Different Approaches to Spontaneous Reporting:  A New Business Model  How a collaboration between Partners Healthcare, CRI...
<ul><li>The spontaneous reporting system remains the primary source of information regarding potential adverse events asso...
How Will This Session Work? <ul><li>We want to leave discussion time at the end, so  </li></ul><ul><li>I’m going to say wh...
<ul><li>Mp3 file </li></ul><ul><li>Copyright </li></ul><ul><li>Ownership </li></ul><ul><li>Napster </li></ul>Cost of a  di...
 
 
<ul><li>This is just beginning to occur in safety </li></ul><ul><li>Digitized healthcare data and new technologies provide...
The ASTER Project
W A R N I N G <ul><li>This is not your typical pharma project… </li></ul><ul><li>Each organization owns their work at the ...
THEN WHY DO THIS? <ul><li>It’s finally possible to do it </li></ul><ul><ul><li>(‘we have the technology…’) </li></ul></ul>...
The Chance of a Lifetime <ul><li>Digital healthcare data is increasing, technology is evolving, the public is calling for ...
What Does It Take? <ul><li>It takes standards, technology, changes in regulations </li></ul><ul><li>It takes a systems app...
How Big Is The Problem? <ul><li>Patients </li></ul><ul><li>Providers </li></ul><ul><li>Hospitals </li></ul><ul><li>Regiona...
Spontaneous Reporting the problem
Problem to be solved: Inconvenience Constrains Reporting  <ul><li>Reporting adverse events interrupts the routine of provi...
Summary (references available upon request) <ul><li>Spontaneous reporting is built on a paper-based model and driven too m...
Public / Private Organization Computer-assisted Surveillance Provider / Patient Manufacturers <ul><li>Data collection inco...
 
 
 
<ul><li>Demonstrate a decreased burden of reporting  </li></ul><ul><li>Demonstrate viability of directly sourcing EMR data...
Implications / Questions <ul><li>What’s the regulatory status of the reported events? </li></ul><ul><li>What’s the regulat...
Who’s   Who <ul><li>Clinical Data Interchange Standards Consortium </li></ul><ul><ul><li>“ The mission of CDISC is to deve...
A Good Idea… <ul><li>When we came up with the ideas described here </li></ul><ul><li>We found that others were thinking of...
<ul><li>The ASTER Collaborators… </li></ul><ul><li>Partners Healthcare </li></ul><ul><li>CRIX, International </li></ul><ul...
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Ibara Michael Aster Ppt Show

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A presentation given on how to improve drug safety surveillance given at the Annual Drug Information Association Meeting in Boston

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  • Ibara Michael Aster Ppt Show

    1. 1. Different Approaches to Spontaneous Reporting: A New Business Model How a collaboration between Partners Healthcare, CRIX, Int’l., FDA, CDISC, Pfizer and others is trying to demonstrate that it’s possible to improve spontaneous reporting
    2. 2. <ul><li>The spontaneous reporting system remains the primary source of information regarding potential adverse events associated with pharmaceutical products. Improving the quality of the data received through this system while lowering the burden on the reporter would immediately benefit public safety. </li></ul><ul><li>The participants in this session will represent major users of the current system who are working together to test practical applications of standards and technology to improve data quality and facilitate use of the system. </li></ul>
    3. 3. How Will This Session Work? <ul><li>We want to leave discussion time at the end, so </li></ul><ul><li>I’m going to say what I have to say in 15 minutes </li></ul><ul><li>The other presenters will then have 20 minutes </li></ul><ul><li>15 minutes limits me to broad concepts (but I can talk all day about this) </li></ul><ul><li>So to explain things in 15 minutes I’ll start with something familiar… </li></ul>
    4. 4. <ul><li>Mp3 file </li></ul><ul><li>Copyright </li></ul><ul><li>Ownership </li></ul><ul><li>Napster </li></ul>Cost of a digital download of the same album on Amazon: Cost of Bruce Springsteen’s Live in Dublin Album CD on Amazon: Cost of recent Nine Inch Nails Album: $14.99 $12.99 $0
    5. 7. <ul><li>This is just beginning to occur in safety </li></ul><ul><li>Digitized healthcare data and new technologies provide us the chance to truly change how we do safety </li></ul><ul><li>It’s an open question as to what the new business model will look like </li></ul><ul><li>Here’s one idea for part of it… </li></ul>
    6. 8. The ASTER Project
    7. 9. W A R N I N G <ul><li>This is not your typical pharma project… </li></ul><ul><li>Each organization owns their work at the end </li></ul><ul><li>No organization is ‘working for’ another one </li></ul><ul><li>If this succeeds, it first benefits drug and device safety as a whole, i.e., public health </li></ul>
    8. 10. THEN WHY DO THIS? <ul><li>It’s finally possible to do it </li></ul><ul><ul><li>(‘we have the technology…’) </li></ul></ul><ul><li>It will truly improve public safety by fixing a clunky system (the SRS) </li></ul><ul><li>This is a rare opportunity in safety where means and motivation are lined up </li></ul>
    9. 11. The Chance of a Lifetime <ul><li>Digital healthcare data is increasing, technology is evolving, the public is calling for change, the government is breaking new ground </li></ul><ul><li>If we don’t act now to try and improve the situation, then shame on us </li></ul>
    10. 12. What Does It Take? <ul><li>It takes standards, technology, changes in regulations </li></ul><ul><li>It takes a systems approach – fix one thing, break another </li></ul><ul><li>It takes collaboration </li></ul><ul><li>It takes good will </li></ul><ul><li>It takes lots of talking </li></ul>
    11. 13. How Big Is The Problem? <ul><li>Patients </li></ul><ul><li>Providers </li></ul><ul><li>Hospitals </li></ul><ul><li>Regional Organizations </li></ul>Payers Point of Care Applications Data Collection and Storage Technologies Communications Technologies Pharmaceutical Companies FDA EMEA Other Regulators Worldwide
    12. 14. Spontaneous Reporting the problem
    13. 15. Problem to be solved: Inconvenience Constrains Reporting <ul><li>Reporting adverse events interrupts the routine of providing care and imposes a burden on providers – greatly decreasing the probability that events will be reported </li></ul><ul><li>Not part of normal routine </li></ul><ul><li>Not available at point of recognition </li></ul><ul><li>Duplicate data entry </li></ul><ul><li>High nuisance factor </li></ul>
    14. 16. Summary (references available upon request) <ul><li>Spontaneous reporting is built on a paper-based model and driven too much by regulations that focus us on process vs science </li></ul><ul><li>Physicians/HCP don’t report mainly because it is such a hassle with no value back to them </li></ul><ul><li>Digitize healthcare data </li></ul><ul><li>Transactions costs disappear </li></ul><ul><li>New business models appear </li></ul>
    15. 17. Public / Private Organization Computer-assisted Surveillance Provider / Patient Manufacturers <ul><li>Data collection incorporated at point of care </li></ul><ul><li>Very light footprint for EMR </li></ul><ul><li>Portable to other EMRs, applications </li></ul><ul><li>Can take advantage of further developments in automated recognition </li></ul><ul><li>Global solution </li></ul>15 *RFD = Retrieve For for Data Capture – an IHE/CDISC profile EMR Regulators <ul><li>Structured by safety elements requirements (E2B/HL7 ICSR) </li></ul><ul><li>Mediated through RFD, Server-side XForms </li></ul>
    16. 21. <ul><li>Demonstrate a decreased burden of reporting </li></ul><ul><li>Demonstrate viability of directly sourcing EMR data to create a postmarketing report </li></ul><ul><li>Demonstrate viability of using an information exchange to receive and distribute postmarketing reports </li></ul><ul><li>Test the mapping of ICH E2B and HL7 ICSR against Partners LMR </li></ul><ul><li>Investigate the definition of quality as it pertains to reports </li></ul>
    17. 22. Implications / Questions <ul><li>What’s the regulatory status of the reported events? </li></ul><ul><li>What’s the regulatory status of CRIX? </li></ul><ul><li>The current E2B fields are built on an original paper-based model of reporting </li></ul><ul><li>All signs point to an increase in the number of events received </li></ul><ul><li>We need to solve this at a systems level </li></ul>
    18. 23. Who’s Who <ul><li>Clinical Data Interchange Standards Consortium </li></ul><ul><ul><li>“ The mission of CDISC is to develop and support global, platform-independent data standards” </li></ul></ul><ul><li>Integrating the Healthcare Enterprise </li></ul><ul><ul><li>“… a multi-year initiative that creates the framework for passing vital health information seamlessly-from application to application…” </li></ul></ul><ul><li>Healthcare Information Management Systems Society </li></ul><ul><ul><li>“… is the healthcare industry's membership organization exclusively focused on providing global leadership for the optimal use of healthcare information technology (IT) and management systems for the betterment of healthcare.” </li></ul></ul><ul><li>Partners Healthcare / Brigham & Women’s Hospital </li></ul><ul><ul><li>“… an integrated health system founded by Brigham and Women's Hospital and Massachusetts General Hospital….also includes…specialty hospitals, community health centers, a physician network, other health-related entities.” </li></ul></ul><ul><li>CRIX International </li></ul><ul><ul><li>“… dedicated to providing a common infrastructure and suite of services that will accelerate and streamline the interaction between sponsors of new drug products…research institutions, academia, and health authorities…” </li></ul></ul><ul><li>FDA CDER / CDRH </li></ul>
    19. 24. A Good Idea… <ul><li>When we came up with the ideas described here </li></ul><ul><li>We found that others were thinking of very similar ideas </li></ul><ul><li>Close discussion and collaboration with Lilly </li></ul><ul><ul><li>(call Kraig Kinchen) </li></ul></ul>
    20. 25. <ul><li>The ASTER Collaborators… </li></ul><ul><li>Partners Healthcare </li></ul><ul><li>CRIX, International </li></ul><ul><li>FDA </li></ul><ul><li>(CDISC) </li></ul>

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