[ 1 ] PRAC Perspective from a Member State
[ 2 ] Today EU regulatory drug safety network PRAC conclusions and recommendations at national level Modern history of pharmacovigilance in Czech Republic
[ 3 ] European drug safety network Harmonisation of drug regulation in EU Collaboration in pharmacovigilance long history Proactive surveillance and shared assessment of drug risks information
[ 4 ] European regulatory drug safety network Member Member States Member States Member States Member States Member States States CHMP EMA PRAC Coordination group EC HMA
[ 5 ] How does pharmacovigilance system work? MS collaboration Shared mailbox Common guideline and templates for assessment Shared procedures Shared assessments Shared conclusions EMA coordination For all areas of pharmacovigilance
[ 6 ] PRAC member PRAC member - ideally in close relations with drug regulatory agency Agency is responsible for national pharmacovigilance system in many MSs Meetings 2 times monthly 1x face to face/ TC
Signal management ADRs reports All MS EMA Signal detection EMA [ 7 ] Recommendation PRAC EU communication EMA Signal assessment Lead MS National level: ü Implementation ü Communicaton All MS Signal validation/ analysis and prioritisation PRAC / Lead MS
[ 8 ] PRAC conclusions at national level Recommendation of PRAC CMDh agreement/ec decision Referrals PSUSA Signals PASS RMP RMM education materials
[ 9 ] PRAC conclusions at national level Marketing authorisation Regulatory action Communication with MAHs Communication to healthcare professionals and patients
[ 10 ] PRAC conclusions at national level Pharmacovigilance and regulatory action Target communication to local MAHs Coordinated action at national level Join DHPC/ PASS
[ 11 ] Wording and timelines for MAHs
[ 12 ]
[ 13 ] PRAC conclusions at national level Communication patients and health care professionals Common EU key elements use in accordance with national clinical practice DHPC agreed at EU level - SÚKL website, special symbol on DHPC CAVE! Target communication to Czech learned societies National ADRs newsletter 4 times a year (1 vaccines ADRs issue this year)
[ 14 ] ADRs newsletter- Information for healthcare professionals Starts with a section From your reports
[ 15 ] Modern history of pharmacovigilance in CZ YEAR 1998 Pharmacovigilance in CZ legislation 2002 3 FTE (700 reports; most of them to vaccines) 2003 Twinning with UK agency 2004 Joining EU pharmacovigilance family 2005 MedDRA translation 2006 New ADRs database 2008 ADRs newsletter From 2012 New EU legislation 2014 15 FTE(2 471 reports)
Pharmacovigilance - in post new legislation world [ 16 ] Close collaboration with EU MS states sharing of workload New age old problem - underreporting Active surveillance - interventions to improve ADRs reporting
[ 17 ] ADRs reports in Czech Republic 3000 2500 Intervention to improve ADRs reporting 2387 2471 2000 1500 1000 500 0 2070 2115 1740 1744 1542 1517 1436 1217 1064 1029 1023 1024 1060 1009 988 1041 848 845 676 721 588 488 213 37 67 2007 2008 2009 2010 2011 2012 2013 2014 zdroj Healthcare hlášení professionals zdravotníci zdroj Patients hlášení pacienti zdroj MAHs hlášení držitelé rozhodnutí o registraci celkový Total number počet of hlášení reports
[ 18 ] Interventions to improve ADRs reporting Education of healthcare professionals physicians, pharmacists Regular presentations of SÚKL on medical congresses and conferences Promotional campaign in collaboration with MAHs last one 2014/2015
[ 19 ] Doctor, I have terrible itching. I ve had such rash since I have been using the new drug. SKIN DISORDERS BELONG TO THE MOST FREQUENT ADVERSE DRUG REACTIONS jana.mlada@sukl.cz