{"id":11052,"date":"2024-12-11T15:19:34","date_gmt":"2024-12-11T14:19:34","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-3-umgang-mit-risiken-und-chancen\/5-3-04-unerwuenschte-arzneimittelwirkungen\/"},"modified":"2025-02-04T13:38:18","modified_gmt":"2025-02-04T12:38:18","slug":"5-3-04-adverse-drug-reactions","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-3-umgang-mit-risiken-und-chancen\/5-3-04-unerwuenschte-arzneimittelwirkungen\/","title":{"rendered":"5.3.04 Adverse drug reactions"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">Purpose and goal<\/h2>\n\n\n\n<p>If adverse drug reactions are observed, they should be reported in the hospital as suggested by the German Medical Commission. Fulfilment of legal requirements. Passing on information on adverse drug reactions <\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Area of application<\/h2>\n\n\n\n<p>Guidelines for ADR reports in children <\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">3 Description<\/h2>\n\n\n\n<p>The forms are available as a PDF file or as an online form on the website of the Drug Commission of the German Medical Association&nbsp;<a href=\"http:\/\/www.akdae.de\/\" target=\"_blank\" rel=\"noreferrer noopener\">http:\/\/www.akdae.de<\/a>&nbsp;before. You can complete the report forms on your computer and send them directly to the Akd\u00c4 by e-mail or print them out and complete them manually. You can send the manually completed report forms to the Akd\u00c4 by fax or post. The address and fax number can be found in the header of the form.<\/p>\n\n\n\n<p>To complete the form on the computer, click with the mouse in the first field of the form and enter the relevant information. You can use the tab key to move within the document. Vaccination reactions must also be reported to the Paul-Ehrlich-Institut (report form Appendix 2)<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Documentation<\/h2>\n\n\n\n<p>ADRs can be reported in a data mask in the WEB (Arzneimittelkommission der Deutschen \u00e4rzteschaft) or on a PDF form to the BfArM. see annexes.<\/p>\n\n\n\n<p>A copy of the notification should be added to the medical records.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"zustaendigkeiten\">Responsibilities<\/h2>\n\n\n\n<p>Physician who has observed the drug effect. Personnel department: staffing plan <\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Notes and comments<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">7 Applicable documents<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur_vorschriften\">7.1 Literature, regulations<\/h4>\n\n\n\n<p>See&nbsp;<a href=\"http:\/\/www.bundesaerztekammer.de\/page.asp?his=1.100.1143#B41\" target=\"_blank\" rel=\"noreferrer noopener\">Model professional code of conduct of the German medical profession<\/a><\/p>\n\n\n\n<p><strong>\u00a7 Section 6 Notification of adverse drug reactions<\/strong><\/p>\n\n\n\n<p>Doctors are obliged to report any adverse drug reactions they become aware of in the course of their medical treatment to the Drug Commission of the German Medical Association (expert committee of the German Medical Association).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">7.2 Terms<\/h4>\n\n\n\n<p>BfArM: Federal Institute for Drugs and Medical Devices AKd\u00c4: Drug Commission of the German Medical Association <\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"anlagen\">Attachments<\/h3>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-2cf69eb3-a98e-4620-b357-51cfab86cb30\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.04_01_iq_formular_uawmeldung.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Adverse drug reaction report form<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.04_01_iq_formular_uawmeldung.pdf\" class=\"wp-block-file__button wp-element-button\" aria-describedby=\"wp-block-file--media-2cf69eb3-a98e-4620-b357-51cfab86cb30\" download>Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-0ff19a07-64c3-423e-97e3-927114147bf3\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.04_00_iq_uaw_impfrekationen.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Report form on vaccination reactions<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.04_00_iq_uaw_impfrekationen.pdf\" class=\"wp-block-file__button wp-element-button\" aria-describedby=\"wp-block-file--media-0ff19a07-64c3-423e-97e3-927114147bf3\" download>Download<\/a><\/div>\n\n\n\n<div class=\"wp-block-file\"><a id=\"wp-block-file--media-a7e68b87-7ae7-432d-b86e-445cbd1e42c5\" href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.04_01_iq_formular_uawmeldung-1.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Report form for BfArM<\/a><a href=\"https:\/\/gutehospitalpraxis.de\/wp-content\/uploads\/2024\/12\/5.3.04_01_iq_formular_uawmeldung-1.pdf\" class=\"wp-block-file__button wp-element-button\" aria-describedby=\"wp-block-file--media-a7e68b87-7ae7-432d-b86e-445cbd1e42c5\" download>Download<\/a><\/div>\n\n\n\n<p><a href=\"http:\/\/www.aerzteblatt.de\/v4\/archiv\/pdf.asp?id=55810\" target=\"_blank\" rel=\"noreferrer noopener\">Guidelines for reporting ADR in children<\/a><\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Zweck und Ziel Werden Nebenwirkungen von Arzneimitteln beobachtet, sollen sie im Krankenhaus so berichtet werden, wie von der Arzneimittelkommission der deutschen \u00c4rzteschaft vorgeschlagen. Erf\u00fcllung gesetzlicher Vorschriften. Weitergabe von Informationen zu unerw\u00fcnschten Arzneimittelwirkungen Anwendungsbereich Leitfaden f\u00fcr UAW-Berichte bei Kindern 3 Beschreibung Die Formbl\u00e4tter liegen als PDF-Datei oder als Online-Formular auf der Seite der Arzneimittelkommission der deutschen [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":11044,"menu_order":63,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11052","docs","type-docs","status-publish","hentry","no-post-thumbnail"],"acf":[],"author_avatar":"https:\/\/secure.gravatar.com\/avatar\/c6b2616140d9fcd6a1c5d6d2ebbf43422308c9322c032ef03f88ec3235855dcf?s=96&d=mm&r=g","author_name":"admin","_links":{"self":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11052","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/comments?post=11052"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11052\/revisions"}],"predecessor-version":[{"id":15116,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11052\/revisions\/15116"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11044"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=11052"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=11052"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=11052"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}