[ 1 ] PRAC. Perspective from a Member State. MUDr. Jana Mladá 2015 Státní ústav pro kontrolu léčiv

Transkript

1 [ 1 ] PRAC Perspective from a Member State

2 [ 2 ] Today EU regulatory drug safety network PRAC conclusions and recommendations at national level Modern history of pharmacovigilance in Czech Republic

3 [ 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 [ 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 [ 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 [ 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

7 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 [ 8 ] PRAC conclusions at national level Recommendation of PRAC CMDh agreement/ec decision Referrals PSUSA Signals PASS RMP RMM education materials

9 [ 9 ] PRAC conclusions at national level Marketing authorisation Regulatory action Communication with MAHs Communication to healthcare professionals and patients

10 [ 10 ] PRAC conclusions at national level Pharmacovigilance and regulatory action Target communication to local MAHs Coordinated action at national level Join DHPC/ PASS

11 [ 11 ] Wording and timelines for MAHs

12 [ 12 ]

13 [ 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 [ 14 ] ADRs newsletter- Information for healthcare professionals Starts with a section From your reports

15 [ 15 ] Modern history of pharmacovigilance in CZ YEAR 1998 Pharmacovigilance in CZ legislation 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 FTE(2 471 reports)

16 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 [ 17 ] ADRs reports in Czech Republic Intervention to improve ADRs reporting zdroj Healthcare hlášení professionals zdravotníci zdroj Patients hlášení pacienti zdroj MAHs hlášení držitelé rozhodnutí o registraci celkový Total number počet of hlášení reports

18 [ 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 [ 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