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September, 2005
HIMSS Interoperability ShowcaseHIMSS Interoperability ShowcaseNew Directions in Life SciencesNew Directions in Life Sciences
Theater PresentationTheater Presentation
Supporting Physician Reporting of Adverse Supporting Physician Reporting of Adverse Reactions and Public Health ThreatsReactions and Public Health Threats
SpeakersSpeakers
Tim Morris Centers for Disease Control and Prevention
Director of Shared Services, National Center for Public Health Informatics (NCPHI)
Michael Ibara Pfizer, Inc.
Head of Pharmacovigilance Information Management
Dixie Baker SAIC
Chief Technology Officer
Inconvenience Constrains Reporting Inconvenience Constrains Reporting
Reporting adverse events and notifiable diseases and conditions interrupts the normal routine of providing care and imposes a burden on providers – greatly decreasing the probability that these events and conditions will be reported.
Not part of normal routine
Not available at point of recognition
Duplicate data entry
High nuisance factor
A Potential Solution: A Potential Solution: Retrieve Form for Data-Capture (RFD)Retrieve Form for Data-Capture (RFD)
Provides standard way to: Retrieve a form from an external source, Display and use the form, Submit the collected information, and Archive a copy of the submitted form…
All within the context of a local application
Many-to-many integration – a single application can retrieve forms from many external sources
What Does The User See?What Does The User See?
GETFORM
SELECT FORMClinical Trial AEMedWatchPublic Health Surveillance
SUBMIT
Form ArchiverForm ReceiverForm Manager
How Does RFD Do This?How Does RFD Do This?
Archive Form (ITI-d)
Retrieve Form (ITI-a) Submit Form (ITI-c)
ClinicalRepository
Invoke Form Filler Prepopulate Form
EHR ApplicationExtendedUI
GETFORM
Health System / Physician PortalRFD Extension EHR Application
RFD Form Filler
Form Source Form Recipient Form Archival
RFD Value PropositionRFD Value Proposition
Simplicity – RFD’s simple components ease integration with clinical applications
Convenience – RFD enables providers to fulfill reporting obligations without interrupting their normal work flow
Interoperability – Adherence to open standards helps facilitate data exchange and semantic interoperability
Example Use CasesExample Use Cases
Pharmacovigilance Reporting of adverse reactions to drugs
• Clinical trials• Post-marketing
Biosurveillance (in cooperation with CDC)
Reporting of suspected and confirmed cases of notifiable diseases and conditions
RFD in Support ofRFD in Support of
PharmacovigilancePharmacovigilance
HIMSS Interoperability Showcase HIMSS Interoperability Showcase DemonstrationDemonstration
Demonstrate the technical feasibility of providing a seamless way for physicians to submit high-quality adverse event reports
Demonstrate the use of the EHR and also the use of a portal (e.g., the National Health Information System) as primary data sources
Stimulate additional thought / work in this area
Pharmacovigilance and Reporting of Pharmacovigilance and Reporting of Adverse Events from the EHR / NHIN PortalAdverse Events from the EHR / NHIN Portal
Safety ReportingSafety Reporting
In the US the spontaneous reporting system relies on volunteer reports to track safety of marketed medicines
Two of the most important limitations of the current system are underreporting and sparse data
Increasing the number of high-data-quality reports of adverse events can have a direct beneficial effect on public safety
To achieve this we must: Lower the burden of reporting on physicians and other health care
professionals, and Raise the quality of the data in the report
Pharmacovigilance (Drug Safety) ScenarioPharmacovigilance (Drug Safety) Scenario
Team: Pfizer, Sentrx/Relsys, Allscripts
Standard(s): XForm, HL7 ICSR, E2B(M/R3)
Scenario: Physician/investigator, using an EHR or the NHIN portal, discovers a suspected adverse drug event and summons a data-capture form from the drug manufacturer or Regulator to provide information on the event and allow for submission back to the Regulator and manufacturer
Typical Safety Reporting FlowTypical Safety Reporting Flow
XX
Ideal Safety Reporting FlowIdeal Safety Reporting Flow
Form ArchiverForm ReceiverForm Manager
How Does RFD Do This?How Does RFD Do This?
Archive Form (ITI-d)
Retrieve Form (ITI-a) Submit Form (ITI-c)
ClinicalRepository
Invoke Form Filler Prepopulate Form
EHR ApplicationExtendedUI
GETFORM
RFD Form Filler
Company / FDA / etc. Company / FDA / 3rd PartyCompany / FDA / etc.
Health System / Physician PortalRFD Extension EHR Application
Interaction of Biopharma and HIT… Interaction of Biopharma and HIT…
Increase in the quality, number and timeliness of spontaneous reports
Better and more rapid assessment of reports
Solution can be applied universally
Direct impact on public health
RFD in Support ofRFD in Support of
BiosurveillanceBiosurveillance
HIMSS Interoperability Showcase HIMSS Interoperability Showcase DemonstrationDemonstration
Demonstrate the technical feasibility of providing a seamless way for physicians to submit standards-based case reports from their desktops
Demonstrate the integration of XForms-based surveillance instruments with EHR applications, using the IHE RFD profile
Stimulate additional thought & work in this area
Biosurveillance from the Clinical WorkflowBiosurveillance from the Clinical Workflow
Foundational WorkFoundational Work
CDC Interchangeable Data-Collection Instruments (IDI) work reported at HIMSS 2006 Forms are constructed using reusable XML fragments
• Standard data model & schema• Standard PHIN terminology bound to questions
W3C XForms standard provides multiple benefits • Forms run on any platform that supports the standard – browser
based, application, or client-server• Model-view-controller separation allows for local customization of
presentation• Off-line and on-line data collection – important for outbreaks!• Integration of public-health business rules (e.g., skip patterns,
cross-field validation)• Integrated form submittal• No scripting – faster form creation
Public Health ReportingPublic Health Reporting
In the US, cases are reported to local public health, often using faxed paper forms
Effective public health surveillance, detection, and response require timely and consistent reporting
Reporting from the point of care, using standards-based, electronic forms, offers potential for earlier detection and more complete epidemiological profile
Effective point-of-care public health reporting requires: Integrating reporting with the physician’s normal work flow Facilitating physician decision-making Use of standard terminology to capture inputs
Biosurveillance ScenarioBiosurveillance Scenario
Team: SAIC, CDC, IBM, Allscripts, Cerner, SAS, University of Washington
Standard(s): XForms, XML, HTML/XHTML, PHIN Vocabulary Standards
Scenario: Patient from local homeless shelter visits clinic and reports symptoms of tuberculosis. Suspecting TB, the physician performs TB skin test and chest x-ray, with results further raising her suspicions of TB. Physician prescribes 4 anti-TB medications and arranges for a respite bed at the shelter. Physician collects sputum specimen and sends it to the lab for confirmation.
You have ordered two or more anti-tuberculosis drugs for your patient, so you need to report this suspected case to the public health department. Do you want to report this now?
Yes, Get FormYes, Get Form Report LaterReport Later Do Not ReportDo Not ReportYes, Get FormYes, Get Form
Submit
Notifiable diseases and conditions typically are reported to local public health agencies
using faxed paper forms.
Local agencies send some of the data on to the State,
which sends an even smaller subset on to the CDC.
CDC reports results from surveillance activities and
disseminates warnings and guidance when a potential
outbreak is detected.
Typical Public Health ReportingTypical Public Health Reporting
ClinicalRepository
Physician records suspected disease in patient’s EHR and
orders treatment.
As physician signs order, EHR application retrieves
public health case reporting form.
When physician submits the form, appropriate
data elements are sent to public health agencies.
Potential outbreaks are
detected earlier, enabling public
health to respond sooner.
Ideal Public Health ReportingIdeal Public Health Reporting
How Does RFD Do This?How Does RFD Do This?
Archive Form (ITI-d)
Retrieve Form (ITI-a) Submit Form (ITI-c)
ClinicalRepository
Invoke Form Filler Prepopulate Form
EHR ApplicationExtendedUI
GETFORM
RFD Form Filler
State Public Health
CDCLocal Public Health
Form Archiver
Form Receiver
Form Receiver Form ReceiverForm Manager
Health System / Physician PortalRFD Extension EHR Application
RFD Value PropositionRFD Value Proposition
Simplicity – RFD’s simple components ease integration with clinical applications
Convenience – RFD enables providers to fulfill reporting obligations without interrupting their normal work flow
Interoperability – Adherence to open standards helps facilitate data exchange and semantic interoperability