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    possible database models for the FDA Sentinel Initiative

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    I read the following material below:

    - Sentinel Initiative.
    - Harvard Medical School's presentation on Defining and Evaluating Possible Database Models to Implement the FDA Sentinel Initiative.

    I now need to summarize possible database models for the FDA Sentinel Initiative and conclude with some recommendations. I would like guidance on completing this assignment; attached is the materials I had to read.



    © BrainMass Inc. brainmass.com October 10, 2019, 1:36 am ad1c9bdddf


    Solution Preview

    Purpose of the Sentinel Initiative

    The Sentinel Initiative is a program proposed by the U.S. FDA, for surveillance,
    monitoring, research and tracking of prescription drugs, via use of electronic data. In order to
    collect information that is useful to the agency, a database selected for the Sentinel Initiative
    should be able to provide many different data sets, such as circumstances surrounding the
    prescribing of drugs, patient outcomes and patient demographic information. Though somewhat
    limited, the initial recommendation of Dr. Jeffrey Brown (2010), of the Harvard Medical School,
    is to "initially focus on health insurer administrative and claims databases covering defined
    populations." While this method of data collection may be somewhat limited, it can still provide
    the information or data the FDA needs to research a wide array of issues surrounding the
    prescribing of drugs to patients.

    Accessing electronic medical records of patients might also be useful in contributing to
    the data obtained by insurers. However, the subgroup of patients with electronic medical records
    throughout the United States may be very limited. When combined with insurer databases, it
    may limit the amount of data collected even further, as not all patients with electronic medical
    records will be insured or will bill insurance for prescription medication. In addition, linking
    various applications used in different health care settings, to create and maintain electronic
    medical records, may create challenges in migrating ...

    Solution Summary

    Ideas are used to summarize possible database models for the FDA Sentinel Initiative.