1. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 1 EMA Geriatric Medicines Strategy: focus on Pharmacovigilance Francesca Cerreta EMA, H-SE-CNS

2. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 2 Objectives of this presentation Recall why we did need a strategy Focus on key points of strategy and update on their implementation Presentation of initial findings and results Geriatric Needs Survey (PhV)

3. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 3 Demographic challenge Stakeholder expectations EMA Roadmap to 2015 CHMP workprogramme 2010-13 Follow up to 2006 analysis requested by EC EU political agenda (parliament intergroup/2012 EU year of ageing/ EC Partnership) Why did we need a strategy?

4. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 4 The Vision: Medicines used by geriatric patients are of high quality, and appropriately researched and evaluated, throughout the lifecycle of the product, for use in this population. Improving the availability of information on the use of medicines for older people, thereby helping informed prescription. EMA Geriatric Medicines Strategy

5. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 5 Initial findings mid-2009 to present: “elderly” vs. “non-elderly” conditions

6. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 6 Initial findings a closer look at “non-elderly” conditions “Non-elderly” conditions Proportion of elderly (65-84 yrs) Proportion of elderly (85+ yrs) Influenza (Fluenz, Aflunov, Humenza, Emerflu) 1.97%>0.01% Schizophrenia (Xeplion) 1.2%0.01% Bipolar I disorder (Sycrest) 1.79%No info

7. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 7 Can we do better? Two-pronged approach is needed to better use the tools we already have: Industry: follow guidelines. Discuss innovative solutions with the regulators Regulators: coordinate activities and improve communication to the patient and to the prescriber !! No new processes or requirements !!

8. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 8 EMA Geriatric Medicines Strategy-Key points (1) “..ensuring that the development and evaluation of new medicines takes into account specific safety and efficacy aspects related to aging, in accordance with current guidelines, particularly ICH E7” Peer Review comments (EMA) AR template (+RMP template) SmPC/PL and EPAR to reflect data appropriately Guideline drafting and revision

9. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 9 Changes to the CHMP AR Both AR templates and guidance Approved September 2011 Changes in line with the spirit of ICH E7 Published/into force Oct/Nov 2011 Aim is to focus attention of reviewer on geriatric data: –Amount –Context –Missing information

10. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 10 Changes to the CHMP AR (Efficacy) include a clear description of epidemiology in relation to age within special populations PK or absence Need for dose adjustment discussed Age 65-74Age 75-84Age 85+ PK Trials number /total number Controlled Trials Non Controlled trials

11. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 11 Changes to the CHMP AR (Safety -1) Specific consideration to risk-benefit analysis in this population available information on concurrent pharmacotherapy should be discussed, particularly when a potentiation of adverse effects could be expected in combination with concurrently administered drugs RMP (risk management plan): Comment on how robustly the safety data is going to be collected. Consider how the data will be summated, in order to avoid a signal dilution

12. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 12 Changes to the CHMP AR (Safety -2) Age <65 yrsAge 65-74Age 75-84Age 85+ Total Fatal Serious Withdrawal CNS (confusion/extrapyramidal) AE related to falling CV events Cerebrovascular events Infections

13. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 13 “..identifying gaps in regulatory and scientific knowledge and taking appropriate measures to tackle them” Provision of Scientific Advice during product development Comments during drafting of guidelines Frailty definition and scales Geriatric formulations and compliance Workshop 20-22 March 2012 (to be confirmed) EMA Geriatric Medicines Strategy – Key points (2)

14. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 14 “..consideration for the need of specific pharmacovigilance activities” We recognise recruitment in CT is difficult- but.. Benefit/risk balance? Specific consideration of undesirable effects? (eg sedation, orthostatic and cardiovascular effects) Signal detection (and problems in ADR reporting) EMA Geriatric Medicines Strategy – Key points (3)

15. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 15 EMA Geriatric Medicines Strategy – Key points (4) “..fostering and utilising a relevant experts’ pool to address specific issues as requested by the CHMP, making full use of its Working Parties and experts groups where appropriate.” Establishment of the CHMP Geriatric Advisory group Mandate adopted May 2011 Two teleconferences to date

16. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 16 Objective: Identify geriatric activities and instruments (or lack of) at national and European level in post-authorisation of medicines. Steps: 1.Initial discussion at informal PhVWP 2.TC with focus group volunteers to finalise questions 3.November 2011: run the survey Identifying the needs: Geriatric Needs Survey to PhVWP

17. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 17 Lists of preferred medicines 1.Do you have a list of preferred medicines for the elderly? 2.Is this list specific to nursing homes? Appropriate prescription 3.In your country, do you have any measures in place to monitor/ avoid dispensing incompatible or inappropriate medications to older people 4.In your country, are there measures in place to monitor that reduced dosage limits are prescribed to older people, when applicable? Identifying the needs: draft Geriatric Needs Survey to PhVWP (1)

18. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 18 Post Marketing activities 5.Do you have any specific pharmacovigilance or post-marketing activities or programmes relating to older people in care or home settings? 6.Has your agency required post marketing trials in the elderly to confirm effectiveness in this population? 7.Do you have any specific databases to record ADRs in the elderly (eg general population, nursing home) 8.Do registries exist to monitor elderly diseases ( eg parkinson Alzheimer) TEAE reporting 9.Do you have any guidelines for ADR reporting in case of polymedicated patients? 10.Do you have any suggestions to improve ADRs reportingin older people? Identifying the needs: draft Geriatric Needs Survey to PhVWP (2)

19. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 19 Geriatric Expert groups 11.In my country the Agency (or ministry) has instituted a specific geriatric advisory group 12.If Yes: the group deals with: Safety and Efficacy topics; HTA topics; Both 13.If no: Are you planning to create such a group? 14.Are patient representatives involved in the group (or will be involved if the group has to be created)? Other 15.Additional comments Identifying the needs: draft Geriatric Needs Survey to PhVWP (3)

20. Geriatric Medicines Strategy - Informal PhVWP Oct 2011 20 Thank you Please send any comments on the draft Survey and volunteer for focus group by October 20th to Francesca.Cerreta@ema.europa.eu