This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
Q14. SCOPING QUESTION: In adults with psychotic disorders (including schizophrenia), what is the comparative effectiveness and safety of second-generation antipsychotic medications?
Diabetes mellitus, also called diabetes, is a chronic metabolic condition in which the hormone insulin is not produced by the
pancreas in sufficient quantities or is not utilized effectively by the body to control blood glucose levels. As a result, blood
glucose levels are abnormally high (hypergl...ycaemia). Chronic uncontrolled hyperglycemia leads to long-term target organ damage, such as: retinopathy, nephropathy and neuropathy (microvascular complications); stroke, coronary heart disease
and peripheral arterial disease (macrovascular complications).
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In many low- and middle-income countries, there is a wide gap between evidencebased recommendations and current practice. Treatment of major CVD risk factors remains suboptimal, and only a minority of patients who are treated reach their target levels for blood pressure, blood sugar and blood choles...terol.
In other areas, overtreatment can occur with the use of non-evidence-based
protocols. The aim of using standard treatment protocols is to improve the quality
of clinical care, reduce clinical variability and simplify the treatment options,
particularly in primary health care. Standard treatment protocols can be developed by preparing new national treatment guidelines or by adapting or adopting international guidelines.
The Evidence-based protocols module uses hypertension and diabetes screening
and treatment as an entry point to control cardiovascular risk factors, prevent target organ damage, and reduce premature morbidity and mortality. A comprehensive risk- based approach for integrated management of hypertension, diabetes, and high cholesterol is included in the Risk-based CVD management module.
This module includes clinical practice points and sample protocols for:
1. hypertension detection and treatment
2. type 2 diabetes detection and treatment
3. identifying basic emergencies – care and referral.
HEARTS emphasizes adaptation, dissemination, and use of a standardized set of
simple clinical-management protocols, which should be drug- and dose-specific,
and include a core set of medications. The simpler the protocols and management tools, the more likely they are to be used correctly, and the higher the likelihood that a programme will achieve its goals.
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The Joint Monitoring Programme (JMP) report – Progress on household drinking water, sanitation and hygiene 2000 - 2020 – presents estimates on household access to safely managed drinking water, sanitation and hygiene services over the past five years, and assesses progress toward achieving the s...ixth sustainable development goal (SDG) to ‘Ensure availability and sustainable management of water and sanitation for all by 2030’.
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These guidelines provide updated evidence-based recommendations on the priority HCV-related topics from the 2018 WHO Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C infection and the 2017 WHO Guidelines on hepatitis B and C testing. These priority areas are:
... direct-acting antiviral (DAA) treatment of adolescents and children ages ≥3 years of age
simplified HCV service delivery (decentralization, integration and task sharing)
HCV diagnostics – use of point-of-care (POC) HCV ribonucleic acid (RNA) assays and reflex HCV RNA testing.
These guidelines also update existing chapters without new recommendations, such as the inclusion of new manufacturers’ protocols on the use of dried blood spot (DBS) for HCV RNA testing and new data to inform the limit of detection for HCV RNA assays as a test of cure, in addition to their use for diagnosis.
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The document "Management of Type 2 Diabetes Mellitus" provides comprehensive guidelines for the diagnosis, prevention, and treatment of type 2 diabetes in adults. It emphasizes the importance of individualized glycemic targets, lifestyle interventions like diet and exercise, and the use of medicatio...ns such as metformin, SGLT2 inhibitors, and GLP1 receptor agonists to manage blood sugar levels and reduce long-term complications. The document also discusses the screening and management of comorbidities such as hypertension, hyperlipidemia, and diabetic complications like retinopathy, neuropathy, and nephropathy. It highlights the role of diabetes self-management education and support in improving adherence to treatment and patient outcomes. The guidelines are evidence-based and aim to reduce morbidity and mortality associated with type 2 diabetes.
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The document "Pocketbook for Management of Diabetes in Childhood and Adolescence in Under-Resourced Countries" (2nd Edition) provides practical guidelines for managing diabetes in children and adolescents, particularly in resource-limited settings. It covers key topics like diagnosing and treating d...iabetes, managing diabetic ketoacidosis (DKA), insulin therapy, blood glucose monitoring, nutritional management, and dealing with complications. The pocketbook aims to support healthcare professionals in delivering effective diabetes care and improving outcomes for young patients in under-resourced areas.
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Background: Cardiovascular disease (CVD), mainly heart attack and stroke, is the
leading cause of premature mortality in low and middle income countries (LMICs).
Identifying and managing individuals at high risk of CVD is an important strategy to prevent and control CVD, in addition to multisector...al population-based interventions to reduce CVD risk factors in the entire population.
Methods: We describe key public health considerations in identifying and managing individuals at high risk of CVD in LMICs.
Results: A main objective of any strategy to identify individuals at high CVD risk is to maximize the number of CVD events averted while minimizing the numbers of
individuals needing treatment. Scores estimating the total risk of CVD (e.g. ten-year risk of fatal and non-fatal CVD) are available for LMICs, and are based on the main CVD risk factors (history of CVD, age, sex, tobacco use, blood pressure, blood cholesterol and diabetes status). Opportunistic screening of CVD risk factors enables identification of persons with high CVD risk, but this strategy can be widely applied in low resource settings only if cost effective interventions are used (e.g. the WHO Package of Essential NCD interventions for primary health care in low resource settings package) and if treatment (generally for years) can be sustained, including continued availability ofaffordable medications and funding mechanisms that allow people to purchase medications without impoverishing them (e.g. universal access to health care). Thisalso emphasises the need to re-orient health systems in LMICs towards chronic diseases management.
Conclusion: The large burden of CVD in LMICs and the fact that persons with high
CVD can be identified and managed along cost-effective interventions mean that
health systems need to be structured in a way that encourages patient registration, opportunistic screening of CVD risk factors, efficient procedures for the management of chronic conditions (e.g. task sharing) and provision of affordable treatment for those with high CVD risk. The focus needs to be in primary care because that is where most of the population can access health care and because CVD programmes can be run effectively at this level.
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This threat assessment addresses the implications of the ongoing Marburg virus disease (MVD) outbreak in
Rwanda for the European Union/European Economic Area (EU/EEA). MVD is a severe disease in humans and,
although uncommon, it has the potential to cause epidemics with significant case fatality. ...All recorded MVD
outbreaks to date have originated in Africa. MVD is not an airborne disease and is considered not to be
contagious before symptoms appear. Direct contact with the blood and other body fluids of infected people
and animals or indirect contact with contaminated surfaces and materials like clothing, bedding and medical
equipment is required for transmission. The risk of infection is minimised when proper infection prevention and
control precautions are strictly followed. There is no approved treatment or vaccine for MVD; however, several
pharmaceuticals and candidate MVD vaccines are under investigation.
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Background
Noncommunicable diseases are major contributors to morbidity and mortality worldwide. Modifying the risk factors for these conditions, such as physical inactivity, is thus essential. Addressing the context or circumstances in which physical activity occurs may promote physical activity a...t a population level. We assessed the effects of infrastructure, policy or regulatory interventions for increasing physical activity.
Methods
We searched PubMed, Embase and clinicaltrials.gov to identify randomised controlled trials (RCTs), controlled before-after (CBAs) studies, and interrupted time series (ITS) studies assessing population-level infrastructure or policy and regulatory interventions to increase physical activity. We were interested in the effects of these interventions on physical activity, body weight and related measures, blood pressure, and CVD and type 2 diabetes morbidity and mortality, and on other secondary outcomes. Screening and data extraction was done in duplicate, with risk of bias was using an adapted Cochrane risk of bias tool. Due to high levels of heterogeneity, we synthesised the evidence based on effect direction.
Results
We included 33 studies, mostly conducted in high-income countries. Of these, 13 assessed infrastructure changes to green or other spaces to promote physical activity and 18 infrastructure changes to promote active transport. The effects of identified interventions on physical activity, body weight and blood pressure varied across studies (very low certainty evidence); thus, we remain very uncertain about the effects of these interventions. Two studies assessed the effects of policy and regulatory interventions; one provided free access to physical activity facilities and showed that it may have beneficial effects on physical activity (low certainty evidence). The other provided free bus travel for youth, with intervention effects varying across studies (very low certainty evidence).
Conclusions
Evidence from 33 studies assessing infrastructure, policy and regulatory interventions for increasing physical activity showed varying results. The certainty of the evidence was mostly very low, due to study designs included and inconsistent findings between studies. Despite this drawback, the evidence indicates that providing access to physical activity facilities may be beneficial; however this finding is based on only one study. Implementation of these interventions requires full consideration of contextual factors, especially in low resource settings.
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About one fourth of the world’s population is estimated to have been infected with the tuberculosis (TB) bacilli, and about 5–10% of those infected develop TB disease in their lifetime. The risk for TB disease after infection depends on several factors, the most important being the person’s im...munological status. TB preventive treatment (TPT) given to people at highest risk of progressing from TB infection to disease remains a critical element to achieve the global targets of the End TB Strategy, as reiterated by the second UN High Level Meeting on TB in 2023. Delivering TPT effectively and safely necessitates a programmatic approach to implement a comprehensive package of interventions along a cascade of care: identifying individuals at highest risk, screening for TB and ruling out TB disease, testing for TB infection, and choosing the preventive treatment option that is best suited to an individual, managing adverse events, supporting medication adherence and monitoring programmatic performance
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About one fourth of the world’s population is estimated to have been infected with the tuberculosis (TB) bacilli, and about 5–10% of those infected develop TB disease in their lifetime. The risk for TB disease after infection depends on several factors, the most important being the person’s im...munological status. TB preventive treatment (TPT) given to people at highest risk of progressing from TB infection to disease remains a critical element to achieve the global targets of the End TB Strategy, as reiterated by the second UN High Level Meeting on TB in 2023. Delivering TPT effectively and safely necessitates a programmatic approach to implement a comprehensive package of interventions along a cascade of care: identifying individuals at highest risk, screening for TB and ruling out TB disease, testing for TB infection, and choosing the preventive treatment option that is best suited to an individual, managing adverse events, supporting medication adherence and monitoring programmatic performance.
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It is widely understood that the food insecurity crisis in the Sahel and the Horn of Africa is one of the world’s fastest growing and most neglected crises. It lacks sufficient global focus, resources and urgency. As in so many crises, women and girls are disproportionately affected and shoulder t...he consequences of protracted neglect, with unconscionable impacts on their safety, life chances and agency.
Gaining a holistic view of the gendered drivers, risks and impacts of food insecurity in the Sahel and the Horn of Africa is difficult. This is due to a lack of data and prioritization, and the large geographical and socioeconomic terrain covered by both regions. However, what we do know about this crisis is more than enough to urgently address the needs of women and girls.
An OCHA discussion paper on this topic (which will be published imminently, and from which this policy brief is drawn) found that there is:
A strong risk of profound regression in gender equality gains made to date in the countries of concern, including on education, sexual and reproductive health, and the economic independence of women and girls (with knock-on effects on broader humanitarian and development outcomes).
An increasing challenge to reverse what must be recognized as a protracted and growing gender-based violence (GBV) emergency in the Sahel and the Horn of Africa.
The food insecurity crisis in the Sahel and the Horn of Africa is protracted, multidimensional and highly gendered, with spiralling impacts on gender equality and food security outcomes. It is driven by interwoven and overlapping factors, including climate change, political instability, conflict, socioeconomic conditions, migration and displacement and, more recently, COVID-19 and the war in Ukraine. Interlinked with these factors are gendered structural drivers of food insecurity, including deeply entrenched gender inequalities and harmful social norms. Gendered risks and impacts of food insecurity include alarming limitations on access to education, sexual and reproductive health rights, women’s agency and participation, and dramatic increases in different existing forms of GBV and the emergence of new ones. Recognition of such gendered dimensions of food insecurity and of the need for a multisectoral approach in the response is key to addressing the crisis, along-side sustained commitment and adequate allocation of resources. This policy brief draws out key findings from the OCHA discussion paper on this topic, which includes a desk review of studies, assessments and reports, and interviews with local women’s organizations on the front lines of the food insecurity crisis in communities across both regions.
Below are the most pressing gendered drivers, risks and impacts of food insecurity (not in order of priority), as well as key gaps in the current humanitarian response to food insecurity, and recommendations to take forward.
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Taenia saginata is a zoonotic tapeworm that is of economic importance in countries where cattle are kept. The parasite is transmitted from human tapeworm carriers (taeniosis) to bovines (cysticercosis) by excretion of eggs or proglottids containing eggs into the environment via the stool. Bovines ca...n then ingest the eggs through contaminated feed or water. After ingestion, the eggs hatch and release oncospheres in the small intestines, where the oncospheres penetrate the intestinal wall to reach the blood circulation. This distributes them throughout the body, but primarily to muscle tissue, where they develop into cysticerci. For humans to become infected with T. saginata, raw or undercooked bovine meat or offal containing infective cysts must be consumed. Bovine cysticercosis has been associated with various environmental factors related to water sources, such as animals having access to surface water, flooding of pastures and proximity to wastewater sources.
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Chagas disease (CD) is caused by the parasite Trypanosoma cruzi, and it is endemic in Central, South America, Mexico and the
South of the United States. It is an important cause of early mortality and morbidity, and it is associated with poverty and stigma. A third of
the cases evolve into chronic... cardiomyopathy and gastrointestinal disease. The infection is transmitted vertically and by blood/organ
donation and can reactivate with immunosuppression. Case identification requires awareness and screening programmes targeting the
population at risk (women in reproductive age, donors, immunocompromised patients). Treatment with benznidazole or nifurtimox is most
effective in the acute phase and prevents progression to chronic phase when given to children. Treating women antenatally reduces but does
not eliminate vertical transmission. Treatment is poorly tolerated, contraindicated during pregnancy, and has little effect modifying the
disease in the chronic phase. Screening is easily performed with serology. Migration has brought the disease outside of the endemic
countries, where the transmission continues vertically and via blood and tissue/organ donations. There are more than 32 million migrants
from Latin America living in non-endemic countries. However, the infection is massively underdiagnosed in this setting due to the lack of
awareness by patients, health authorities and professionals. Blood and tissue donation screening policies have significantly reduced
transmission in endemic countries but are not universally established in the non-endemic setting. Antenatal screening is not commonly
done. Other challenges include difficulties accessing and retaining patients in the healthcare system and lack of specific funding for the
interventions. Any strategy must be accompanied by education and awareness campaigns directed to patients, professionals and policy
makers. The involvement of patients and their communities is central and key for success and must be sought early and actively. This review
proposes strategies to address challenges faced by non-endemic countries
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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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4th edition
The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety.
LBM encouraged countries t...o accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of biological agents in laboratories within their geographical borders.
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
This novel evidence- and risk-based approach will allow optimised resource use and sustainable laboratory biosafety and biosecurity policies and practices that are relevant to their individual circumstances and priorities, enabling equitable access to clinical and public health laboratory tests and biomedical research opportunities without compromising safety.
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Interim guidance. 12 May 2021. The Continuity of essential health services: Facility Assessment Tool can be used by countries to rapidly assess the capacity of health facilities to maintain the provision of essential health services during the COVID-19 pandemic. It can help to alert the authorities ...and other stakeholders about where service delivery and utilization may require modification and/or investment. This assessment tool covers the following aspects of essential health services:
health workforce (numbers, absences, COVID-19 infections, health workforce management, training and support);
financial management and barriers;
service delivery and utilization (facility closures, changes in service delivery, community communication campaigns, changes in service utilization and catch-up strategies);
IPC capacities (protocols, safety measures, guidelines and the availability of personal protective equipment (PPE) for staff);
availability of therapeutics, diagnostics and supplies, and vaccine readiness; and
provision of COVID-19 primary care services.
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Countries around the world are facing the challenge of increased demand for care of people with COVID-19, compounded by fear, misinformation and limitations on movement that disrupt the delivery of health care for all conditions. Maintaining essential health services: operational guidance for the CO...VID-19 context recommends practical actions that countries can take at national, subregional and local levels to reorganize and safely maintain access to high-quality, essential health services in the pandemic context. It also outlines sample indicators for monitoring essential health services, and describes considerations on when to stop and restart services as COVID-19 transmission recedes and surges.
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