{"id":29978,"date":"2017-02-24T11:50:28","date_gmt":"2017-02-24T10:50:28","guid":{"rendered":"http:\/\/www.fedaiisf.it\/?p=29978"},"modified":"2017-03-08T10:32:33","modified_gmt":"2017-03-08T09:32:33","slug":"sospette-reazioni-avverse-ai-medicinali-possibile-segnalarle-online-vigifarmaco-it-n-d-r","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/sospette-reazioni-avverse-ai-medicinali-possibile-segnalarle-online-vigifarmaco-it-n-d-r\/","title":{"rendered":"Suspected adverse drug reactions. It is possible to report them online on Vigifarmaco.it. Ed"},"content":{"rendered":"<p>The Italian Medicines Agency informs health professionals and citizens that the\u00a0<a href=\"http:\/\/www.agenziafarmaco.gov.it\/node\/60\/\" target=\"_blank\" rel=\"noopener\">page<\/a>\u00a0of the portal that describes how to report suspected adverse reactions to medicines with the link to report directly online on the site <a class=\"ext\" href=\"http:\/\/www.vigifarmaco.it\/\" target=\"_blank\" rel=\"noopener\">www.vigifarmaco.it.<\/a><\/p>\n<p>AIFA recalls that the European legislation on <a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/glossary\/term\/1454\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Complex of activities aimed at continuously evaluating all information relating to the safety of medicines and ensuring, for all medicines on the market, a favorable benefit\/risk ratio for the population.\">pharmacovigilance<\/dfn><\/a> requires all healthcare professionals and citizens to report any suspects <a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/glossary\/term\/1475\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Unfavorable or dangerous effect that occurs in response to a treatment.\">adverse reaction<\/dfn><\/a> (serious and not serious, known and not <img loading=\"lazy\" decoding=\"async\" class=\"alignright\" src=\"http:\/\/www.ilikepuglia.it\/uploads\/16207\/segnalazione-di-sospetti-effetti-indesiderati-alluso-dei-farmaci-a-novembre-campagna-social-di-aifa--1478720339-grande.png\" alt=\"Risultati immagini per vigifarmaco la nuova piattaforma per la segnalazione online\" width=\"448\" height=\"336\" \/>Note).<\/p>\n<p>The Decree of the Ministry of Health of 30 April 2015 reaffirmed the obligation to promptly report suspected adverse reactions from drugs and vaccines and defined time limits within which healthcare professionals are required to report to the National Network of <a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/glossary\/term\/1454\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Complex of activities aimed at continuously evaluating all information relating to the safety of medicines and ensuring, for all medicines on the market, a favorable benefit\/risk ratio for the population.\">Pharmacovigilance<\/dfn><\/a> (RNF) of AIFA.<\/p>\n<p>Suspected adverse drug reactions should be reported within 2 days of when your doctor or healthcare professional becomes aware of them. The reporting obligation drops to 36 hours in the case of ADRs from medicinal products of biological origin (including vaccines).<\/p>\n<p>It is possible to make a spontaneous report of suspicion <a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/glossary\/term\/1475\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Unfavorable or dangerous effect that occurs in response to a treatment.\">adverse reaction<\/dfn><\/a> in one of the following ways:<\/p>\n<ul>\n<li>directly online on the site <a class=\"ext\" title=\"www.vigifarmaco.it\" href=\"http:\/\/www.vigifarmaco.it\/\" target=\"_blank\" rel=\"noopener\">www.vigifarmaco.it<\/a> following the wizard;<\/li>\n<li>by filling in the form (electronic or paper) to be sent to the Head of <a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/glossary\/term\/1454\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Complex of activities aimed at continuously evaluating all information relating to the safety of medicines and ensuring, for all medicines on the market, a favorable benefit\/risk ratio for the population.\">pharmacovigilance<\/dfn><\/a> of your facility or to the Marketing Authorization Holder (<a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/glossary\/term\/1432\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Marketing authorization for a drug. It is granted by AIFA after a group of experts has evaluated its safety and effectiveness. It constitutes the &quot;identity card&quot; of the medicinal product since it indicates the essential characteristics that identify it.\">AIC<\/dfn><\/a>) of the medicine that is suspected to have caused the <a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/glossary\/term\/1475\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Unfavorable or dangerous effect that occurs in response to a treatment.\">adverse reaction<\/dfn><\/a>. It will be the responsibility of the latter to forward it to the Manager of <a class=\"glossary-term\" href=\"http:\/\/www.agenziafarmaco.gov.it\/glossary\/term\/1454\" target=\"_blank\" rel=\"noopener\"><dfn title=\"Complex of activities aimed at continuously evaluating all information relating to the safety of medicines and ensuring, for all medicines on the market, a favorable benefit\/risk ratio for the population.\">pharmacovigilance<\/dfn><\/a> of the structure to which the reporter belongs.<\/li>\n<\/ul>\n<p>For further information go to the page on\u00a0<a href=\"http:\/\/www.agenziafarmaco.gov.it\/node\/60\/\" target=\"_blank\" rel=\"noopener\">AIFA portal<\/a><\/p>\n<p>Watch the<a class=\"ext\" href=\"https:\/\/youtu.be\/SVHCu24xwu4?list=UUPLAYER_aifaufficiale\" target=\"_blank\" rel=\"noopener\">\u00a0European awareness campaign video on reporting suspected adverse reactions<\/a><\/p>\n<p><a href=\"http:\/\/www.agenziafarmaco.gov.it\/content\/sospette-reazioni-avverse-ai-medicinali-possibile-segnalarle-online-su-vigifarmacoit-0\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #0000ff;\">AIFA \u2013 02\/24\/2017<\/span><\/a><\/p>\n<p>Related news: <a href=\"http:\/\/www.aifa.gov.it\/content\/elenco-dei-segnali\" target=\"_blank\" rel=\"noopener\"><span style=\"color: #0000ff;\">AIFA. Signal list<\/span><\/a><\/p>\n<p><strong><span style=\"color: #ff0000;\">Ed<\/span>:<\/strong> <em>Please note that the art. 130 of <span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"http:\/\/www.camera.it\/parlam\/leggi\/deleghe\/06219dl.htm\" target=\"_blank\" rel=\"noopener\">Legislative Decree 219\/06<\/a><\/span> establishes that the marketing authorization holder for medicinal products must have, on a stable and continuous basis, a person in charge of the pharmacovigilance service.<\/em><\/p>\n<p><em>The person in charge of the pharmacovigilance service must be a different person from the person in charge of the scientific service envisaged by article 111 of this decree, and must be able to use all the data of this service. The responsibility of the person in charge extends to all medicines whose marketing authorization is held by the company he employs, even if marketed by other companies.<\/em><\/p>\n<p><em>The marketing authorization holder is obliged to disseminate the information notes and updates on the safety of medicinal products to the prescribers, according to the indications, times and methods established by AIFA, whenever new information emerges relating to the tolerability profile of the medicinal product.<\/em><\/p>\n<p><em>The head of the pharmacovigilance service ensures that all information relating to the safety of medicinal products, subsequent to the act of authorization, is quickly brought to the attention of healthcare personnel <strong>also through the contacts of the scientific information service<\/strong> of your company.<\/em><\/p>\n<p><em>The <strong>scientific informants<\/strong> they must report to the scientific service referred to in article 126, on which they depend, and to the head of the pharmacovigilance service referred to in paragraph 4 of article 130, all the information on the undesirable effects of medicines, attaching, where possible, a copy of the reporting forms used by the doctor in accordance with Title IX.<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>L\u2019Agenzia Italiana del Farmaco informa gli operatori sanitari e i cittadini che \u00e8 stata aggiornata la\u00a0pagina\u00a0del portale che descrive le modalit\u00e0 di segnalazione delle sospette reazioni avverse ai medicinali con il link per effettuare una segnalazione direttamente online sul sito www.vigifarmaco.it. AIFA ricorda che la normativa europea sulla farmacovigilanza richiede a tutti gli operatori sanitari &hellip;<\/p>","protected":false},"author":4,"featured_media":27482,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[49,55],"class_list":["post-29978","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizie","tag-aifa","tag-farmacovigilanza"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/29978","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/comments?post=29978"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/29978\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/27482"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=29978"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=29978"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=29978"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}