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.
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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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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This manual summarizes key issues related to the safety of NTD medicines and their administration, with a focus on essential medicines used in mass drug administration (MDA), also called preventive chemotherapy. It can be used as a standalone reference manual, but is intended to be used in conjuncti...on with the accompanying training modules, which provide practical instruction, and the aide-mémoires. Versions of the aide-mémoires and training modules are available respectively for both (i) programme managers and district-level health officials and (ii) community drug distributors and community health workers
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To support countries in adapting their response to different COVID-19 scenarios, the World Health
Organization (WHO) Department of Maternal, Newborn, Child and Adolescent Health and Ageing commissioned this scoping review of published and grey literature. The objective was to identify interventions... implemented to maintain the provision and use of essential services for MNCAAH during disruptive events and to summarize lessons learned during these interventions. The review included outbreaks of Ebola virus disease (EVD), severe acute respiratory syndrome (SARS), Zika virus disease (ZVD), the ongoing COVID-19 pandemic, and natural disasters and humanitarian emergencies that caused disruption to services, transport and other activities.
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The clinical guidelines and protocols for the practice of emergency medicine presented in this document are designed to be a useful resource not only for those wishing to become emergency medicine specialists, but also for general practitioners and other healthcare providers tasked with caring for p...atients in hospital emergency departments. Healthcare providers using this Emergency Medicine Clinical Guideline (EMCG) are provided with fundamental concepts and principles essential to emergency medicine and the management of patients with undifferentiated emergency conditions.
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The availability of controlled medicines is crucial for patients requiring palliative care, pain relief and symptom management. Many individuals worldwide, especially in low- and middle-income countries, continue to experience limited access to these essential medicines. Enhancing access to controll...ed medicines is paramount in promoting universal health coverage. This report offers a detailed situational analysis of policies and programmes aimed at improving access to affordable, high-quality controlled medicines for pain management in the WHO South-East Asia Region. The report identifies the existing barriers, challenges and possible solutions to facilitate access to such medicines across all Member States.
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The document contains a set of indicators that can be used for monitoring traditional and complementary medicine (T&CM) systems in a country.
The core indicator set consists of 16 indicators that were considered essential and collectively able to provide information on T&CM inputs, processes and ou...tputs. A longer list of reference indicators is also available for countries that wish to monitor more indicators or that want to consider alternative metrics that would better suit each country’s T&CM situation, priorities and monitoring capacities.
Each core and reference indicator is accompanied by a set of metadata. This provides information on the indicator rationale, definitions, data elements (numerator, denominator and data disaggregation), frequency of measurement, and data sources. It is a guide towards more standardized data measurement as well as data interpretation.
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The new guidelines provide public health guidance on pharmacological agents for managing hyperglycaemia in type 1 and type 2 diabetes for use in primary health-care in low-resource settings. These guidelines update the recommendations for managing hyperglycaemia in the WHO Package of Essential NCD I...nterventions (WHO PEN) for primary care in low-resources settings, reviewing several newer oral agents as second- and third-line treatment: dipeptidyl peptidase-4 inhibitors, sodium-glucose co-transporter 2 inhibitors and thiazolidinediones. The guidelines also present recommendations on the selection of type of insulin (analogue versus human insulin) for adults with type 1 and type 2 diabetes.
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Full eHandbook under: http://www.msh.org/resources/health-systems-in-action-an-ehandbook-for-leaders-and-managers
Effective supply management has the potential to make a powerful contribution to the reliable availability of essential medicines, which are a crucial part of the delivery of highqualit...y health care services. Because medicines are costly and poor management so often results in waste, good supply management is also crucial to the cost-effectiveness of providing medicines.
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The aim of these Guidelines is to provide a framework for the conservation and sustainable use of plants in medicine. To do this, the Guidelines describe the various tasks that should be carried out to ensure that where medicinal plants are taken from the wild, they are taken on a basis that is sust...ainable.
The Guidelines conform to the principles of Caring for the Earth, prepared in partnership by IUCN, UNEP and WWF. Caring for the Earth extends the message and scope of the World Conservation Strategy to an ethic of sustainable living, and explains how to integrate conservation with development. Its message is particularly relevant to the issue of medicinal plants, which in many parts of the world are being seriously depleted due to over-exploitation and loss of habitats, resulting in a lack of essential medicines and so reducing options for the future.
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2018
9th Edition
Offering information on HIV/AIDS treatment, prevention, and research
Reproductive health needs are particularly acute in countries affected by armed conflict. Reliable information
on aid investment for reproductive health in these countries is essential for improving the efficiency and effectiveness of
aid. The purpose of this study was to analyse official developm...ent assistance (ODA) for reproductive health activities in
conflict-affected countries from 2003 to 2006.
Methods and Findings: The Creditor Reporting Syst
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The Ideal Clinic Realisation and Maintenance (ICRM) programme was initiated by the National Department of Health in July 2013 in order to systematically improve primary health care (PHC) facilities and the quality of care they provide. The Ideal Clinic framework/dashboard sets out the standards for ...PHC facilities to provide good-quality health services. An Ideal Clinic is defined as a clinic with good infrastructure, adequate staff, adequate medicines and supplies, good administrative processes, and sufficient adequate bulk supplies. Applicable clinical policies, protocols and guidelines are adhered to, and it harnesses partner and stakeholder support.
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One health Response to AMR Containment.
In a significant move for the public health sector, Kerala has become the first state in India to launch an action plan to combat the growing cases of antimicrobial immunity, arising primarily from irrational use of medicines and excessive antibiotics used in... livestock and poultry.
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In 2015, the United Nations set important targets to reduce premature
cardiovascular disease (CVD) deaths by 33% by 2030. Africa disproportionately
bears the brunt of CVD burden and has one of the highest risks of dying
from non-communicable diseases (NCDs) worldwide. There is currently
an epide...miological transition on the continent, where NCDs is projected
to outpace communicable diseases within the current decade. Unchecked
increases in CVD risk factors have contributed to the growing burden of three
major CVDs—hypertension, cardiomyopathies, and atherosclerotic diseasesleading to devastating rates of stroke and heart failure. The highest age
standardized disability-adjusted life years (DALYs) due to hypertensive heart
disease (HHD) were recorded in Africa. The contributory causes of heart failure
are changing—whilst HHD and cardiomyopathies still dominate, ischemic
heart disease is rapidly becoming a significant contributor, whilst rheumatic
heart disease (RHD) has shown a gradual decline. In a continent where health
systems are traditionally geared toward addressing communicable diseases,
several gaps exist to adequately meet the growing demand imposed by CVDs.
Among these, high-quality research to inform interventions, underfunded
health systems with high out-of-pocket costs, limited accessibility and
affordability of essential medicines, CVD preventive services, and skill
shortages. Overall, the African continent progress toward a third reduction
in premature mortality come 2030 is lagging behind. More can be done in
the arena of effective policy implementation for risk factor reduction and
CVD prevention, increasing health financing and focusing on strengthening
primary health care services for prevention and treatment of CVDs, whilst
ensuring availability and affordability of quality medicines. Further, investing
in systematic country data collection and research outputs will improve the accuracy of the burden of disease data and inform policy adoption on
interventions. This review summarizes the current CVD burden, important
gaps in cardiovascular medicine in Africa, and further highlights priority
areas where efforts could be intensified in the next decade with potential
to improve the current rate of progress toward achieving a 33% reduction
in CVD mortality.
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These guidelines are based on the 3rd Edition of the WHO Guidelines (Published 2015) World Health Organization’s Guidelines for the treatment of malaria. Additional literature surveys have been undertaken. Factors that were considered in the choice of therapeutic options included effectiveness, sa...fety, and impact on malaria transmission and on the emergence and spread of antimalarial drug resistance. On-going surveillance is critical given the spread of artemisinin resistance in Southeast Asia, although not yet confirmed anywhere in Africa. The guidelines on the treatment of malaria in South Africa aim to facilitate effective, appropriate and timeous treatment of malaria, thereby reducing the burden of this disease in our communities. This is essential to further reduce the malaria case fatality rates currently recorded in South Africa, to decrease malaria transmission and to limit resistance to antimalarial drugs.
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The strategic framework gives guidance to public and private health facilities and health workers on compliance with standards relating to IPC practices. To further assist health facilities to implement the IPC strategic framework, this practical implementation manual has been developed in parallel ...to accompany the document.
These implementation strategies should be read in conjunction with the National Infection Prevention and Control (IPC) Strategic Framework (2020) to support an IPC programme at health facility level towards reducing healthcare-associated infections (HAI) and antimicrobial resistance (AMR). This manual is aligned with the World Health Organization (WHO) Core Component IPC programme recommendations and highlights the essentials for developing and improving IPC at health facility level in a systematic, stepwise manner for South Africa. It supports the Framework for the Prevention and Containment of AMR in South African Hospitals (2018).
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The project will support preventive actions, traditional medicine and the coordination and
implementation capacities of the national framework for HIV/AIDS control.