china annual drug information association meeting
TRANSCRIPT
Utilizing Digital Healthcare Data to Create a New Business Model in Drug Safety
Michael A. Ibara
Pfizer, Inc.
TRACK 5Capability & Capacity Building,
Clinical DevelopmentModernize Clinical Development
Through New Technology
Agenda• THE IMPACT OF THE DIGITIZATION OF
HEALTHCARE DATA
• AN EXAMPLE FROM DRUG SAFETY: THE ASTER STUDY
• IMPLICATIONS FOR RESEARCH AND INDUSTRY
• CHINA AS EXAMPLE
Agenda• THE IMPACT OF THE DIGITIZATION OF
HEALTHCARE DATA
• AN EXAMPLE FROM DRUG SAFETY: THE ASTER STUDY
• IMPLICATIONS FOR RESEARCH AND INDUSTRY
• CHINA AS EXAMPLE
Digitization of Healthcare Data• The digitization of healthcare data will be one
of the most significant events in the history of the pharmaceutical industry
• It allows for the emergence of new business models based on digitized data rather than current practices evolved from paper and pen
• As a result, dramatic improvements are possible, although this is not a linear path of continuous improvement – it is a nonlinear change in direction
A Paradigm Shift• Applying new technologies using old
assumptions will deliver incremental improvements
• We only gain dramatic benefits by applying the new technologies to new business models
• This is what Thomas Kuhn, historian of science, called a ‘Paradigm Shift’
• A Paradigm Shift doesn’t entail new solutions to old problems – it changes the very nature of the problem
“The transition from a paradigm in crisis to a new one from which a new tradition of normal science can emerge is far from a cumulative process, one achieved by an articulation or extension of the old paradigm. Rather it is a reconstruction of the field from new fundamentals, a reconstruction that changes some of the field's most elementary theoretical generalizations as well as many of its paradigm methods and applications. During the transition period there will be a large but never complete overlap between the problems that can be solved by the old and by the new paradigm. But there will also be a decisive difference in the modes of solution. When the transition is complete, the profession will have changed its view of the field, its methods, and its goals.”
Thomas Kuhn The Structure of Scientific Revolutions (1962), 84-5.
“The transition from a paradigm in crisis to a new one from which a new tradition of normal science can emerge is far from a cumulative process, one achieved by an articulation or extension of the old paradigm. Rather it is a reconstruction of the field from new fundamentals, a reconstruction that changes some of the field's most elementary theoretical generalizations as well as many of its paradigm methods and applications. During the transition period there will be a large but never complete overlap between the problems that can be solved by the old and by the new paradigm. But there will also be a decisive difference in the modes of solution. When the transition is complete, the profession will have changed its view of the field, its methods, and its goals.”
Thomas Kuhn The Structure of Scientific Revolutions (1962), 84-5.
The old ways aren’t working any more…- costs- efficiency- process driven- outsourcing- transparency
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THE PROBLEM AS P R O C E S S
Inconvenience Constrains Reporting
• Not part of normal routine
• Not available at point of recognition
• Duplicate data entry• High nuisance factor
Reporting interrupts the routine of providing care and imposes a burden on providers – greatly decreasing the probability that events will be reported
M.Ibara ASTER
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Regulations Drive The Process
" Overall, the fulfillment of regulatory requirements…has become too great a process driver that has diverted attention away from scientific approaches to gaining better evidence…”
Waller, P.C. and Evans, S.J.W.“A model for the future conduct of pharmacovigilance”
Pharmacoepidemiology and Drug Safety 2003; 12: 17–29
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THE PROBLEM AS D A T A
Regulator
Hospitals
Health InformationExchanges
Large MedicalPractices
Silos and Underreporting = stranded data
Lab Data
Rx Data
Underutilized sourcesPharma replicating the same front-endprocess across companies
Consumers
Doctors
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THE PROBLEM AS S Y S T E MD E S I G N
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"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
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"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
The task is not to design information-distributing systems but intelligent information-filtering systems.“
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THE PROBLEM AS C U L T U R E
M.Ibara ASTER
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"Management scholars have identified a strong attachment to the status quo in many organizations and a tendency to commit “sunk cost” errors by pursuing a course of action because so much has already been invested in it…
…there was an attitude of “comfort with existing beliefs” that justified a resistance to internal or external criticism and a stifling of dissenting views…”
The Future of Drug Safety:Promoting and Protecting the Health of the Public
IOM, 2007
We’ve electronified our old business model
We need business models that will take advantage of digitized healthcare data
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
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
ASTER at Brigham and Women’s
Patient Physician
EHR
Ambulatory Clinics
Service Provider
Regulator
Manufacturer
*AE Report- EHR pt data- Physician Assessment- Coding & Bus Rule Results- Electronic Wrapper
*CodingBus Rules
*
*”Triggered” Adverse Event Reports
CDISC/IHE RFD
10:30:00
A doctor is working at an ambulatory clinic in the metropolitan Boston area.
They discontinue a patient’s drug due to an adverse event…
Screen Shots
Screen shots #2
Screen shots #3
Screen shots #4
Screen shots #7
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
"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
• 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
ASTER Safety Consortium
A group of like-minded companies and individuals determined to take full advantage of digitized healthcare data
Goals are twofold:
1. Explore the implications of the ASTER model to improve pre/post safety reports and other areas of clinical research
2. Design and execute a working model in the real world
Pfizer
GSK
Astra Zeneca
Cerner
GE
Greenway Medical
CDISC
Agenda• THE IMPACT OF THE DIGITIZATION OF
HEALTHCARE DATA
• AN EXAMPLE FROM DRUG SAFETY: THE ASTER STUDY
• IMPLICATIONS FOR RESEARCH AND INDUSTRY
• CHINA AS EXAMPLE
Implications for Safety• As regulations become more demanding and
data becomes more available, the distinction between pre-marketing safety and post-marketing safety is disappearing
• Companies will be required to monitor the safety of their drugs in a much more active manner
Implications for Safety (cont.)• In the same way, the requirements for a
company monitoring an individual drug will merge with the need to monitor the larger public health, which includes drug safety
• The consumer and patient will become direct and significant sources for information on drug safety
Agenda• THE IMPACT OF THE DIGITIZATION OF
HEALTHCARE DATA
• AN EXAMPLE FROM DRUG SAFETY: THE ASTER STUDY
• IMPLICATIONS FOR RESEARCH AND INDUSTRY
• CHINA AS EXAMPLE
Drug Safety in China
• Pharmaceutical companies developing and marketing drugs in China must monitor the safety of their companies’ drugs
• At the same time, China has the task of monitoring the public health of it’s citizens, including the safety of drugs
• Should China develop a drug safety monitoring system the same as the West has done historically, when we see how many problems the West now faces as a resulting of the digitization of healthcare data?
An Example1. When a patient receives a drug, they are given an
email address and a phone number to text or call if they believe they are having problems caused by the drug
2. When they email/text/call, the information is recorded centrally and they receive a simple form asking a few more questions
3. This information is evaluated centrally and it is determined whether to follow up more directly with the patient and/or their doctor
4. These reports form the basis of the drug safety / public health system
Central Organization
Regulatory Functions
TechnicalFunctions
Safety Data
SFDA
Pharma
QualifiedResearchers
Medical Organizations
Patients
A Public Health / Drug Safety Model Built on the ASTER Model
ConsumerPortal
PhysicianPortal
Doctors
Consumers Patients
China’s Drug Safety Challenge
• Digitization of healthcare data provides an opportunity for advancement of public health and drug safety
• China can take full advantage of developments without having to recapitulate Western development
• To do this will require a deep understanding of the fundamentals and a willingness to think in new ways
• If this is done, China could create a modern public health, industry utility model which is one of the first of it’s kind
Thank you
Utilizing Digital Healthcare Data to Create a New Business Model in Drug Safety