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 Sierra Leone National Infection Prevention and Control Guidelines were jointly developed and updated by the Ministry of Health and Sanitation in collaboration with the World Health Organization and the US Centers for Disease Control and Prevention.
This publication offers practical advice on implementing HIV and STI programmes for transgender people, with a focus on transgender women, aligned with the 2011 Recommendations and the 2014 Key Populations Consolidated Guidelines. It contains examples of good practice from around the world that may ...support efforts in planning programmes and services, and describes issues that should be considered and how to overcome challenges.
This tool describes how services can be designed and implemented to be acceptable and accessible to transgender women. To accomplish this, respectful and ongoing engagement with them is essential.
This tool gives particular attention to programmes run by transgender people themselves, in contexts where this is possible.
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Operational Guidelines for Programme Managers & Service Providers
Testing and diagnosis of hepatitis B (HBV) and C (HCV) infection is the gateway for access to both prevention and treatment services, and is a crucial component of an effective response to the hepatitis epidemic. Early identification of persons with chronic HBV or HCV infection enables them to recei...ve the necessary care and treatment to prevent or delay progression of liver disease. Testing also provides an opportunity to link people to interventions to reduce transmission, through counselling on risk behaviours and provision of prevention commodities (such as sterile needles and syringes) and hepatitis B vaccination.
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This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribut...ion of pharmaceutical products.
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The provision of safe and efficacious blood and blood components for transfusion or manufacturing use involves a number of processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of patient samples, the issue of compatible blood and ...its administration to the patient. There is a risk of error in each process in this “transfusion chain” and a failure at any of these stages can have serious implications for the recipients of blood and blood products. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of bloodborne infections.
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels.
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The European Resuscitation Council Guidelines for Resuscitation provide specific instructions for how resuscitation should be practiced and take into account ease of teaching and learning, as well as the science. They were developed by Europeans and have been specifically written with European pract...ice in mind.
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Early-warning indicators to prevent stock-outs and overstocking of antiretroviral, antituberculosis and antimalaria medicines.
The present Consolidated guidelines include a comprehensive set of WHO recommendations for the treatment and care of DR-TB, derived from these WHO guidelines documents. The consolidated guidelines include policy recommendations on treatment regimens for isoniazid-resistant TB (Hr-TB) and MDR/RR-TB, ...including longer and shorter regimens, culture monitoring of patients on treatment, the timing of antiretroviral therapy (ART) in MDR/RR-TB patients infected with the human immunodeficiency virus (HIV), use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care.
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The recommendations in this guideline are intended to inform the development of relevant national- and local-level health policies and clinical protocols. Therefore, the target audience includes national and local public health policy-makers, implementers and managers of maternal and child health pr...ogrammes, health care facility managers, nongovernmental organizations (NGOs), professional societies involved in the planning and management of maternal and child health services, health care professionals (including nurses, midwives, general medical practitioners and obstetricians) and academic staff involved in training health care professionals.
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Direct acting antivirals (DAAs) have revolutionized treatment for hepatitis C. Combi-
nations of DAAs can cure infection with HCV in 12 weeks, are highly effective and
have limited side-effects. Affordability of DAAs has improved significantly, but access remains lim-
i...ted. Initially, due to their high prices, affordability of DAAs was limited in high-, middle- and low-
income countries alike. Now there is a divide between those countries where, because of intellectual
property barriers, prices have remained (very) high and other countries where generics are, or can be,
available at much lower prices. The result is a dual market
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The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug... Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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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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Drugs and medical supplies are dispensed at the cutting edge level of the interface between the public health system and the people. Availability or lack of it brings either credit or discredit to the public health system. The primary reason for holding stocks of medicines and medical supplies in a ...proper scientific manner is to ensure continuous and uninterrupted availability to prevent stock-outs, especially of critical items of supply while at the same time ensuring that stocks of medicines do not get expired. An efficient inventory management is a pre-requisite for optimal stock management. It enables the management of health facilities to know the current pattern of consumption of drug trends over a period of time and also variances. The environmental control of the drugs and other medical supplies play an important role to keep the products' efficacy intact. Some medicines and vaccines need special storage temperature, otherwise, there may be wastage. The quality of the medicines can be adversely affected by poor storage, transportation and distribution. Thus, maintaining proper storage condition for health commodities is vital for ensuring their quality. So, by this training, CDMU wants to educate different people dealing with medicines and equip them for the roles they have to perform efficiently so that the wastage does not take place or can be minimized.
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23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeters, patient monitors, thermometers, infusion and suc...tion pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
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The document, "Sustainable Management of Radiotherapy Facilities and Equipment," by WHO and IAEA, provides guidelines for managing radiotherapy equipment and facilities to ensure effective and safe cancer treatment. It covers essential aspects like preventive and corrective maintenance, funding, inf...rastructure, and staffing requirements for sustainable operation. The document aims to support radiotherapy departments, especially in low-resource settings, by outlining strategies for equipment procurement, maintenance, and replacement, emphasizing safety, quality assurance, and optimal patient care.
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This guide is intended to assist
state, local, and tribal public health
professionals in the initiation of
response activities during the
first 24 hours of an emergency
or disaster. It should be used in
conjunction with existin...g emergency
operations plans, procedures,
guidelines, resources, assets, and
incident management systems. It
is not a substitute for public health
emergency preparedness and
planning activities. The response to
any emergency or disaster must be
a coordinated community effort.
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Due to high routine vaccination coverage, overall counts of diphtheria case have significantly declined in the Western Pacific Region recently. However, diphtheria is still prevalent in several countries and areas of the Region and remains a public health issue due to its high case fatality rate.
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This Field Guide for Preparedness and Response to Diphtheria Outbreaks in the Western Pacific Region is a reference resource for Member States to develop national guidelines adapted to their local context. Countries may also use this Guide to facilitate outbreak preparedness and public health responses to reduce morbidity and mortality due to diphtheria.
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This working paper aims to provide a rough over-view of existing rules and guidelines on the coopera-tion between the UN and the private sector – at least as they are publicly available. It will describe com-mon features and discuss advances and shortcomings of the most prominent a...nd debated rules and guide-lines. Finally, it will present proposals for improve-ment of the existing rules and steps towards a new regulatory and institutional framework for interac-tion between the UN and the private sector.
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