Transcript EMA geriatric medicines strategy

EMA Geriatric Medicines Strategy:
focus on
Pharmacovigilance
Francesca Cerreta
EMA, H-SE-CNS
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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)
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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)
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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.
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Geriatric Medicines Strategy - Informal PhVWP Oct 2011
Initial findings mid-2009 to present:
“elderly” vs. “non-elderly” conditions
"Non-elderly" conditions
"Elderly" conditions
100%
100%
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
34.58%
Total number Total number
enrolled
of elderly
enrolled
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3.38%
0.13%
75-84 yrs
≥ 85 yrs
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Geriatric Medicines Strategy - Informal PhVWP Oct 2011
3.19%
Total number Total number
of elderly
enrolled
enrolled
0.34%
0.06%
75-84 yrs
≥ 85 yrs
Initial findings
a closer look at “non-elderly” conditions
“Non-elderly” conditions
Influenza
Proportion Proportion
of elderly of elderly
(65-84 yrs) (85+ yrs)
1.97%
>0.01%
(Fluenz, Aflunov, Humenza, Emerflu)
Schizophrenia
1.2%
0.01%
1.79%
No info
(Xeplion)
Bipolar I disorder
(Sycrest)
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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 !!
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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
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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
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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
PK Trials
Age 75-84
number /total
number
Controlled Trials
Non Controlled
trials
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Geriatric Medicines Strategy - Informal PhVWP Oct 2011
Age 85+
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
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Geriatric Medicines Strategy - Informal PhVWP Oct 2011
Changes to the CHMP AR (Safety -2)
Age <65 yrs
Total
Fatal
Serious
Withdrawal
CNS (confusion/extrapyramidal)
AE related to falling
CV events
Cerebrovascular events
Infections
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Geriatric Medicines Strategy - Informal PhVWP Oct 2011
Age 65-74
Age 75-84
Age 85+
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)
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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)
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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
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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
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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?
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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?
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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
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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
[email protected]
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Geriatric Medicines Strategy - Informal PhVWP Oct 2011