Cases of human monkeypox are rarely seen outside of west and central Africa. There are few data regarding viral kinetics or the duration of viral shedding and no licensed treatments. Two oral drugs, brincidofovir and tecovirimat, have been approved for treatment of smallpox and have demonstrated eff...icacy against monkeypox in animals. Our aim was to describe the longitudinal clinical course of monkeypox in a high-income setting, coupled with viral dynamics, and any adverse events related to novel antiviral therapies.
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Clinical guideline, Methods, Evidence and Recommendations
In this guideline the following is covered: information needs of people with chronic hep
titis B and their carers; where children, young people and adults with chronic hepatitis B a-
should be assessed; assessment of liver disease, includi...ng the use of non-invasive tests and genotype testing; criteria for offering antiviral treatment; the efficacy, safety and cost effectiveness of currently available treatments; selection of first-line therapy; management of treatment failure or drug resistance; prophylactic treatment during im-
munosuppressive therapy; and monitoring for treatment response
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10 May 2021. Manufactureres:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
The ChAdOx1-S/nCoV-19 [recombinant] vaccine is a replication-deficient adenoviral vecto...r vaccine against coronavirus disease 2019 (COVID-19). The vaccine expresses the SARS-CoV-2 spike protein gene, which instructs the host cells to produce the protein of the S-antigen unique to SARS-CoV-2, allowing the body to generate an immune response and to retain that information in memory immune cells. Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) irrespective of interval between the doses was 63.1%, based on a median follow-up of 80 days, but tended to be higher when this interval was longer. The data reviewed at this time support the conclusion that the known and potential benefits of ChAdOx1-S/nCoV-19 [recombinant] vaccine outweigh the known and potential risks.
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14.04.2016
Pharm -Ed
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The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alcohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited resources, it is essential to respect the Good Man...ufacturing Practices to ensure the quality, efficacy and safety of the product.
If you need production sheet, checklist of the material needed etc., please click on the following link: https://pharmed.datapharma.ch/courses...
Pharm-Ed (www.Pharm-Ed.net) is an initiative of the Pharmacy of the Geneva University Hospitals in Switzerland. The platform is free but registration (for free) is needed to access the e-learning courses and resources.
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This chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
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PQM conducted an assessment of the medicine quality assurance and quality control systems in Rwanda during November 9-13, 2009. Medicine quality assurance remains to be developed in Rwanda: the country has neither a medicine regulatory authority (MRA) nor a national medicine quality control laborato...ry – the two key institutions to ensure the quality, safety, and efficacy of medicines. The MOH Pharmacy Taskforce (PTF) is to be commended however for successfully controlling the pharmaceutical market to the extent that there is no informal medicines market in Rwanda. Based on its findings, the assessment team expects Rwanda to be able to make great strides in evidence-based medicines quality assurance in the short to medium term, provided it receives adequate technical assistance and financial support.
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Recent systematic reviews and meta-analysis of the impact of chemical-based mollusciciding (King et al., 2015, Sokolow et al., 2016) have concluded that regular mollusciciding is likely to contribute significantly towards elimination of schistosomiasis in high-risk areas. The WHO roadmap’s new foc...us on “transmission control, wherever possible” (WHO, 2012a) reinforces the need to promote intermediate-host snail control to prevent schistosomiasis transmission.
This operational manual is intended to facilitate the reintroduction of practices and protocols for use of molluscicides in the field in schistosomiasis control programmes. It is complemented by guidelines on the laboratory and field testing of the efficacy of molluscicides for schistosomiasis control (WHO, 2017 [in preparation]).
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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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Glob Ment Health (Camb). 2015; 2: e12. Published online 2015 Jul 14. doi: 10.1017/gmh.2015.10
Low and middle income countries (LMICs) are facing an increase of the impact of mental health problems while confronted with limited resources and limited access to mental health care, known as the ‘me...ntal health gap’. One strategy to reduce the mental health gap would be to utilize the internet to provide more widely-distributed and low cost mental health care. We undertook this systematic review to investigate the effectiveness and efficacy of online interventions in LMICs.
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This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its obj...ectives are to minimize the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance. It is also important to provide for the safe and effective use of veterinary antimicrobial drugs in veterinary medicine by maintaining their efficacy. This document defines the respective responsibilities of authorities and groups involved in the authorization, production, control, distribution and use of veterinary antimicrobials such as the national regulatory authorities, the veterinary pharmaceutical industry, veterinarians, distributors and producers of food-producing animals.
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The Lancet olume 395, ISSUE 10232, P1259-1267, April 18, 2020. Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifa...mpicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions.
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West Africa is experiencing the largest, most severe, most complex outbreak of Ebola virus disease in history. On 11 August 2014, WHO convened a consultation where the participants concluded that in the particular context of the current Ebola outbreak in West Africa, it is ethically acceptable to of...fer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluat-
ed for safety and efficacy in humans as potential treatment or prevention
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Development of one or more vaccines for Neisseria gonorrhoeae is an important objective for sexual and reproductive health worldwide, and for the fight against antimicrobial resistance.
WHO preferred product characteristics (PPCs) provide strategic guidance as to WHO’s preferences for new vacci...nes in priority disease areas. PPCs are intended to encourage innovation and development of vaccines for use in settings most relevant to the global unmet public health need.
Gonococcal vaccine PPCs describe global public health goals for gonococcal vaccines and preferred parameters pertaining to vaccine indications and target populations, safety and efficacy considerations, and immunization strategies.
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August 2020, The Africa Joint Continental Strategy for COVID-19 is underpinned by the need to limit transmission, prevent deaths and reduce associated harms. Participation by African nations in clinical trials is an essential step to ensure that sufficient data is generated on the safety and efficac...y of the most promising vaccine candidates among the region’s populations.
While current COVID-19 clinical trial activity on the continent is limited, Africa has substantial experience and capabilities to conduct clinical trials for preventative vaccines across a range of diseases, and many organizations on the continent are working tirelessly to help prepare additional trials on potential COVID-19 vaccines. As the number of candidate vaccines in the development pipeline continues to increase, it will be important for organizations responsible for managing clinical trials in the region to partner with vaccine developers to identify potential and appropriate trial locations, provide support to remove any critical obstacles impeding commencement and progress of trials, and to provide oversight ensuring that trials are conducted safely and ethically.
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On 15–16 December 2020, WHO and the Medicines for Malaria Venture co-convened a technical consultation to consider the preferred product characteristics (PPCs) for drugs used in malaria chemoprevention. The main goal of the technical consultation was to agree on the most important PPCs for drugs t...o protect populations from malaria (chemoprevention), while considering relevant measures of efficacy and the safety data needed to support WHO policy recommendations.
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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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BMJ Global Health, Vol. 4 (2019) no.2
Antibiotic resistance is threatening global health, development and food security; however, measures for assessing and communicating the threat of resistance are lacking. The Drug Resistance Index (DRI) allows for global assessment of the relative efficacy of ...countries’ antibiotic therapy.
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The COVID-19 vaccine tracker and landscape compiles detailed information of each COVID-19 vaccine candidate in development by closely monitoring their progress through the pipeline.
The COVID-19 vaccine tracker:
Provides summary tables of COVID-19 vaccine candidates in both clinical and pre-...clinical development;
Provides analysis and visualization for several COVID-19 vaccine candidate categories;
Tracks the progress of each vaccine from pre-clinical, Phase 1, Phase 2 through to Phase 3 efficacy studies and including Phase 4 registered as interventional studies;
Provides links to published reports on safety, immunogenicity and efficacy data of the vaccine candidates;
Includes information on key attributes of each vaccine candidate and
Allows users to search for COVID-19 vaccines through various criteria such as vaccine platform, schedule of vaccination, route of administration, developer, trial phase and clinical endpoints.
The database is updated regularly - twice a week (Tuesday and Friday, 17:00 CET).
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As of 12 December 2022, over 645 million people worldwide have been diagnosed with COVID-19, with over 6.6 million deaths (4).
The Omicron variant, which emerged in late November 2021, and its subvariants, are now the dominant circulating viruses, contributing to the ongoing surge in several countr...ies (4). Vaccination has substantially reduced case numbers and hospitalizations in many countries,but limitations in global access to vaccines mean that many populations, including those in low- and middle-income countries, remain vulnerable. Even in vaccinated individuals, uncertainties remain about duration of protection and efficacy, and the degree of crossprotection with new variants.
There remains a need for more effective treatment and management for those affected by COVID-19. The pandemic – and the
explosion of both research and misinformation – has highlighted the need for trustworthy, accessible and regularly updated living
guidelines to place emerging findings into context and provide clear recommendations for clinical practice
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