English version - This handbook sets out a the new paradigm for pharmacy practice. Its aim is to guide pharmacy educators in pharmacy practice, to educate pharmacy students and to guide pharmacists in practice to update their skills. The handbook, which brings together practical tools and knowledge,... has been written in response to a need to define, develop and generate global understanding of pharmaceutical care at all levels.
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The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
This third booklet of the World Drug Report 2022 has a dual focus: opioids and cannabis.
The first chapter of the booklet provides an overview of opioids as a group of substances and their patterns of non-medical use at the global level. It also reviews the latest trends in the global supply of opi...ates and synthetic opioids and the availability of pharmaceutical opioids for medical consumption. Issues specific to regional patterns and trends in opioid markets are also analysed, including the opioid crisis in North America and in Africa and the Middle East. The chapter also includes a discussion of the potential impact, in the region and worldwide, of changes in opium poppy cultivation and opium production in Afghanistan. reireg
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The growing challenges for people in low and middle-income countries to access new medicines.
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The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o...ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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WHO’s Essential Medicines List and List of Essential Diagnostics are core guidance documents that help countries prioritize critical health products that should be widely available and affordable throughout health systems. The updated Essential Medicines List adds 23 medicines for children.
The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
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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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The International Pharmaceutical Federation (FIP) is a global federation of national associations of pharmacists and
pharmaceutical scientists. In order to support these associations in their fight against AMR, FIP has prepared this
briefing document. It is an overview of the different activities ...that community and hospital pharmacists are involved
into prevent AMR and to reverse AMR rates.
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Supply of essential medicines and health technologies (6 April 2020)
This paper is one of a set of technical guidance papers developed by the WHO Regional Office for Europe to provide practical information and resources for decision-makers on measures to strengthen the health system response to C...OVID-19.
The purpose of this paper is to provide WHO Regional Office for Europe Country Offices and Member States with guidance on how to maintain supplies of medicines and health technologies, including devices, diagnostics and blood products, during the COVID-19 outbreak.
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This global guidance provided the framework for over 100 countries to develop their NDVPs. This updated (second) version supersedes the previous version published in 16 November 2020. New information has been added on the following areas:
the COVID-19 Partners Platform;
the use of COVID...-19 simulation exercises to test deployment strategies;
the indemnity agreement and no-fault compensation programme for vaccines secured through the COVAX Facility in the Advance Market Commitment (AMC) eligible economies;
the availability and use of the WHO-UNICEF COVID-19 Vaccine Introduction and deployment Costing (CVIC) tool;
the COVAX Facility’s humanitarian buffer that enables allocation of vaccine to cover high-risk populations in humanitarian settings;
recommendations for vaccination of pregnant and lactating women;
supplementary information on infection prevention and control (IPC) measures to be used to deliver COVID-19 vaccines safely;
the WHO licensed COVID-19 vaccines product-specific information;
use of geospatial data and digital micro plans for equitable access and delivery of COVID-19 vaccines;
lessons learned from the development of NDVPs and early experiences in COVID-19 vaccine deployment in countries; and
updated additional resources at the end of each chapter.
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Access to controlled medicines. 3rd edition
PHARMA’S RESPONSE TO THE COVID-19 VACCINES CRISIS. Update Feb., 14, 2022. In September 2021, Amnesty International published A Double Dose of Inequality, which assessed the extent to which the pharmaceutical industry was restricting access to Covid-19 vaccines. This report updates that assessment ...of five leading vaccine manufacturers, AstraZeneca plc, BioNTech SE, Johnson & Johnson, Moderna Inc., and Pfizer Inc. It also includes for the first time an assessment of the two largest Chinese vaccine producers, China National Pharmaceutical Group Co., Ltd. (Sinopharm) and Sinovac Biotech Ltd. (Sinovac).
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WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availability Monitoring Mobile Application. This tool fac...ilitates rapid and inexpensive data collection at the facility level.
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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 Inspection 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 in their clinical practice. Continuous evaluation o...f 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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Despite high regional demand for vaccines valued at over US$ 1 billion annually, Africa’s vaccine industry provides only 0.1% of global supply. Vaccine inequity and hoarding at the start of the pandemic, which resulted in delays in obtaining COVID-19 doses, stimulated new resolve to address future... supply security. In 2021, the AU set a target to produce and supply more than 60% of the vaccine doses on the continent by 2040.
In the last 18 months alone, more than 30 new African manufacturing projects have been announced and estimates indicate that the African vaccine market across all existing and projected novel products could range between US$ 2.8 billion and US$ 5.6 billion by 2040*, demonstrating the potential for a thriving regional industry to emerge.
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The Pharmaceutical Forum of the Americas (PFA) has previously published guidelines and organised campaigns for community pharmacists on the prevention, detection and control of arbovirus infections in 2018 with a grant from the FIP Foundation for Pharmacy Education and Research. Building on that exp...ertise, FIP joined efforts with the PFA and is now publishing its first-ever handbook to support pharmacists in the
area of vector-borne diseases. As the integration of the regional forums in FIP advances, such collaborative projects are tangible results of an increasingly regionally informed and regionally targeted work by FIP.
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