Recent Trends in Pharmacovigilance in Australia

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Recent Trends in Pharmacovigilance in Australia
IFPMA 2008

• Pharmacovigilance and impact on product
  information
• Dr Leonie Hunt
• TGA,Australia

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National Medicines Policy

• 1 Quality, safety TGA
• and efficacy
• 2 Equity of access Pharmaceutical benefits
• 3 Viable industry Government support
• 4 Quality of Pharmaceutical
• use of medicines education
  programs

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What TGA aims to do?

• To ensure that there is timely access to
  therapeutic products that are of good quality,
  safe and efficacious
• To monitor products to ensure that products in
  use remain of good quality, safe and efficacious
  
• Increasingly, to work with others as a partner in
  facilitating appropriate use of therapeutic
  products

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Why have regulation

• Most important single event was identification of
  thalidomide embryopathy in 1961
• Several countries set up committees of experts to
  
• review applications to market new drugs
• Australian Drug Evaluation Committee (ADEC) 1963

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• In addition, National Adverse Drug Reaction
  Spontaneous Monitoring Schemes were set up
  (Australia 1964), and later the
• WHO Collaborative Program for International Drug
  Monitoring
• Australia and New Zealand were two of the ten
  countries that took part in the feasibility study
  in 1968. Japan joined in 1972.

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Australian requirements

• Sponsors are required to comply with
  pharmacovigilance responsibilities. These
  include
• - Qualified person role
• - Appropriate systems for collecting, collation
  and reporting of ADR
• - Notifying TGA of any new information

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Features of the Australian System

• High proportions of direct reporting by health
  professionals (initially doctors and dentists) -
  follow-up facilitated
• Expert ADR committee set up (ADRAC -1970)
• Medical review of individual reports by
  internal officers with ADRAC oversight
• Feedback to the professions-eg Australian ADR
  Bulletin

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Some recent initiatives

• Web -based electronic report form in Australia
  with reporting facility in GP software
• Dedicated pilot consumer reporting line
• Risk Management Plans being introduced
• Life cycle management of products

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Challenges

• Pharmacovigilance still largely limited to
  spontaneous reporting
• Data mining-potentials and pitfalls
• Risk management
• Pharmacoepidemiology
• Global problems global responses

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When to act?

• Occasionally, a series of reports (case series)
  is sufficient support for regulatory action
• Generally, need robust comparative information on
  incidence or relative risk for a confident risk
  assessment,
• But we all operate in a rapid knowledge global
  environment, as do the health professionals and
  consumers we serve

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Who is involved in pharmacovigilance activities
today?

• Regulators
• Industry
• Health providers and Health professionals
• Consumers
• Media
• Society

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Paradigm shift

• From
• Regulatory agencies and companies largely
  control regulatory information flow
• To
• Access for all to large amounts of information
  of unknown or uncertain reliability from
  everywhere- a global and unregulated market for
  information

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Product Information (PI)

• The PI seeks to ensure that medicines are used
  appropriately in the community, that is, as
  recommended by the sponsor, and agreed by the
  regulator.

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PI documents are important

• PI documents communicate information to health
  professionals
• Information that provides guidance on
• what medicine to choose for a patient
• at what dose and for how long
• what are likely, or possible, problems from use.

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The value of the PI

• Value of the PI is when seen as a trusted, up to
  date and reliable source of information by its
  users
• Users can be health professionals or consumers
• (Australia has dedicated consumer documents in
  lay language reflecting PI messages-CMI)

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Challenge of the PI for industry and regulators

• Need to adapt to the new environment in terms of
• Modes of delivery of PI and information
• Preparedness to include information to make the
  PI a reliable source
• Preparedness for transparency on unknowns
• Need for clear messages

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TGA website http//www.tga.gov.au

• Pharmacovigilance information
  http//www.tga.gov.au/safety/monitoring.htm