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    Dia Psur 6-15-04

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    "The Utility of the Periodic Safety Update Report as a Useful Source of medical Information" 2004 Topics Purpose and Origin of the PSUR Format and Content Strengths and Weaknesses. 2004 Proposed US Safety Regulations - "the TOME" Change periodic report to PSUR format (c) ISS, Inc.

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    Dia Psur 6-15-04

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    "The Utility of the Periodic Safety Update Report as a Useful Source of medical Information" 2004 Topics Purpose and Origin of the PSUR Format and Content Strengths and Weaknesses. 2004 Proposed US Safety Regulations - "the TOME" Change periodic report to PSUR format (c) ISS, Inc.

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    "The Utility of the Periodic Safety Update Report as a Useful Source of medical Information" 2004 Topics Purpose and Origin of the PSUR Format and Content Strengths and Weaknesses. 2004 Proposed US Safety Regulations - "the TOME" Change periodic report to PSUR format (c) ISS, Inc.

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    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    80 views31 pages

    Dia Psur 6-15-04

    Uploaded by

    shilpapillai
    "The Utility of the Periodic Safety Update Report as a Useful Source of medical Information" 2004 Topics Purpose and Origin of the PSUR Format and Content Strengths and Weaknesses. 2004 Proposed US Safety Regulations - "the TOME" Change periodic report to PSUR format (c) ISS, Inc.

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    of 31

    "The Utility of the Periodic Safety Update Report as a Useful Source of Medical Information"

    Michael J. Klepper, MD President and CEO Integrated Safety Systems, Inc. Research Triangle Park, NC
    ISS, Inc. 2004

    Topics
    Purpose and Origin of the PSUR Format and Content Strengths and Weaknesses Utility for Providing Important Medical Information

    ISS, Inc. 2004

    Purpose and Origin of the PSUR

    ISS, Inc. 2004

    Periodic Safety Report for Marketed Drugs = PSUR

    ISS, Inc. 2004

    Purpose of the PSUR


    A stand alone global-standardized document that can be used worldwide for:
    Identification of new safety signals Identification of changes to benefit-risk profile of medical product
    Change in product label Change in product name/package/promotional material Dear Doctor Letter Need for risk management initiatives Withdrawal from the market

    Monitoring effectiveness of risk management initiatives


    ISS, Inc. 2004

    Periodic Reports
    For marketed products Quarterly for first three years, annually thereafter (US) - current PSUR - every 6 months for first 2 years, annual for 3 years, then every 5 years US Traditional Adverse Drug Reaction Periodic Report very different than PSUR PSUR currently used in European Union, Japan, other countries
    ISS, Inc. 2004

    Origin of PSUR
    1992 - International Reporting of Periodic Drug-Safety Update Summaries (Council for International Organizations of Medical Sciences [CIOMS] II) 1996 - Guidance for Industry E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs

    ISS, Inc. 2004

    Origin of PSUR
    2001 - Current Challenges in Pharmacovigilance: Pragmatic Approaches (CIOMS V) 2002 Draft Consensus Guideline Addendum to ICH E2C Clinical Safety Data Management Periodic Safety Update Reports for Marketed Drugs
    ISS, Inc. 2004

    Proposed US Safety Regulations The TOME


    Change periodic report to PSUR format (ICH E2C) Periodicity
    Every six months for the first 2 years Annually for the next 3 years Every 5 years thereafter

    Interim Periodic Safety Report (IPSR)


    At 7.5 years and 12.5 years after U.S. approval Same information as PSUR excluding summary tabulations
    ISS, Inc. 2004

    Format and Content

    ISS, Inc. 2004

    Key PSUR Definitions


    Company core data sheet (CCDS) Company core safety information (CCSI)
    Safety information in CCDS

    Listed/Unlisted
    Based on CCSI (expected/unexpected based on country-specific product information)
    ISS, Inc. 2004

    Key PSUR Definitions


    International Birth Date (IBD)
    First approval in the world

    Data Lock Point (DLP)


    Cut-off date for data to be included in report

    ISS, Inc. 2004

    Table of Contents of PSUR


    Introduction Worldwide market authorization Update of regulatory authority or MAH actions taken for safety reasons Changes in reference safety information Patient exposure Presentation of individual case histories
    ISS, Inc. 2004

    Table of Contents of PSUR


    Studies Other information Overall safety evaluation Conclusion Appendix
    Company Core Data Sheet Consumer Reports (US)
    ISS, Inc. 2004

    Table of Contents of PSUR


    Introduction
    Brief summary of the the drugs characteristics When the data lock date was, and what period of time the report covers What number the report represents, e.g., this is the first periodic report, this is the 6th periodic report
    ISS, Inc. 2004

    Table of Contents of PSUR


    Worldwide market authorization
    Typically a table summarizing:
    Countries where the drug has been approved Countries where there was a lack of approval, etc.

    ISS, Inc. 2004

    Table of Contents of PSUR


    Update of regulatory authority or MAH actions taken for safety reasons - for example:
    Failure to obtain marketing re-authorization Withdrawal from the market Suspension of clinical trials, etc.

    ISS, Inc. 2004

    Table of Contents of PSUR


    Changes in reference safety information
    Summarizes what changes to CCSI have or will be made from current one

    ISS, Inc. 2004

    Table of Contents of PSUR


    Patient exposure
    Estimate of exposure and methodology used:
    Number of tablets sold Number of bottles of medication distributed Number of prescriptions written

    ISS, Inc. 2004

    Table of Contents of PSUR


    Presentation of individual case histories
    Listings Capsule view of all the AEs reported by a patient with the most serious listed first
    All serious reactions, and non-serious unlisted reactions, from spontaneous notifications; All serious reactions (attributable to drug by either investigator or sponsor), available from studies or namedpatient (compassionate) use; All serious reactions, and non-serious unlisted reactions, from the literature; All serious reactions from regulatory authorities

    Tabulation of AEs including a tabulation for nonserious, listed reactions Analysis of individual case histories
    ISS, Inc. 2004

    Table of Contents of PSUR


    Studies
    Completed studies with new safety information

    ISS, Inc. 2004

    Table of Contents of PSUR


    Other information
    New relevant efficacy information Late breaking news

    ISS, Inc. 2004

    Table of Contents of PSUR


    Overall safety evaluation - A concise analysis of the data presented, taking into account any late-breaking information, and followed by the MAHs assessment of the significance indicating a change in the benefit-risk profile of the drug
    In addition:
    Specifically looks at certain populations, e.g., elderly, pediatric, pregnancy Drug interactions Overdose Long-term effects Etc
    ISS, Inc. 2004

    Table of Contents of PSUR


    Conclusion
    Should indicate the safety findings that are different than that found in the current reference safety information Indicate what actions were or will be taken
    Change in CCSI Risk management initiatives, etc.

    ISS, Inc. 2004

    Table of Contents of PSUR


    Appendix
    Company Core Data Sheet Consumer Reports (US)

    ISS, Inc. 2004

    Strengths and Weaknesses

    ISS, Inc. 2004

    Strengths
    Aggregate data to better identify new safety signals especially rare adverse events Worldwide data safety signal strengthened if seen in more than one country Multiple sources of information - also strengthens the safety signal
    Spontaneous reports Healthcare professionals, Consumers (US) Literature Studies Animal Findings ISS, Inc. 2004

    Weaknesses
    Resource intensive Quality dependent Garbage in garbage out No set numerator or denominator to calculate accurate incidences Retrospective, potentially biased Safety signal identification (not verification) Label change required before information can be used officially
    ISS, Inc. 2004

    Utility for Providing Important Medical Information

    ISS, Inc. 2004

    Utility for Providing Important Medical Information


    Hypothesis generating need for new study(ies) results ultimately affect medical information Change in label new medical information Dear Doctor Letter new medical information Metrics determines effectiveness of content of/mechanism of providing, medical information
    ISS, Inc. 2004

    Knowledge is Power!

    ISS, Inc. 2004

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