The FDA Sentinel program began back in 2008 and you an see we are here in 2014 and it takes time to accumulate and format the data from the donors.  This is good to see an update and the list of contributorimages that committed to add patient data to the surveillance system when it started.  You also see data efforts out there today resembling some of the same with data for sale too. 

Pharma and Health Insurance Companies Pairing Up, Humana’s Analytics Subsidiary and Lilly To Figure Out How to Save (Make) Money and Provide Better Patient Care–Selling Research Data That Competes With FDA sentinel Initiative

From the Website:

The Sentinel Initiative began in 2008 as a multi-year effort to create a national electronic system for monitoring the safety of FDA-regulated medical products.

The Initiative is the FDA’s response to the Food and Drug Administration Amendments Act (FDAAA) requirement that the FDA work with public, academic, and private entities to develop a system to obtain information from existing electronic health care data from multiple sources to assess the safety of approved medical products.

You can visit the link here to see who the collaborators are with supplying data and collaborating as a data partner.

So far there are records on 160 million patients and that’ growing pretty fast.  Some patients can be tracked for over 10 years and this is related to drugs and medical devices patients may have and it’s focus is safety and it helps with additional information needed not only in this area but provides additional background data for drugs and devices looking for approval. 

There are three categories of Mini-Sentinel methods development:

  • Statistical Methods Development

    Projects focus on determining how well existing statistical methods work for Mini-Sentinel activities and whether new statistical methods yield more accurate results.image

  • Identification of Health Outcomes

    Projects focus on determining which codes (such as ICD9 codes, procedure codes, etc.) in electronic medical record data and administrative claims-based data are the most valid and reliable indicators of the presence of particular medical conditions.

  • Validation of Health Outcomes

    Projects focus on checking codes derived from electronic medical records and administrative claims-based data against medical chart information to verify that the electronic codes validly and reliably identify individuals with particular medical conditions.

  • Every wonder where all that ICD coding information ends up…right here for one along with claim data.  This is pretty neat too with a page where the FDA has provided some Complimentary Data box makes it easy. 

    If you are consumer there’s also the FDA Medwatch tool to report injuries or deaths from devices or drugs to the agency.  BD

    FDA Creates New Mobile Cellphone App to Help Doctors And Consumers Report Deaths and Injuries From Medical Devices and Drugs to the Agency And They Won’t Sell Your Data Either

    The scale of the FDA postmarketing data gathering system was revealed in a report released this week summarizing the first three years of the operation. As of July 2012 the database included details of 160 million individuals, 3.5 billion medication dispensings and 3.8 billion unique medical encounters, Regulatory Focus reports. The figures surpass the goals set by Congress, which called for data from 100 million patients by the start of July 2012. Last year Mini-Sentinel received a 35% funding boost in recognition of its unexpectedly fast growth.

    Having such a large data set gives the FDA a new way to quickly detect, analyze and evaluate the risks posed by drugs. In presentations, Mini-Sentinel staffers have demonstrated how they can dig into the database to show hospital visits for acute myocardial infarction stratified by age and sex. At the end of December, the FDA revealed a practical application for the database when it requested feedback on a study protocol. The proposal outlined the use of Mini-Sentinel data to assess rates of bleeding and thromboembolic outcomes associated with use of Boehringer Ingelheim's blood thinner, Pradaxa.

     The FDA's Mini-Sentinel healthcare surveillance database is growing quickly - FierceBiotechIT


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