Pharmacovigilance & Social Media A new approach to Safety Signal - PowerPoint PPT Presentation

Pharmacovigilance & Social Media A new approach to Safety Signal Detection: Potential & Issues Karen Whitelock, Drug Safety Responsible, Novartis Pharma Australia Dr David Lewis, Global Head of Pharmacovigilance Melbourne, May 2015

Disclaimer The information within this presentation is based on the presenters expertise and experience and represents the views of the presenter for the purpose of this presentation. 2 | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social Media| Business Use Only

Overview: Pharmacovigilance of social media  Social media landscape and pharmaceutical medicines  Regulations & guidelines for PV of digital media  AE reporting via Social Media  Overview of Novartis PV of digital media  WEB-RADR IMI project • Assessment of pharmacovigilance using social media • Mobile reporting of suspected adverse reactions • Digital Drug Safety Surveillance • Data Protection for Health Apps - Data Privacy 3 | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social Media| Business Use Only

The digital media landscape... Trends in Consumer Technology Internet-based applications that allow for the creation and Computer & smartphone evolution exchange of user-generated content From: Chopra R - Pharmacovigilance & Digital Media (http://de.slideshare.net/rkc78834/pharmacovigilance-digital-media) 4 | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social Media| Business Use Only

Multiple threads of digital media Electronic Health Mobile Health @ Facebook 1.25b users (eHealth) (mHealth) @ Twitter 302m users Using information and Using mobile communication communication technologies for the systems for the provision of health related provision of health services (diagnosis, related services monitoring treatment) Telemedicine Digital Health The intersection of the Delivery of health digital revolution with care at a distance consumer healthcare, using information includes genomics (use of and communication gene chips to store a @ YouTube >1b users patient’s genetic technologies consumer healthcare. identifiers and responses) @ Pinterest 70m users 5 | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social Media| Business Use Only

Engaging with patients via digital media Social media Gamification Use to provide Applying game design information & engage techniques and mechanics to “real life” with stakeholders. Also valuable within the applications in order to organisation to make them more encourage collaboration engaging Apps Wearables and smart sensors An increasingly wide array in the market So far, largely only ranging from information wristbands and sensors only through to but the potential is for sophisticated sensors much more and medical devices 6 | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social Media| Business Use Only

Pharmaceutical industry use of digital media MAHs main use of digital media is for marketing and sales  Sponsors are primarily using social media for commercial purposes to distribute information about: • Medicines (to healthcare professionals and non-HCPs) • Diseases, and the treatment of disease • Company matters including announcements • To listen to patient and professional conversations about marketed medicines, and not to support clinical research  A minority of companies use social and digital media for: • Patient engagement • Patient recruitment and retention within clinical trials | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social 7 | Streamlining Media| Business Use Only Multi-Centre Research May

TGA:Monitoring the internet or digital media 1.2.2 Sponsors should regularly screen internet or digital media under their management or responsibility, for potential reports of suspected ARs. • includes digital media that is owned, paid for and/or controlled by the sponsor. • frequency of screening allows for valid ARs to be reported within reporting timeframe based on the date the information was posted on the internet site/digital medium . • Sponsors may utilising their websites to facilitate collection of suspected ARs.  If a sponsor becomes aware of a suspected AR described in non-company sponsored digital medium, • the report should be assessed to determine whether it qualifies for reporting.  Cases from the internet or digital media, the identifiability of the reporter refers to the existence of a real person, that is, it is possible to verify the contact details of the reporter • e.g., an email address under a valid format has been provided | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social 8 | Streamlining Media| Business Use Only Multi-Centre Research May

EEA Good Pharmacovigilance Practice (GVP) VI PV guidance on digital media (July 2012) focuses on ICSRs VI.B.1.1.4. Information on suspected adverse reactions from the internet or digital media MAHs should regularly screen internet or digital media under their management or responsibility , for potential reports of suspected ADRs . In this aspect, digital media is considered to be company sponsored if it is owned, paid for and/or controlled by the MAH. • The frequency of the screening should allow for potential valid ICSRs to be reported to the competent authorities within the appropriate reporting timeframe • Marketing authorisation holders may also consider utilising their websites to facilitate the collection of suspected ADRs 9 | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social Media| Business Use Only

Digital media and safety issues (GVP Module VI)  VI.B.1.1.4. Information on ADRs from digital media (ctd.) If a MAH becomes aware of a report of suspected adverse reaction described in any non-company sponsored digital medium, the report should be assessed to determine whether it qualifies for reporting .  VI.C.2.2.6 Emerging safety issues Good practice for the MAH to monitor special internet sites or digital media (e.g. patients ’ support or special diseases groups) • Check if they describe significant safety issues which may necessitate reporting in accordance with VI.C.2.2.6. • Frequency of the monitoring depends on the risks associated to the medicinal product 10 | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social Media| Business Use Only | Streamlining Multi-Centre Research May

MAH governance of the use of digital media Most MAHs have developed controls governing use of digital media  Nearly all MAHs have developed guidelines to address use of social media  General guidelines include: • Rules for discussing company business on personal sites, how to set up a page or site, and privacy issues; • Guidelines concerning authorized and unauthorized uses by personnel of social media; • Social Media Advisory Board-specified practices; • Guidelines for posting video online; • Directives that stipulate one-way communication between personnel and patients involved in clinical studies; • Restrictions, e.g., for company business only. 11 | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social | Streamlining Media| Business Use Only Multi-Centre Research May

AE reporting via social media All brand mentions Contain AE keywords 257,177 posts; 224 brands 12,530 posts 100% Filtered for relevance 3.3% mentions 24% are case reports With AE terms 5% 1 in 7 = name & contact info Adverse Event reports 0.4% of all brand mentions 3.3% contain AE-specific data Source: White paper on Adverse Event Reporting by Visible R , Oct. 2011, | Streamlining http://www.visibletechnologies.com/resources/white-papers/adverse-events/ Multi-Centre Research May

Overview of Novartis PV of digital media Highlighting challenges of monitoring the different channels Novartis Pharma Novartis Pharma Social Media Social Media Programmes Listening Programmes Novartis associate/vendor Novartis associate/vendor screening non-NVS controlled screening platforms NVS controlled platforms Single Reports Single Reports • AEs with 4 minimum criteria • AEs with 4 minimum criteria Aggregate Reports • AEs with 2 minimum criteria • AEs with 2 minimum criteria (Novartis product & ADR) Single Case Safety Reports Single Case Safety Reports • Within 24 hours • Send to DSE in the country where AE occurred • Within 24 hours (if UNK send to country where AE was • Send to DSE in the country where received or reviewed (Local Programs) or the AE took place (if UNK send to Switzerland/US (Global Programs) country where AE was received or reviewed (Local Programs) or Aggregate Reports Switzerland/US (Global • Monthly reports / End of programme Programs) • Send to country of the Programme Owner 13 | Streamlining Multi-Centre Research May 2015 Workshop | Karen Whitelock & Dave Lewis|6 May 2015 | PV & Social Media| Business Use Only