Adverse drug events (ADEs) are required by law to be reported, researched in clinical trials and included into the patient information accompanying medical devices and drugs for sale to the public.
However, it is estimated that healthcare professionals report only around 1 to 5% of adverse effects to the authorities. This means no up-to-date knowledge about adverse effects of drugs, which can cause substantial patient casualties and major costs for public health.
Tedious and time-consuming
The main causes of under-reporting, as identified by studies, are the tedious and time-consuming character of the reporting process, double data entry, together with a lack of awareness of the importance of reporting ADEs for patient safety.
The EU-funded SALUS project has developed a Reporting Tool to shortcut these difficulties: If the data needed to report the event is available in the Electronic Health Record of the patient, the tool will enable automatic filling of the form.
More information on the SALUS ICSR Reporting Tool.
Other tools developed by SALUS: A general overview of SALUS activities.
Call of the project: ICT FP7 - FP7-ICT-2011-7 (CP)
Start date: 01/02/2012, end date: 31/01/2015
Total Cost: 5.077.781 €, EU-Contribution: 3.325.966 €
Partners in TR, FR, SE, DE, BE, NL, IT, CH