Pharmacovigilance

As part of an agreement with the University of Pisa, a web platform designed to store several pharmacovigilance studies has been developed:

ALEXANDROS Study – Adverse reactions in oncology, monitoring drug toxicity and therapies for cancer patients, enrolled at the Careggi Hospital, Florence.

ANCESTRAL studies on adverse reactions in elderly patients under different critical conditions. Patients are enrolled at either the Pisa University Hospital (AOUP) Emergency Room, ìat the General Medicine outpatients of Florence and Pistoia Local Health Units (ASL), or at the AOUP Geriatrics Departments and Siena University Hospital (AOUS) Internal Medicine Departments

All studies primarily aim at monitoring drug toxicity and targeted therapies for patients suffering from different pathologies, having given their informed consent.

Our Research Department performed both the definition of the data collection protocol, and the design, development and release of the software platform that is hosted on-site.

The collected data feed a centralized database underlying the platform, accessible by different specialized user profiles, authenticated via Web access and with HTTPS security protocol.

The software application, developed with open source technologies (PHP framework and MySQL database), is based on different digital resources:

standard dictionaries such as MEDRA for disease diagnosis, and the ATC dictionary for drug therapies

specific pathology dictionaries such as TNM system for cancer staging

data structures designed to collect monitoring parameters such as diagnostic tests, emergency room examinations, drug-drug interaction data, criteria for the definition of adverse reactions, and interfacing with the Italian Medicines Agency (AIFA) in order to report archived adverse reactions

The platform is currently in use at the Careggi Hospital (https://epid-prod.ifc.cnr.it/yii/pharmacowikilance/) and the activity of data archiving is ongoing to allow for follow-up statistical analysis.