Pharmacovigilance in Australia The Past, Present and Future

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Pharmacovigilance in AustraliaThe Past, Present
and Future

• Dr Rohan Hammett
• Principal Medical Adviser
• Therapeutic Goods Administration

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How hazardous is healthcare? (Leape)
Dangerous Regulated Ultrasafe (gt1/1000) (lt
1/100 000)
Total lives lost per year
Healthcare
100 000
Driving
10 000
1000
Chemical manufacturing
Scheduled airlines
100
Mountain climbing
European railroads
10
Chartered flights
Nuclear power
Bungee jumping
1
10
100
1000
10 000
100 000
1M
10 M
1
Number of encounters for each fatality
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National Medicines Policy
Access/Subsidy
Quality, safety and efficacy
Quality use of medicines
Responsible and viable medicines industry
TGA
Best possible health outcomes for all Australians
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PharmacovigilanceIndustry perspective

• What isnt working?
• What is working?

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Pharmacovigilance Issues

• Pre-market focus
• Lack of transparency
• Consistency in decision making
• Anecdotal data
• Reporting for reportings sake
• Lack of consumer input
• Crisis management

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Pharmacovigilance The Past

• 1961 thalidomide embryopathy

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Pharmacovigilance The Present

• Evaluation
• Periodic safety update reports
• ADR reporting
• voluntary (health professionals)
• mandatory (industry)
• Product testing
• Data linkage analysis
• Pharmacoepidemiology

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ADR reporting

• of 10,000 reports annually
• 94 involve prescription medicines
• 3 each OTC and complementary medicines
• 80-90 from GPs, hospitals, industry, and State
  Health Departments
• 3 from consumers over recent years

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Current pharmacovigilance system

• Strengths
• Rigorous evaluation
• Signal detection
• Expert input
• Participation rates

• Vulnerabilities
• Pre-market focus
• Anecdotal reports
• Ascertainment bias
• Hypothesis generation not testing
• Reactive not proactive
• Regular crises
• Knee-jerk reactions
• Participation falling
• Tip of the iceberg

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• Every system is perfectly designed to get the
  results it gets
• Don Berwick IHI

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What results from our current system?

• Pre-market studies 500-3000 patients
• detection of adverse event rates to 1 in 100.
• Post-market serious events
• Regular crises of public confidence
• 1 in 25 medicines withdrawn from market for
  safety
• Long-term lack of trust in medicines industry and
  all associated with it
• More risk averse pre-market evaluation
• Delayed release to market
• Reduced market share/falling bottom line

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We need to redesign the system

• EMEA Guidelines on Pharmacovigilance for
  Medicinal Products for Human Use
• Pharmacovigilance plans
• Risk managed prescribing
• Sentinel sites
• Intensive monitoring schemes
• Registeries
• Post-market studies
• Data base linkage
• Pharmacogenomics
• ADR reports
• Bayesian analysis
• etc

• Maintain rigorous pre-market assessment but
  acknowledge its limitations
• Greater planning of post-market vigilance e.g
  EMEA guidelines
• Caution in early post-market phase conditional
  registration
• Rigorous post-market studies
• Transparency in regulatory and reporting process
• Community and political understanding of risks

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How it could work practically

• International data cooperation
• Provisional registration of first of class NCEs
• Industry produced and implemented
  pharmacovigilance plans
• Post-market studies and registeries
• Web access to ADR reports, decisions, CMI/PI
• Communication, communication, communication
• US Joint Commission on Prescription Drug Use 1980

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Benefits of redesign

• Consumers
• Realistic understanding of risks
• Greater monitoring of safety
• Earlier access to product
• Industry
• Earlier access to market
• Greater understanding amongst community/ better
  risk management
• Improved transparency/consistency of regulation
• International harmonisation
• Government
• Fewer crises
• Proactive management of public safety
• Cost neutral

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Its not just a problem here
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Where to from here?

• Thats up to you
• Thank you.