ICH E2B Individual Case Safety Report ICSR Current Status by tga99793

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									ICH E2B Individual Case Safety
Report (ICSR):
Current Status and Next Steps



Presented by: Sabine Brosch
P     t d b S bi     B    h
PharmacoVigilance and Risk Management Sector
European Medicines Agency                      An agency of the European Union
Background (1)
    ICH E2B(R2)* guideline: Data Elements for
    Transmission of Individual Case Safety Reports
    (ICSRs)
        – Provides a description of the data elements and
          instructions on how to use these for adverse reaction
          reporting

    ICH M2 Version 2.1 of the DTD
        – Provides a messaging format for ICSRs
           • ICH ICSR M2 Version 2.3 Specification Document
           • ICH ICSR Acknowledgment Message, DTD
               Version 1.1


2       http://estri.ich.org/icsr/index.htm      * Former E2B(M)
Background (2)
    FDA introduced the HL7 ICSR message Release 1
    (Normative Edition 2005)
         equ es      sta da ds    t e
    FDA requires HL7 standards in the US
    HL7 ICSR supports the exchange of data and other
    safety reporting requirements between various public
    health and patient safety organizations:
         –   Reporting of adverse events
         –   Product problems associated with the use of drugs
         –   Therapeutic biologics
         –   Vaccines
    The message can support international safety reporting
    between public health organizations

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Background (3)
    EU requires that a standard must be ISO or CEN based
    to be referenced in EU legislation
       Such requirements are also applicable in Canada
    Therefore to meet overall ICH needs a standard must
    be issued by ISO/CEN and HL7




4
    Background (4)
    May 2005:
      ICH released for public consultation
         Revised guideline for Clinical Safety Data
         Management: Data Elements for Transmission of
         Individual Case Safety Reports (E2B(R3))
         Ne guideline on Identification of Medicinal
         New g ideline
         Products (IDMP) (M5)
      ICH Steering Committee decided that technical
      specifications should no longer be developed solely
      within ICH, but should be created in collaboration
      with international Standards Development
      Organisations (SDOs)

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    New International Standardisation
    Co-operation

    ICSR and IDMP were recognised as joint
    initiative projects:
     European Committee for Standardization (CEN)
     Clinical Data Interchange Standards Consortium (CDISC)

     Health Level 7 (HL7)
     International Health Terminology Standards
     Development Organisation (IHTSDO)

     International Organization for Standardization (ISO)


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New I
N            i
    Internationall
Standardisation Co-operation
    Objectives:
       – Improve the current ICH E2B(R2) guideline

       – Enable wider interoperability across the
         regulatory and healthcare communities (e.g.
         Electronic Patient/Health Record -
         pharmacovigilance)

       – Exchange, manage and integrate data that
         support clinical patient care and the
         management, delivery and evaluation of
         healthcare services
         h lth            i
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New I
N            i
    Internationall
Standardisation Co-operation

    Approach:
          Use           i   t d d for ICSR
        – U HL7 messaging standards f ICSRs
          and acknowledgements

        – ISO ICSR standard constrains HL7
          messaging to its specific needs

        – ICH develops ICSR Implementation
          Guide and conducts testing of new
          standards
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New International
Standardisation Co-operation

    Approach:
       – Clear definition of medicinal product/device
         concepts in ICSRs

                             y     g
              – HL7 ICSR fully integrates HL7 Common
                Product Model (CPM)

       – ISO Identification of Medicinal Products (IDMP)
           ill ll   for t   t   d    di i l    d t /d i
         will allow f structured medicinal product /device
         reporting in ICSRs

       – ICH M5 will develop Implementation Guide for
         IDMP in context of ICSR
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New I t
N           ti
    Internationall
Standardisation Co-operation
     ISO 27953 Part 1
                    p
         – Wider scope than Human Pharmaceuticals
         – Veterinary products, Food, Feed, Dietary supplements,
           Medical Devices and Cosmetics


     ISO 27953 Part 2
         – Restricted version of Part 1 covering Human
           Pharmaceuticals
         – ICSR and acknowledgement messaging based on HL7
           standards


10
HL7 ICSR Standard




11
    C         P d    M d l
HL7 Common Product Model (CPM)
medicinal products and devices


                                         Package




     l
 Regulator

             Manufacturer               Product




                            Substance



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 ICSR: ICH and HL7




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Changes to ICH E2B/M2
Ch
Specifications (1)
     Examples for changes
      – Fields removed/updated
        • A.3.2 Receiver
        • A.1.10.1 and A.1.10.2 Worldwide Case IDs merged
        • Seriousness at event level

      – New concept of ‘amendment report’

      – Fields added
        • Study registration number
        • Improved description of medication errors and drug
            abuse

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Changes to ICH E2B/M2
Ch
Specifications (2)
     Examples for changes:
         • Revised drug section and full integration with ISO
            d    f         f
           Identification of Medicinal Products (IDMP)
                               d     l    d     (    )

         • Fields becoming repeatable
             • Dosage information
             • Drug indication

         • Reporting of counterfeit medicines




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Changes to ICH E2B(R2)/M2
Ch
Specifications (3)
 B.1.7 Relevant medical history and concurrent conditions

                                            fields
                                   HL7 ICSR fi ld
                                   observation Process
     E2B(R3) fields                (Disease)
     B.1.7
     Disease/surgical
     procedure/etc
     procedure/etc.                procedure Process
                                   (Surgical procedure)




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Changes to ICH E2B(R2)/M2
Ch
Specifications (4)

     Dosage information B.4.k.5

 E2B(R2) field     E2B(R2) value   HL7

 B.4.k.5.1         10              10

 B.4.k.5.2         mg              mg

 B.4.k.5.3         3               --------

 B.4.k.5.4         1               8

 B.4.k.5.5         Day             Hours

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Changes to ICH E2B(R2)/M2
Specifications (5)


 • Submission of attachments
     • The new ICSR standard supports the
       submission of attachment files (e.g. PDF of
                f                             f
       copies of literature articles, copies of test
       results) within the ICSR message




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Changes to ICH E2B(R2)/M2
Specifications (6)

 • ICSR Acknowledgment Messages
     • HL7 Message Transmission standard used to
       acknowledge ICSRs
     • Like the new ICSR standard this will be
       different to the current E2B(R2)
       acknowledgment but the content will be
       aligned




19
Project Planning
 Standards development has to be conducted at
 three levels:
 • HL7: ICSR and acknowledgement messaging
   standards
 • ISO: HL7 ICSR constrained for human
   medicinal products for ICH use
 • ICH: conduct ISO ICSR testing and prepare
   ICH ICSR Implementation Guide


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ISO/ICH ICSR –
Project Milestones

     ISO ICSR Draft International Standard (DIS)
     ballot:
         – Initiated 1 April 2009
         – Closed 30 September 2009

     ICH awareness publication of the ISO ICSR Draft
     Standard and the ICH Implementation Guide ( )
                             p                  (IG)
         – Initiated on 26 June 2009


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ISO/ICH ICSR –
Project Milestones

     Testing of ICSR Draft International Standard (DIS)
     Regional ICH testing of ISO ICSR Standard
           – Completed in August 2009
           – EU Regional Testing involving 18 Testers:
               •   Nine Regulatory Authority and Pharmaceutical
                   Industry testers each
           – Japan and US conducted similar regional testing




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ISO/ICH ICSR –
Project Milestones

     ISO ICSR DIS ballot outcome
     Six countries voted negatively in ISO
      • A second ISO DIS ballot is required to progress the
        work in ISO

     A repeat of the ICSR DIS ballot was approved in
     the October ISO TC 215 meeting in Durham
     (US)
      • Agreement on how all comments received would be
        addressed
      • Estimated duration two months (completion in June
23      2010)
ISO/ICH ICSR –
Project Milestones

 ICH
   Resolve issues and comments raised with the
   Implementation Guide (IG) during 1st ISO ICSR
   DIS testing

     Complete sections in the Implementation Guide
          − Attachments
          − Backwards and Forwards conversion
          − Acknowledgements

      g ee on C   5 teg at o          ( 3)
     Agree o ICH M5 integration in E2B(R3)
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ISO/ICH ICSR
Project Milestones
     ICH
           – Prepare for the 2nd round of ICSR DIS testing
                p                                        g

           – To be completed within two months following
             official initiation of ICSR DIS ballot

              •   One month for testing
              •   One month of reconciliation of test results and
                  submission to ISO member bodies



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    I  l       i     d
ICH Implementation and
ISO ICSR

     ICH Backwards and Forwards Conversion

      The current ICH E2B(R2) standard and the future ISO
      ICSR standard will be structured in different ways
      A coordinated implementation approach is required to
      allow for smooth transition between current and new
      ICSR




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    Implementation
ICH I  l       i
and ISO ICSR

     ICH Backwards and Forwards Conversion rules

         – ICH conversion rules developed to help organisations
           during the period of switching between the current
           standard and the new standard

         − Rules will be provided in the ICH IG

         − XML style sheets will allow for automatic conversion

         − Applicable for ICSR and acknowledgement messages

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    Implementation
ICH I  l       i
and ISO ICSR

     Use of MedDRA

        − MedDRA will remain standard terminology for the
          coding of all medical information in ICSRs

        − This will be reflected in the ICH Implementation Guide




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ICH E2B(R3)/M2 Work Plan




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HL7 Activities

ICSR ballot comment reconciliation within HL7 has
been completed
• The ICSR Models are being updated for the ISO
  standard
• Work ongoing to include updates to ICSR to take
  account of the IDMP work
• Draft HL7 acknowledgements are to be balloted so
  that they become normative content


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ISO

ISO ICSR DIS ballot documents to be provided to
                               mid March
the ISO Central Secretariat by mid-March
Second DIS ballot to start beginning of May
lasting two months
If the outcome of this DIS ballot is positive the
standard will move to Final Draft International
Standard (FDIS) after the October 2010 ISO TC
215 meeting in the Netherlands


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ISO

Once the standard becomes an FDIS no technical
changes can be made.
     – If technical comments are received they will only
       be registered for consideration during a future
       revision of the International Standard
The final standard following this timeline would
then be published in April 2011




32
 Thank you


 Sabine.brosch@ema.europa.eu




33
Acknowledgements

     Nick Halsey (European Medicines
     Agency)

     Anja van Haren (MEB, NL)

     EudraVigilance Expert Working Group
     (EV-EWG) conducting EU testing




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Acronyms

     CEN European Committee for Standardization
     CDISC Clinical Data Interchange Standards Consortium
     CPM Common Product Model
     DIS Draft International Standard
     DSTU Draft Standard for Trial Use
     DTR Draft Technical Report
     HL 7 Health Level 7
     ICH International Conference on Harmonisation of Technical Requirements
     for Registration of Pharmaceuticals for Human Use
     IDMP Identification of Medicinal Products
     IHTSDO International Health Terminology Standards Development
     Organisation
     ISO International Organization for Standardization
     JI Joint Initiative
     NMBs National Member Bodies
     SDOs Standards Development Organisations
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