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