{"id":1268,"date":"2024-12-24T08:11:19","date_gmt":"2024-12-24T08:11:19","guid":{"rendered":"https:\/\/unicare-pharma.com.sa\/?page_id=1268"},"modified":"2024-12-24T08:21:34","modified_gmt":"2024-12-24T08:21:34","slug":"pharmacovigilance-report","status":"publish","type":"page","link":"https:\/\/unicare-pharma.com.sa\/index.php\/pharmacovigilance-report\/","title":{"rendered":"pharmacovigilance report"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row el_id=&#8221;who-we-are&#8221; el_class=&#8221;m-t-n-md p-t-md&#8221;][vc_column width=&#8221;2\/6&#8243;][vc_custom_heading text=&#8221;Adverse Drug Reaction (ADR)&#8221; font_container=&#8221;tag:h2|font_size:2em|text_align:left|line_height:1&#8243; use_theme_fonts=&#8221;yes&#8221; el_class=&#8221;mb-4&#8243;][vc_column_text]Is a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility[\/vc_column_text][vc_custom_heading text=&#8221;Serious adverse reaction; is an adverse reaction which :<br \/>\n&#8221; font_container=&#8221;tag:h2|font_size:2em|text_align:left|line_height:1&#8243; use_theme_fonts=&#8221;yes&#8221; el_class=&#8221;mb-4&#8243;][vc_column_text]<\/p>\n<ul>\n<li>Results in death,<\/li>\n<li>Is life-threatening,<\/li>\n<li>Requires in-patient hospitalization or prolongation of existing hospitalization<\/li>\n<li>Is a congenital anomaly\/birth defect<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;4\/6&#8243;][vc_custom_heading text=&#8221;Adverse Drug Reaction (ADR) Reporting Form<br \/>\n&#8221; font_container=&#8221;tag:h2|font_size:2em|text_align:left|line_height:1&#8243; use_theme_fonts=&#8221;yes&#8221; el_class=&#8221;mb-4&#8243;]\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f1242-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"1242\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/index.php\/wp-json\/wp\/v2\/pages\/1268#wpcf7-f1242-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"1242\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.5\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f1242-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7_recaptcha_response\" value=\"\" \/>\n<\/fieldset>\n<style>\n.wpcf7 input[type=\"url\"], .wpcf7 input[type=\"email\"], .wpcf7 input[type=\"text\"],.wpcf7 input[type=\"tel\"]{\n width: 100%;\n}\n<\/style>\n<p style=\"font-size:20px; font-weight: 700;\">A. Patient Details\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"text-198\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Patient Initials\" value=\"\" type=\"text\" name=\"text-198\" \/><\/span>&nbsp;&nbsp;&nbsp;<span class=\"wpcf7-form-control-wrap\" data-name=\"text-211\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Date Of Birth*\" value=\"\" type=\"text\" name=\"text-211\" \/><\/span><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"text-99\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Weight\" value=\"\" type=\"text\" name=\"text-99\" \/><\/span>&nbsp;&nbsp;&nbsp;<span class=\"wpcf7-form-control-wrap\" data-name=\"text-535\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Height\" value=\"\" type=\"text\" name=\"text-535\" \/><\/span>\n<\/p>\n<p style=\"font-size:20px; font-weight: 700;\">B. Suspected Drug\/s\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"text-894\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Suspected Drugs Name\" value=\"\" type=\"text\" name=\"text-894\" \/><\/span>&nbsp;&nbsp;&nbsp;<span class=\"wpcf7-form-control-wrap\" data-name=\"text-564\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Suspected Manufacturing  &amp; Batch No.\" value=\"\" type=\"text\" name=\"text-564\" \/><\/span><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"text-733\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Start Date\" value=\"\" type=\"text\" name=\"text-733\" \/><\/span>&nbsp;&nbsp;&nbsp;<span class=\"wpcf7-form-control-wrap\" data-name=\"text-570\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Dose Route\" value=\"\" type=\"text\" name=\"text-570\" \/><\/span><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"text-66\"><input size=\"40\" maxlength=\"100\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"Purpose Of Use\" type=\"text\" name=\"text-66\" \/><\/span>\n<\/p>\n<p style=\"font-size:20px; font-weight: 700;\">C. Concomitant Drug\/s (Exclude Those Used To Treat Reaction)\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"text-441\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Concomitant Drugs Name\" value=\"\" type=\"text\" name=\"text-441\" \/><\/span>&nbsp;&nbsp;&nbsp;<span class=\"wpcf7-form-control-wrap\" data-name=\"text-282\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text\" aria-invalid=\"false\" placeholder=\"Concomitant Manufacturing  &amp; Batch No.\" value=\"\" type=\"text\" name=\"text-282\" \/><\/span><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"text-652\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Start Date\" value=\"\" type=\"text\" name=\"text-652\" \/><\/span>&nbsp;&nbsp;&nbsp;<span class=\"wpcf7-form-control-wrap\" data-name=\"text-537\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"End Date\" value=\"\" type=\"text\" name=\"text-537\" \/><\/span><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"text-182\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Dose Route\" value=\"\" type=\"text\" name=\"text-182\" \/><\/span>&nbsp;&nbsp;&nbsp;<span class=\"wpcf7-form-control-wrap\" data-name=\"text-84\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Purpose Of Use\" value=\"\" type=\"text\" name=\"text-84\" \/><\/span>\n<\/p>\n<p style=\"font-size:20px; font-weight: 700;\">D. Adverse Drug Reaction Description\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"text-12\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Adverse event including relevant test\/lab data &amp; Dates\" value=\"\" type=\"text\" name=\"text-12\" \/><\/span>&nbsp;&nbsp;&nbsp;<span class=\"wpcf7-form-control-wrap\" data-name=\"text-414\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text\" aria-invalid=\"false\" placeholder=\"Other relevant history, including pre-existing medical conditions;  (Diagnosis, allergies, pregnancy, hepatic, renal etc. \u2026)\" value=\"\" type=\"text\" name=\"text-414\" \/><\/span>\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"text-558\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Date when event started\" value=\"\" type=\"text\" name=\"text-558\" \/><\/span>&nbsp;&nbsp;&nbsp;<span class=\"wpcf7-form-control-wrap\" data-name=\"text-313\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Date when event end\" value=\"\" type=\"text\" name=\"text-313\" \/><\/span>\n<\/p>\n<p style=\"font-size:20px; font-weight: 700;\">E. Action Taken\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"radio-811\"><span class=\"wpcf7-form-control wpcf7-radio Action Taken\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"radio-811\" value=\"Drug discontinued\" \/><span class=\"wpcf7-list-item-label\">Drug discontinued<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-811\" value=\"Dose reduced\" \/><span class=\"wpcf7-list-item-label\">Dose reduced<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-811\" value=\"Dose increased\" \/><span class=\"wpcf7-list-item-label\">Dose increased<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-811\" value=\"Dose not changed\" \/><span class=\"wpcf7-list-item-label\">Dose not changed<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-811\" value=\"Unknown\" \/><span class=\"wpcf7-list-item-label\">Unknown<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"radio-811\" value=\"Not applicable\" \/><span class=\"wpcf7-list-item-label\">Not applicable<\/span><\/label><\/span><\/span><\/span>\n<\/p>\n<p style=\"font-size:20px; font-weight: 700;\">F. Outcome of ADR\n<\/p>\n<p style=\"font-size:16px;\">Patient*\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"radio-988\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"radio-988\" value=\"Recovered\" \/><span class=\"wpcf7-list-item-label\">Recovered<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-988\" value=\"Recovering\" \/><span class=\"wpcf7-list-item-label\">Recovering<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-988\" value=\"No improvement\" \/><span class=\"wpcf7-list-item-label\">No improvement<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-988\" value=\"Died\" \/><span class=\"wpcf7-list-item-label\">Died<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"radio-988\" value=\"Unknown\" \/><span class=\"wpcf7-list-item-label\">Unknown<\/span><\/label><\/span><\/span><\/span>\n<\/p>\n<p style=\"font-size:16px;\">Event subsided after stopping the suspected drug (Dechallenge)\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"radio-346\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"radio-346\" value=\"No\" \/><span class=\"wpcf7-list-item-label\">No<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-346\" value=\"Yes\" \/><span class=\"wpcf7-list-item-label\">Yes<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"radio-346\" value=\"Unknown\" \/><span class=\"wpcf7-list-item-label\">Unknown<\/span><\/label><\/span><\/span><\/span>\n<\/p>\n<p style=\"font-size:16px;\">Event reappeared after reintroducing to the suspected drug (Rechallenge)\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"radio-749\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"radio-749\" value=\"No\" \/><span class=\"wpcf7-list-item-label\">No<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-749\" value=\"Yes\" \/><span class=\"wpcf7-list-item-label\">Yes<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"radio-749\" value=\"Not applicable\" \/><span class=\"wpcf7-list-item-label\">Not applicable<\/span><\/label><\/span><\/span><\/span>\n<\/p>\n<p style=\"font-size:16px;\">Specific antagonist used\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"radio-619\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"radio-619\" value=\"No\" \/><span class=\"wpcf7-list-item-label\">No<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"radio-619\" value=\"Yes specify\" \/><span class=\"wpcf7-list-item-label\">Yes specify<\/span><\/label><\/span><\/span><\/span>\n<\/p>\n<p style=\"font-size:20px; font-weight: 700;\">G. Seriousness of ADR\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"radio-868\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"radio-868\" value=\"Patient died\" \/><span class=\"wpcf7-list-item-label\">Patient died<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-868\" value=\"Life threatening\" \/><span class=\"wpcf7-list-item-label\">Life threatening<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-868\" value=\"Hospitalization\" \/><span class=\"wpcf7-list-item-label\">Hospitalization<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-868\" value=\"Permanent disability\" \/><span class=\"wpcf7-list-item-label\">Permanent disability<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-868\" value=\"Congenital anomaly\" \/><span class=\"wpcf7-list-item-label\">Congenital anomaly<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-868\" value=\"Prolonged hospitalization more than 24 hr\" \/><span class=\"wpcf7-list-item-label\">Prolonged hospitalization more than 24 hr<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"radio-868\" value=\"Required intervention to prevent permanent impairment\/damage\" \/><span class=\"wpcf7-list-item-label\">Required intervention to prevent permanent impairment\/damage<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"radio-868\" value=\"None of the above (Not serious)\" \/><span class=\"wpcf7-list-item-label\">None of the above (Not serious)<\/span><\/label><\/span><\/span><\/span>\n<\/p>\n<p style=\"font-size:20px; font-weight: 700;\">H. Reporter Details\n<\/p>\n<p><span class=\"wpcf7-form-control-wrap\" data-name=\"text-521\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Reporter Name *\" value=\"\" type=\"text\" name=\"text-521\" \/><\/span>&nbsp;&nbsp;&nbsp;<span class=\"wpcf7-form-control-wrap\" data-name=\"text-287\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Reporter Address\" value=\"\" type=\"text\" name=\"text-287\" \/><\/span><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"text-361\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Reporting Date\" value=\"\" type=\"text\" name=\"text-361\" \/><\/span> &nbsp;&nbsp;&nbsp; <span class=\"wpcf7-form-control-wrap\" data-name=\"email-224\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"Email\" value=\"\" type=\"email\" name=\"email-224\" \/><\/span><br \/>\n<span class=\"wpcf7-form-control-wrap\" data-name=\"tel-0\"><input size=\"40\" maxlength=\"50\" class=\"wpcf7-form-control wpcf7-tel wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-tel\" aria-required=\"true\" aria-invalid=\"false\" placeholder=\"phone\" value=\"\" type=\"tel\" name=\"tel-0\" \/><\/span>\n<\/p>\n<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"SEND REPORT\" \/>\n<\/p><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n[\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row el_id=&#8221;who-we-are&#8221; el_class=&#8221;m-t-n-md p-t-md&#8221;][vc_column width=&#8221;2\/6&#8243;][vc_custom_heading text=&#8221;Adverse Drug Reaction (ADR)&#8221; font_container=&#8221;tag:h2|font_size:2em|text_align:left|line_height:1&#8243; use_theme_fonts=&#8221;yes&#8221; el_class=&#8221;mb-4&#8243;][vc_column_text]Is a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility[\/vc_column_text][vc_custom_heading text=&#8221;Serious adverse reaction; is an adverse reaction which : [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1268","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/unicare-pharma.com.sa\/index.php\/wp-json\/wp\/v2\/pages\/1268","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/unicare-pharma.com.sa\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/unicare-pharma.com.sa\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/unicare-pharma.com.sa\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/unicare-pharma.com.sa\/index.php\/wp-json\/wp\/v2\/comments?post=1268"}],"version-history":[{"count":9,"href":"https:\/\/unicare-pharma.com.sa\/index.php\/wp-json\/wp\/v2\/pages\/1268\/revisions"}],"predecessor-version":[{"id":1277,"href":"https:\/\/unicare-pharma.com.sa\/index.php\/wp-json\/wp\/v2\/pages\/1268\/revisions\/1277"}],"wp:attachment":[{"href":"https:\/\/unicare-pharma.com.sa\/index.php\/wp-json\/wp\/v2\/media?parent=1268"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}