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.
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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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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This training and guidance has been developed to provide an in-depth understanding on what it means to respect legal capacity in mental health and related areas as well as concrete strategies to ensure that people are able to exercise their right to legal capacity in all areas of their life. In this... context a wide range of scenarios are used to describe how different models of supported decision making can be applied in practice.
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Making the Case for Alcohol as a Public Health Threat in the Region. The purpose of this document is to explain the need for making alcohol a top public health priority in the region and the need for national and regional action. Current evidence-based research shows that alcohol consumption and dri...nking patterns in the Americas are at damaging levels, with the region surpassing global averages for many alcohol related problems.
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Background: Traumatic stress may arise from various incidents often leading to posttraumatic stress disorder (PTSD). The lifetime prevalence of PTSD is estimated at 1% – 2% in Western Europe, 6% – 9% in North America and at just over 10% in countries exposed to long-term
violence. In South Afri...ca, the lifetime prevalence for PTSD in the general population is estimated at 2.3%.
Aim: To examine the prevalence of posttraumatic stress symptomatology and related psychological functioning in a community sample of adolescents.
Setting: Low-socioeconomic communities in KwaZulu-Natal.
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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The pharmaceutical sector of any nation is responsible for providing society with quality medicines and other pharmaceutical services. According to the World Health Organization (WHO), Pharmaceuticals may constitute as much as 40% of the national health budget in developing countries, yet portions o...f the population may lack access to the most essential medicines; while the limited funds available for health are spent on unnecessary, ineffective and even dangerous medications.
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This report assesses the impact of the conflict in Ukraine and its implications for organized crime and security-related issues for neighbouring countries, with a focus on Moldova.
These include:
Organized crime and illicit trafficking (including trafficking in persons, drugs, arms, illicit toba...cco, and other goods); Cybercrimes and fraud; Disinformation and propaganda; and Chemical, Biological, Radiological, and Nuclear (CBRN) threats.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these... or other herbal medicines; and
• facilitate information exchange among Member States.
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Situational Analysis: 13-23 October 2014
Report prepared using the WHO/SEARO workbook tool for undertaking a situational analysis of medicines in health care delivery in low and middle income countries
The Global Reference List of 100 Core Health Indicators is a standard set of core indicators prioritized by the global community to provide concise information on the health situation and trends, including responses at national and global levels.
This second (2018) edition builds on the previous ...work of the inter-agency working group that was commissioned by global health leaders to reduce reporting burden. The 2018 list of indicators contains modifications and additions to indicators and metadata elements to reflect the recommended health and health-related indicators of the Sustainable Development Goals, including universal health coverage.
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This document seeks to help health communication professionals working on the topic of immunization more effectively communicate about Events Supposedly Attributed to Vaccination and Immunization (ESAVI) by building trust in National Immunization Programs, understanding risk perceptions related to v...accination, and responding to false information related to vaccination. It includes practical dos and don’ts regarding risk communication and community engagement processes and principles, messaging, risk perceptions, handling false information, collaborating with partners, and pharmacovigilance, as well as real-world examples.
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Chapter 7 from the book People's Movements in the 21st Century - Risks, Challenges and Benefits
This document has been developed to provide training and guidance on how to integrate a human rights approach in mental health and related areas, based on international human rights instruments, in particular the UN Convention on the Rights of Persons with Disabilities (CRPD).
Young children are especially susceptible to exposure to trauma. Rates of abuse and neglect among this population are staggering. This article presents a review of relevant literature, including research findings specific to early childhood vulnerability to trauma, symptoms associated with traumatic... events, diagnostic validity of early childhood trauma, and treatments for young children. In the past, misconceptions about the mental health of young children have hindered accurate diagnosis and treatment of trauma-related mental illness. Due to the prevalence of trauma exposure in early childhood, counselors are encouraged to become familiar with ways that clients and families are impacted and methods for treatment. Implications for future research also are presented.
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The essential medicines are those that meet the priority needs of the healthcare of the population. While reviewing the 5th edition of the essential Medicines, special attention focused on the health sector policy. Indeed, medicines play an important role in protecting, maintaining and restoring th...e peoples’ health and credibility of health facilities. Their availability is a fundamental aspect of primary health care as defined in different declarations including Alma-Ata of 1978.
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This brief advocacy document highlights the burden, risks and prevention of injuries and violence, which took the lives of 4.4 million people in 2019 and constitute 8% of all deaths. Among the injury-related causes of death include road traffic crashes, drowning, falls, burns, poisoning and violence... against oneself or others. For people age 5-29 years, three of the top five causes of death are injury-related, including road traffic injuries, homicide, and suicide. Injuries and violence are not evenly distributed across or within countries – some people are more vulnerable than others depending on the conditions in which they are born, grow, work, live and age; in general, being young, male and of low socioeconomic status all increase the risk of injury. This document, aimed at public health professionals; injury prevention researchers, practitioners and advocates; and donors, draws attention to specific strategies based on sound scientific evidence that are effective and cost-effective at preventing injuries and violence; it is critical that these strategies are more widely implemented.
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In this edition, medicines used in ICU, haemodialysis and chemotherapy unit has also been added under NEML. The medicines under disinfectants and antiseptics, intrauterine devices and barrier methods under contraceptives has been deleted and moved to medical supplies and equipment list. A section... on traditional essential medicines list is also included at the end of the NEML
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The Kenya Essential Medicines List 2019 is an indispensable guide to the medicines recommended for the management of common conditions in Kenya. It is primarily directed at health care providers and medicines supply managers in the public and non-public health sectors. It should be used together wit...h the current versions of updated national clinical guidelines for those conditions for which such guidelines exist
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