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					    EMA Geriatric Medicines Strategy:

                                           focus on

                           Pharmacovigilance


    Francesca Cerreta

    EMA, H-SE-CNS

1   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
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)

2   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
     Why did we need a strategy?
•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)

3    Geriatric Medicines Strategy - Informal PhVWP Oct 2011
EMA Geriatric Medicines Strategy


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.

4   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
            Initial findings mid-2009 to present:
            “elderly” vs. “non-elderly” conditions
                       "Elderly" conditions                                    "Non-elderly" conditions
              100%                                                      100%
    100%                                                      100%
     90%                                                       90%
     80%                                                       80%
     70%                                                       70%
     60%                                                       60%
     50%                                                       50%
     40%                   34.58%                              40%
     30%                                                       30%
     20%                                                       20%
     10%                                3.38%       0.13%      10%                   3.19%        0.34%      0.06%
      0%                                                        0%
           Total number Total number   75-84 yrs   ≥ 85 yrs          Total number Total number   75-84 yrs   ≥ 85 yrs
             enrolled     of elderly                                   enrolled     of elderly
                          enrolled                                                  enrolled




5      Geriatric Medicines Strategy - Informal PhVWP Oct 2011
                 Initial findings
    a closer look at “non-elderly” conditions

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

7   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
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

 8   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
                       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

9   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
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 65-74                Age 75-84   Age 85+
     PK Trials               number /total
                             number
     Controlled Trials
     Non Controlled
     trials


10   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
     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
11   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
     Changes to the CHMP AR (Safety -2)
                                              Age <65 yrs     Age 65-74   Age 75-84   Age 85+


Total
Fatal
Serious
Withdrawal
CNS (confusion/extrapyramidal)
AE related to falling
CV events
Cerebrovascular events
Infections




12   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
EMA Geriatric Medicines Strategy – Key points (2)
“..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)


 13   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
EMA Geriatric Medicines Strategy – Key points (3)

“..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)


14   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
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


15   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
                  Identifying the needs:
             Geriatric Needs Survey to PhVWP
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

16   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
            Identifying the needs:
 draft Geriatric Needs Survey to PhVWP (1)
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?

17   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
            Identifying the needs:
 draft Geriatric Needs Survey to PhVWP (2)
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?

18    Geriatric Medicines Strategy - Informal PhVWP Oct 2011
            Identifying the needs:
 draft Geriatric Needs Survey to PhVWP (3)
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

19   Geriatric Medicines Strategy - Informal PhVWP Oct 2011
                                        Thank you

     Please send any comments on the draft Survey
                       and volunteer for focus group
                                   by October 20th to


                 Francesca.Cerreta@ema.europa.eu



20   Geriatric Medicines Strategy - Informal PhVWP Oct 2011

				
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