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Presentation: Risk Minimisation
This document discusses risk minimization activities for pharmaceutical products. It explains that risk minimization involves selecting, implementing, and evaluating activities to reach the target population and minimize adverse drug reactions. Key steps include selecting additional risk minimization measures, implementing them by disseminating information to the target groups, and evaluating the implementation through process and outcome indicators with the goal of minimizing adverse drug reactions. The document provides examples of implementation plans and evaluating effectiveness through surveys. It notes that risk minimization activities may need to be reassessed and adjusted if not working as intended.
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Presentation: Risk Minimisation
- 1. 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
- 2. How does riskminimisation work? Risk minimisation activities Reaching the target population (implementation) Clinical knowledge Clinical actions Ultimate Goal Minimal occurrence of ADR Select, implement, and evaluate risk minimisation activities March 2019 1
- 3. Select additional riskminimisation activities Select, implement, and evaluate risk minimisation activities March 2019 2
- 4. How does riskminimisation work? Risk minimisation activities Reaching the target population (implementation) Clinical knowledge Clinical actions Ultimate Goal Minimal occurrence of ADR Select, implement, and evaluate risk minimisation activities March 2019 3
- 5. Implement risk additionalminimisation 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 Select, implement, and evaluate risk minimisation activities March 2019 4
- 6. Table 4: Australianimplementation 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 Mailing 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 Mailing list reviewed every 6 months and brochure mailed to new additions. Repeat mail at 18 months after launch Select, implement, and evaluate risk minimisation activities March 2019 5
- 7. How does riskminimisation work? Risk minimisation activities Reaching the target population (implementation) Clinical knowledge Clinical actions Ultimate Goal Minimal occurrence of ADR Process indicators Outcome indicators Ultimate Goal Minimal occurrence of ADR Select, implement, and evaluate risk minimisation activities March 2019 6
- 8. Evaluate additional riskminimisation activities Select, implement, and evaluate risk minimisation activities March 2019 7
- 9. You hope itworks like this… Risk minimisation activities Reaching the target population (implementation) Clinical knowledge Clinical actions Ultimate Goal Minimal occurrence of ADR PASS, AE reporting, PSUR, other 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 Select, implement, and evaluate risk minimisation activities March 2019 8
- 10. What if itdoesn’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 occurrence 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 Select, implement, and evaluate risk minimisation activities March 2019 9
- 11. Standard clinical practice Reassessand adjust Eventually it works like this… Risk minimisation ↓ ADRs from AE reporting, PSURs, other post-market data Select, implement, and evaluate risk minimisation activities March 2019 10
- 12. 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 11