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

Author

Listed:
  • Gianluca Trifirò

    (University of Messina
    Policlinico Universitario G. Martino)

  • 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)

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.

Suggested Citation

  • Gianluca Trifirò & Rosa Gini & Francesco Barone-Adesi & Ettore Beghi & Anna Cantarutti & Annalisa Capuano & Carla Carnovale & Antonio Clavenna & Mirosa Dellagiovanna & Carmen Ferrajolo & Matteo Franch, 2019. "The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?," Drug Safety, Springer, vol. 42(3), pages 347-363, March.
  • Handle: RePEc:spr:drugsa:v:42:y:2019:i:3:d:10.1007_s40264-018-0732-5
    DOI: 10.1007/s40264-018-0732-5
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    References listed on IDEAS

    as
    1. Gianluca Trifirò & Janet Sultana & Andrew Bate, 2018. "From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources," Drug Safety, Springer, vol. 41(2), pages 143-149, February.
    2. Carmen Ferrajolo & Katia M. C. Verhamme & Gianluca Trifirò & Geert W. ‘t Jong & Gino Picelli & Carlo Giaquinto & Giampiero Mazzaglia & Bruno H. Stricker & Francesco Rossi & Annalisa Capuano & Miriam C, 2017. "Antibiotic-Induced Liver Injury in Paediatric Outpatients: A Case-Control Study in Primary Care Databases," Drug Safety, Springer, vol. 40(4), pages 305-315, April.
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    Cited by:

    1. Manuela Casula & Federica Galimberti & Marica Iommi & Elena Olmastroni & Simona Rosa & Mattia Altini & Alberico L. Catapano & Elena Tragni & Elisabetta Poluzzi, 2022. "Impact of the COVID-19 Pandemic on the Therapeutic Continuity among Outpatients with Chronic Cardiovascular Therapies," IJERPH, MDPI, vol. 19(19), pages 1-11, September.
    2. Ippazio Cosimo Antonazzo & Carla Fornari & Sandy Maumus-Robert & Eleonora Cei & Olga Paoletti & Sara Conti & Paolo Angelo Cortesi & Lorenzo Giovanni Mantovani & Rosa Gini & Giampiero Mazzaglia, 2021. "Impact of COVID-19 Lockdown, during the Two Waves, on Drug Use and Emergency Department Access in People with Epilepsy: An Interrupted Time-Series Analysis," IJERPH, MDPI, vol. 18(24), pages 1-10, December.
    3. Janet Sultana & Francesco Trotta & Antonio Addis & Jeffrey S. Brown & Miguel Gil & Francesca Menniti-Ippolito & Federica Milozzi & Samy Suissa & Gianluca Trifirò, 2020. "Healthcare Database Networks for Drug Regulatory Policies: International Workshop on the Canadian, US and Spanish Experience and Future Steps for Italy," Drug Safety, Springer, vol. 43(1), pages 1-5, January.

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