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