The document discusses a study called ASTER that tested a new model for postmarketing adverse event reporting. Physicians using electronic health records were able to generate and submit MedWatch reports to the FDA when they discontinued a patient's drug due to an adverse event. Over 200 reports were submitted in 3 months from 30 physicians. Physicians found the process quick and easy to use directly in their workflow. The model shows potential for more efficient adverse event reporting that utilizes digitized healthcare data.

1. ASTER One Year Later
A 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
“Unfortunately, many health professionals do
not think to report adverse events that might
16 YEARS
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, 1993 Vol 269, No. 21

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

7. Screen shots #2

8. Screen shots #3

9. Screen shots #4

10. Screen shots #5

11. Screen shots #6

12. Screen shots #7

13. 10:31:00
10:30:00
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
Computer-assisted Surveillance • Data collection incorporated
at point of care
• Very light footprint for EMR
EHR • Portable to other EMRs,
applications
• Can take advantage of
Provider / Patient further developments in
automated recognition
• Global solution
• Structured by safety elements
requirements (E2B/HL7 ICSR)
• Mediated through RFD, Web
Forms
Manufacturers
Public / Private
Organization
Regulators 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. In f o r m a t io n in R e p o r t s
• 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. P h y s ic ia n R e p o r t in g
• 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. P h y s ic ia n A c c e p t a n c e
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. D is lik e s …
“Took a while for the screen
to pop up”
“Too many clicks, screen too
slow”
“Takes a little extra time, but
worth it”

25. L ik e s …
“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. “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, 1993 Vol 269, No. 21

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
“What information consumes is rather obvious: it
consumes the attention of its recipients. Hence a
wealth of information creates a poverty of
attention
attention, and a need to allocate that attention
efficiently among the overabundance of
information sources that might consume it."
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

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
the scarce
for a world in which
factor is attention.
The task is not to design information-
distributing systems but intelligent
information-filtering systems.“
Herbert Simon
The Sciences of the Artificial
p.144

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

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