{"id":123,"date":"2022-01-16T20:24:44","date_gmt":"2022-01-16T19:24:44","guid":{"rendered":"https:\/\/www.alims.gov.rs\/english\/?page_id=123"},"modified":"2023-08-22T11:04:00","modified_gmt":"2023-08-22T10:04:00","slug":"reporting-of-adverse-drug-reactions","status":"publish","type":"page","link":"https:\/\/www.alims.gov.rs\/english\/pharmacovigilance\/reporting-of-adverse-drug-reactions\/","title":{"rendered":"Reporting of Adverse Drug Reactions"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_4 1_4 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:25%;--awb-margin-top-large:0px;--awb-spacing-right-large:7.68%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:7.68%;--awb-width-medium:25%;--awb-order-medium:0;--awb-spacing-right-medium:7.68%;--awb-spacing-left-medium:7.68%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\" style=\"--awb-font-size:16px;--awb-text-transform:none;--awb-text-color:var(--awb-color1);--awb-text-font-family:&quot;Source Sans Pro&quot;;--awb-text-font-style:normal;--awb-text-font-weight:700;\" id=\"navigacija_naslov\"><p>Pharmacovigilance<\/p>\n<\/div><nav class=\"awb-menu awb-menu_row awb-menu_em-hover mobile-mode-collapse-to-button awb-menu_icons-left awb-menu_dc-yes mobile-trigger-fullwidth-off awb-menu_mobile-toggle awb-menu_indent-left mobile-size-full-absolute loading mega-menu-loading awb-menu_desktop awb-menu_dropdown awb-menu_expand-right awb-menu_transition-fade\" style=\"--awb-font-size:14px;--awb-items-padding-bottom:0.5em;--awb-color:#0d4873;--awb-active-color:#0d4873;--awb-main-justify-content:flex-start;--awb-mobile-justify:flex-start;--awb-mobile-caret-left:auto;--awb-mobile-caret-right:0;--awb-fusion-font-family-typography:&quot;Source Sans Pro&quot;;--awb-fusion-font-style-typography:normal;--awb-fusion-font-weight-typography:700;--awb-fusion-font-family-submenu-typography:inherit;--awb-fusion-font-style-submenu-typography:normal;--awb-fusion-font-weight-submenu-typography:400;--awb-fusion-font-family-mobile-typography:inherit;--awb-fusion-font-style-mobile-typography:normal;--awb-fusion-font-weight-mobile-typography:400;\" aria-label=\"meni_farmakovigilanca\" data-breakpoint=\"1024\" data-count=\"0\" data-transition-type=\"fade\" data-transition-time=\"300\"><button type=\"button\" class=\"awb-menu__m-toggle awb-menu__m-toggle_no-text\" aria-expanded=\"false\" aria-controls=\"menu-meni_farmakovigilanca\"><span class=\"awb-menu__m-toggle-inner\"><span class=\"collapsed-nav-text\"><span class=\"screen-reader-text\">Toggle Navigation<\/span><\/span><span class=\"awb-menu__m-collapse-icon awb-menu__m-collapse-icon_no-text\"><span class=\"awb-menu__m-collapse-icon-open awb-menu__m-collapse-icon-open_no-text fa-bars fas\"><\/span><span class=\"awb-menu__m-collapse-icon-close awb-menu__m-collapse-icon-close_no-text fa-times fas\"><\/span><\/span><\/span><\/button><ul id=\"menu-meni_farmakovigilanca\" class=\"fusion-menu awb-menu__main-ul awb-menu__main-ul_row\"><li  id=\"menu-item-81\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-81 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"81\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/pharmacovigilance\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Pharmacovigilance<\/span><\/a><\/li><li  id=\"menu-item-116\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-116 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"116\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/pharmacovigilance\/how-we-monitor-the-safety\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">How we monitor the safety?<\/span><\/a><\/li><li  id=\"menu-item-841\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-841 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"841\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/security-information\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Safety information<\/span><\/a><\/li><li  id=\"menu-item-127\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-127 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"127\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/pharmacovigilance\/reporting-of-adverse-drug-reactions\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Reporting of Adverse Drug Reactions<\/span><\/a><\/li><li  id=\"menu-item-135\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-135 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"135\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/pharmacovigilance\/medicines-under-intensive-monitoring\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">List of medicines under additional monitoring<\/span><\/a><\/li><li  id=\"menu-item-146\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-146 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"146\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/pharmacovigilance\/meddra-and-ime-lists\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">MedDRA and IME lists<\/span><\/a><\/li><li  id=\"menu-item-842\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-842 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"842\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/drug-license-holders\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Marketing authorisation holders<\/span><\/a><\/li><li  id=\"menu-item-161\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-161 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"161\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/pharmacovigilance\/annual-report\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Annual reports<\/span><\/a><\/li><li  id=\"menu-item-861\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-861 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"861\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/questions-and-answers\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">Questions and answers<\/span><\/a><\/li><li  id=\"menu-item-862\"  class=\"menu-item menu-item-type-post_type menu-item-object-page menu-item-862 awb-menu__li awb-menu__main-li awb-menu__main-li_regular\"  data-item-id=\"862\"><span class=\"awb-menu__main-background-default awb-menu__main-background-default_fade\"><\/span><span class=\"awb-menu__main-background-active awb-menu__main-background-active_fade\"><\/span><a  href=\"https:\/\/www.alims.gov.rs\/english\/medsafetyweek\/\" class=\"awb-menu__main-a awb-menu__main-a_regular fusion-flex-link\"><span class=\"awb-menu__i awb-menu__i_main fusion-megamenu-icon\"><i class=\"glyphicon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><span class=\"menu-text\">MedSafetyWeek<\/span><\/a><\/li><\/ul><\/nav><\/div><\/div>\n<div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_3_4 3_4 fusion-flex-column\" style=\"--awb-padding-right:50px;--awb-bg-size:cover;--awb-width-large:75%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.56%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:2.56%;--awb-width-medium:75%;--awb-order-medium:0;--awb-spacing-right-medium:2.56%;--awb-spacing-left-medium:2.56%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><nav class=\"fusion-breadcrumbs fusion-breadcrumbs-1\" style=\"--awb-breadcrumb-sep:&#039;\/&#039;;\" aria-label=\"Breadcrumb\"><ol class=\"awb-breadcrumb-list\"><li class=\"fusion-breadcrumb-item awb-breadcrumb-sep\" ><a href=\"https:\/\/www.alims.gov.rs\/english\" class=\"fusion-breadcrumb-link\"><span >Home<\/span><\/a><\/li><\/ol><\/nav><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-one\"><h1 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h5>Reporting of Adverse Drug Reactions<\/h5><\/h1><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-text-transform:none;\"><p>Adverse drug reaction reporting is the main method for post-marketing surveillance of a medicine which leads to new insights about its safety profile.<\/p>\n<p>The Medicines and Medical Devices Agency of Serbia (ALIMS) is responsible for monitoring adverse drug reactions. Thus, in the Republic of Serbia, all cases of adverse drug reactions are collected in ALIMS i.e. its National Pharmacovigilance Centre (NPC).<\/p>\n<p>Adverse reactions are reported to ALIMS by healthcare institutions and healthcare professionals, as well as patients (spontaneous reporting), marketing authorization holders and sponsors of clinical trials.<\/p>\n<\/div><div class=\"fusion-title title fusion-title-2 fusion-sep-none fusion-title-text fusion-title-size-four\"><h4 class=\"fusion-title-heading title-heading-left\" style=\"margin:0;\"><h4>Spontaneous adverse drug reaction reporting<\/h4><\/h4><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-bottom:10px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"--awb-height:20px;--awb-amount:20px;border-color:var(--awb-color3);border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-text-transform:none;\"><p>The main and most important part of post-marketing safety monitoring of medicines, i.e. the cornerstone of the national pharmacovigilance system, is spontaneous adverse drug reaction reporting.<\/p>\n<p>Spontaneous reporting involves the voluntary reporting of adverse reactions to medicines placed on the market by healthcare professionals and patients.<\/p>\n<p>The unique position of healthcare workers in their day-to-day professional practice enables them to identify and report adverse reactions to medicines placed on the market. Therefore, healthcare professionals should report recorded and suspected adverse reactions even when there is no reliable evidence of a causal relationship with the medicine administered in order to protect the health of patients.<\/p>\n<p>The efficiency and success of the national program for monitoring safety of medicines, from the moment they are placed on the market, directly depends on the active participation of healthcare professionals in reporting suspected adverse reactions. Spontaneous reporting should be viewed through the prism of professional and ethical responsibility, and healthcare professionals should direct their future efforts towards intensifying the reporting of adverse drug reactions and integrating pharmacovigilance into their professional practice, as part of routine activities.<\/p>\n<p>The healthcare professional and patient\/user of the medicinal product should report suspected adverse reactions to a medicinal product via the Adverse reaction reporting form for healthcare professionals or patient\/user of the medicinal product or via the <a href=\"https:\/\/primaryreporting.who-umc.org\/RS\"> <strong>online application for ADRs reporting (available in Serbian)<\/strong><\/a>.<\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":75,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-123","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/123","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/comments?post=123"}],"version-history":[{"count":12,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/123\/revisions"}],"predecessor-version":[{"id":912,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/123\/revisions\/912"}],"up":[{"embeddable":true,"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/pages\/75"}],"wp:attachment":[{"href":"https:\/\/www.alims.gov.rs\/english\/wp-json\/wp\/v2\/media?parent=123"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}