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 third edition, released in 2018, has grown to include a total of 18 chapters, contributed by 20 experts and authors from many countries. The goal remains the same: to educate primary care providers on the best practices in TB diagnosis, treatment and follow-up. All articles are richly illustrate...d, and most include quizzes and CME questions for self learning. The 3rd edition includes new chapters on MDR-TB, adverse effects of TB drugs, adherence monitoring strategies, and nutritional support. There is also content on how to manage children with TB, care for patients co-infected with TB and HIV, how to read and interpret chest x-rays, and how to avoid common pitfalls in TB management.
To download book chapters or the whole book go to the website: http://www.letstalktb.org/download/
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These Guidelines on prudent use of antimicrobials in human health are based on a technical report prepared by the European Centre for Disease Prevention and Control (ECDC) with input from EU Member States experts and stakeholders, which should be referred to for details of the methodology used in cr...eating the guidelines as well as for additional references
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The pharmacological management of asthma has changed considerably in recent decades, as it has come to be understood that it is a complex, heterogeneous disease with different phenotypes and endotypes. It is now clear that the goal of asthma treatment should be to achieve and maintain control of the... disease, as well as to minimize the risks (of exacerbations, disease instability, accelerated loss of lung function, and adverse treatment effects). That requires an approach that is personalized in terms of the pharmacological treatment, patient education, written action plan, training in correct inhaler use, and review of the inhaler technique at each office visit. A panel of 22 pulmonologists was invited to perform a critical review of recent evidence of pharmacological treatment of asthma and to prepare this set of recommendations, a treatment guide tailored to use in Brazil. The topics or questions related to the most significant changes in concepts, and consequently in the management of asthma in clinical practice, were chosen by a panel of experts. To formulate these recommendations, we asked each expert to perform a critical review of a topic or to respond to a question, on the basis of evidence in the literature. In a second phase, three experts discussed and structured all texts submitted by the others. That was followed by a third phase, in which all of the experts reviewed and discussed each recommendation. These recommendations, which are intended for physicians involved in the treatment of asthma, apply to asthma patients of all ages.
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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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Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
Despite some improvements, current levels of air pollution still pose a considerable risk to the environment and to human health in the WHO European Region. One issue of concern is that monitoring of particulate matter is very limited in the countries of eastern Europe, the Caucasus and central Asia.... This paper summarizes the evidence about the health effects of air pollution from particulate matter and presents the policy implications, the aim being to stimulate policy-makers to develop more effective strategies to reduce air pollution and its health effects in those countries.
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New and updated information.
Adverse health effects of hot weather and heat-waves are largely preventable. Prevention requires a portfolio of actions at different levels:from health system preparedness, coordinated with meteorological early warning systems, to timely public ... and medical advice andimprovements to housing and urban planning. This publication offers detailed information for various target audiences, and on medicaladvice and treatment practices
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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The combined effects from ambient (outdoor) air pollution and indoor (household, in particular) air pollution cause approximately 7 million premature deaths every year, largely as a result of increased mortality from stroke, IHD, COPD, lung cancer and acute respiratory infections (1). Air pollution ...can occur in both the outdoor and indoor environments. Cook-stoves in homes, motor vehicles, industrial facilities and forest fires are common sources of air pollution. Air pollutants with the strongest evidence for adverse health outcomes include particulate matter (PM; both PM 2.5 (i.e. particles with an aerodynamic diameter
equal to or less than 2.5 μm) and PM10 (i.e. particles with an aerodynamic diameter equal to or less than 10 μm), ozone (O 3), nitrogen dioxide (NO 2 ), sulfur dioxide (SO 2 ) and carbon monoxide (CO). Air pollution is however composed of many more pollutants (1).
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1.HIV infections – drug therapy. 2.Anti-HIV agents – adverse effects. 3.Anti-retroviral agents. 4.Benzoxazines – adverse effects. 5.Pregnancy. 6.Disease transmission, Vertical - prevention and control. 7.Treatment outcome. I.World Health Organization
SCOPING QUESTION: In adults with established status epilepticus (i.e., seizures persisting after the first-line treatment with benzodiazepines [or benzodiazepines-resistant status epilepticus]), which anti-epileptic medications are associated with cessation of seizures and reduced adverse effects)?
...
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Introduction Pharmacovigilance (PV) systems to monitor drug and vaccine safety are often inadequate in sub-Saharan
Africa. In Malawi, a PV enhancement initiative was introduced to address major barriers to PV.
Objective The objective of this initiative was to improve reporting of adverse events (A...Es) by strengthening passive safety
surveillance via PV training and mentoring of local PV stakeholders and healthcare providers (HCPs) at their own healthcare
facilities (HCFs).
Methods An 18-month PV training and mentoring programme was implemented in collaboration with national stakeholders,
and in partnership with the Ministry of Health, GSK and PATH. Two-day training was provided to Expanded Programme on
Immunisation coordinators, identified as responsible for AE reporting, and four National Regulatory Authority representa-
tives. Abridged PV training and mentoring were provided regularly to HCPs. Support was given in upgrading the national
PV system. Key performance indicators included the number of AEs reported, transmission of AE forms, completeness of
reports, serious AEs reported and timeliness of recording into VigiFlow.
Results In 18 months, 443 HCPs at 61 HCFs were trained. The number of reported AEs increased from 22 (January 2000 to
October 2016) to 228 (November 2016 to May 2018), enabling Malawi to become a member of the World Health Organization
Programme for International Drug Monitoring. Most (98%) AE report forms contained mandatory information on reporter,
event, patient and product, but under 1% were transmitted to the national PV office within 48 h.
Conclusion Regular PV training and mentoring of HCPs were effective in enhancing passive safety surveillance in Malawi,
but the transmission of reports to the national PV centre requires further improvement.
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