Three Years After Enactment of the Drug Quality and Security Act
FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them. Here you can find informations to laws &policies, compliance action, ....
Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
The aim of the operational framework is to ensure 1) accurate collection, handling, shipment and storage of specimens collected in countries implementing HIV drug resistance surveillance; and 2) the availability of quality-assured HIV genotyping laboratory services producing comparable and reliable ...results at the national, regional and global levels.
This publication updates the WHO HIVResNet HIV drug resistance laboratory operational framework published in 2017 and reflects technical and strategic developments over the past three years.
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WHO’s antiretroviral treatment (ART) clinic-based acquired drug resistance survey method yields robust estimates of HIV viral suppression and acquired HIV drug resistance in adults, children and adolescents taking both dolutegravir and non-dolutegravir based regimens.
Results are used to inform A...RT programme decision making regarding optimal ART regimens and support evaluation of programme quality with respect to maximizing viral load suppression and minimizing emergence of resistance in people taking ART.
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The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priorit...y areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines.
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This document is based on currently available scientific evidence on treatment for drug use disorders and sets out a framework for the implementation of the Standards, in line with principles of public health care. The Standards identify major components and features of effective systems for the tre...atment of drug use disorders. They describe treatment modalities and interventions to match the needs of people at different stages and severities of drug use disorders, in a manner consistent with the treatment of any chronic disease or health condition. The Standards are aspirational, and such, national or local treatment services or systems need not attempt to meet all the standards and recommendations made in this document all at once. However over time, progressive quality improvement, with ‘evidence-based and ethical practice’ as an objective, can and should be expected to achieve better organized, more effective and ethical systems and services for people with drug use disorders.
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Antibiotic Stewardship (AS) is a coordinated program that promotes the appropriate use of antimicrobials to improve patient outcomes, reduce microbial resistance, and decrease the spread of multi-drug resistant organisms. In clinical settings, stewardship activities focus on measuring and improving ...how antibiotics are prescribed by clinicians and used by patients. Improving antibiotic prescribing involves implementing effective strategies to modify prescribing practices to align them with evidence-based recommendations for diagnosis and management.
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Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health prof...essionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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Antimicrobial Resistance Surveillance and Research Network | This manual describes well accepted methods to carry out drug susceptibility testing on important gram positive and gram negative clinically relevant bacteria. Methods of specimen collection, transport, culture, anti-microbial drug suscept...ibility testing (common, special phenotypic and
molecular techniques) as well as quality control and quality assurance have been described in a concise manner.
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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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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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In many low- and middle-income countries, there is a wide gap between evidencebased recommendations and current practice. Treatment of major CVD risk factors remains suboptimal, and only a minority of patients who are treated reach their target levels for blood pressure, blood sugar and blood choles...terol.
In other areas, overtreatment can occur with the use of non-evidence-based
protocols. The aim of using standard treatment protocols is to improve the quality
of clinical care, reduce clinical variability and simplify the treatment options,
particularly in primary health care. Standard treatment protocols can be developed by preparing new national treatment guidelines or by adapting or adopting international guidelines.
The Evidence-based protocols module uses hypertension and diabetes screening
and treatment as an entry point to control cardiovascular risk factors, prevent target organ damage, and reduce premature morbidity and mortality. A comprehensive risk- based approach for integrated management of hypertension, diabetes, and high cholesterol is included in the Risk-based CVD management module.
This module includes clinical practice points and sample protocols for:
1. hypertension detection and treatment
2. type 2 diabetes detection and treatment
3. identifying basic emergencies – care and referral.
HEARTS emphasizes adaptation, dissemination, and use of a standardized set of
simple clinical-management protocols, which should be drug- and dose-specific,
and include a core set of medications. The simpler the protocols and management tools, the more likely they are to be used correctly, and the higher the likelihood that a programme will achieve its goals.
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First Revised Edition
March 2000