Background
Haemophilia and related disorders are inherited conditions that result in patients experiencing excessive bleeding. Bleeding is primarily in the joints and can occur spontaneously or following trauma or surgery. Treatment is by replacement of the missing clotting factor with infused factor concentrate.
In the past, infections transmitted by contaminated concentrates resulted in many patients becoming infected with HIV and hepatitis C viruses. Although current concentrates are safer in terms of infections, continued close surveillance is required. The main adverse effect of clotting factor concentrate treatment now is the development of antibodies to the clotting factor (inhibitors).
Because haemophilia and other inherited bleeding disorders are rare illnesses and because adverse events related to their treatment are also rare events it is necessary to follow a large number of patients in order to precisely define the relative risk of developing these complications after treatment with the different products. This is what EUHASS has been designed to do by creating a prospective adverse event reporting system for Europe.
Aims
To monitor the safety of treatments for people with haemophilia and other inherited bleeding disorders in Europe.
To inform clinicians, regulators and other interested parties of the treatment patterns and adverse events reported for these patients in Europe.
To set up a publicly available database of all the Haemophilia centres in Europe with details of how they can be accessed by patients, and information on relevant patient, doctor, nurse and physiotherapist organisations in each country.
To set up a publicly available directory containing information and publications lists for all the clotting factor products used in Europe to treat haemophilia and other inherited bleeding disorders.
To set up a Rapid Alert System so that all professionals treating people with haemophilia and other inherited bleeding disorders can be notified immediately if a severe or unexpected adverse event has been reported from anywhere in Europe.
The ultimate aim of this project is to support improvements in patient safety for those with haemophilia and other inherited bleeding disorders by creating a European network for the monitoring and communication of health information and treatment safety data.
IT Development and Support by MDSAS