This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica...tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
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GPHF Minilab manuals on basic dye and thin layer chromatographic testing. The newest version of the manual (Volume I + II) from 2008 is available in three languages: English, French, Spanish. Combining the main manual with the supplements issued each year between 2010 and 2015, label claims on drug... identity and content can now be verified for 75 active ingredients and their fixed-dose combination products using simple, rapid and affordable thin layer chromatographic tests. Please note: Only the demo versions are online available!! The complete manuals are only available after purchasing the Minilab!
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Global UNIDO Project: Strengthening the local production of essential generic drugs in the least developed and developing countries
Emergence of antimicrobial resistance is a result of the use, overuse and misuse of antibiotics both in humans and animals. In Ethiopia, there are indications on the misuse of antibiotics by health care providers’, unskilled practitioners, and drug consumers. These coupled with rapid spread of res...istant bacteria and inadequate surveillance contributed to the problem. Bacterial infections are the major causes of death in Ethiopia. Studies on antibacterial resistance and on bacterial infections have shown that emerging antibacterial resistance threatens the management of bacterial infections; however, the prevention and containment has received far too little attention.
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World Drug Report 2017
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Accessed: 14.03.2019
An update from the EU Early Warning System
The emergence of multifrug-resistant malaria in the Greater Mekong Subregion (GMS) has been identified as an emergency issue that may have catastrophic consequences on the future of malaria elimination in the GMS as well as globally. In recognition of the need for a cohesive regional response,... GMS countries have committed to a shared goal of eliminating malaria from the GMS by 2030 working within the framework of the Strategy for Malaria Elimination in the Greater Mekong Subregion 2015-2030. Population mobility has been identified as a key concern in the context of multidrug-resistant malaria; and in a region of highly porous borders where the majority of intra-Mekong migration occurs through informal channels, addressing the health needs of migrant populations has never been more critical.
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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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Document No. : FDA/SMC/SMD/GL-RAR/2013/01
The safety of medicines in Zambia - why health workers need to take action | Produced by the National Pharmacovigilance Unit (NPVU)
Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
Scientists have known for more than half a century that patients could develop resistance to the drugs used to treat them. Alexander Fleming, who is credited with creating the first antibiotic, penicillin, in 1928, cautioned of the impending crisis while accepting his Nobel prize in 1945: “There ...is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.” Since then antibiotics have proved one of the most effective interventions in human medicine. Sadly, the overuse and misuse of this precious resource have brought us to a global crisis of antimicrobial resistance (AMR). To address this crisis nearly seven decades after Fleming’s lecture the first UN general assembly meeting on drug resistance bacteria was convened in September 2017.
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In Vietnam, most of the examination and treatment facilities are facing with of spread of bacteria resistant to many antibiotics. The level and speed of drug resistance are increasing, at alarming level. The burden of drug resistance is increasing due to the increasing cost of treatment, prolonged t...reatment,. That will affect patients’ health, community and social development. In the future, many
nations will be able to face the possibility of having no effective drugs to treat infectious diseases if they do not make appropriate interventions.
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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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Antibiotics 2022, 11(3), 329; https://doi.org/10.3390/antibiotics11030329.
The authors found that the most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate ...deviations were found, suggesting that regular quality control of antibiotics is needed in Rwanda.
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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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