Dolores Montero Division of Pharmacoepidemiology and Pharmacovigilance

Department of Human Medicines

Regulatory initiatives for measuring the impact of risk minimisation measures

EMA Workshop, 5-6 December 2016

• Evaluation on the effectiveness of risk minimisation measures is also a responsability of national agencies and EMA (as per legislation)

• Priorisation criteria being developed • Collaboration, so that national initiatives are

shared, and work under a common protocol is promoted whenever feasible

• Awareness of risk minimisation measures?

• Effectiveness of risk minimisation measures?

• Awareness of risk minimisation measures

Results from a survey of healthcare professionals under SCOPE Joint Action (Strenghtening collaboration for operation of pharmacovigilance in European Union)

DK, ES, IE, IT, HR, NL, NO, SE, UK

Familiarity 90% 87%

66%

0%

20%

40%

60%

80%

100%

DHPC NCA Educationalmaterial

Yes, I have received this type of information and I sometimes read it

• Evaluation of risk minimisation measures

Some examples from Spain on recent referrals • Tetrazepam

• Cyproterone/ethinylstradiol

• Ibuprofen/dexibuprofen

Consequences of tretrazepam withdrawal in Spain

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New users/10.000 persons

TETRAZEPAM

DIAZEPAM-MR USE

CYCLOBENZAPRINE

METHOCARBAMOL

TIZANIDINE

BACLOFEN

Global Use

2nd Safety communication (12Apr): PRAC Recommendation

3rd Safety communication (7Jun): Effective suspension1Jul

1st AEMPS communication (17Jan):

Start of the Referral of Tetrazepam

Cyproterone/ethinylestradiol.- Knowledge of approved indications after post-referral RMM (survey by MAH)

• Moderate to severe acne - 92.0%

• Hirsutism - 69.2%

• Mild acne* is not an approved indication - 47.6%

• Contraception is not an approved

indication - 81%

• Androgenic alopecia is not an approved indication - 34.0%

Physicians’ knowledge of the

contraindications was high overall (92.2%-98.8%)

* A higher percentage of physicians who reported receipt of any of the CPA/EE materials correctly indicated that this was not an approved indication compared with physicians who received no educational materials

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CYPROTERONE / ETHINYL ESTRADIOL CONSUMPTION in Spain

2nd AEMPS communication (May 20th): PRAC recommendation

DHPC (June)

1st AEMPS communication

(January 30th): Start review

Cyproterone/ethinylestradiol- Prescription-related diagnosis in BIFAP database (primary healthcare electronic records)

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

40.0%

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

W11 CONTRACEPCION ORAL EN LAMUJERS96 ACNE

X99 OTRAS ENFERMEDADES GENITALFEMENINO / MAMAS

S24 OTROS SINTOMAS PELO

X02 DOLOR MENSTRUAL

X05 MENSTRUACION ESCASA /AUSENTE

X07 MENSTRUACION IRREGULAR /FRECUENTE

S23 CALVICIE / CAIDA DE PELO

A98 PROMOCION DE LA SALUD

X11 SIGNOS SINTOMAS MENOPAUSIA

Knowledge about use (important for RMMSs)

Use of high doses of ibuprofen and dexibuprofen in patients with history of CV risk

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Ibuprofeno Dexibuprofeno

Dosis Alta sin Hª Enf. CV

Dosis Alta con Hª Enf. CV

Dosis Moderada/Baja

Lessons learnt • Work in tailoring communications to receiver

preferences (SCOPE results)

• Take into account therapeutic context within evaluation (not just product-oriented) (tetrazepam)

• Different approaches needed for a complete picture (cyproterone/ethinylestradiol)

• National context important when issuing communications (dexibuprofen)

• Besides… many factors influencing uptake of measures

So much work still to do!!!!

Thank you for the attention!!!