How does risk minimisation work? Risk Reaching the Ultimate Goal - - PowerPoint PPT Presentation

Risk minimisation

Selecting, implementing, and evaluating activities

Vicky Dong Risk Management Plan Evaluation Section, Pharmacovigilance & Special Access Branch Medicines Regulation Division, TGA Australian Pharmacovigilance regulatory Requirements and Risk Management Plans Summit March 2019

How does risk minimisation work?

Risk minimisation activities Reaching the target population (implementation) Clinical knowledge Clinical actions Ultimate Goal Minimal

• ccurrence of

ADR

Select, implement, and evaluate risk minimisation activities March 2019 1

Select additional risk minimisation activities

Select, implement, and evaluate risk minimisation activities March 2019 2

How does risk minimisation work?

Risk minimisation activities Reaching the target population (implementation) Clinical knowledge Clinical actions Ultimate Goal Minimal

• ccurrence of

ADR

Select, implement, and evaluate risk minimisation activities March 2019 3

Implement risk additional minimisation activities: reaching target population

What to consider How to plan

Target population Specific Layout and content Measurable Timing and frequency of distribution Attainable Methods of distribution Relevant Time-based

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Table 4: Australian implementation of additional risk minimisation activities (example)

Record your implementation plan in the ASA

Additional risk minimisation activity Target audience Implementation details, including method (s) of dissemination Time-points for and frequency of dissemination e.g. health professional guide and checklist GPs pharmacists Paper copies posted to GPs and pharmacists on sponsor- held mailing list At launch M ailing list reviewed every 6 months and brochure mailed to new additions Repeat mail at 18 months after launch e.g. patient guide Patients Paper copies posted to GPs to provide to patients (initial mailing of 5 copies); GPs can re order through sales reps and medical information. Electronic copies available through patient support program website At launch M ailing list reviewed every 6 months and brochure mailed to new additions. Repeat mail at 18 months after launch

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How does risk minimisation work?

Risk minimisation activities Reaching the target population (implementation) Clinical knowledge Clinical actions Ultimate Goal Minimal

• ccurrence of

ADR

Process indicators Outcome indicators

Ultimate Goal Minimal

• ccurrence of

ADR

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Evaluate additional risk minimisation activities

Select, implement, and evaluate risk minimisation activities March 2019 7

You hope it works like this…

Risk minimisation activities

Reaching the target population (implementation)

Clinical knowledge Clinical actions Ultimate Goal Minimal

• ccurrence of

ADR PASS, AE reporting, PSUR,

• ther post-

market data HCP education Material sent to doctors by email Survey to test knowledge and action 6 months after the product supply. Target: to send 100 survey invitations, to receive ≥ 30 responses. Knowledge test: ≥ 90% pass rate

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What if it doesn’t work out as expected…

20 doctors responded to the survey. 19 doctors knew the safety risk, but only 9 knew they needed to conduct regular monitoring.

Reassess

Risk minimisation activities Reaching the target population (implementation) Clinical knowledge Clinical actions Ultimate Goal Minimal

• ccurrence of

ADR HCP education Material sent to doctors by emails Recommendation on regular monitoring was on page 10 of the 15-page educational material. PASS, AE reporting, PSURs, other post-market data Cut educational material down to 3 pages, move monitoring recommendation to 1st page

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Standard clinical practice Reassess and adjust

Eventually it works like this…

Risk minimisation ↓ ADRs from AE reporting, PSURs, other post-market data

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Resources

• TGA guidance: Risk management plans for

medicines and biologicals TGA guidance: Australian-Specific Annex template TGA adopted EMA Guideline on good pharmacovigilance practices Module XVI

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