Federal Institute for Drugs and Medical Devices (BfArM) makes drug admin-istration monitoring database accessible online
Doctors, the scientific community and patients now have access to a public database, online since the end of March, showing them which drugs are the subject of administration monitoring. With the launch of this database, the Federal Institute for Drugs and Medical Devices (BfArM) has implemented the new regulations on transparency in drug administration monitoring as set out in the German Medicines Law (Arzneimittelgesetz – AMG) from August 2013. These regulations apply to existing monitoring activities on-going as at 31 December 2013 and to new monitoring starting from 13 August 2013. The database also includes post-authorisation safety studies (PASS) initiated as of 26 October 2012.
Information on the drugs monitored, the title, object, start and end of the monitoring project is accessible, as well as the monitoring plans and final reports submitted to BfArM.
Background and outlook
Drug administration monitoring is performed to obtain data on the administration of approved or registered drugs. These are administered not according to fixed test schedules but in the course of medical practice and under medical supervision and the results are then evaluated by pharmaceutical companies or independent university research groups.
Critics say that administration monitoring predominantly serves as a marketing tool for the pharmaceutical companies involved and is of little benefit to research as doctors are usually paid for their participation. The admissibility requirements of administration monitoring are also considerably less strict than those of clinical drug trials, particularly as approval by the competent authorities or healthcare bodies is not required. All that is required is for the responsible institutions to be notified of the monitoring project and certain parameters, such as venue, time and aim of the project, and to be provided with a monitoring plan and final report.
An online database listing suspected adverse drug reactions has already existed under the aegis of BfArM for two years. The implementation of this second endeavour to ensure transparency now aims to further boost patients’ confidence in drugs and the medical profession.
In view of both the detailed nature of the drug administration monitoring data now freely accessible and the resultant increased public visibility of individual projects, it remains to be seen whether the pharmaceutical industry will continue to pursue such activities with the same intensity, or whether these might decrease or be performed more and more outside Germany.
The drug administration monitoring database is accessible here.
Any questions? Please contact: Fabian Raddatz
Practice Group: Health Care