Role of healthcare databases and registries for surveillance of orphan drugs in the real-world setting: the Italian case study

Author:

Crisafulli Salvatore1,Sultana Janet2,Ingrasciotta Ylenia1,Addis Antonio3,Cananzi Pasquale4,Cavagna Lorenzo5,Conter Valentino6,D’Angelo Gabriella78,Ferrajolo Carmen9,Mantovani Lorenzo10ORCID,Pastorello Maurizio11,Scondotto Salvatore12,Trifirò Gianluca1

Affiliation:

1. Unit of Clinical Pharmacology, A.O.U. Policlinico “G. Martino”, Messina, Italy

2. Department of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy

3. Department of Epidemiology, Lazio Regional Health Service, Roma, Italy

4. Health Department of Sicily, Sicilian Regional Centre of Pharmacovigilance, Palermo, Italy

5. Division of Rheumatology, University and IRCCS Policlinico S. Matteo Foundation, Pavia, Italy

6. Department of Pediatrics, University of Milano-Bicocca, Ospedale S Gerardo, Monza, Italy

7. Department of Clinical and Experimental Medicine, A.O.U. Policlinico “G. Martino”, Messina, Italy

8. Neonatal and Pediatric Intensive Care Unit, Department of Human Pathology in Adult and Developmental Age “Gaetano Barresi”, University of Messina, Messina, Italy

9. Department of Experimental Medicine, University of Campania “Vanvitelli”, and Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Naples, Italy

10. Research Centre on Public Health (CESP), University of Milan-Bicocca, Monza, Italy

11. Department of Pharmacy, Palermo Local Health Unit, Palermo, Italy

12. Epidemiologic Observatory of the Sicily Regional Health Service, Palermo, Italy

Publisher

Informa UK Limited

Subject

Pharmacology (medical),General Medicine

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