Post on 11-Jun-2015
POST-APPROVAL Summit11-12 May 2010
ASTERMichael Ibara
Disclaimer
Pfizer supports and funded ASTER and continues to invest in the concepts and goals involved in this work.
During this talk, any opinions, suggestions or crazy statements are entirely my own.
10:30:00
A Thursday in February, 2009A doctor is working at an ambulatory clinic affiliated with Brigham and Women’s HospitalThey discontinue a patient’s drug due to an adverse event…
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10:30:00
The doctor goes back to seeing the patient
10:31:00
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
ADE Spontaneous Triggered Electronic Reports
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 *ASTERAssistant Professor of Medicine, Harvard Medical SchoolDivision of General Medicine and Primary Care, Brigham and Women's Hospital, Boston MA
ASTER at Brigham and Women’s
Patient Physician
EHR
Ambulatory Clinics
Service Provider
Regulator
MAH
*AE Report- EHR pt data- Physician Assessment- Coding & Bus Rule Results- Electronic Wrapper
*CodingBus Rules
*
*”Triggered” Adverse Event Reports
CDISC/IHE RFD
*ASTER started Nov 200830 Ambulatory care physicians
Completing June 2009> 200 Reports Sent to FDA
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
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
"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, FACPBrigham and Women’s Hospital / Partners Healthcare
PI on ASTER Study
RESULTS
...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
• Paper or separate site
• 36 minutes
• Several days or more
• 0 reports per physician
• 1 page of information
• At point of care
• 60 seconds
• 20 minutes (triaged)
• 5 reports per physician
• 7 pages of information
Traditional ASTER
Why was it so easy to improve on how we were doing things ?
Specifically…
• Solved the reporter’s (provider’s) problems• Solved the EHR owner’s problems• Made the final product palatable for the end-
users (used appropriate standards for regulators, manufacturers)
• Used digitized data to simplify the workflow across groups and create economies of scale
"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
Gedankenexperiment
When 60% of healthcare data is digitized, what will postmarketing safety look like?
Current post marketing safety reporting model in U.S. is built on vertical organizations having the resources to find, collect and process safety information
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
Two developments allow for a dramatic lowering of the ‘transaction cost’ of finding, collecting and reporting safety information- Healthcare data is moving toward greater
digitization- There are established and evolving standards
for exchanging safety information
Once transaction costs drop, new business models will be possible
The Hypothesis
Regulator
Hospitals
Health InformationExchanges
Large MedicalPractices
Currently…stranded data
Lab Data
Rx Data
Underutilized sourcesPharma replicating the same front-endprocess across companies
Consumers
Doctors
Secure Portal
FDA
Pharma
QualifiedResearchers
SecureInterface
Hospitals
Health InformationExchanges
Large MedicalPractices
PatientOrganizations
Vision: A Public / Private PV Hub
Lab Data
Rx DataPatient Safety
Org*
Regulatory Functions
Technical Functions
Safety Data
Physicians
Consumers Doctors
ConsumersPatients*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
National Picture: Regionally-based Centers serve the country
• Collect reports from and provide services to their region
• Networked via NHIN / CONNECT• Maintain data model, standards that
allow querying of combined data
Global Picture: Common standards allow for data sharing and combined analyses
• Participating centers can share data • Certain centers act as centers of excellence and provide guidance and analysis for
other centers• Queries can be run across select data at participating centers greatly increasing
power and hypothesis testing capabilities
Value• Simple, iterative
– Local rules– Multiple actors– Low threshold to join
• Existing complexity is distributed– Data mapping– Triggers– Iterative
• Potential to transcend traditional limitations– Denominators
• Potential to form evidenced-based loop– Communications channel– Baseline => Actions => Change
• ASTER scales in proportion to the amount of digitized healthcare data– EHRs– eRX– Registries
Thank You