This manual provides a practical method for determining the pharmacovigilance indices. It is designed to be simple and can be understood by any worker in pharmacovigilance without formal training in monitoring and evaluation. Pharmacovigilance as a medical discipline is crucial in preventing medicin...e-related adverse effects in humans, promoting patient safety, and the rational use of medicines. The indicators proposed in this manual are based on the expected functions of pharmacovigilance centres as described in the WHO Mimimum Requirements for a Functional Pharmacovigilance System (1) (see Annex 1 of the manual).
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The Global Programme on Tuberculosis & Lung Health of the World Health Organization (WHO/GTB) is now combining all current recommendations into one overall set of consolidated guidelines on TB. The guidelines contain recommendations pertaining to all areas related to the programmatic management of T...B (e.g. screening, preventive treatment, diagnostics, patient support, and the treatment of drug-susceptible TB and DR-TB). The consolidated guidelines contain modules specific to each programmatic area.
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On 15–16 December 2020, WHO and the Medicines for Malaria Venture co-convened a technical consultation to consider the preferred product characteristics (PPCs) for drugs used in malaria chemoprevention. The main goal of the technical consultation was to agree on the most important PPCs for drugs t...o protect populations from malaria (chemoprevention), while considering relevant measures of efficacy and the safety data needed to support WHO policy recommendations.
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The main objective of these guidelines is to provide guidance on up-to-date, uniform, evidence-informed practices for suspecting, diagnosing and managing various forms of extra-pulmonary tuberculosis (EPTB) at all levels of healthcare delivery. They can then contribute to the National Programme to i...mprove detection, care and outcomes in EPTB; to help the programme with initiation of treatment, adherence and completion whilst minimizing drug toxicity and overtreatment; and contribute to practices that minimize the development of drug resistance.
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Review of International, Regional and National Policies and Legal Frameworks that Promote Migrants and Mobile Populations' Access to Health and Malaria Services in the Greater Mekong Subregion (Cambodia, Lao People's Democratic Republic, Myanmar, Thailand and Viet Nam)
Migrants and mobile popul...ations face many obstacles in accessing equitable essential health care services due to factors such as living and working conditions, education level, gender, irregular migration status, language and cultural barriers, anti-migrant sentiments, and lack of migrant-inclusive health policies among others. Despite significant progress having been made in the context of malaria control in the Greater Mekong Subregion (GMS), human movements can impact malaria transmission patterns and potentially introduce drug-resistant parasites. This legal framework review therefore serves as a guidance document on approaches to address malaria and malaria elimination for migrant and mobile populations (MMPs) in five countries of the GMS.
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This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
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 Operational guide: use of referral laboratories for the analysis of foodborne hazards in the Pacific aims to strengthen the food analysis capacity of Pacific Island countries and areas by identifying national and reference laboratories capable of testing for priority foodborne hazards. The Pacif...ic Island countries and areas are often vulnerable to food safety incidents and emergencies due to their geographical distribution and dependence on food imports. The guide outlines key considerations for selecting referral laboratories and submitting samples to them, enabling continuous improvement of food safety systems and providing safe food for all. The target audiences are health and food safety authorities.
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The recommendations in these guidelines promote the use of simple, non-invasive diagnostic tests to assess the stage of liver disease and eligibility for treatment; prioritize treatment for those with most advanced liver disease and at greatest risk of mortality; and recommend the preferred use of n...ucleos(t)ide analogues with a high barrier to drug resistance (tenofovir and entecavir, and entecavir in children aged 2–11 years) for first- and second-line treatment. Recommendations for the treatment of HBV/HIV-coinfected persons are based on the WHO 2013 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection, which will be updated in 2015.
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The Ministry of Health has developed the first version of the Service Standards and Service Delivery Standards for the health sector in Uganda. The main objective is to provide a common understanding of what is expected by the public, service users and service providers in ensuring provision of cons...istently high quality service delivery. These standards also provide a roadmap for improving the quality, safety and reliability of healthcare in Uganda.
The application of these standards is expected to improve transparency and accountability in service delivery; fairness and equity in service provision; building a culture of quality management; regulation, management and control of public and private providers; and management of expectations of service recipients.
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The Libyan national action plan has been aligned with WHO five objectives. Analysis of the current situation and addressing the gaps and the needs to reach the main goal “one health” approach involves several national sectors and actors, including human and veterinary health, agriculture and foo...d and drug control center and environmental agencies. Therefore, a large committee of all stakeholders was formed with four technical subcommittees were established to addresses every aspect to contain antimicrobial resistance in the country.
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Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi...demic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
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This publication is intended for professionals training or practicing in mental health and not for the general public. The opinions
expressed are those of the authors and do not necessarily represent the views of the Editor or IACAPAP. This publication seeks to
describe the best treatments and pra...ctices based on the scientific evidence available at the time of writing as evaluated by the authors and may change as a result of new research. Readers need to apply this knowledge to patients in accordance with the guidelines and laws of their country of practice. Some medications may not be available in some countries and readers should consult the specific drug information since not all dosages and unwanted effects are mentioned. Organizations, publications and websites are cited or linked to illustrate issues or as a source of further information. This does not mean that authors, the Editor or IACAPAP endorse their content or recommendations, which should be critically assessed by the reader. Websites may also change or cease to exist.
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This publication seeks to describe the best treatments and practices based on the scientific evidence available at the time of writing as evaluated by the authors and may change as a result of new research. Readers need to apply this knowledge to patients in accordance with the guidelines and laws o...f their country of practice. Some medications may not be available in some countries and readers should consult the specific drug information since not all the unwanted effects of medications are mentioned.
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West Africa is experiencing the largest, most severe, most complex outbreak of Ebola virus disease in history. On 11 August 2014, WHO convened a consultation where the participants concluded that in the particular context of the current Ebola outbreak in West Africa, it is ethically acceptable to of...fer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluat-
ed for safety and efficacy in humans as potential treatment or prevention
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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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The global increase of healthcare-associated infections (HAI) presents a growing concern in healthcare worldwide. According to the European Centre for Disease Prevention and Control (ECDC), the annual number of HAI exceeds 2.6million and produces the highest estimated amou...nt of disability-adjust-ed-life-years, surpassing all other reported communicable diseases in the European Union and European Economic Area. Multi-drug-resistant Gram-negative (MDR-GN) bacteria have become increasingly common as a cause for HAI, such as central line-as-sociated bloodstream infections, wound or surgical site infections and catheter-associated urinary tract infections
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Q7. SCOPING QUESTION: In adults with moderate-severe depressive disorder, what is the effectiveness and safety of antidepressant medication (ADM) in comparison with psychological treatment?
The WHO mhGAP programme’s existing guidelines recommend that either structured brief psychological treatm...ents (e.g., interpersonal psychotherapy or cognitive behavioural therapy, including behavioural activation) or antidepressant medication (e.g., SSRIsi and tricyclic antidepressants) be considered in adults with moderate-severe depression. Health care workers need to know whether these treatments have different effects, including side-effects, in treating depressive disorder in the short and long term, in order to improve clinical decision-making.
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sthma prevalence is increasing worldwide, and surveys indicate that most patients in developed and developing countries, including South Africa, do not receive optimal care and are therefore not well controlled. Standard management guidelines adapted to in-country realities are important to support ...optimal care. The South African Thoracic Society (SATS) first published a guideline for the management of chronic persistent asthma in 1992, which has subsequently been revised several times.
The main aim of the present document was to revise and update SATS’ statement on the suggested management of chronic asthma, based on the need to promote optimal care and control of asthma, together with the incorporation of new concepts and drug developments. This revised document reinforces optimal care and incorporates the following primary objectives to achieve the recent advances in asthma care:
• continued emphasis on the use of inhaled corticosteroids (ICS) as the foundation of asthma treatment
• to reduce the reliance on short-acting beta-2 agonist (SABA) monotherapy for asthma symptoms
• to incorporate the evidence and strategy for the use of the combination of an ICS and formoterol for acute symptom relief (instead of a SABA)
• to incorporate the evidence and strategy for the use of as-needed ICS-long-acting beta agonists (LABA) for patients with infrequent symptoms or ‘mild’ asthma
• to incorporate the evidence and strategy for the use of a long-acting muscarinic antagonist (LAMA) in combination with ICS-LABA; and
• to incorporate the evidence and strategy for the use of and management with a biologic therapy in severe asthma.
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Arsenical monotherapies were previously very successful for treating human African trypanosomiasis (HAT).
Melarsoprol resistance emerged as early as the 1970s and was widespread by the late 1990s.
Melarsoprol resistance represents the only example of widespread drug resistance in HAT patients wher...e the genetic mechanism has been established.
The current goal of elimination of HAT as a public health problem by 2020 may be undermined by the emergence and spread of resistance to current or new drugs.
Insights into potential resistance mechanisms for current and new drugs will facilitate predictions of the likelihood of resistance and will also facilitate rational approaches to minimizing, monitoring, and tackling the future emergence of resistance.
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