Regulatory initiatives for measuring the impact of risk minimisation measures EMA Workshop, 5-6 December 2016 Dolores Montero Division of Pharmacoepidemiology and Pharmacovigilance Department of Human Medicines
• 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 Yes, I have received 100% 90% 87% this type of 80% information and I 66% sometimes read it 60% 40% 20% 0% DHPC NCA Educational material
• Evaluation of risk minimisation measures Some examples from Spain on recent referrals • Tetrazepam • Cyproterone/ethinylstradiol • Ibuprofen/dexibuprofen
Consequences of tretrazepam withdrawal in Spain 2nd Safety 3rd Safety 1st AEMPS communication communication (12Apr): communication (7Jun): (17Jan): PRAC Recommendation Effective suspension1Jul Start of the New users/10.000 persons Referral of Tetrazepam 30 TETRAZEPAM 25 DIAZEPAM-MR USE 20 CYCLOBENZAPRINE METHOCARBAMOL 15 TIZANIDINE BACLOFEN 10 Global Use 5 0 Septem… Novemb… Decemb… Septem… Novemb… Decemb… January February March April June July August October January February March April June July August October May May
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
CYPROTERONE / ETHINYL ESTRADIOL CONSUMPTION in Spain 100000 90000 DHPC (June) 80000 Number of packages 70000 1st AEMPS 60000 communication (January 30th): Start 50000 review 40000 30000 2nd AEMPS communication (May 20th): PRAC recommendation 20000 10000 0 JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC 2012 2013 2014 2015
Cyproterone/ethinylestradiol- Prescription-related diagnosis in BIFAP database (primary healthcare electronic records) W11 CONTRACEPCION ORAL EN LA 40.0% MUJER S96 ACNE 35.0% X99 OTRAS ENFERMEDADES GENITAL FEMENINO / MAMAS 30.0% S24 OTROS SINTOMAS PELO 25.0% X02 DOLOR MENSTRUAL 20.0% X05 MENSTRUACION ESCASA / AUSENTE X07 MENSTRUACION IRREGULAR / 15.0% FRECUENTE S23 CALVICIE / CAIDA DE PELO 10.0% A98 PROMOCION DE LA SALUD 5.0% X11 SIGNOS SINTOMAS MENOPAUSIA 0.0% 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Knowledge about use (important for RMMSs) Use of high doses of ibuprofen and dexibuprofen in patients with history of CV risk 100% 90% 80% Dosis Alta sin Hª Enf. CV 70% 60% Dosis Alta con Hª Enf. CV 50% Dosis Moderada/Baja 40% 30% 20% 10% 0% Ibuprofeno Dexibuprofeno
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!!!
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