Patient reporting update Franois Houez Director of Treatment - PowerPoint PPT Presentation

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

Spontaneous reporting in EEA * (data provided by EMA) 295,043 281,357 300,000 226,513 250,000 200,000 150,000 100,000 50,000 0 Pre Legislation After Legislation After Legislation 02/07/11 - 01/07/12 02/07/12 - 01/07/13 02/07/13 - 01/07/14 * Number of ICSRs received in EudraVigilance before de-duplication eurordis.org 2

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

Spontaneous reporting by patients in EEA * Split by country: N ◦ reports by 1M population 400 350 If all EU citizens would report as much as the 300 Dutch do, this would represent 250 170 000 reports per year! 200 150 100 50 0 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 After Legislation After Legislation 02/07/11 - 01/07/12 02/07/12 - 01/07/13 02/07/13 - 01/07/14 * Number of ICSRs received in EudraVigilance before de-duplication eurordis.org 4

Top 15 reactions reported by HCP or non-HCP adapted from EMA 5 6 3 10 Severity: does it match? 9 8 2 7 4 1 15/09/2014 eurordis.org 5

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

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

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

15 choices 15/09/2014 eurordis.org 9

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

Does everyone know ? Puzzling what subcutaneous 63 Batch number. means as opposed to chara What’s this? intradermal? cters What if ADR occurs after 6 months of treatment 6, but in the Humm… How during which the patient alternatively took the elderly: average do I add a sheet originator product or a generic or a second generic? 10 medicines. to a pdf? e.g. loose tools and ricin oil as excipient in the generic 15/09/2014 eurordis.org 11

Croatia – dose 15/09/2014 eurordis.org 12

Publicising self-reporting 15/09/2014 eurordis.org 13

2003 Stem cell transp. (expired) 15/09/2014 eurordis.org 14

2006 Pompe’s 15/09/2014 eurordis.org 15

2007 Epilepsy 15/09/2014 eurordis.org 16

2008 Multiple myeloma 15/09/2014 eurordis.org 17

2005 HIV 15/09/2014 eurordis.org 18

Withdrawn obesity 15/09/2014 eurordis.org 19

Corroborates PhWP recommendation Including 6 CS Signal 15/09/2014 eurordis.org 20

PRAC Rodin/PedNet study corroborated by ADR reports 15/09/2014 eurordis.org 21

 ? eurordis.org 22

 2006 MS 15/09/2014 eurordis.org 23

 2011 HIV 15/09/2014 eurordis.org 24

 2012 cystic fib. 15/09/2014 eurordis.org 25

 2012 Keratosis 15/09/2014 eurordis.org 26

 2012 Meningitis meningoc. 15/09/2014 eurordis.org 27

Spontaneous reporting by patients in EEA * Top 15 Substances 0 200 400 600 800 1,000 1,200 Etanercept 1,096 Adalimumab 810 767 Interferon Beta-1A Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) 606 Levonorgestrel 601 Rivaroxaban 599 591 Measles, Mumps And Rubella Vaccine (Live) Diphtheria, Tetanus, Pertussis (Acellular, Component), Hepatitis B (Rdna), Poliomyelitis 543 (Inact.) And Haemophilus Type B Conjugate Vaccine (Adsorbed) Diphtheria, Tetanus, Pertussis (Acellular, Component) And Poliomyelitis (Inactivated) 502 Vaccine (Adsorbed) Human Papillomavirus Vaccine 466 431 Carbidopa, Levodopa Amoxicillin, Clavulanic Acid 387 Metformin 375 Diclofenac 370 345 Influenza Vaccine (Split Virion, Inactivated) * Number of ICSRs received in EudraVigilance before de-duplication – Period: 02/ 07/ 13 - 01/ 07/ 14 eurordis.org 28

Conclusions • Eudravigilance = a live database, not a cemetery of data • Patient reporting and active involvement of patients in pharmacovigilance: a reality • www.adrreports.eu 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