This presentation provides an overview of the principles for selecting and implementing risk minimisation tools

1. Risk minimisation activities – identification and application
Dr Jane Cook
Branch Head
Pharmacovigilance and Special Access Branch
11 November 2015

2. What are risk minimisation activities?
• Initiatives that attempt to positively influence patients or health care professional
behaviours, and through these changes lead to an improved patient outcomes
• Focus on minimising harms
• Need to plan the level of change or achievement of outcome indicators that the
intervention was successful
• A protocol for how the evaluation will occur needs to be developed and this
should specify the metrics and thresholds by which the programme success will
be measured and audited
• Should be supplied with the Risk Management Plan (RMP)
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3. Risk minimisation activities
Focus on:
• Risk prevention – identifying those at particular risk through testing and not
prescribing, adjusting dose, etc.
• Risk mitigation – usually relies on monitoring during therapy to identify
increases in risk and allow for intervention
• Neither preventable or able to be mitigated – may be acceptable depending
on the risk-benefit profile
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4. Types of risk minimisation activities
• Communication
– DHCP letters/information
– Prescribing dispensing guidelines
– Patient brochures, alert cards
– Education
• Restricted access
– Registration programmes for patients
– Certification programmes for prescribers/dispensers
– Limited pack size, repeats, dosage forms
– Dispensing linked to test confirmation
– Certain types of prescribers
– Limited to patient specific group – limited pharmacogenomic profile
• Controlled regulatory framework - scheduling 3

5. Tool selection factors
• 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
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6. Tool selection
Risk identification
• Patient journey mapping (from point of diagnosis until drug cessation, incl. risk)
• For any part of the patient journey:
– Identification and characterisation of points where additional risk minimisation
may be needed
– Identification of stakeholders (i.e. the target of the intervention)
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7. Tool selection
Risk identification
• For each potential issue:
– Risk recognition (triage/signal detection)
– Risk characterisation and categorisation:
§ Consider severity/likelihood (for risk-benefit balance and public health
impact)
– Risk categorisation:
§ By level of evidence (important identified risk, important potential risk,
missing information)
§ By level of risk
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8. Tool selection
Goal setting
• Identification of:
– Goals (global strategy for risk minimisation)
– Objectives (how the goal is achieved)
– Targets (stakeholders or sites of risk minimisation intervention)
• Consider SMART criteria for goals and objectives – specific, measurable,
achievable, relevant, time-bound.
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9. Tool selection
Health care system integration and burden considerations
• Analysis of health care system:
– Considers existing health care system (incl. health care infrastructure;
prescriber characteristics; potential variability in standards of care across
regions)
– Considers patient requirements (incl. access for vulnerable populations)
– Considers proportionality and potential burden:
§ Individual vs. population burden
§ Burden tolerance (potentially higher for more favourable risk-benefit balance)
§ Prior stakeholder experience
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10. Tool selection
Evidence-based activities
• Additional risk minimisation activities should be evidence based
• Potential considerations include:
– Comprehensive literature review (including competent authority websites and
grey literature)
– Experience with similar products
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11. Tool selection
Tool matching
• One tool can address more than one objective and an objective could be
addressed by more than one tool.
• Consider choosing the most effective tool to achieve an objective.
• Tools need to achieve an acceptable risk-benefit balance for a product.
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12. Governance
• The governance structure should provide:
– Approval, advice and oversight of the process and plan;
– Consistency of local programmes with the strategy, risk minimisation plan and
regulatory requirements;
– A robust tracking system for local implementation;
– Appropriate metrics and corrective and preventive actions (CAPA) and their
regular review;
– Adequate resources for implementation and evaluation.
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13. Implementation
• In implementing its risk minimisation strategies, MAHs should ensure:
– Adequate internal communication and infrastructure, including the education of
key internal stakeholders;
– Support of local implementation efforts including development of a core risk
minimisation plan and tools, provision of educational materials for affiliates on
their use, and institution of tracking procedures that provide a way to measure
implementation of risk minimisation activities at the local level.
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14. Risk Minimisation Programme
• You have identified the risks to be mitigated.
• You have selected the tools (activities) to be used in the programme.
• You need to ensure appropriate governance and implementation.
• You now need to ensure the activities will meet their objectives and be successful
in mitigating the identified risks (separate presentation).
• You now need to develop an evaluation framework (separate presentation).
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15. Summary
• Life-cycle approach
• Should be simple, pragmatic and user friendly to prevent undue clinician and
patient workload
• Risk management programme should aim to in the real world ensure that “the
right prescriber provides the right medicine to the right patient at the right dose
and right time”.
• Appropriate implementation and governance measures need to be in place.
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