IT APPLICATION FOR POST MARKETING DRUG REGISTRIES

Author(s)

De Rosa M;Covezzoli A;Bosio MA*, Ortali M CINECA Interuniversity Consortium, Casalecchio di Reno, Italy

OBJECTIVES: Establishing an active postmarketing safety surveillance and analysis system, used by health professionals, regulatory bodies and sponsors.  METHODS: The solution consists in making available to the entire community a set of online tools aimed to the data collection and analysis on innovative drugs. The introduction of online integrated environments ensures the appropriate use of drugs, help to monitor drug consumption and related costs and improves the real-time reporting of suspected adverse drug events. The surveillance system collects patients data in a common IT infrastructure within the same network. For 24 antineoplastic drugs the system provides also automatic procedures to manage the ‘risk sharing’ & ‘payment by result’ approach, that foresees partial or  total refund of the cost sustained by the hospital pharmacy for the drug in case  of progressive disease or unacceptable toxicity. RESULTS: This presentation will illustrate the Cineca methodological IT approach used also by the Italian National Medicines Agency. The system has been used for 70 innovative drugs from eleven different drugs categories: antineoplastic, antidiabetics, neurological, dermatological, antiasmatics, ophtalmologic, antireumatics and others. More than 500.000 patients were registered by more than 900 health structures in a timeframe of seven years. CONCLUSIONS: The introduction of an online integrated environments ensures a more appropriate drug usage, help to monitor drug consumption and related costs and improves the real-time reporting of suspected adverse drug events.

Conference/Value in Health Info

2013-09, ISPOR Latin America 2013, Buenos Aires, Argentina

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PHP51

Topic

Study Approaches

Topic Subcategory

Registries

Disease

Multiple Diseases

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