world. Infections caused by resistant microbes fail to respond to treatment, resulting in prolonged illness and greater risk of death. This document focuses on the mechanism to develop a practically applicable h...ospital antibiotic policy and standard treatment guidelines (STG). In addition, the document contains information on various effective strategies for implementation of STG. It also discusses various activities and information required for the development of the antibiogram, antibiotic policy and standard treatment guidelines, such as surveillance programmes, the cause and controlling strategies for AMR and HAI; performance measures of antibiogram, antibiotic policy and standard treatment guidelines. A model hospital STG for community-acquired pneumonia in adults is included.
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Prepared as an outcome of ICMR Expert Group on Immunophenotyping of Hematolymphoid Neoplasms | Coordinated by Division of Non Communicable Diseases | This document addresses on various issue related to good quality practices in laboratory work up of flow cytometric immunophenotyping and will be of u...se to pathologists, cytometrists, hematologists, technologists and scientists working in this field.
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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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This resource consists of technical guidelines for District Medical Officers, counselors and laboratory technicians for second-line antiretroviral therapy drugs, operational guidelines for pilot roll-out in two centres and laboratory guidelines for viral-load testing and standard operating procedure...s.
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The Ministry of Health together with its partners realizes that efficient and effective
delivery of clinical care is highly dependent on the availability of appropriately
upgraded environment, which is in well facilitated space. Such facilities and utilities
should always be properly designed, bu...ilt, and maintained, so as to ensure efficient
treatment in clean and safe from infection.
The main challenges in achieving this include the lack of, appropriate holistic and
futuristic management plans, human resource for facility/utility management and
maintenance, adequate budget funds for renovation/maintenance activities at all
levels which means daily and long-term of facility maintenance plans and executions.
It is hoped that the guidelines will help to standardise
design of medical facilities and utilities country wide and result in efficient and
effective establishment of these life-saving function
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This document builds on the Background document prepared for the September 4-5, 2014 Consultation. It includes proposed elements to consider during the development of a framework to assist decision-making at global and national level.
The aim of the document is to assist Member States and releva...nt partners in their discussions to identify the best approaches to ensure the accelerated evaluation and use of available or near-term therapies and vaccines for the treatment and prevention of EVD. The document calls for a coordinated effort by the international community to remove unnecessary obstacles towards this goal.
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Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte...d with the Ebola virus:
BCX4430 (Biocryst);
Brincidofovir (Chimerix);
Favipiravir (Fujifilm Corporation/Toyama);
TKM-100802 (Tekmira);
AVI-7537 (Sarepta);
ZMapp (Leafbio Inc.);
Anti-Ebola F(ab’)2 (Fab’entech).
The amount of information available for the seven treatments is highly variable. For some compounds there is no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans, albeit for the treatment of other viral diseases.
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The WHO South-East Asia (SEA) Region bears a high burden of tuberculosis (TB) and MDR-TB. In 2015, the Region accounted for nearly 200 000 or 35% of the global estimated new RR/MDR-TB cases eligible for treatment. Extensively drug-resistant TB (XDRTB) has also been reported from s...ix countries of the SEA Region. MDR-TB could potentially replace drug-susceptible TB, and constitutes a threat to global public health security. The South- East Asia Regional Response Framework for DR-TB 2017–2021 complements the Ending TB in the South-East Asia Region: Regional Strategic Plan 2016–2020” and outlines key strategies for reducing morbidity, mortality and transmission of DR-TB.
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Guidelines for the registration of microbial, botanical and semiochemical pest control agents for plant protection and public health uses.
These guidelines are intended to guide pesticide regulatory authorities in the registration of microbial, botanical, and semiochemical pest control agents for p...lant protection and public health uses.
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Replacement of Annex 2 of WHO Technical Report Series, No. 964... morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
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The intent of these guidelines is to develop a holistic, coordinated, proactive and technology driven strategy for management of biological disasters through a culture of prevention, mitigation and preparedness to generate a prompt and effective response in the event of an emergency. Th...e document contains comprehensive guidelines for preparedness activities, biosafety and biosecurity measures, capacity development, specialised health care and laboratory facilities, strengthening of the existing legislative/
regulatory framework, mental health support, response, rehabilitation and recovery, etc. It specifically lays down the approach for implementation of the guidelines by the central ministries/departments, states, districts and other stakeholders, in a time bound manner.
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The International Pharmaceutical Federation (FIP) is a global federation of national associations of pharmacists and
pharmaceutical scientists. In order to support these associations in their fight against AMR, FIP has prepared this
briefing document. It is an overview of the different activities ...that community and hospital pharmacists are involved
into prevent AMR and to reverse AMR rates.
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Scientists have known for more than half a century that patients could develop resistance to the drugs used to treat them. Alexander Fleming, who is credited with creating the first antibiotic, penicillin, in 1928, cautioned of the impending crisis while accepting his Nobel prize in 1945: “There ...is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.” Since then antibiotics have proved one of the most effective interventions in human medicine. Sadly, the overuse and misuse of this precious resource have brought us to a global crisis of antimicrobial resistance (AMR). To address this crisis nearly seven decades after Fleming’s lecture the first UN general assembly meeting on drug resistance bacteria was convened in September 2017.
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Intensive Care Med (2009) 35:9–29DOI 10.1007/s00134-008-1336-9
Although thousands of papers have been devoted tohospital-acquired pneumonia (HAP), many controversiesremain, and management of HAP is probably often sub-optimal. Several reviews or guidelines have been pub-lished rec...ently, mostly by North American initiatives(CDC, ATS). Three European Societies (ERS, ESCMID andESICM) were interested in producing a document thatcould complement in some way the last IDSA/ATS guidelines published 3 years ago. In addition, the Helics
working group supported this initiative.
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The current document is anupdate of the guidelines developed by the EUCAST subcommittee on detection of resistance mechanisms. The EUCAST Steering Committee has carried out the current update. The document has been developed mainly for routine use in clinical laboratories and doesnot cover technical... procedures for identification of resistance mechanisms at a molecular level by reference or expert laboratories. However, much of the content is also applicable tonational reference laboratories. Furthermore, it is important to note that the document does not cover screening for asymptomatic carriage (colonization) of multidrug-resistant microorganismsor direct detectionof resistancein clinical samples.
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The guidelines are to be used to guide the management of adults with lower respiratory tract infection (LRTI). As will be seen in the following text, this diagnosis, and the other clinical syndromes within this grouping, can be difficult to make accurately. In the absence of agreed definitions of th...ese syndromes these guidelines are to be used when, in the opinion of a clinician, an LRTI syndrome is present. The following are put forward as def-initions to guide the clinician, but it will be seen in the ensuingtext that some of these labels will always be inaccurate. These definitions are pragmatic and based on a synthesis of available studies. They are primarily meant to be simple to apply in clinical practice, and this might be at the expense of scientific accuracy. These definitions are not mutually exclusive, with lower respiratory tract infection being an umbrella term that includes all others, which can also be used for cases that cannot be classified into one of the other groups. No new evidence has been identified that would lead to a change in the clinical definitions,which are therefore unchanged from the 2005 publication.
Clin Microbiol Infect 2011;17(Suppl. 6): 1–24 The full version of these guidelines can be found on Wiley Online Library.
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Modern healthcare has given rise to extremely complex and multifaceted ethical dilemmas. All too often physicians are unprepared to manage these competently. This publication is specifically structured to reinforce and strengthen the ethical mindset and prac...tice of physicians and provide tools to find ethical solutions to these dilemmas. It is not a list of “rights and wrongs” but an attempt to sensitise the conscience of the physician, which is the basis for all sound and ethical decision-making. To this end, you will find several case studies in the book, which are intended to foster individual ethical reflection as well as discussion within team settings.
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On 13 August 2024, Africa Centres for Disease Control and Prevention (Africa CDC) declared the ongoing Mpox outbreak a Public Health Emergency of Continental Security (PHECS). This was followed the next day by the World Health Organization (WHO), which extended the alert internationally as a public ...health emergency of international concern (PHEIC). After these declarations, many countries have made efforts to mobilize resources to introduce or expand laboratory testing, surveillance, and response activities. In particular, as the number of suspected cases surges in the Democratic Republic of Congo (DRC), Burundi, and the Central African Republic, and an increasing number of new countries report cases, there is an urgent need to implement testing to strengthen the Mpox response. However, access to appropriate quality assured diagnostics is a challenge. There is limited information on important characteristics, such as available test kits’ performance and ability to detect relevant clades.
To address the challenge of mpox access in the continent, the Africa CDC Diagnostic Advisory Committee (DAC) met in Kigali from 19-23 August 2024 to review the available evidence on molecular tests for Mpox and to shortlist tests that may be useful for Mpox testing in countries. The shortlist aims to provide guidance to Africa CDC, countries and partners on appropriate high-quality molecular tests to procure and use for the mpox response.
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