ASTER One Year Later A New Business Model for Postmarketing Reporting

1. ASTER One Year LaterA New Business Model for Postmarketing Reporting

2. Session Participants • Michael Ibara (Pfizer) • Setting the stage • ASTER • Landen Bain (CDISC Liaison to Healthcare) • Experiences in ASTER • Reflections on role of not for profits • Atif Zafar, MD (Associate Professor of Medicine, Indiana University / Regenstrief Institute Inc.) • Reporting events and patient outcomes related to therapy • Lise Stevens (Data Standards Project Manager, FDA Office of Critical Path Programs) • FDA’s work • Results

3. 1993 to 2009 16 YEARS “Unfortunately, many health professionals do not think to report adverse events that might be associated with medications or devices to the Food and Drug Administration (FDA) or to the manufacturer. That needs to change...” Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems David A. Kessler, MD, for the Working Group JAMA, June 2, Vol 269, No. 21 1993

5. 10:30:00 In the greater metro Boston area, a doctor affiliated with Brigham and Women’s Hospital or Mass General Hospital discontinues a patient’s drug due to an adverse event. If the doctor is participating in a certain effort, here’s what will happen…

6. Screen Shots Partners Native LMR

7. Screen shots #2 Partners Native LMR

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12. Screen shots #7 Partners Native LMR

13. 10:30:00 10:31:00 The doctor goes back to seeing the patient

14. 10:40:00 A MedWatch report* derived directly from the source document (EHR), validated by the doctor, is delivered to FDA *The report is MedDRA coded and has an initial ‘serious/nonserious’ assessment

15. Improving The Reporting of Adverse Events and Making Spontaneous Reporting Work

16. The ASTER Collaboration… Partners Healthcare CDISC CRIX / CERNER FDA Pfizer

17. Scalable Model for “Triggered” Reporting EHR • Structured by safety elements requirements (E2B/HL7 ICSR) • Mediated through RFD, Web Forms Regulators Computer-assisted Surveillance • Data collection incorporated at point of care • Very light footprint for EMR • Portable to other EMRs, applications • Can take advantage of further developments in automated recognition • Global solution Provider / Patient Manufacturers Public / Private Organization 15

18. HOW DID IT GO?

19. *ASTER started Nov 2008 30 Ambulatory care physicians Completing June 2009 > 200 Reports Sent to FDA David Westfall Bates, MD, M.Sc. 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) Jeffrey A. Linder, MD, MPH, FACP - PI of *ASTER Assistant Professor of Medicine, Harvard Medical School Division of General Medicine and Primary Care, Brigham and Women's Hospital, Boston MA

20. RESULTS TO DATE ...Physician interaction – ”a blink (60 secs)” ...time for reviewing instructions - no instructions needed ...searching existing data sources - no searching required ...gathering and maintaining the data needed - transparent ...completing and reviewing the information - minimal interaction

21. Information in Reports • Approximately 20% of reported events were deemed ‘Serious’ defined as: • Matching regulatory serious outcome • Coded event matching an ‘always serious list’ • 100% had height/weight, lab data

22. Physician Reporting • 91% of participating physicians had submitted no ADE reports in the prior year • During the study, participants reported an average of approximately 5 reports in a 3 month time period • All participants reported at least 1 ADE

23. Physician Acceptance • What could make it better? • Majority would like feedback from FDA • e.g., Actions taken on the report • e.g., Acknowledgement of report • Vast majority would like to be able to view national data of similar reports • 87% thought ASTER would improve their ability to accurately report drug risks “a lot”

24. Dislikes… “Took a while for the screen to pop up” “Too many clicks, screen too slow” “Takes a little extra time, but worth it”

25. Likes… “Easy, pops right up - Nothing to do later, can do it right on the spot.” “very quick, automatic load” “help to pt safety”

26. "Overall ASTER was well-accepted by the participating physicians, who felt it was unobtrusive and who saw the public health potential. “The clinicians, most of whom submitted no reports in the prior year - submitted over 200 reports in 3 months." Jeffrey A. Linder, MD, MPH, FACP Brigham and Women’s Hospital / Partners Healthcare PI on ASTER Study

27. Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems David A. Kessler, MD, for the Working Group JAMA, June 2, Vol 269, No. 21 1993 “Unfortunately, many health professionals do not think to report adverse events that might be associated with medications or devices to the Food and Drug Administration (FDA) or to the manufacturer. That needs to change...”

29. Herbert Simon Richard King Mellon University Professor of Computer Science and Psychology at Carnegie Mellon University (b. Milwaukee 1916 - d. Pittsburgh 2001) 52-year career in artificial intelligence, psychology, administration and economics. Nobel Prize Economics 1975: Won A.M. Turing Award for his work in computer science 1978: Received the Alfred Nobel Memorial Prize in Economic Sciences 1986: National Medal of Science 1993: American Psychological Association Award for Outstanding Lifetime Contributions to Psychology 1994: One of only 14 foreign scientists ever to be inducted into the Chinese Academy of Sciences 1995: Two prominent awards - International Joint Conferences on Artificial Intelligence (the Award for Research Excellence) and the American Society of Public Administration (the Dwight Waldo Award) 1996: Inducted into the Automation Hall of Fame because of his pioneering work in the field of artificial intelligence Received major national awards from the Association for Computing Machinery, the American Political Science Association, the Academy of Management, the Operations Research Society and the Institute of Management Science, among others. Books include Administrative Behavior; Human Problem Solving, jointly with Allen Newell; The Sciences of the Artificial; Scientific Discovery, with Pat Langley, Gary Bradshaw, and Jan Zytkow; Models of Bounded Rationality; Models of Thought; Models of Discovery; and his autobiography, Models of My Life.

30. “What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention, and a need to allocate that attention efficiently among the overabundance of information sources that might consume it." "What information consumes is rather obvious: it consumes the attention of its recipients. Hence a wealth of information creates a poverty of attention Simon, H. A. (1971), "Designing Organizations for an Information-Rich World", written at Baltimore, MD, in Martin Greenberger, Computers, Communication, and the Public Interest, The Johns Hopkins Press, ISBN 0-8018-1135-X "What information consumes is rather obvious: it consumes the attention of its recipients.

31. "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.” Herbert Simon The Sciences of the Artificial p.144

32. "A design representation suitable to a world in which the scarce factor is information may be exactly the wrong one for a world in whichthe scarce factor is attention. Herbert Simon The Sciences of the Artificial p.144 The task is not to design information-distributing systems but intelligent information-filtering systems.“

33. We need business models that will take advantage of digitized healthcare data We’ve electronified our old business model

34. Scalable Model for “Triggered” Reporting EHR Regulators Computer-assisted Surveillance Provider / Patient Manufacturers Public / Private Organization 15

35. What does ASTER solve? Problems for… The reporter The EHR owner The Regulator* *and manufacturer

36. Does this matter… ?

37. Imagine… Collecting all drug discontinuations due to AEs… Interfacing seamlessly with any clinical system using ‘triggers’ to recognize AEs… Having as much safety data from source docs as we do claims data… Having a denominator from each reporting institution…

38. This is not your fathers spontaneous reporting…

39. By utilizing digitized healthcare data and new business models we can develop, in the near future, a new type of ‘triggered reporting’ system, which is pervasive, efficient, delivers high quality information, and improves patient safety.

40. Lessons…?