{"id":411,"date":"2014-02-08T11:51:43","date_gmt":"2014-02-08T11:51:43","guid":{"rendered":"http:\/\/eurekainfomed.it\/en\/?p=411"},"modified":"2017-04-04T12:01:11","modified_gmt":"2017-04-04T12:01:11","slug":"la-letteratura-scientifica-e-alla-base-della-farmacovigilanza","status":"publish","type":"post","link":"https:\/\/eurekainfomed.it\/en\/la-letteratura-scientifica-e-alla-base-della-farmacovigilanza\/","title":{"rendered":"La letteratura scientifica \u00e8 alla base della farmacovigilanza"},"content":{"rendered":"

La comparsa di eventi avversi di grado severo ha portato a ritirare dal mercato europeo 19 farmaci in 10 anni (dal 2002 al 2011).
\nGli eventi cardiovascolari hanno causato 9 ritiri su 19 , quelli epatici o psichiatrici hanno portato ognuno a 4 ritiri su 19.
\nAnche se la segnalazione spontanea delle reazioni avverse<\/strong> \u00e8 stata fondamentale nella decisione del ritiro, gli studi clinici pubblicati dalle riviste di letteratura scientifica<\/strong>\u00a0hanno contribuito a due terzi delle decisioni.<\/p>\n

<\/p>\n

uno studio sui case report<\/em> spiega l’importanza della letteratura scientifica<\/h3>\n

In particolare i case report<\/em> erano citati nel 95% dei ritiri (18\/19 casi) , gli studi clinici randomizzati (RCT) nel 63% (12\/19 casi) , le meta-analisi nel 26% (5\/19 casi), gli studi casi-controllo e gli studi coorte nel 21% (4\/19 casi) rispettivamente. Sono i risultati pubblicati da Rhian McNaughton e colleghi sul British Medical Journal<\/strong><\/a>, che hanno analizzato le evidenze scientifiche legate alla decisione del ritiro attraverso una ricerca in Pubmed e nei siti di EMA (European Medicine Agency<\/em>) e delle agenzie regolatorie europee.<\/p>\n

\n

\u201cLe segnalazioni spontanee devono essere utilizzate insieme ad altri strumenti di farmacovigilanza<\/a> quali studi osservazionali o studi clinici per valutare pi\u00f9 approfonditamente ogni segnale di safety<\/strong> a causa del pericolo di sovra- o sotto- segnalazione, confusioni, bias e cattiva classificazione\u201d<\/p>\n

Rhian McNaughton<\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"

La comparsa di eventi avversi di grado severo ha portato a ritirare dal mercato europeo 19 farmaci in 10 anni (dal 2002 al 2011). Gli eventi cardiovascolari hanno causato 9…<\/p>\n","protected":false},"author":1,"featured_media":334,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,25],"tags":[],"class_list":["post-411","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-pharmacovigilance"],"yoast_head":"\nLa letteratura scientifica \u00e8 alla base della farmacovigilanza - Eureka Info Med<\/title>\n<meta name=\"description\" content=\"un studio sui case report spiega l'importanza della letteratura scientifica nel processo di farmacovigilanza e nell'individuazione di reazioni avverse\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eurekainfomed.it\/en\/la-letteratura-scientifica-e-alla-base-della-farmacovigilanza\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La letteratura scientifica \u00e8 alla base della farmacovigilanza - 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