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Antimicrobial resistance (AMR) is a threat to human and animal health and refers to the ability of microorganisms to defy the medicines prescribed. For instance when antibiotics are used improperly, such as an incorrect dose, insufficient duration or wrong frequency, resistance is heightened. The mi
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suse of antimicrobials affects their efficacy, and increasingly more infections and diseases become untreatable. Many gains made in modern medicine throughout the 20th century will be lost, making AMR a global public and animal health issue that requires concerted action. AMR and the use of antimicrobials (AMU) affect food safety and security, people’s livelihoods, as well as economic and agricultural development.
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Pregnancy often results in exclusion from clinical trials of antiretroviral (ARV) drugs, resulting in limited data on pharmacokinetics (PK), drug safety, and the efficacy of new ARV drugs in pregnancy and lactation. However, pregnancy, lactation, or
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the potential for pregnancy should not preclude the use of drug regimens that would be chosen for people who are not pregnant, unless adequate drug levels are not likely to be attained in pregnancy or known adverse effects outweigh potential benefits
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The WHO Framework for the clinical evaluation of devices for male circumcision
outlines a multi-phase process to ensure the safety, efficacy, and acceptability of new devices, especially for use in resource-limited settings
verall strategy and objective of the European Antibiotic Awareness Day The overall objective of the European Antibiotic Awareness Day is to support national activities aimed at raising awareness concerning the proper use of antibiotics so as to maintain the
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efficacy of antibiotics and avoid the emergence of resistant bacteria. To this aim, ECDC has decided to produce basic campaign communication materials that communicators in EU Member States can use in devising and implementing national campaigns. At the same time, a dedicated website will be launched in July 2008. These materials aim to provide a visual identity to the campaigns across the EU member states and make the messages more recognisable and consistent, thus memorable to the target audience. The choice of supporting visuals responds to the need of making the messages accessible to parents and young people, who represent the main target for the 2008 campaign.
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This document provides up-to-date guidance on laboratory studies as well as smallscale (semi-field) and large-scale field trials to assess the efficacy and determine field application rates of new molluscicide products for control of schistosomiasis
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.
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The authors state that researchers, governments and global agencies should proceed with particular care in the evaluation of candidate SARS-CoV-2 vaccines in LMICs, with effective communication to build trust and avoid generation of vaccine hesitancy. Vaccine
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efficacy is often highly variable between high-resource and low-resource settings
Archives of Disease in Childhood, vol.106 Issue 2
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Manufacturers:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
Efficacy shown in clinical trials in participants w
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ho 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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Many countries are using the approach of mixing vaccine doses from different manufacturers. What do we know about the safety and efficacy of this approach? What does the evidence tell us about using a fraction of the vaccine dose ? Dr Katherine O’
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Brien explains in Science in 5 this week.
Closed Captioning is available for Science in 5 in several languages on YouTube:Spanish,Portuguese,Thai,Nepali,Maithili,BahasaandJapanese.
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Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
There is strong demand for alternatives to pharmaceuticals for a variety of common illnesses due to concerns of safety, efficacy, and a desire for more “natural” products. Despite this growing interest, “conventional” healthcare providers ma
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y have little to no knowledge about herbal medicines, which is further compounded by the sometimes misleading information in the media and on the internet. This course provides the necessary background for providers to begin to incorporate herbal medicines into their practice, particularly in regards to their therapeutic properties, efficacy (or lack thereof), and safety concerns, including quality control and potential adverse effects
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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Ins
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pection Cooperation Scheme (jointly known as PIC/S). PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used
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in their clinical practice. Continuous evaluation of medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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This technical report summarizes the discussions on the status of programmatic transition to tenofovir, lamivudine and dolutegravir (TLD) in low– and middle- income countries, addressing the best practices and major challenges faced by HIV programmes.
The latest data on safety and
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efficacy of dolutegravir (DTG) containing regimens were also reviewed. The document identified the remaining gaps in knowledge, research, monitoring, and surveillance on DTG and TLD transition and listed the future priorities.
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The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine ma
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rket authorization system is one of the top priority areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines.
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Evidence-based guidelines are one of the most useful tools for improving public health and clinical practice. Their purpose is to formulate interventions based on strong evidence of efficacy, avoid unnecessary risks, use resources efficiently, reduc
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e clinical variability and, in essence, improve health and ensure quality care, which is the purpose of health systems and services. These guidelines were developed following the GRADE methodology, with the support of a panel of clinical experts from different countries, all convened by the Pan American Health Organization. By responding to twelve key questions about the clinical diagnosis and treatment of dengue, chikungunya, and Zika, evidence-based recommendations were formulated for pediatric, youth, adult, older adult, and pregnant patients who are exposed to these diseases or have a suspected or confirmed diagnosis of infection. The purpose of the guidelines is to prevent progression to severe forms of these diseases and the fatal events they may cause. The recommendations are intended for health professionals, including general, resident, and specialist physicians, nursing professionals, and medical and nursing students, who participate in caring for patients with suspected dengue, chikungunya, or Zika. They are also intended for health unit managers and the executive teams of national arboviral disease prevention and control programs, who are responsible for facilitating the process of implementing these guidelines.
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The protozoan parasite Trypanosoma cruzi causes Chagas disease, an important public health problem throughout Latin America. Current therapeutic options are characterised by limited efficacy, long treatment regimens and frequent toxic side-effects.
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Advances in this area have been compromised by gaps in our knowledge of disease pathogenesis, parasite biology and drug activity. Nevertheless, several factors have come together to create a more optimistic scenario. Drug-based research has become more systematic, with increased collaborations between the academic and commercial sectors, often within the framework of not-for-profit consortia. High-throughput screening of compound libraries is being widely applied, and new technical advances are helping to streamline the drug development pipeline. In addition, drug repurposing and optimisation of current treatment regimens, informed by laboratory research, are providing a basis for new clinical trials. Here, we will provide an overview of the current status of Chagas disease drug development, highlight those areas where progress can be expected, and describe how fundamental research is helping to underpin the process.
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Full Perscribing information on Fexinidazole Tablet for oral use
INDICATIONS AND USAGE
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in pati
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ents 6 years of age and older and weighing at least 20 kg.
Limitations of Use
Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/μL) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options [see Warnings and Precautions (5.1)]
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The coronavirus disease 2019 (COVID-19) pandemic revealed systemic weaknesses in health-care systems
worldwide. The breadth of challenges left health workers overwhelmed and overstretched, reducing their professional efficacy and causing long-term
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issues with retention, recruitment and education of future cohorts
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The document "ABCs of Using a Nebulizer" by the American Lung Association provides instructions for using a nebulizer effectively for COPD or other lung conditions. It covers assembling the device, using it for treatment, and proper cleaning procedures to ensure medication
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efficacy. The guide also offers tips for maintaining the nebulizer, such as routine disinfection and avoiding water exposure for certain parts.
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The present guidelines incorporate all these changes, leading to a substantial reconfiguration of therapeutic choices for both disease forms.
HAT is a serious, life-threatening disease and the efficacy of fexinidazole depends on swallowing the medi
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cine after an appropriate intake of food as well as on completing the full 10-day treatment schedule. Therefore, the recommendations regarding fexinidazole administration are considered key elements that must be carefully followed. When the conditions listed in these guidelines are not met for any individual patient, the alternative available treatments should be prescribed.
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