Transcript eHR Clinical data repository and pharmacovigilance

eHR Clinical data
repository and
pharmacovigilance
Suzanne Markel-Fox
12 October 2007
Discussion points
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eHR systems
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Penetration of eHR systems
Characteristics of health information technology systems
Standards and interoperability
Pharmacovigilance and surveillance
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Post-marketing surveillance
 Passive (spontaneous reporting)
 Active surveillance
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Automated (computer database)
Manual chart review
Observational studies, secondary analysis and registries
Penetration of eHR
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Ambitious regional and national goals for eHealth
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EU Commission plan for eHealth
UK Connecting for Health
US Office of National Coordinator
Australia HealthConnect
Obstacles to meeting those goals
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Organisational/cultural approaches to health care delivery
Limited interoperability of eHealth systems
Lack of regulation and fragmentation of eHealth market
Privacy and information security concerns
Investment required (cost, time, effort)
Standards and
interoperability
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Standard data structure
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Master Patient Index is essential
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eHR designs vary widely
New certification requirements cross-reference ISO/TC215, HL7, CCHIT and
other eHealthcare standards
Not all systems use a unique identifier
Some regional systems create a system-specific synthetic identifier
Interoperability* is key
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Technical/functional interoperability = “point to point flow of information”
Process interoperability is another way of talking about workflow
management
Semantic interoperability = the successful communication of meaning
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Semantic interoperability is at the very core of health care information
exchange
Interoperability = the ability to communicate and exchange data accurately, effectively, securely,
consistently with different information technology systems, software applications & networks in various
settings, so that clinical & operational purpose & meaning are preserved and unaltered (Halamka, 2007)
eHR systems
Postmarketing surveillance
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Spontaneous reporting
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Active surveillance
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AERS, VAERS (physician, consumer reporting)
CIOMS, ICH safety reporting requirements
Manual chart review: better at detecting symptom-related
mild adverse events
Automated (computerised) surveillance: better for
reporting drug interactions and laboratory-based changes
Disease-state registries: focused on improvement of care
Observational studies, secondary data analysis
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Exploratory analyses
Disease modelling
ICU-based severe sepsis
patient e-registry network
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Global sharing of clinical data (38 countries)
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Electronically connecting physicians globally
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Remove technology barriers
Resolve coordination issues
Manage privacy requirements
Objectives
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To improve treatment decision making and outcomes
Provide ‘real-time’ reports for participating institutions
Allow sites to compare their experience to the corresponding provincial,
national, and worldwide aggregate
Benefits
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On-demand access to track outcomes and improve performance
Standardisation of definitions 7 guidelines
Courtesy of A. Impicciche, Eli Lilly & Co
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eHRs Can Improve Access & Usability
of Clinical Care Data
Clinical Trials:
Data are high integrity due to validation, but are sourced from limited patient populations
Post-launch Clinical Care:
Today, data from payers & providers are lower quality, fragmented, and challenging to access
Providing Clinical Research requirements for eHRs has the potential to make Clinical Care
data higher quality, more easily accessible, and more useful for safety, outcomes, and
other types of analyses.
Quantity of Electronic
Patient Health Data
Clinical Care Data: Availability & Access
TODAY
•Fragmented
•Limited accessibility
•Limited populations
•Narrow uses
eHRs
FUTURE?
•Easily aggregated
•Broad access
•National coverage
•Many applications
Pre-Launch
Clinical Development
Courtesy of Pfizer Health Informatics
Time in Years
Mix of efficacy, safety,
and commercial data
with multiple uses
Legend:
= Highly controlled
Clinical Trial Data
Drug
Launch
= Clinical Care
Data from
Patients, Payers,
& Providers
Graph Is For Illustrative Purposes Only
8
backup
AMIA Secondary Data Panel
Recommendations*
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Increase the transparency of data use and public awareness.
Secondary use of health data must be conducted and managed
solely through the use of open and transparent processes
Focus ongoing discussions on data access, use, and control (not
“ownership”)
Continue discussions on privacy policy and security with regard
to the secondary use of health data
Increase public awareness efforts on the benefits and challenges
associated with the secondary use of health data
Create a taxonomy of the secondary use of health data
Address increasingly difficult current and evolving questions
related to the secondary use of health data in a comprehensive
manner
Focus national and state attention on the secondary use of
health data
*http://www.amia.org/inside/initiatives/healthdata.asp