Quality, Research and Public Health Technical Committee Agenda 2008-06-19

Minutes, Drug Safety Content Profile June 19, 2008

Attendees

• Floyd Eisenberg (Siemens) - Technical Co-chair
• Jason Colquitt (Greenway Medical Systems) - Technical Co-chair
• Ana Estelrich (GIP-DMP) - Planning Co-chair
• Lori Fourquet (e-Health Sign)
• Michael Ibara (Pfizer)
• Thom Kuhn (ACP)
• Dan Levy (Outcomes Research)
• Jan Orton (Intermountain Healthcare)
• Jacob Reider (Misys)
• Charles Rica (GIP-DMP)
• Lise Stevens (FDA)
• Mick Talley (University Bank)
• Didi Davis (HIMSS - Sponsor)

Public Health Data Standards Consortium White Paper

Review and vote on endorsement by QRPH of Public Health Data Standards Consortium White Paper

• Motion to endorse the Public Health Data Standards Consortium White Paper by the QRPH Domain and to provide public availabiilty of the white paper on the IHE web site --- Unanimously approved by all voting members (quorum of 7 in attendance)

Drug Safety Content

Prior Discussions for Reference:

• Minutes_Drugs_Safety_Content_Profile_June_5,_2008
• May 22, 2008 - Review of Massachusetts Implementation
• Drug Safety Content Profile Proposal

• Two issues were addressed on prior calls:
  • Requirement for E2BM mapping expertise
  • Management of triggers for generating drug safety content
    • Triggers are generally managed within the EHR workflow to request from a clinician a determination as to whether or not an adverse event has occurred. Some triggers that have been used include:
      • In the EHR used in the ASTER project, a question each time a medication is discontinued for the ordering physician to enter if the discontinuation is due to an adverse event
      • Automated triggers based on specific medication orders or laboratory results or clinical events as listed in Minutes_Drugs_Safety_Content_Profile_June_5,_2008
    • Regardless, triggers require clinician determination before a drug safety content report can be initiated and, therefore, triggers are the responsibility / expectation of the originating EHR.
• Current status of standards in the drug safety content process
  • ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) has published a Step 2 document and plans to amend E2BM (Data Elements For Transmission Of Individual Case Safety Reports). The exchange format will be HL7 ICSR (Individual Case Safety Report).
  • The E2BR3 guideline is currently under revision to reconsider data elements not previously considered, specifically drug/device combinations. There is some preliminary mapping to the guideline completed in the HL7 Patient Safety Workgroup. A draft ballot is expected August 1, 2008 for ballot resolution during the September HL7 Working Meeting in Vancouver. The plan is to include the ICH conformance profile as an annex to the ballot to reference E2BR3. The content will then be taken to the ISO October meeting for reconciliation and testing can begin after that ballot.
  • Since standards are rapidly evolving and progressing, the committee agreed it most prudent to convert the Drug Safety Profile to a White Paper to provide an overview of the industry and standards
    • Expectation is completion of the white paper on Drug Safety Content by August 1 to allow a 30 day comment period and approval in September to allow for work toward the New Directions area in HIMSS 2009.
    • Requirements for White Paper - Drug Safety Content:
      • Use Cases:
        • Drug trial
        • Phase IV Studies
        • Post-market surveillance
        • Medication Errors
      • Data Categories
        • Data requested by FDA/regulators
        • Data requested for outcomes - definitions, mappings
        • Data not requested but valuable - e.g., lab studies, relevant deltas
      • E2BM Mapping expertise - Michael Ibara
      • E2BR3 Guideline update information - HL7 Ballot - Lise Stevens

Next Steps

• Follow up conference call July 3 1-3 PM CDT regarding update and status of the Drug Safety Content White Paper
• Approved endorsement of Public Health Data Standards Consortium White Paper for publication on IHE website; review also by GMP-DIP for international comment
• Recap for face-to-face meeting as 4 days, starting Tuesday, 22 July through Friday 25 July
  • First 2 days for resolution of public comments for Clinical Research Profile and Quality White Paper
  • Second 2 days for writing / completion of Drug Safety Content White paper

Quality, Research and Public Health Technical Committee