The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?
| Autor: | Trifirò, G, Gini, R, Barone-Adesi, F, Beghi, E, Cantarutti, A, Capuano, A, Carnovale, C, Clavenna, A, Dellagiovanna, M, Ferrajolo, C, Franchi, M, Ingrasciotta, Y, Kirchmayer, U, Lapi, F, Leone, R, Leoni, O, Lucenteforte, E, Moretti, U, Mugelli, A, Naldi, L, Poluzzi, E, Rafaniello, C, Rea, F, Sultana, J, Tettamanti, M, Traversa, G20, Vannacci, A, Mantovani, L, Corrao, G, Trifirò, Gianluca |
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| Přispěvatelé: | Trifiro G., Gini R., Barone-Adesi F., Beghi E., Cantarutti A., Capuano A., Carnovale C., Clavenna A., Dellagiovanna M., Ferrajolo C., Franchi M., Ingrasciotta Y., Kirchmayer U., Lapi F., Leone R., Leoni O., Lucenteforte E., Moretti U., Mugelli A., Naldi L., Poluzzi E., Rafaniello C., Rea F., Sultana J., Tettamanti M., Traversa G., Vannacci A., Mantovani L., Corrao G., Trifirò, Gianluca, Gini, Rosa, Barone-Adesi, Francesco, Beghi, Ettore, Cantarutti, Anna, Capuano, Annalisa, Carnovale, Carla, Clavenna, Antonio, Dellagiovanna, Mirosa, Ferrajolo, Carmen, Franchi, Matteo, Ingrasciotta, Ylenia, Kirchmayer, Ursula, Lapi, Francesco, Leone, Roberto, Leoni, Olivia, Lucenteforte, Ersilia, Moretti, Ugo, Mugelli, Alessandro, Naldi, Luigi, Poluzzi, Elisabetta, Rafaniello, Concita, Rea, Federico, Sultana, Janet, Tettamanti, Mauro, Traversa, Giuseppe, Vannacci, Alfredo, Mantovani, Lorenzo, Corrao, Giovanni, Trifirò, G, Gini, R, Barone-Adesi, F, Beghi, E, Cantarutti, A, Capuano, A, Carnovale, C, Clavenna, A, Dellagiovanna, M, Ferrajolo, C, Franchi, M, Ingrasciotta, Y, Kirchmayer, U, Lapi, F, Leone, R, Leoni, O, Lucenteforte, E, Moretti, U, Mugelli, A, Naldi, L, Poluzzi, E, Rafaniello, C, Rea, F, Sultana, J, Tettamanti, M, Traversa, G, Vannacci, A, Mantovani, L, Corrao, G |
| Rok vydání: | 2018 |
| Předmět: |
Drug
Value (ethics) Pharmacovigilance Drug Toxicity spontaneous reporting Databases Factual Drug-Related Side Effects and Adverse Reactions National Health Programs media_common.quotation_subject National Health Program MEDLINE spontaneous reporting Information Storage and Retrieval Disease Toxicology computer.software_genre 030226 pharmacology & pharmacy Pharmacovigilance 03 medical and health sciences Pharmacology Pharmacology (medical) 0302 clinical medicine Drug Utilization Review Drug Toxicity Health care Product Surveillance Postmarketing Medicine Electronic Health Records 030212 general & internal medicine media_common Database business.industry Health technology Italy Observational study Electronic Health Record business Drug-Related Side Effects and Adverse Reaction computer |
| Zdroj: | Drug safety. 42(3) |
| ISSN: | 1179-1942 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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