The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?

Gianluca Trifirò (), Rosa Gini, Francesco Barone-Adesi, Ettore Beghi, Anna Cantarutti, Annalisa Capuano, Carla Carnovale, Antonio Clavenna, Mirosa Dellagiovanna, Carmen Ferrajolo, Matteo Franchi, Ylenia Ingrasciotta, Ursula Kirchmayer, Francesco Lapi, Roberto Leone, Olivia Leoni, Ersilia Lucenteforte, Ugo Moretti, Alessandro Mugelli, Luigi Naldi, Elisabetta Poluzzi, Concita Rafaniello, Federico Rea, Janet Sultana, Mauro Tettamanti, Giuseppe Traversa, Alfredo Vannacci, Lorenzo Mantovani and Giovanni Corrao
Additional contact information
Gianluca Trifirò: University of Messina
Rosa Gini: Agenzia Regionale di Sanità della Toscana
Francesco Barone-Adesi: University of Eastern Piedmont
Ettore Beghi: IRCCS-Mario Negri Pharmacology Research Institute
Anna Cantarutti: University of Milano-Bicocca
Annalisa Capuano: Second University of Naples
Carla Carnovale: University of Milan
Antonio Clavenna: IRCCS, Mario Negri Pharmacology Research Institute
Mirosa Dellagiovanna: Regional Centre for Pharmacovigilance, Lombardy Region
Carmen Ferrajolo: Second University of Naples
Matteo Franchi: University of Milano-Bicocca
Ylenia Ingrasciotta: University of Messina
Ursula Kirchmayer: Lazio Regional Health Service
Francesco Lapi: Italian College of General Practitioners and Primary Care
Roberto Leone: University of Verona
Olivia Leoni: Regional Centre for Pharmacovigilance, Lombardy Region
Ersilia Lucenteforte: University of Pisa
Ugo Moretti: University of Verona
Alessandro Mugelli: University of Florence
Luigi Naldi: Centro Studi Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED)
Elisabetta Poluzzi: University of Bologna
Concita Rafaniello: Second University of Naples
Federico Rea: University of Milano-Bicocca
Janet Sultana: University of Messina
Mauro Tettamanti: Mario Negri Pharmacology Research Institute
Giuseppe Traversa: National Centre for Epidemiology, National Institute of Health
Alfredo Vannacci: University of Florence
Lorenzo Mantovani: University of Milan-Bicocca
Giovanni Corrao: University of Milano-Bicocca

Drug Safety, 2019, vol. 42, issue 3, No 3, 347-363

Abstract: Abstract Enormous progress has been made globally in the use of evidence derived from patients’ clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world data can be collected in various types of electronic sources, such as electronic health records, claims databases and drug or disease registries. These data sources vary in nature from country to country, according to national healthcare system structures and national policies. In Italy, a growing number of healthcare databases have been used to evaluate post-marketing drug utilisation and safety in the last two decades. The aim of this narrative review is to describe the available Italian sources of real-world data and their contribution to generating post-marketing evidence on drug use and safety. We also discuss the strengths and limitations of the most commonly used Italian healthcare databases in addressing various research questions concerning drug utilisation, comparative effectiveness and safety studies, as well as health technology assessment and other areas.

Date: 2019
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DOI: 10.1007/s40264-018-0732-5

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