Risk minimisation activities identification and application Dr Jane - - PowerPoint PPT Presentation

Risk minimisation activities – identification and application

Dr Jane Cook Branch Head Pharmacovigilance and Special Access Branch 11 November 2015

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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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
• n the risk-benefit profile

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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

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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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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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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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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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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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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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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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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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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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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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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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