{"id":3629,"date":"2025-01-22T10:22:29","date_gmt":"2025-01-22T09:22:29","guid":{"rendered":"https:\/\/birm.com.ec\/pharmacovigilance\/"},"modified":"2025-03-25T13:30:47","modified_gmt":"2025-03-25T12:30:47","slug":"pharmacovigilance","status":"publish","type":"page","link":"https:\/\/birm.com.ec\/en\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"3629\" class=\"elementor elementor-3629 elementor-3528\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8f58e65 e-flex e-con-boxed e-con e-parent\" data-id=\"8f58e65\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-475382c e-con-full e-flex e-con e-child\" data-id=\"475382c\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-265689c elementor-widget elementor-widget-spacer\" data-id=\"265689c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a4e8a2e e-flex e-con-boxed e-con e-parent\" data-id=\"a4e8a2e\" data-element_type=\"container\" data-e-type=\"container\" id=\"queesbirm\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-0e7a0d1 e-con-full e-flex e-con e-child\" data-id=\"0e7a0d1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0069d1b elementor-widget elementor-widget-heading\" data-id=\"0069d1b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">PHARMACOVIGILANCE<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0c52ba3 elementor-widget elementor-widget-text-editor\" data-id=\"0c52ba3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Patients are at the center of everything we do at BIRM. We work to provide excellence in medicines. <b>Pharmacovigilance<\/b> is a system that monitors the safety of marketed medicines. Its objective is to detect, evaluate, understand and prevent adverse drug-related events.   <\/p>\n\n<h3>What are adverse effects?<\/h3>\n<p>These are undesirable and unintended responses to the use of a product. That is, a clinical episode that may manifest with the use of a drug, but does NOT necessarily have a causal relationship with this treatment. <\/p>\n\n<h3>Importance of Pharmacovigilance<\/h3>\n<p>Before a product is marketed, safety and efficacy evaluations are limited to our experiences in clinical studies, which are conducted under controlled conditions. These ideal conditions do not necessarily reflect the use of the product in actual clinical practice. In addition, there are rare adverse reactions that may not manifest themselves during studies. Therefore, it is essential that the company maintains a well-structured <b>Pharmacovigilance<\/b> system.   <\/p>\n\n<h3>Who can notify?<\/h3>\n<ul>\n  <li>Consumer<\/li>\n  <li>Treating physician<\/li>\n  <li>Nurse<\/li>\n  <li>Pharmacist<\/li>\n  <li>Biomedical<\/li>\n  <li>Physiotherapist<\/li>\n  <li>Internal and external customers<\/li>\n<\/ul>\n\n<h3>What is an adverse reaction?<\/h3>\n<p>According to the World Health Organization (WHO), an <b>adverse reaction<\/b> is any response to a drug that is harmful and unintended, and that occurs at doses normally used in humans for prophylaxis, diagnosis, treatment of disease or modification of physiological functions.<\/p>\n\n<h3>What to notify?<\/h3>\n<ul>\n  <li><b>Adverse event:<\/b> Any untoward medical occurrence that may be related to the use of a drug.<\/li>\n  <li><b>Adverse reaction:<\/b> Any harmful or undesirable response directly related to a drug or product.<\/li>\n  <li><b>Therapeutic ineffectiveness:<\/b> Absence or reduction of the expected response of a drug or product under the conditions prescribed or indicated in the package insert (lack of efficacy).<\/li>\n<\/ul>\n\n<h3>Medication errors:<\/h3>\n<p>Any preventable event that may cause or lead to the inappropriate use of a drug or product, or that may cause harm to a patient. Examples include: illegible handwriting on the prescription, similar drug or product names, distraction, misuse, among others. <\/p>\n\n<h3>How to notify?<\/h3>\n<p>BIRM guarantees the safety of its products and receives spontaneous reports of adverse events from consumers and health professionals. This information is confidential and of great importance to the company. <\/p>\n\n<p>Notification can be made through:<\/p>\n<ul>\n  <li>Phone call +593 2 992910 ext 2003<\/li>\n  <li>E-mail addressed to: <a href=\"mailto:farmacovigilancia@ecuabirm.com\">farmacovigilancia@ecuabirm.com<\/a><\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-ba74464 e-flex e-con-boxed e-con e-parent\" data-id=\"ba74464\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e823591 elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"e823591\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;Next&quot;,&quot;step_previous_label&quot;:&quot;Previous&quot;,&quot;button_width&quot;:&quot;100&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" name=\"Pharmacovigilance Form\" aria-label=\"Pharmacovigilance Form\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"3629\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"e823591\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"BIRM\u00ae\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-above\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-name elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-name\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tName and Surname\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[name]\" id=\"form-field-name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Name\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tE-mail\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"E-mail\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-field_cbf927b elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_cbf927b\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tAddress\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[field_cbf927b]\" id=\"form-field-field_cbf927b\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Address\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-tel elementor-field-group elementor-column elementor-field-group-field_5b88bac elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_5b88bac\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tPhone\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<input size=\"1\" type=\"tel\" name=\"form_fields[field_5b88bac]\" id=\"form-field-field_5b88bac\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Phone\" pattern=\"[0-9()#&amp;+*-=.]+\" title=\"Only numbers and phone characters (#, -, *, etc) are accepted.\">\n\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-select elementor-field-group elementor-column elementor-field-group-field_93d1fe0 elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_93d1fe0\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tProduct Involved\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field elementor-select-wrapper remove-before \">\n\t\t\t<div class=\"select-caret-down-wrapper\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-caret-down\"><\/i>\t\t\t<\/div>\n\t\t\t<select name=\"form_fields[field_93d1fe0]\" id=\"form-field-field_93d1fe0\" class=\"elementor-field-textual elementor-size-sm\" required=\"required\">\n\t\t\t\t\t\t\t\t\t<option value=\"BIRM CONCENTRATE CAPSULES\">BIRM CONCENTRATE CAPSULES<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"BIRM ORAL SOLUTION CONCENTRATE\">BIRM ORAL SOLUTION CONCENTRATE<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"BIRM PREVENTIVE ORAL SOLUTION\">BIRM PREVENTIVE ORAL SOLUTION<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"BIRM PREVENTIVE CAPSULES\">BIRM PREVENTIVE CAPSULES<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"BIRM KIDS\">BIRM KIDS<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"BIRM SPORT CAPSULES\">BIRM SPORT CAPSULES<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"HH HEALING HELPER CAPSULES\">HH HEALING HELPER CAPSULES<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"VIVA SHAMPOO\">VIVA SHAMPOO<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"VIVA CONDITIONER\">VIVA CONDITIONER<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"NACE CREAM\">NACE CREAM<\/option>\n\t\t\t\t\t\t\t<\/select>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-select elementor-field-group elementor-column elementor-field-group-field_f6c1b52 elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_f6c1b52\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tReport\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field elementor-select-wrapper remove-before \">\n\t\t\t<div class=\"select-caret-down-wrapper\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-caret-down\"><\/i>\t\t\t<\/div>\n\t\t\t<select name=\"form_fields[field_f6c1b52]\" id=\"form-field-field_f6c1b52\" class=\"elementor-field-textual elementor-size-sm\" required=\"required\">\n\t\t\t\t\t\t\t\t\t<option value=\"Healthcare Professional\">Healthcare Professional<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Consumer\">Consumer<\/option>\n\t\t\t\t\t\t\t<\/select>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tDescription of the adverse effect occurred\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Description of the adverse effect occurred\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-100 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Submit<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/form>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-1a8e8c2 e-flex e-con-boxed e-con e-parent\" data-id=\"1a8e8c2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-7e3e26d e-con-full e-flex e-con e-child\" data-id=\"7e3e26d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c6c6d65 elementor-widget elementor-widget-text-editor\" data-id=\"c6c6d65\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><b>Do you have any doubts?<\/b><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-131b9eb elementor-widget elementor-widget-text-editor\" data-id=\"131b9eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Don&#8217;t worry, we are here to answer all your questions.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7e24575 elementor-align-left elementor-widget elementor-widget-button\" data-id=\"7e24575\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/birm.com.ec\/en\/frequently-asked-questions\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">GO TO FAQ<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>PHARMACOVIGILANCE Patients are at the center of everything we do at BIRM. We work to provide excellence in medicines. Pharmacovigilance is a system that monitors the safety of marketed medicines. Its objective is to detect, evaluate, understand and prevent adverse drug-related events. What are adverse effects? These are undesirable and unintended responses to the use [&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-3629","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharmacovigilance | BIRM\u00ae Ecuador<\/title>\n<meta name=\"description\" content=\"Patients are at the center of everything at BIRM. 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