Introduction for Health Authorities

The Notify Library of adverse events and reactions

Health authorities have particular responsibilities in relation to safety and quality of organs, tissues, cells and blood used in transplantation, transfusion and in assisted reproduction. Serious adverse outcomes should be reported at a regional and/or national level to allow safety improvements on the basis of consolidated data. Investigations of adverse reactions and events should be followed and approved by health authorities to ensure that causes are appropriately identified and appropriate corrective and preventive actions taken.

The Notify Library is designed to be a useful tool for health authorities receiving reports of adverse outcomes related to transfusion, transplantation and assisted reproduction. You can explore previous experience globally to understand the possible causes and the approaches that have been taken to investigation. The library aims to be exhaustive, including types of reaction or event that might have didactic value or assist in the estimation of risk. It includes articles published in scientific and medical literature and cases reported to vigilance systems managed by international professional societies and by Health Authorities.

It should be noted that this tool is not a real time reporting system and will not replace national and regional vigilance reporting programmes in any way. Rather, it is a historical library of analysed incidents that is provided as a didactic tool for supporting adverse incident investigations and for improving practice generally. It will improve over time, as reliable quantitative data on adverse reactions and events becomes more available.

Health authorities are invited to collaborate in this initiative by sharing information on cases reported to them and documented in their records that might add didactic value to the library. A user guide for Competent Authorities on how to select and prepare SARE cases of didactic value for insertion in the Notify Library has been one of the outputs of a Work Package dedicated to NOTIFY during VISTART (Vigilance and Inspection for the Safety pf Transfusion, Assisted Reproduction and Transplantation) Joint Action, an European Union co-funded Joint Action led by the Italian National Transplant and Blood Centres (GA/676969, 2015-2018)

Competent Authorities willing to contribute with cases captured by their national biovigilance systems can sign the Statement of Support, fill in the template record below and send everything to notifylibrary@iss.it 

To search the Notify Library click here

AttachmentSize
PDF icon Statement of support201.33 KB
File template record15.76 KB