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 Reaching the Ultimate Goal Clinical minimisation target Minimal knowledge Clinical actions activities population occurrence of (implementation) ADR Select, implement, and evaluate risk minimisation activities 1 March 2019

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

How does risk minimisation work? Risk Reaching the Ultimate Goal minimisation target Clinical Minimal Clinical actions activities population knowledge occurrence of (implementation) ADR Select, implement, and evaluate risk minimisation activities 3 March 2019

Implement risk additional minimisation activities: reaching target population What to consider How to plan S pecific Target population M easurable Layout and content A ttainable Timing and frequency of distribution R elevant Methods of distribution T ime-based Select, implement, and evaluate risk minimisation activities 4 March 2019

Record your implementation plan in the ASA Table 4: Australian implementation of additional risk minimisation activities (example) Additional risk minimisation Target audience Implementation details, Time-points for and activity including method (s) of frequency of dissemination dissemination e.g. health professional guide GPs Paper copies posted to GPs At launch and checklist pharmacists and pharmacists on sponsor- M ailing list reviewed every 6 held mailing list 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 At launch provide to patients (initial M ailing list reviewed every 6 mailing of 5 copies); GPs can months and brochure mailed re order through sales reps to new additions. and medical information. Repeat mail at 18 months Electronic copies available after launch through patient support program website Select, implement, and evaluate risk 5 minimisation activities March 2019

How does risk minimisation work? Risk Reaching the Ultimate Goal Ultimate Goal minimisation target Clinical Minimal Minimal Clinical actions activities population knowledge occurrence of occurrence of (implementation) ADR ADR Process indicators Outcome indicators Select, implement, and evaluate risk minimisation activities 6 March 2019

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

You hope it works like this… Ultimate Goal Risk Minimal Reaching the target minimisation Clinical Clinical actions occurrence of population activities knowledge (implementation) ADR Survey to test knowledge and action 6 months after the product supply. Target: PASS, AE HCP education Material sent to to send 100 survey invitations, to receive reporting, PSUR, doctors by email ≥ 30 responses. Knowledge test: ≥ 90% other post- pass rate market data Select, implement, and evaluate risk minimisation activities 8 March 2019

What if it doesn’t work out as expected… Risk Reaching the Ultimate Goal Clinical minimisation target Minimal Clinical actions knowledge activities population occurrence of (implementation) ADR Cut educational 20 doctors responded to the survey. 19 material down to PASS, AE Material sent to Recommendation on regular monitoring doctors knew the safety risk, but only 9 HCP education reporting, 3 pages, move doctors by was on page 10 of the 15-page knew they needed to conduct regular PSURs, other monitoring emails educational material. monitoring. recommendation post-market data to 1st page Reassess Select, implement, and evaluate risk minimisation activities 9 March 2019

Eventually it works like this… Standard clinical practice ↓ ADRs from AE Risk reporting, minimisation PSURs, other post-market data Reassess and adjust Select, implement, and evaluate risk minimisation activities 10 March 2019

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