5.3.04 Adverse drug reactions

Purpose and goal

If adverse drug reactions are observed, they should be reported in the hospital as proposed by the German Medical Commission. Compliance with legal regulations. Passing on information on adverse drug reactions

Area of application

Guidelines for ADR reports in children

3 Description

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 http://www.akdae.de before. You can fill in the report forms on your computer and send them directly to the AkdÄ by e-mail or print them out and fill them in manually. You can send the manually completed report forms to the AkdÄ by fax or post. The address and fax number can be found in the header of the form.

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)

Documentation

ADRs can be reported in a data mask in the WEB (Arzneimittelkommission der Deutschen ärzteschaft) or on a PDF form to the BfArM. see annexes.

A copy of the notification should be added to the medical records.

Responsibilities

Physician who observed the drug effect. Personnel department: staffing plan

Notes and comments

7 Applicable documents

7.1 Literature, regulations

See Model professional code of conduct of the German medical profession

§ 6 Notification of adverse drug reactions

Doctors are obliged to notify the Drug Commission of the German Medical Association (expert committee of the German Medical Association) of any adverse drug reactions of which they become aware in the course of their medical treatment activities.

7.2 Terms

BfArM: Federal Institute for Drugs and Medical Devices AKdÄ: Drug Commission of the German Medical Association

Attachments

Guidelines for reporting ADR in children