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![Page 1: Regulatory initiatives for measuring the impact of ... · Regulatory initiatives for measuring the impact of risk minimisation measures EMA Workshop, 5- 6 December 2016 •Evaluation](https://reader033.vdocuments.us/reader033/viewer/2022052518/5f0775767e708231d41d15c3/html5/thumbnails/1.jpg)
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
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• 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
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• Awareness of risk minimisation measures?
• Effectiveness of risk minimisation measures?
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• 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
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Familiarity 90% 87%
66%
0%
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40%
60%
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100%
DHPC NCA Educationalmaterial
Yes, I have received this type of information and I sometimes read it
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• Evaluation of risk minimisation measures
Some examples from Spain on recent referrals • Tetrazepam
• Cyproterone/ethinylstradiol
• Ibuprofen/dexibuprofen
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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
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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
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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
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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
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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
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So much work still to do!!!!
Thank you for the attention!!!