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

2018; Adis, Springer Healthcare; Volume: 42; Issue: 3 Linguagem: Inglês

10.1007/s40264-018-0732-5

1179-1942

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, Concetta Rafaniello, Federico Rea, Janet Sultana, Mauro Tettamanti, Giuseppe Traversa, Alfredo Vannacci, LG Mantovani, Giovanni Corrao,

Pharmacovigilance and Adverse Drug Reactions

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.