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From Big Data to Smart Data for Pharmacovigilance: The Role of Healthcare Databases and Other Emerging Sources

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  • Gianluca Trifirò

    (University of Messina
    Erasmus Medical Centre)

  • Janet Sultana

    (University of Messina
    Erasmus Medical Centre)

  • Andrew Bate

    (Pfizer
    New York University (NYU))

Abstract

In the last decade ‘big data’ has become a buzzword used in several industrial sectors, including but not limited to telephony, finance and healthcare. Despite its popularity, it is not always clear what big data refers to exactly. Big data has become a very popular topic in healthcare, where the term primarily refers to the vast and growing volumes of computerized medical information available in the form of electronic health records, administrative or health claims data, disease and drug monitoring registries and so on. This kind of data is generally collected routinely during administrative processes and clinical practice by different healthcare professionals: from doctors recording their patients’ medical history, drug prescriptions or medical claims to pharmacists registering dispensed prescriptions. For a long time, this data accumulated without its value being fully recognized and leveraged. Today big data has an important place in healthcare, including in pharmacovigilance. The expanding role of big data in pharmacovigilance includes signal detection, substantiation and validation of drug or vaccine safety signals, and increasingly new sources of information such as social media are also being considered. The aim of the present paper is to discuss the uses of big data for drug safety post-marketing assessment.

Suggested Citation

  • 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.
    • Handle: RePEc:spr:drugsa:v:41:y:2018:i:2:d:10.1007_s40264-017-0592-4
    DOI: 10.1007/s40264-017-0592-4
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    References listed on IDEAS

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    1. Carrie E. Pierce & Khaled Bouri & Carol Pamer & Scott Proestel & Harold W. Rodriguez & Hoa Le & Clark C. Freifeld & John S. Brownstein & Mark Walderhaug & I. Ralph Edwards & Nabarun Dasgupta, 2017. "Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts," Drug Safety, Springer, vol. 40(4), pages 317-331, April.
    2. Rebecca E. Chandler & Kristina Juhlin & Jonas Fransson & Ola Caster & I. Ralph Edwards & G. Niklas Norén, 2017. "Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase®," Drug Safety, Springer, vol. 40(1), pages 81-90, January.
    3. Yuan Luo & William K. Thompson & Timothy M. Herr & Zexian Zeng & Mark A. Berendsen & Siddhartha R. Jonnalagadda & Matthew B. Carson & Justin Starren, 2017. "Natural Language Processing for EHR-Based Pharmacovigilance: A Structured Review," Drug Safety, Springer, vol. 40(11), pages 1075-1089, November.
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    Cited by:

    1. Janet Sultana & Ugo Moretti & Antonio Addis & Pia Caduff & Annalisa Capuano & Agnes Kant & Joan-Ramon Laporte & Marie Lindquist & June Raine & Daniele Sartori & Gianluca Trifirò & Marco Tuccori & Maur, 2019. "Workshop on the Italian Pharmacovigilance System in the International Context: Critical Issues and Perspectives," Drug Safety, Springer, vol. 42(5), pages 683-687, May.
    2. Vassilis Koutkias, 2019. "From Data Silos to Standardized, Linked, and FAIR Data for Pharmacovigilance: Current Advances and Challenges with Observational Healthcare Data," Drug Safety, Springer, vol. 42(5), pages 583-586, May.
    3. 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.

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