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The views expressed are those of the author and do not represent an by alicejenny


									   Post-Marketing Safety Information on Medical
   Products: Potentials for Improvements

        Overview for perspective

Marc K. Walton, M.D., Ph.D.

The views expressed are those of the author, and do not represent an
   official FDA position
          Postmarketing safety information

 Requirements stated in regulations (21CFR 600 & 314)
 Review – promptly review all AE information (any source)
 Reporting – PM 15d Alert Reports
    Serious & Unexpected AE
    Follow-up information
 Reporting – Periodic Reports – All additional AEs yearly
  (quarterly first 3 yrs) – primarily spontaneous reporting
    Added to FDA AERS database
    Includes MEDWATCH direct repots to FDA
 PM Studies - Typically as agreed between FDA and
  manufacturer; primarily for topics with known basis for
  reasonable concern
          Postmarketing safety information
               Current chief sources

 Agreed-upon PM studies – limited to issues where there
  is a basis for reasonable concern

 Spontaneous reports
    Relationship of AE to drug may not be recognized,
     and thus not reported
    Substantial underreporting
    Weak ability to estimate relevant denominator
                 Existing Methodology

 Can be useful to refine understanding of known or
  clearly suspected AE related to drug
 Can be useful to detect clinically notable AE that occur in
  a manner revealing relationship (e.g., events with
  temporal characteristic, rechallenge, otherwise rare)
 Weaknesses in other situations widely discussed

 One FDA approach to improving medical product safety
  is termed the ‘Sentinel Network’
The Problem
   The effectiveness of Federal government postmarket
    surveillance and risk communication efforts have
    been constrained due to limitations in the:
      Quality of data
      Quantity of data
      Timeliness of data receipt and analysis
      Capacity to rapidly conduct postmarket safety
       studies, when needed
      Risk communication tools used
      Available resources
A Proposed Solution
 The private sector has taken steps that can facilitate
  surveillance activities:
    Developing new information technology tools
    Exploring informatics methods and applications
    Creating the capacity to conduct postmarket safety
 Therefore, link private and public sector efforts to
  address these limitations through better integration of
  the nation’s postmarket medical product safety
  activities to create a “Sentinel Network” – a virtual,
  integrated, electronic medical product safety network
Sentinel Network
   The network would foster the seamless, timely,
    electronic flow of medical product safety information
    from electronic databases and surveillance reporting
    systems, through risk identification and analysis
    processes, to healthcare practitioners and patients at
    point-of-care, while protecting patient privacy
   The network would be assembled through public-
    private partnerships and build on existing efforts
    rather create entirely new systems
   The network would use national and international
Components of the Sentinel Network
   Data Collection
      Integrate clinical practice and adverse event
         EHRs
         Integrated   databases
   Risk Identification and Analysis
      Integrated research networks
      Data mining tools
      Reach agreement on methodologies
      Conduct subgroup analyses and identify
       biological/genomic markers
   Risk Communication
      Leverage medical community’s expertise
      Integrate new risk information into the workflow of
       clinical practice (e.g., decision support systems)
              Legislative Initiatives

    PDUFA, MDUFA reauthorization
    Multiple other potential FDA procedural,
     organizational, responsibility aspects
 Senate version has been passed
 House version in committee
 Final enacted version yet to be determined
                 S. 1082 Drug Safety

 FDA shall work to establish within 2 years a system(s)
  for drug safety surveillance
    Described with similar data collection, analysis
      characteristics as were used for Sentinel Network

 Goal of 100 Million patients by July 2012
     S. 1082 Drug Safety – Qualified Entities

 ‘‘(aa) has the research capability and expertise to
  conduct and complete the activities under this
 ‘‘(bb) has in place an information technology
  infrastructure to support adverse event surveillance data
  and operational standards to provide security for such
 ‘‘(cc) has experience with, and expertise on, the
  development of drug safety and effectiveness research
  using electronic population data;
 ‘‘(dd) has an understanding of drug development and
  risk/benefit balancing in a clinical setting; and
            Data Sources and Adequacy

 Claims data
 EMRs

 ‘Compatability’ of data needs with data sources
    Richness of detail
    Common granularity, format, meaning to permit
     combining information from multiple systems
 Informatics systems in development can be planned to
  satisfy needs
 Data needs driven by clinical question and analytic

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