Patient reporting update

Transcription

1 Patient reporting update François Houÿez Director of Treatment Information & Access, EURORDIS 8 th Pharmacovigilance stakeholders forum EMA, 15/06/ /09/2014 eurordis.org 1

2 Spontaneous reporting in EEA * (data provided by EMA) 281, , , , , , , ,000 50,000 0 Pre Legislation 02/07/11-01/07/12 After Legislation 02/07/12-01/07/13 After Legislation 02/07/13-01/07/14 * Number of ICSRs received in EudraVigilance before de-duplication eurordis.org 2

3 Spontaneous reporting by patients in EEA * 40,000 35,000 33,292 35,642 30,000 25,000 20,560 20,000 15,000 10,000 5,000 0 Pre Legislation 02/07/11-01/07/12 After Legislation 02/07/12-01/07/13 After Legislation 02/07/13-01/07/14 * Number of ICSRs received in EudraVigilance before de-duplication eurordis.org 3

4 Spontaneous reporting by patients in EEA * Split by country: N reports by 1M 400 population If all EU citizens would report as much as the Dutch do, this would represent reports per year! NL SE BE GB DK AT DE IS IT IE FI GR NO FR PT LU MT HR HU CZ PL ES EE SI CY SK LV LT BG RO LI Pre Legislation 02/07/11-01/07/12 After Legislation 02/07/12-01/07/13 After Legislation 02/07/13-01/07/14 * Number of ICSRs received in EudraVigilance before de-duplication eurordis.org 4

5 Top 15 reactions reported by HCP or non-hcp adapted from EMA Severity: does it match?

6 ADR reporting tools as of May 2012 On-line reporting form Printed form No information available Non-EU/EEA other than CH eurordis.org 6

7 ADR reporting tools as of April 2014 On-line reporting form Printed form No information available Non-EU/EEA other than CH eurordis.org 7

8 HOW HELPFUL ARE THESE TOOLS? For some: 6 clicks to find the form eurordis.org 8

9 15 choices 9

10 As proposed 24 June 2010 (after release of Google Goggle) Med App checks moles for irregularities in size, shape, colour and border eurordis.org 10

11 Puzzling Batch number. What s this? Does everyone know what subcutaneous means as opposed to intradermal?? 63 chara cters 6, but in the elderly: average 10 medicines. Humm How do I add a sheet to a pdf? What if ADR occurs after 6 months of treatment during which the patient alternatively took the originator product or a generic or a second generic? e.g. loose tools and ricin oil as excipient in the generic 11

12 Croatia dose 12

13 Publicising self-reporting 13

14 2003 Stem cell transp. (expired) 14

15 2006 Pompe s 15

16 2007 Epilepsy 16

17 2008 Multiple myeloma 17

18 2005 HIV 18

19 Withdrawn obesity 19

20 Corroborates PhWP recommendation Including 6 CS Signal 20

21 PRAC Rodin/PedNet study corroborated by ADR reports 21

22 ? eurordis.org 22

23 2006 MS 23

24 2011 HIV 24

25 2012 cystic fib. 25

26 2012 Keratosis 26

27 2012 Meningitis meningoc. 27

28 Spontaneous reporting by patients in EEA * Top 15 Substances Etanercept Adalimumab Interferon Beta-1A Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Levonorgestrel Rivaroxaban Measles, Mumps And Rubella Vaccine (Live) Diphtheria, Tetanus, Pertussis (Acellular, Component), Hepatitis B (Rdna), Poliomyelitis (Inact.) And Haemophilus Type B Conjugate Vaccine (Adsorbed) Diphtheria, Tetanus, Pertussis (Acellular, Component) And Poliomyelitis (Inactivated) Vaccine (Adsorbed) Human Papillomavirus Vaccine Carbidopa, Levodopa Amoxicillin, Clavulanic Acid Metformin Diclofenac Influenza Vaccine (Split Virion, Inactivated) ,000 1,200 1, * Number of ICSRs received in EudraVigilance before de-duplication Period: 02/07/13-01/07/14 eurordis.org 28

29 Conclusions Eudravigilance = a live database, not a cemetery of data Patient reporting and active involvement of patients in pharmacovigilance: a reality informs on where more efforts can be invested: Understanding the drivers of patient reporting Specific research by disease area, by MS, or not, orphan or not, drug authorised ante/post 2012, delays MA- first reports May help targeting the communication on reporting tools May help in defining appropriate measures as defined in article 102 Pharmacovigilance Directive Be curious: look for the drugs in your own disease area! 15/09/2014 eurordis.org 29