SCOPE Event 2015-09-21 View from General Advisory Board
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Transcript of SCOPE Event 2015-09-21 View from General Advisory Board
eurordis.orgeurordis.org
François Houÿez21 September 2015, London
SCOPE progresses - patients’ viewsStrengthening Collaborations for Operating Pharmacovigilance in Europe (SCOPE)
109/11/2015
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Directive 2010/84/EU, article 102 & 106
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WORK WITH PHARMACOVIGILANCE EXPERTS / NCA
Patients’ organisations learning how to
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Example of actions with patients, by a national authority Ireland (HPRA)• Ms. Niamh Arthur, Pharmacovigilance Manager
– HPRA - Pharmacovigilance Information Day, 21/11/2014, Dublin
• Supporting and Stimulating Patient Reporting – May involve detailed review, evaluation, follow up and
feedback, case by case – Systematic provision of DHPCs/DSNs to relevant patient
organisations – Verbal and email updates on topical issues, as appropriate– Proposal to arrange a seminar/conference for patient
groups in 2015 – Development of apps to support reporting in the context of
related EU initiatives
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French regulatory agency (ANSM) call for projects to patients’ organisations Objectives :
to stimulate and support independent associations’ initiatives aiming at reducing the risks related to health products
In 2012 : 39 projects received, 38 eligible 9 selected Total amount of grants: 260 000 euros
In 2013 : 38 projects received, 36 eligible 10 selected Total amount of grants: 230 500 euros
In 2014 : 23 projects received, 22 eligible 7 selected Total amount of grants: 165 300 €
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• Information for patients taking baclofen for alcohol dependence
• Self‐evaluation of behaviour disorders induced by Parkinson drugs
• Prevention and health education for women with HIV/AIDS
• Information for adults who had cancer during childhood about long term consequences of treatments
• Translation of package leaflets to sign language
• Observance study for inhaled products for cystic fibrosis in relation with their side effects
• Patient leaflet for an automated implantable defibrillator
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Behcet's syndrome community map @ 3 months: 900/1,348 patients indicated their location
09/11/2015 6
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https://www.rareconnect.org/en/community/behcet‐s‐syndrome/article/behcet‐s‐syndrome‐community‐poll‐resultshttp://eurordiscloud.s3.amazonaws.com/treatments.pdf
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Interferonthalidomide
dapsonecyclosporinepentoxifylline
etanerceptmycophenolate
morphine sulfateadalimumab
no medicationinfliximab
methotrexateazathioprine
colchicine
Q11 What medications are you currently taking for Behcet's syndrome?
daily as needed
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Patient-data post-authorisation
• When taking the medicine for the first time– Participants register online at the hospital pharmacy– They receive questionnaires by email or SMS 2, 6 weeks,
3 months and 6 months after the start of the drug use
• Analysis– Collection of data over up to 24 months– Data on patient characteristics, drug use, effect and
suspected ADRs are collected and analysed– Incidence densities, time course of ADRs are studied
• Other data could be collected, e.g. positive effects
Longitudinal monitoring of the safety of drugs by using a web‐based system: the case of pregabalin. Pharmaco‐epidemiology and Drug Safety 2011; 20: 591–597
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Possible outcomes
Longitudinal monitoring of the safety of drugs by using a web‐based system: the case of pregabalin. Pharmaco‐epidemiology and Drug Safety 2011; 20: 591–597
Kaplain–Meier curves illustrating the incidence densities of the five most frequently reported adverse drug reactions. From the top down to the first line represents: increased weight fatigue feeling drunk somnolence dizziness ‘Survival’ pertains to those patients who did not develop particular ADR
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ADR REPORTING SYSTEMSAudit of national
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ADR reporting tools as of 05/2012
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On‐line reporting formPrinted form
No information availableNon‐EU/EEA other than CH
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On‐line reporting formPrinted form
No information availableNon‐EU/EEA other than CH
ADR reporting tools as of April 2014
www.eurordis.org/pharmacovigilance
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Spontaneous reporting by patients in EEA*
by country: reports by 1Mio pop. www.adrreports.eu
* 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!
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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 Legislation02/07/11 ‐ 01/07/12
After Legislation02/07/12 ‐ 01/07/13
After Legislation02/07/13 ‐ 01/07/14
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Major role in Web‐RADRMajor role in SCOPE
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Awareness level and reporting tools development• 27 MS promote ADR reporting to the public
– But mostly via an update on website: impact?• Only 32% of MS have a specific budget to communicate on ADR reporting
• Public campaigns with patients’ organisations still rare
• 13 MS have patient user testing– Less than half MS carried out studies prior to the development of their forms
– 30% MS used external web site designers
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Audit of national reporting systems
• To learn more on which feedback is provided, and how people appreciate this– 24 MS follow up with reporters– 18 send acknowledgments– 15 provide individual feedback
• 25 MS take spontaneous reports as valid with no further medical confirmation
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Patient reporting
• And work with representatives of the public to improve the tools! – All MS now have an online form. Quality? cfunfriendly tools
• Among measures needed: communication campaign to make people aware of ADR reporting +++
• (add article 102 of directive)
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What else can we think of? Among others:
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• Cost? Efficacy?
Large media campaign?Large media campaign?
• Contact persons in patients’ organisations and social media? Review understandability, test how information is received. Training?
Targeted communication?Targeted communication?
• Cost? Logistics?
Leaflet, message at dispensing pharmacy?Leaflet, message at dispensing pharmacy?
• Logistics? Resources?
Registration in a service for first timers?Registration in a service for first timers?
Create the award of the most useful spontaneous reports of the year?Create the award of the most useful spontaneous reports of the year?
09/11/2015
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Issues with reporting forms
• Often outdated, design > 10 years– Not taking the best of available technologies (Web-RADR)
• Often a rough adaptation of the form for HCPs– Technical words– No tools to translate the text as described by patients into
regulatory information (e.g. MedDRA terms)• Patients consulted for the creation of the form: rarely• Hard to find on authorities’ web sites• Poorly publicised• Usually no help line to assist when reporting• Web-RADR
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Puzzling
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63 characters
Does everyone know what subcutaneous means as opposed to
intradermal?
Batch number. What’s this?
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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For an efficient communication: use nicknames that people can remember!• Preferred
– Lareb (NLD)– Kilen (SWE)– Yellow Card (UK)– Medwatch (USA)
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• Avoid– www.ansm.sante.fr (FRA)– http://sundhedsstyrelsen.dk (DNK)– www.pei.de/DE/arzneimittelsicherheit-
vigilanz/arzneimittelsicherheit-node.html (GER)
And most important: involve users in the design and specificities’ definitions!
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Other possible features
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“My belly is slightly enlarged…”
Drug ineffective (counterfeit), shortage…
Environmental factors (Pharmaco‐eco‐epidemiology)
Need for a guide to choose MeDdrapreferred term
Questions 1 week after report: improved? worsened?
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Risk communication
09/11/2015
• Which national methods of communication exist?• Can their impact be measured?• Can they be improved?
– Opinion of pharmacovigilance experts, healthcare professionals
– Patient survey to start soon (EUPATI 16/09/2015), to be launched on a larger scale (focus groups, targeted groups, patients online communities…)
• Again: specific functions in health medical apps– Register to receive safety information on the treatments
you’re taking
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THANK YOU.www.eurordis.eu/pharmacovigilance
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