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

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

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Patient reporting update Franois Houez 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

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François Houÿez

Director of Treatment Information & Access, EURORDIS 8th Pharmacovigilance stakeholders’ forum EMA, 15/06/2014

Patient reporting update

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15/09/2014

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Spontaneous reporting in EEA*

(data provided by EMA)

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* Number of ICSRs received in EudraVigilance before de-duplication 50,000 100,000 150,000 200,000 250,000 300,000 Pre Legislation 02/07/11 - 01/07/12 After Legislation 02/07/12 - 01/07/13 After Legislation 02/07/13 - 01/07/14 226,513 281,357 295,043

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Spontaneous reporting by patients in EEA*

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* Number of ICSRs received in EudraVigilance before de-duplication 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 Pre Legislation 02/07/11 - 01/07/12 After Legislation 02/07/12 - 01/07/13 After Legislation 02/07/13 - 01/07/14 20,560 33,292 35,642

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Spontaneous reporting by patients in EEA* Split by country: N◦ reports by 1M population

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* Number of ICSRs received in EudraVigilance before de-duplication

If all EU citizens would report as much as the Dutch do, this would represent 170 000 reports per year!

50 100 150 200 250 300 350 400 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

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Top 15 reactions reported by HCP or non-HCP

adapted from EMA

15/09/2014

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1 2 3 4 5 6 7 8 9 10

Severity: does it match?

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ADR reporting tools as of May 2012

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On-line reporting form Printed form No information available Non-EU/EEA other than CH

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On-line reporting form Printed form No information available Non-EU/EEA other than CH

ADR reporting tools as of April 2014

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

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15 choices

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As proposed 24 June 2010

(after release of Google Goggle)

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Med App checks moles for irregularities in size, shape, colour and border

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Puzzling

15/09/2014

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63 chara cters Does everyone know what subcutaneous means as opposed to intradermal? Batch number. What’s this? What if ADR occurs after 6 months of treatment during which the patient alternatively took the

  • riginator product or a generic or a second generic?

e.g. loose tools and ricin oil as excipient in the generic 6, but in the elderly: average 10 medicines. Humm… How do I add a sheet to a pdf? ?

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Croatia – dose

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Publicising self-reporting

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2003 Stem cell transp. (expired)

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2006 Pompe’s

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2007 Epilepsy

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2008 Multiple myeloma

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2005 HIV

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Withdrawn obesity

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Corroborates PhWP recommendation

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Including 6 CS Signal

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PRAC

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Rodin/PedNet study corroborated by ADR reports

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?

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 2006 MS

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 2011 HIV

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 2012 cystic fib.

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 2012 Keratosis

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 2012 Meningitis meningoc.

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Spontaneous reporting by patients in EEA* Top 15 Substances

28 1,096 810 767 606 601 599 591 543 502 466 431 387 375 370 345 200 400 600 800 1,000 1,200

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)

* Number of ICSRs received in EudraVigilance before de-duplication – Period: 02/ 07/ 13 - 01/ 07/ 14

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Conclusions

15/09/2014

  • 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!

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