The Angelo Bianchi Bonomi Haemophilia and Thrombosis Centre, under the direction of Prof Flora Peyvandi, developed an interactive online registry, accessible to doctors and patients through a free smartphone app and web portal. Called mAPPHemo, the application allows for data collection on post-marketing surveillance of new haemophilia drugs.
This initiative follows recent recommendations by experts of the ISTH/SSC Subcommittee on Factor VIII, Factor IX and Rare Coagulation Disorders and aims to comply with and facilitate the implementation of the European regulations and directives on pharmacovigilance (Directives 2010/84/EU and 2012/26/EU).
The mAPPHemo system allows pooling of datasets from different haemophilia treatment centres in order to detect low-frequency adverse effects and eventually link the information to other international databases. This would also make it possible to detect new, unlabelled adverse events and address long-term safety issues of novel products for the entire patient base or for specific subgroups of interest.
The project has the goal of strengthening the pharmacovigilance of new haemophilia products that have recently received or will soon receive market authorisation, and to increase the participation of patients and health professionals in systems reporting adverse reactions to the competent authorities. This way, regulators will have access to real-life data and will be able to identify any unexpected increases in immunogenicity or unexpected or unknown side effects of a newly licensed product.
Interested in learning more about the project and how to participate? You can contact Dr. Roberta Palla (firstname.lastname@example.org).