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.
Procurement and supply management activities are fundamental to consistent and reliable access to essential medicines and health products. To reduce the impact of CVD, action needs to be taken to improve prevention, diagnosis, care and management of CVD diseases. Affordable essential medicines and t...echnologies to manage CVD disease must be available where and when they are required. Medicines and technologies need to be managed appropriately to ensure that the correct medicines are selected, procured in the right quantities, distributed to facilities in a timely manner, and handled and stored in a way that maintains their quality. This needs to be backed up by policies that enable sufficient quantities to be procured in order to reduce cost inefficiencies, ensure the reliability and security of the distribution system, and encourage the appropriate use of these health products. In order to avoid stock-outs and the disruption of treatment, all related activities need to be conducted in a timely manner, with performance continually monitored, and prompt action taken in response to problems that may arise. Additionally, medication must be dispensed correctly and used rationally by the healthcare provider and patient alike. The purpose of this guide is to explain the necessary steps.
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Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pan...demic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
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The Guidelines for the Diagnosis, Treatment and Prevention of Leprosy provide state-of-the-art knowledge and evidence on leprosy diagnosis, treatment and prevention based on a public health approach in endemic countries. The target audience of this document includes policy-makers in leprosy or infec...tious diseases in the ministries of health (especially but not limited to endemic countries), nongovernmental organizations, clinicians, pharmaceutical companies, donors and affected persons
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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.
Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health. Submitted to the United Nations Children’s Fund by JSI, Arlington, VA: JSI Research & Training Institute, Inc....
This guide will assist program managers, service providers, and technical experts when conducting a quantification of commodity needs for the 13 reproductive, maternal, newborn, and child health commodities prioritized by the UN Commission on Life-Saving Commodities for Women and Children. This quantification supplement should be used with the main guide—Quantification of Health Commodities: A Guide to Forecasting and Supply Planning for Procurement. * This supplement describes the steps in forecasting consumption of these supplies when consumption and service data are not available; after which, to complete the quantification, the users should refer to the main quantification guide for the supply planning step.
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Chinese Medicine, (2016) 11:37
Medicinal plants are globally valuable sources of herbal products, and they are disappearing at a high speed. This article reviews global trends, developments and prospects for the strategies and methodologies concerning the conservation and sustainable use of me...dicinal plant resources to provide a reliable reference for the conservation and sustainable use of medicinal plants. We emphasized that both conservation strategies (e.g. in situ and ex situ conservation and cultivation practices) and resource management (e.g. good agricultural practices and sustainable use solutions) should be adequately taken into account for the sustainable use of medicinal plant resources. We recommend that biotechnical approaches (e.g. tissue culture, micropropagation, synthetic seed technology, and molecular marker-based approaches) should be applied to improve yield and modify the potency of medicinal plants.
https://doi.org/10.1186/s13020-016-0108-7
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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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Guidelines for Handling Temperature Sensitive Vaccines and Pharmaceuticals
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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An Act to provide for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and to repeal the Food
(Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978 and to provide for related matters.
This report provides an update on the key facets of HIV treatment access, including the latest HIV treatment guidelines from World Health Organization (WHO), an overview on pricing for first-line, second-line, and salvage regimens, and a summary of the opportunities for – and threats to – expand...ing access to affordable antiretroviral therapy (ART).
The report is supplemented by 11 drug profiles that contain more detailed information on pricing trends and patent barriers for key antiretroviral drugs and fixed-dose combinations. Also included is an annex of conditions that define eligibility for reduced prices from 15 pharmaceutical companies.
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Community pharmacists are the health professionals most accessible to the public and are a cornerstone of primary health care. The role of community pharmacists is expanding globally. This report provides an overview of existing components and provisions of the legal and regulatory framework for com...munity pharmacies and their activities in Europe. It presents the diverse approaches to community pharmacy licenses and to establishment of new pharmacies and their ownership. It also details the framework for community pharmacy operating requirements (including opening hours, workforce, premises and equipment, services provided and identification of a community pharmacy) and the types of activity undertaken. Provisions associated with possible alternative forms of dispensing medicines (over-the-counter medicines, prescription-only medicines, dispensing by medical doctors and online medicine sales) are also described
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Following review of evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and Laboratory Strengthening, the World Health Organization (WHO) announces that current WHO recommendations for the use of interferon-gamma release assays (IGRA) are also valid for Beij...ing Wantai’s TB-IGRA and Qiagen QuantiFERON-TB Gold Plus products. This expands the range of tests available to detect TB infection. Full details are provided in this WHO policy statement.
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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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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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The Pandemic Influenza Preparedness (PIP) Framework is a World Health Assembly resolution adopted unanimously by all Member States in 2011. It brings together Member States, industry, other stakeholders and WHO to implement a global approach to pandemic influenza preparedness and response. The Frame...work includes a benefit-sharing mechanism called the Partnership Contribution (PC). The PC is collected as an annual cash contribution from influenza vaccine, diagnostic, and pharmaceutical manufacturers that use the WHO Global Influenza Surveillance and Response System (GISRS). Funds are allocated for: (a) pandemic preparedness capacity building; (b) response activities during the time of an influenza pandemic; and (c) PIP Secretariat for the management and implementation of the Framework.
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The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of noncommunicable diseases (NCDs). This report examines the effect of the COVID-19 pandemic on access to NCD medicines, and the policies and strategies implemented by countries and health sys...tems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
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Access to safe blood and blood products is recognized as one of the key requirements for delivery of modern health care in the journey towards health for all. The foundation of safe and sustainable blood supplies depends on the collection of blood from voluntary non-remunerated and low-risk donors. ...Data from the WHO Global Database for Blood Safety (GDBS) brings out several inadequacies related to the supply and safety of blood and blood products. These inadequacies include a number of variations in safe blood practices across the world, including the quantity of blood donated (voluntary and replacement types), quality and adequate testing of the donated blood (immunohaematology [IH] and transfusion-transmitted infections [TTIs]), rational use of blood and blood components such as appropriate patient blood management protocols. These variations are very high in countries of the South-East Asian Region and most of them are either low- or middle-income countries (LMICs).
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The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of noncommunicable diseases (NCDs). This report examines the effect of the COVID-19 pandemic on access to NCD medicines, and the policies and strategies implemented by countries and health sys...tems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
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