Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
Version 10.1_5 October 2020
These Guidelines are available in different formats: As a paper booklet, a PDF, a mobile app, and now also as a website.
The 2019 version of the Guidelines introduces a new drug-drug interaction panel and now consists of six main sections, including a general overview ...table of all major issues in PLWH, recommendations on antiretroviral treatment, drug-drug interactions, diagnosis, monitoring and treatment of co-morbidities, co-infections and opportunistic diseases.
Available in English, French, Spanish, German, Portuguese, Russian, Chinese and Japanese
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There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
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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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In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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This guide is a resource for physicians and other health care professionals who provide care and treatment to patients with drug-resistant tuberculosis.
The purpose of this manual is to define a limited number of indicators that will objectively describe the management and use of antimicrobials in hospitals and to provide tools and step-by-step instructions for designing and carrying out an assessment of antibiotic use and management in hospitals. T...he indicators in this manual will complement the existing WHO (1993) indicators of outpatient antimicrobial use suggested in How to Investigate Drug Use in Health Facilities (including percentage of encounters in which an antibiotic was prescribed and percentage of medicine costs spent on antibiotics) and will address the need for antimicrobial indicators for inpatient conditions.
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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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Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr...am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
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The Ghanaian Cabinet approved the antimicrobial resistance (AMR)Policy and Implementation plan(hereafter referred to as the national action plan or NAP)in December 2017, whilst the country case study was in progress. This has set in motion the implementation phase for Ghana, which is a long awaited... event since the drafting of the Policy started in 2011. This case study, whilst limited in its ability to interact with all stakeholders, has identified entrypoints within the operational divisions of Ghana Health Services,as potential areas where the AMR policy platform may seek to embed AMR activities. Much work has already been done within Ghana to identify the key entrypoints within the various ministries and government agencieswhere AMR can be incorporated. These stakeholders already form part of the AMR Policy Platform which is the governance structure for AMR and have been participating actively in the development of the AMR Policy and NAP activities formulation.
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Antimicrobials have been a critical public health tool since the discovery of penicillin in 1928, saving the lives of millions of people around the world. Today, however, the emergence of drug resistance is reversing the miracles of the past eighty years, with drug choices for the treatment of many ...infections becoming increasingly limited, expensive, and, in some cases, non-existent.
Conscious of the public health threats of AMR to both humans, animals and the environment, the ministries of health and sanitation, agriculture forestry and food security and the environmental protection agency put together a national multi-sectoral coordinating group tasked with the responsibility of establishing mechanisms to integrate all initiatives into a single concerted action and development of the national AMR strategic plan (2018-2022). The National Strategic Plan on Antimicrobial Resistance is the first approach which addresses AMR specifically.
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The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, ...Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The document provides information on different aspects of care and support for TB patients. In particular, the handbook provides practical guidance on the implementation of the interventions that enable treatment adherence such as social support, treatment administration options, digital adherence technologies. The practical guidance also includes models of care for all TB patients, models of care for children and adolescents, integrated care for TB, HIV and comorbidities, engagement of private sector, managing of TB in health emergencies. This new practical handbook also includes two important chapters on health education and counselling, and palliative care for patients with TB.
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Palliative care for children with life-limiting illness is the active total care of the child’s body, mind, and spirit. It begins at diagnosis and continues regardless of whether the child receives treatment directed at the disease. It seeks to control all forms of suffering related to the illness..., including pain. It involves social, psychological, spiritual, and legal support to siblings, parents, and other close family members. Effective palliative care for children requires health professionals trained to assess symptoms, care for children of different ages and developmental stages, and to provide medicines in pediatric formulations. Care may be provided in tertiary care facilities, community health centers, and at home. The child’s best interest must inform all aspects of the treatment andcare, and the child’s rights must be protected at all times.
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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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Tuberculosis (TB) is, and should be, a curable disease; however, each year significant numbers of patients acquire or develop drug-resistant TB, which has a much lower cure rate. Patients with drug-resistant TB have a high prevalence of symptoms; hence, staff caring for these patients should h...ave some familiarity with palliative care, so that general palliative care principles are available to all patients. The timely identification, and addressing, of adverse events occurring during the treatment course is considered as general palliative care for those receiving curative treatment. This publication summarizes the general palliative care approach, which is recommended for use in settings and services that occasionally treat palliative care patients, but do not provide palliative care as the main focus of their work. The review focuses on 18 high TB priority countries of the WHO European Region.
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This manual summarizes key issues related to the safety of NTD medicines and their administration, with a focus on essential medicines used in mass drug administration (MDA), also called preventive chemotherapy. It can be used as a standalone reference manual, but is intended to be used in conjuncti...on with the accompanying training modules, which provide practical instruction, and the aide-mémoires. Versions of the aide-mémoires and training modules are available respectively for both (i) programme managers and district-level health officials and (ii) community drug distributors and community health workers
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N Engl J Med 2022; 386:911-922, DOI: 10.1056/NEJMoa2104535
Four months of antituberculosis treatment was noninferior to 6 months of treatment in children with drug-susceptible, nonsevere, smear-negative tuberculosis (SHINE Study)
Leishmaniasis is a spectrum of disease caused by the infection of protozoan parasite Leishmania mainly affecting the antigen presenting cell of the host. The disease is although considered as neglected tropical disease still it is not completely eradicated. Majority of the issues related to the ther...apeutic approach is due to increased cytotoxicity of the drugs, less effectiveness, high cost and occurrence of drug resistance. Therefore, recent advancement in the field of parasitology has taken into consideration of the specific arms of immunity which can be triggered with the help of natural products, synthetic molecules or parasite specific ligands which helps in the restoration of host protective immunity and recovery from the infection. Therefore, in this review, we have highlighted the recent advancement in the field of Leishmania research taken into consideration of the therapeutic perspective. We have shown that apart from therapeutic potential of the available drugs and vaccination approach, the immune-therapy are emerging as the modern regime of treatment where the effectiveness of the therapy is significantly increased and making it safer and promising.
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The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world.
In addition, this edition includes summary and recommendations from the virtual meeting of the members of the WHO Programme f...or International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
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The Country Cooperation Strategy is the World Health Organization (WHO)’s reference for country work guiding planning and resource allocation through alignment with national health priorities and harmonization with other development partners. It clarifies roles and functions of WHO in supporting t...he national strategic plan for health through the Sector-Wide Approach and Malawi Growth and Development Strategy II. The Country Cooperation Strategy is based on a systematic assessment of the recent national achievements, emerging health needs,
challenges, government policies and expectations. An evaluation of the previous CCS was conducted and jointly discussed with the Ministry of Health as well as other key stakeholders. This process led to the identification of the, achievements, challenges and shortfalls of the previous CCS. Through this process the areas where WHO needed to focus on were also identified. The CCS development has also been done in parallel with the formulation of the new Health Sector Strategic Plan (HSSP) to ensure that there is a linkage between the two.
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