{"id":749,"date":"2020-02-17T21:40:58","date_gmt":"2020-02-17T16:10:58","guid":{"rendered":"https:\/\/medicineplexus.com\/?p=749"},"modified":"2020-02-17T21:40:58","modified_gmt":"2020-02-17T16:10:58","slug":"pharmacovigilance","status":"publish","type":"post","link":"https:\/\/medicineplexus.com\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"\n
Pharmacovigilance<\/u><\/strong><\/p>\n\n\n\n The etymological root<\/u><\/strong>: pharmakon<\/em> (Greek) means drug and vigilare<\/em> (Latin) means to keep awake or alert, to keep watch.<\/p>\n\n\n\n WHO Definition:<\/u><\/strong> The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.<\/p>\n\n\n\n Why <\/u><\/strong>Pharmacovigilance?<\/u><\/strong><\/p>\n\n\n\n Disasters:<\/u><\/strong><\/p>\n\n\n\n Incidence of hospital admissions related to adverse drug reactions<\/strong><\/strong><\/p>\n\n\n\n Hence is responsible for huge expenditure on health.<\/p>\n\n\n\n Aims of the Pharmacovigilance:<\/u><\/strong><\/p>\n\n\n\n Terms in Pharmacovogilance<\/u><\/strong><\/p>\n\n\n\n A serious adverse event or reaction is any untoward medical occurrence that at any dose:<\/p>\n\n\n\n Individual Case Safety Report (ICSR)<\/strong><\/p>\n\n\n\n A report that contains \u2018information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient\u2019<\/p>\n\n\n\n Causality assessment<\/strong><\/p>\n\n\n\n The evaluation of the likelihood that a medicine was the causative agent of an observed adverse reaction. Causality assessment is usually made according established algorithms.<\/p>\n\n\n\n SUSAR (Suspected Unexpected Serious Adverse Reaction):<\/strong><\/p>\n\n\n\n Serious adverse drug reaction (SAR) that is unexpected or for which the development is uncommon (unexpected issue) observed during a clinical trial and for which there is a relationship with the experimental drug, whatever the tested drug or its comparator.<\/p>\n\n\n\n WHO Programme for International Drug Monitoring:<\/u><\/strong><\/p>\n\n\n\n It consists of a network of the<\/u><\/strong><\/p>\n\n\n\n 1. National Centers,<\/p>\n\n\n\n 2. WHO Headquarters and<\/p>\n\n\n\n 3. Uppsala Monitoring Centre which is WHO Collaborating Centre for International Drug Monitoring, in Uppsala, Sweden.<\/p>\n\n\n\n Functions:<\/u><\/strong><\/p>\n\n\n\n Pharmacovigilance Programme of India (PvPI):<\/u><\/strong><\/p>\n\n\n\n