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Presentation: Risk minimisation in the Australian context

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

18 August 2016


These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.


  • Presented by: Dr Claire Larter
  • Presented at: ARCS Scientific Congress Canberra
  • Presentation date: 10-11 August 2016
  • Presentation summary: This presentation describes Risk Minimisation including general principles and the tools available for the development of Risk Minimisation Plans (RMPs)


Risk minimisation in the Australian context

Dr Claire Larter
Acting Co-Director, Risk Management Plan Evaluation Section
Pharmacovigilance & Special Access Branch
Medicines Regulation Division, TGA

ARCS Scientific Congress Canberra 2016, 11 August 2016

Slide 1 - Presentation overview

  • What is risk minimisation?
  • General principles for risk minimisation plans
  • Tools available for risk minimisation
  • How to describe your risk minimisation plan in the ASA

Slide 2 - What is risk minimisation?

  • Part of risk management → described in the RMP
  • Intended to improve patient outcomes
    • Optimise risk: benefit
    • Minimise harm
  • Includes both risk prevention and risk mitigation
    • Some risks are neither preventable or able to be mitigated
    • May be acceptable depending on benefit

Slide 3 - Risk minimisation requires understanding the risks of the product

  • Inherent risks, including:
    • Likelihood
    • Severity (including reversibility)
    • Preventability
  • Risk factors in the population
  • Intended and potential use

Slide 4 - General risk minimisation principles

  • Iterative process that continues throughout the lifecycle of the product
    • Pre-registration → plan to minimise risks identified during development, know where the gaps are
    • Post-registration → address emerging risk
  • Consider the burden of risk minimisation
    • On patients and the healthcare system
    • Burden should be proportionate to risk

Slide 5 - Developing an effective risk minimisation plan

  • Appropriate tool selection
    • Choose most effective tool to achieve an objective
  • Must be well planned
    • Clear goals
    • More likely to succeed if integrated into the health system
    • What success is should be well defined and measurable
      • Process indicators
      • Outcome indicators
    • Plan should be adapted as necessary

Slide 6 - Risks requiring additional risk minimisation should be carefully selected

  • Are there risks that cannot be minimised by routine measures?
  • This requires knowledge of the medicine:
    • Indication, population, risks
    • Overall risk-benefit
    • Setting of use
    • Will "real-world" use likely differ from intended use?
    • Potential for misuse

Need to consider how these factors may interact

Slide 7 - Risk minimisation tools

Routine Additional
Product Information Patient education
Consumer Medicine Information Patient Alert Cards
Product labeling Healthcare profession education
Legal (prescription) status Dear healthcare professional letter
Pack size & design Safety device design
  Restricted access
  Patient registry

Slide 8 - Selecting the appropriate tools

  • Will depend on the following factors:
    • Risk identification: recognition (existence of a risk) and characterisation (level of risk)
    • Goal setting: goals, objectives and targets
    • Health care system integration: adaptation to local requirements
    • Evidence-based activities: based on scientific literature or other evidence
    • Proportionality/Burden considerations: reasonable minimisation-burden balance
  • A comprehensive strategy may require a range of interventions

Slide 9 - Commonly used tools in Australia

  • 37 RMPs were evaluated for new chemical entities in 2015.
  • 26 included additional risk minimisation activities
  • Education was the most common activity

Graph displaying commonly used risk minimisation tools in Australia. Patient education: 10, Health professional education: 14, Controlled access scheme: 2, Pregnancy prevention program: 1

Slide 10 - Patient Education

  • Patient brochures, websites for patients
  • Targeted to specific patient populations
  • Useful for products where patient behaviors can influence safety
Advantages Disadvantages
Promote appropriate use Requires periodic assessment ± updating
May increase early detection of AEs Can be a burden for dispensers
Reinforce instructions given by healthcare professionals May be dependent on health literacy
May be perceived as marketing

Slide 11 - Healthcare professional communication

Dear healthcare professional letters

  • Useful for:
    • Medicines that require adherence to special guidance to manage risks
    • Changes in indication that may involve a different dosing regimen
    • Emerging safety concerns
  • Broad and rapid dissemination of information
  • Effect can fade over time
  • Can be overlooked

Slide 12 - Healthcare professional communication

  • Prescribing/ dispensing guides
    • Useful for complicated dosing regimens, managing drug-drug interactions or medicines that may require dose adjustments, etc...
  • Targeted education
    • Useful for medicines that require additional monitoring (e.g. renal function), different use in different populations, etc...
Advantages Disadvantages
Enhance prescriber knowledge Requires periodic assessment ± updating
Clinically useful - can keep for future reference Can be a burden for dispensers
Can be integrated into continuing professional development activities May be perceived as marketing

Slide 13 - Restricted access schemes

  • Less commonly used
  • Different models
    • Patient registration
    • Prescriber/ dispenser certification
    • Dispensing linked to test confirmation
    • Certain types of prescribers
  • Detailed documentation critical
    • How the system will work
    • How it will be checked for effectiveness

Slide 14 - Describing risk minimisation in the ASA

  • Follow the template

Australian-Specific Annex template

  1. Risk minimisation plan
    1. 3.1 How risk minimisation activities will be implemented in Australia.
    2. 3.2 Potential for medication errors or other risks if applicable
    3. 3.3 How risk minimisation activities will be evaluated in Australia
  2. Summary of the RMP

Slide 15 - Consider what is different about Australia?

What are the features of our health system, medical practice, geography, population and culture that could influence how risk minimisation tools are selected and implemented?

  • Indigenous population
  • Large Asian population
  • Rurality/ lack of access to specialist services
  • State vs federal control over some aspects of how medicines are used
  • Access to health professionals and information

Slide 16 - Key areas in the ASA for risk minimisation

  • Compare activities between EU and Australia for all safety concerns
    • Identify and justify differences
    • Describe local implementation
    • Include exact wording of PI statements
  • Include evaluation plan
  • Include any proposed educational materials as an appendix

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