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possible database models for the FDA Sentinel Initiative

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Hi.

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.

http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm

Thanks!

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Solution Summary

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

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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 ...

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  • BSc, DeVry University
  • MPH, Walden University
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