Aster ibara post approvalsummit final

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Aster ibara post approvalsummit final

  1. 1. POST-APPROVAL Summit<br />11-12 May 2010<br />ASTER<br />Michael Ibara<br />
  2. 2. Disclaimer<br />Pfizer supports and funded ASTER and continues to invest in the concepts and goals involved in this work.<br />During this talk, any opinions, suggestions or crazy statements are entirely my own.<br />
  3. 3. 10:30:00<br />A Thursday in February, 2009<br />A doctor is working at an ambulatory clinic affiliated with Brigham and Women’s Hospital<br />They discontinue a patient’s drug due to an adverse event…<br />
  4. 4. Screen Shots<br />Partners Native LMR<br />
  5. 5. Screen shots #2<br />Partners Native LMR<br />
  6. 6. Screen shots #3<br />
  7. 7. Screen shots #4<br />
  8. 8. Screen shots #5<br />
  9. 9. Screen shots #6<br />
  10. 10. Screen shots #7<br />Partners Native LMR<br />
  11. 11. 10:30:00<br />10:31:00<br />The doctor goes back to seeing the patient<br />
  12. 12. 10:40:00<br />A MedWatch report* derived directly from the source document (EHR), validated by the doctor, is delivered to FDA<br />*The report is MedDRA coded and has an initial ‘serious/nonserious’ assessment<br />
  13. 13. ADE Spontaneous Triggered Electronic Reports<br />David Westfall Bates, MD, M.Sc.<br />Chief of the Division of General Internal Medicine at the Brigham and Women's Hospital; Professor of Medicine at Harvard Medical School and Professor of Health Policy and Management at the Harvard School of Public Health (Co-Director of the Program in Clinical Effectiveness)<br />Jeffrey A. Linder, MD, MPH, FACP - PI of *ASTER<br />Assistant Professor of Medicine, Harvard Medical School<br />Division of General Medicine and Primary Care, Brigham and Women's Hospital, Boston MA<br />
  14. 14. Physician<br />EHR<br />Ambulatory Clinics <br />MAH<br />ASTER at Brigham and Women’s<br />Service Provider<br />Patient<br />*<br />*<br />Regulator<br />Coding<br />Bus Rules<br />CDISC/IHE RFD<br />*AE Report<br /><ul><li> EHR pt data
  15. 15. Physician Assessment
  16. 16. Coding & Bus Rule Results
  17. 17. Electronic Wrapper</li></ul>*”Triggered” Adverse Event Reports<br />
  18. 18. *ASTER started Nov 2008<br />30 Ambulatory care physicians<br />Completing June 2009<br />> 200 Reports Sent to FDA<br />
  19. 19. Information in Reports<br /><ul><li> Approximately 20% of reported events were deemed ‘Serious’ defined as:
  20. 20. Matching regulatory serious outcome
  21. 21. Coded event matching an ‘always serious list’
  22. 22. 100% had height/weight, lab data</li></li></ul><li>Physician Reporting<br /><ul><li> 91% of participating physicians had submitted no ADE reports in the prior year
  23. 23. During the study, participants reported an average of approximately 5 reports in a 3 month time period
  24. 24. All participants reported at least 1 ADE</li></li></ul><li>"Overall ASTER was well-accepted by the participating physicians, who felt it was unobtrusive and who saw the public health potential.<br />“The clinicians, most of whom submitted no reports in the prior year - submitted over 200 reports in 3 months."<br />Jeffrey A. Linder, MD, MPH, FACP<br />Brigham and Women’s Hospital / Partners Healthcare<br />PI on ASTER Study<br />
  25. 25.
  26. 26. RESULTS <br />...Physician interaction – ”a blink (60 secs)”<br />...time for reviewing instructions - no instructions needed<br />...searching existing data sources - no searching required<br />...gathering and maintaining the data needed - transparent<br />...completing and reviewing the information - minimal interaction<br />
  27. 27. Traditional ASTER<br />Paper or separate site<br />36 minutes<br />Several days or more<br />0 reports per physician<br />1 page of information<br />At point of care<br />60 seconds<br />20 minutes (triaged)<br />5 reports per physician<br />7 pages of information<br />
  28. 28. Why was it so easy to improve on how we were doing things ?<br />
  29. 29. Specifically…<br />Solved the reporter’s (provider’s) problems<br />Solved the EHR owner’s problems<br />Made the final product palatable for the end-users (used appropriate standards for regulators, manufacturers)<br />Used digitized data to simplify the workflow across groups and create economies of scale<br />
  30. 30. "A design representation suitable to a world in which the scarce factor is information may be exactly the wrong one for a world in which the scarce factor is attention.”<br />Herbert Simon <br />The Sciences of the Artificial<br />p.144<br />
  31. 31. Gedankenexperiment<br />When 60% of healthcare data is digitized, what will postmarketing safety look like?<br />
  32. 32. Current post marketing safety reporting model in U.S. is built on vertical organizations having the resources to find, collect and process safety information<br />Manufacturers have been the de facto owners of safety information and responsible for it (focus of regulations) because they were the only organizations able to afford the transaction costs<br />Two developments allow for a dramatic lowering of the ‘transaction cost’ of finding, collecting and reporting safety information<br /><ul><li> Healthcare data is moving toward greater digitization
  33. 33. There are established and evolving standards for exchanging safety information</li></ul>Once transaction costs drop, new business models will be possible<br />The Hypothesis<br />
  34. 34. Hospitals<br />Lab Data<br />Rx Data<br />Large Medical<br />Practices<br />Health Information<br />Exchanges<br />Currently…stranded data<br />Regulator<br />Consumers<br />Doctors<br />Pharma replicating the same front-end<br />process across companies <br />Underutilized sources<br />
  35. 35. Hospitals<br />FDA<br />Pharma<br />Lab Data<br />Rx Data<br />Qualified<br />Researchers<br />Large Medical<br />Practices<br />Patient<br />Organizations<br />Health Information<br />Exchanges<br />Vision: A Public / Private PV Hub<br />Regulatory Functions<br />Technical Functions<br />Secure<br />Interface<br />Secure Portal<br />Safety Data<br />Patient Safety Org*<br />Doctors<br />Consumers<br />Consumers<br />Patients<br />*The Patient Safety Org. (PSO) is used here as an example of a public/private organization that can fulfill the requirements to serve as a pharmacovigilance hub<br />Physicians<br />
  36. 36. National Picture: Regionally-based Centers serve the country<br />Collect reports from and provide services to their region<br />Networked via NHIN / CONNECT<br />Maintain data model, standards that allow querying of combined data<br />
  37. 37. Global Picture: Common standards allow for data sharing and combined analyses<br />Participating centers can share data <br />Certain centers act as centers of excellence and provide guidance and analysis for other centers<br />Queries can be run across select data at participating centers greatly increasing power and hypothesis testing capabilities<br />
  38. 38. Value<br />Simple, iterative<br />Local rules<br />Multiple actors<br />Low threshold to join<br />Existing complexity is distributed<br />Data mapping<br />Triggers<br />Iterative<br />Potential to transcend traditional limitations<br />Denominators<br />Potential to form evidenced-based loop<br />Communications channel<br />Baseline => Actions => Change<br />ASTER scales in proportion to the amount of digitized healthcare data<br />EHRs<br />eRX<br />Registries<br />
  39. 39. Thank You<br />

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