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An agency of the European Union

How does the EU Regulatory Network communicates about risk minimisation?

PCWP/HCPWP Workshop on risk minimisation measures - 16 September 2015

Viola Macolić-Šarinić, Agency for Medicinal Products and Medical Devices (HALMED), (Croatia)

Juan Garcia-Burgos, European Medicines Agency (EMA)

Introduction

• New legislation in pharmacovigilance: – Unprecedented focus on (safety) communication by regulatory authorities

– Communication as a key instrument for risk minimisation

– environment of enhanced openness and transparency

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• Risk communication:

– part of risk assessment and risk minimisation

– clear messages - right audience - right time

– tailored to audiences - appropriate tools and language

– always in context- benefit

– always address uncertainties

– use of quantitative measures

– Involve users of medicines - preparation

– Measure effectiveness

2

Communicating within the EU Regulatory Network

EMA does not target individual EU patients and healthcare professionals, instead:

– Strong coordination with EU Member States

– EU patients and health professionals receive clear, timely and consistent messages on

the safety of their medicines

– Strong collaboration with patients and healthcare professionals'’ organisations

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Target audiences

Communication about risk minimisation issued by regulators:

– Primary target audience: patients and healthcare professionals

– Media

– Health ministries, public and private health bodies

– Others

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Information made available at central level

• ‘Product Information’ kept up-to-date (and multilingual) for all medicines centrally authorised

– Reference source for routine minimisation measures

– aligned with additional measures

• Dear Health Care Professional Communication (DHPC)

– not published at central level

• EMA safety communications

• Information on Risk Management Plans

– e.g. RMP summaries

• Information on PSURs assessment & signals

5

EMA safety communication

Start of safety review by PRAC

PRAC recommendation

CHMP/CMD(h)

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EMA safety communication

7

Direct healthcare professional communication (DHPC)

• Involves both industry and regulators

– important safety information

– delivered directly to individual healthcare professionals

– Ask them to take actions or adapt their practices

• Process has been streamlined – clear criteria applies

• DHPCs agreed at EU level involve PRAC

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Summary of risk management plan

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Summary of risk management plan

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Input from patients, consumers and healthcare professionals

• Individuals nominated by ‘EU Network of eligible organisations’:

− through PCWP and HCPWP

− No financial support available

• Help us in:

− Designing and adapting communication tools

− Preparation of actual communication materials

− Dissemination of key information timely among members

• Excellent feedback and experience.

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Patient input – EMA safety communication

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Patient input - EMA safety communication

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Patient/healthcare professional input

Example: Combined Hormonal Contraceptives (CHCs)

European Society of Gynaecology

European association of general practitioners

European association of consumers (BEUC)

European Institute of women’s health

Positive feedback on pre-tested messages

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15

16

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18

EM

A

NC

As

HC

Ps

MA

Hs

PRAC

CHMP

MAH

Patients

MAH(s)

Patients

Patients

HCPs

HCP

DHPC and

communication

plan (in English)

Submission of

translated DHPC

to the NCAs

Dissemination of

DHPC

Implemetation of the

communicated

issues

Communication plan

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19

Challenges

• Translation of the DHCP – timelines and collaboration with the

MAHs

• Collaboration between MAHs to issue one DHCP

• Dissemination of the DHCP

• Availability of the information for HCPs and patients

• Impact of the DHCP to clinical practice?

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20

NCAs need

PhV dedicated person for safety

communication and strong PR team

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DHCP in a case of a referral

Example

21

22

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24

25

26

Dissemination and availability of the DHPC

Example

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28

29 Ivabradine – 2 DHPCs

E-prescription system (GP software/health database)

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1

. 2

.

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Collaboration with patient organisations

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32

http://www.rijetke-bolesti.hr/

Croatian patient organisation for rare diseases

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33 http://www.rijetke-bolesti.hr/

Croatian patient organisation for rare diseases

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Educational materials

Have to be approved nationally

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35

36

Other ways of communication

The theatre example

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38

You should talk

about and report

side effects of

your medicines

What are

side effects?

Antiepileptics 39

Questions?

40

Thank you for your attention

Further information

Juan.Garcia@ema.europa.eu

Viola.Macolic@halmed.hr

Agencija za lijekove i medicinske proizvode

Ksaverska cesta 4, 10 000 Zagreb

Tel.: +385 1 4884 100 (centrala) • Faks: +385 1 4884 110

E-pošta: halmed@halmed.hr

www.halmed.hr