Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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Antimicrobial resistance (AMR) is an increasing worldwide public health problem with
important implications for the European Union (EU). When antibiotics become
ineffective, bacterial infections lead to increased morbidity, use of healthcare,
mortality and cost. Globally, estimates suggest that ...AMR leads to 700 000 deaths
per annum. For the EU, the European Centre for Disease Prevention and Control
(ECDC) has estimated that AMR currently causes 25 000 deaths annually and losses of
at least EUR 1.5 billion per annum in extra healthcare costs and productivity.
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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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Against this background of nearly 20 years of experience of research, development and
improvement in patient safety, the role of incident and adverse event reporting, as well as the
benefits that derive from it, is still a work in progress.This document has two main purposes:
• to provide an up...-to-date perspective on patient safety incident reporting and
learning systems currently in place, including how to fill in existing gaps in these
systems;
• to provide practical guidance on the establishment and effective use of patient
safety incident reporting and learning systems.
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The pandemic has emphasized the high risk of avoidable harm to patients, health workers, and the general public, and has identified a range of safety gaps across all core components of health systems at all levels.
The rapid review ‘Implications of the COVID-19 pandemic for patient safety’ ex...plores impacts that the COVID-19 pandemic did have on patient safety in terms of risks and avoidable harm, specifically in terms of diagnostic, treatment and care management related issues as well as highlights the main patterns of these implications within the broader health system context.
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Patient safety standards are critical for the establishment and assessment of patient safety programmes within hospitals. This third edition of the Patient safety assessment manual provides an updated set of standards and assessment criteria that reflect current best practice and WHO guidance. The m...anual will support the implementation of patient safety assessments and improvement programmes within hospitals as part of the Patient Safety Friendly Hospital Framework to ensure that patient safety is prioritized and facilities and staff implement best practices. The manual is a key tool for use by professional associations regulatory accrediting or oversight bodies and ministries of health to improve patient safety.
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Maintaining proper storage conditions for health commodities is vital to ensuring their quality. Product expiration dates are based on ideal storage conditions and protecting product quality until their expiration date is important for serving customers and conserving resources. Guidelines for the S...torage of Essential Medicines and Other Health Commodities is a practical reference for those managing or involved in setting up a storeroom or warehouse. The guide contains written directions and clear illustrations on receiving and arranging commodities; special storage conditions; tracking commodities; maintaining the quality of the products; constructing and designing a medical store; waste management; and resources. It was written to meet the needs of district-level facilities; however, the guidelines and information it contains apply to any storage facility, of any size, in any type of environment.
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This series of supportive tools are based on the WHO Therapeutics and COVID-19: living guideline. They are intended to provide supportive information for healthcare workers who are prescribing, administering and monitoring patients receiving nirmatrelvir-ritonavir for non-severe COVID-19.
WHO today published the new edition of its Model Lists of Essential Medicines and Essential Medicines for Children, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetes, new medicines to assist people who want to stop smoking, and new antimicrobials... to treat serious bacterial and fungal infections.
The listings aim to address global health priorities, identifying the medicines that provide the greatest benefits, and which should be available and affordable for all. However, high prices for both new, patented medicines and older medicines, like insulin, continue to keep some essential medicines out of reach for many patients.
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COVID-19 Vaccines: 1 Safety Surveillance 2 Manual
While there is no indication that pregnant women have an increased susceptibility to infection with SARS-CoV-2, there is evidence that pregnancy may increase the risk of severe illness and mortality from COVID-19 disease in comparison with non-pregn...ant women of reproductive age. As seen with non-pregnant women, a high proportion of pregnant women have asymptomatic SARS-CoV-2 infection and severe disease is associated with recognized medical (e.g., high body-mass index (BMI), diabetes, pre-existing pulmonary or cardiac conditions) and social (e.g., social deprivation, ethnicity) risk factors. Pregnant women with symptomatic COVID-19 appear to have an increased risk of intensive care unit admission, mechanical ventilation and death in comparison with non-pregnant women of reproductive age, although the absolute risks remain low. COVID-19 may increase the risk of preterm birth, compared with pregnant women without COVID-19, although the evidence is inconclusive.
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A desk guide for health facilities . It outlines a comprehensive approach to respiratory health, which health facilities can adapt and implement in resource-limited settings
The new, all oral, 20-month MDR-TB regimens range from US $1,600* (using bedaquiline and linezolid for 6 months and levofloxacin as the fluoroquinolone) to US $2,100* (using linezolid for 12 months and moxifloxacin as the fluoroquinolone.
Misceláneo
Capítulo J.2
Edición: Matías Irarrázaval & Andres Martin
Traductores: Fernanda Prieto-Tagle & Montserrat Pamias
Med J DY Patil Univ 2017;10:229-33
4th edition.
This report – now in its fourth edition – analyses the barriers and factors affecting access to treatment regimens for drug-resistant tuberculosis (DR-TB), including new and repurposed drugs. We provide detailed pricing profiles of key DR-TB drugs, using manufacturer responses to s...tandardised questionnaires and the Global TB Drug Facility website.
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The growing challenges for people in low and middle-income countries to access new medicines.
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