Regulatory initiatives for measuring the impact of risk minimisation - - PowerPoint PPT Presentation

▶

Jul 12, 2023 644 likes •831 views

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

SLIDE 1

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

SLIDE 2

Evaluation on the effectiveness of risk

minimisation measures is also a responsability

f 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

SLIDE 3

Awareness of risk minimisation measures?
Effectiveness of risk minimisation

measures?

SLIDE 4

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

SLIDE 5

SLIDE 6

Familiarity

90% 87% 66% 0% 20% 40% 60% 80% 100% DHPC NCA Educational material

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

SLIDE 7

SLIDE 8

SLIDE 9

Evaluation of risk minimisation

measures Some examples from Spain on recent referrals

Tetrazepam
Cyproterone/ethinylstradiol
Ibuprofen/dexibuprofen

SLIDE 10

Consequences of tretrazepam withdrawal in Spain

5 10 15 20 25 30 January February March April May June July August Septem… October Novemb… Decemb… January February March April May June July August Septem… October Novemb… Decemb… 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

SLIDE 11

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

SLIDE 12

10000 20000 30000 40000 50000 60000 70000 80000 90000 100000 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

Number of packages

CYPROTERONE / ETHINYL ESTRADIOL CONSUMPTION in Spain

2nd AEMPS communication (May 20th): PRAC recommendation DHPC (June) 1st AEMPS communication (January 30th): Start review

SLIDE 13

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 LA MUJER S96 ACNE X99 OTRAS ENFERMEDADES GENITAL FEMENINO / 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

SLIDE 14

Knowledge about use (important for RMMSs)

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

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Ibuprofeno Dexibuprofeno

Dosis Alta sin Hª Enf. CV Dosis Alta con Hª Enf. CV Dosis Moderada/Baja

SLIDE 15

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

SLIDE 16