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Pharmacovigilance & Digital Media Presentation Transcript

  • 1. The Internet & DrugSafety.Implications for Pharmacovigilance. Rishi Kiran Chopra. BSc. Biochem. Dip. PV. MSc. Pharm. Sci.
  • 2. Hi,How many people have smart phones?How many have used the web to searchfor Health information?Are you pro-digital, anti, or undecided? 2
  • 3. Disclaimer.The opinions expressed here are theviews of the author and do not necessarilyreflect the views and opinions of anycompany or body. 3
  • 4. Agenda.• A Digital Intro• The Social Media Debate• PV Implications• The Future• Take Home 4
  • 5. “ Social media essentially is a category of online media where people are talking, participating, sharing, networking, and bookmarking online ” 1. “ Social Media is the use of web based and mobile technologies to turn communication into interactive dialogue ” 2. A Digital Intro. Definition.1. Jones, R. Symetri Internet Marketing. Social Media Marketing 101.2. Kaplan, A. M. et al. Business Horizons 2010. 5
  • 6. SOCIAL MEDIA PUBLISH SHARE DISCUSS NETWORK MICROBLOGA Digital Intro. The Digital Landscape. 6
  • 7. A Digital Intro. The Social Media Map.1. Image by Flowtown. http://www.flowtown.com/. 7
  • 8. 1. Health (14%) What are the top 2. Games (13%) most talked about 3. Auto & Moto (13%) topics online 4. IT & Tech (9%) worldwide ? 1 5. Sports (8%) 70% How many patients use the internet to with a third deciding not to visit their GP afterwards as they were able to search for health find the information they were looking for. information ? 2 A Digital Intro. Fact.1. Synthesio, October 2010.2. The Department of Health. ‘Internet is 1st choice for health advice’. November 2010. 8
  • 9. The Social Media Debate.• Started in the late 90’s - Not new• Progress has been slow moving• Regulation has not responded• 2010 - Pharma increases its engagement• Debate is gathering steam 9
  • 10. Aug 2010, Roche releases on-line guidance • Overarching rules & principles 1 • Personal Vs. Professional engagement • Talking about Vs. Talking on behalf of • Employees are ‘social media scouts’ • Adverse Events should be reported The S.M. Debate. Roche.1. Roche & Social Media. http://www.roche.com/about_roche/at_a_glance/socialmedia.htm. 10
  • 11. The S.M. Debate. Roche. 11
  • 12. The S.M. Debate. Roche. 12
  • 13. Feb 2011, AZ releases S.M White Paper• FDA should recognise S.M as a new channel• Regulator should work with Pharma• Regulation will address current areas of grey• Patient/HCP need most critical factor• Online ‘balance’ is requiredThe S.M. Debate. AstraZeneca. 13
  • 14. • AZ forms S.M steering team inc. Safety • Team produces 5 principles for engagement 1 • Acknowledges evolving process The S.M. Debate. AstraZeneca.1. http://www.astrazeneca-us.com/_mshost795281/content/media/AZ_Social_Media_White_Paper.pdf 14
  • 15. The S.M. Debate. AstraZeneca. 15
  • 16. • AE pragmatism in the absence of Regulation?• Difference between reporting in-company and to Regulators.The S.M. Debate. AstraZeneca. 16
  • 17. Oct 2010, Janssen launch into Facebook• Psoriasis 360 disease awareness campaign• Potential reach of 1.5 Mill. sufferers in UK• Pharma’s 1st post-moderated Facebook page• Caveat for posts; no brand mention• Campaign also uses YouTube, Twitter & iPhoneThe S.M. Debate. Janssen. 17
  • 18. 1 The S.M. Debate. Janssen.1. Psoriasis 360 Campaign. http://psoriasis360.com/. 18
  • 19. • Awareness: Severity, impact on life, & HCP info• Real patients sharing experiences• Still a risk of brand mentions & AEs• Risk of wrong health advice• Contraventions of house rules removed• Over 500 ‘likes’; 200 Twitter followersThe S.M. Debate. Janssen. 19
  • 20. • The debate has spread to Twitter 1 1 1st feed released yesterday ! The S.M. Debate. S.M. on Twitter.1. Healthcare Social Media UK Twitter. https://twitter.com/#!/hcsmuk. 20
  • 21. • Evolving Platform • Resource• Build Relationships • Measuring ROI• Reputational Gain • Reputational Risk• Convenient • Regulatory Grey• Marketing Savings • AE ‘Noise’• New Safety Data Pool • Incomplete infoPROs CONsThe Social Media Debate. Pros & Cons. ( Perceived ! ) 21
  • 22. PV Implications.• Current PV Regulations are inadequate• FDA, MHRA, EFPIA & ABPI W.I.P• 1st step is the hardest• FDA delayed guidance to 2011• Piecemeal fashion 22
  • 23. • Challenges in collecting meaningful data• S.M. conversations can be unstructured• Language may not match with MedDRA• Anonymous postings hard to follow up• With a ‘collect ALL AEs’ approach - challenging• Without I.T. solutions means manual processPV Implications 23
  • 24. • PV Vol. 9a 1: “MAH should screen websites ... under their responsibility ... for adverse reactions” “MAH is not expected to screen external websites ...” “However if MAH becomes aware ... on any other website ... MAH should review the case” “The MAH should consider utilising their websites for adverse event collection.” PV Implications1. Eudralex. http://ec.europa.eu/health/documents/eudralex/vol-9/index_en.htm. 24
  • 25. • CIOMS V 1: “procedure should be in place to ensure daily screening...of the website in order to identify potential safety case reports” “...the working group does not believe it necessary for regulators or companies routinely to surf the internet beyond their own sites...” PV Implications1. Current Challenges in Pharmacovigilance. Pragmatic Approaches. CIOMS Working Group. 25
  • 26. • MHRA Good PV Practice Guide 1: “...the internet and its widespread accessibility means it is an increasing popular way to seek and share information...” “...the MAH must consider the mechanism by which incoming information is monitored...” PV Implications1. MHRA Good Pharmacovigilance Practice. http://www.mhra.gov.uk. 26
  • 27. • If it is a company sponsored (content controlled) site/page you are obliged to proactively monitor• At least once every working day• If it is non company sponsored (no content control) site or page then there is no obligation• BUT this does not mean you should ignore; USE the data you come across pragmatically; record & expedite where necessaryPV Implications 27
  • 28. • Free text areas on company sites (UGC)• Include disclaimers and terms• Provide contact provisions for reporting• Check your vendors; train to report• Track your sites and digital projectsPV Implications 28
  • 29. • Talk to your Marketing colleagues• How are they adopting Digital Marketing• Establish if there is a Digital Steering group• Pharmacovigilance is a key member• Establish an efficient process for reporting AEs• Train your colleagues in identifying AEsPV Implications 29
  • 30. The Future.• Current PV mechanisms are not fit for purpose• There is a need for a new model• Away from individual based reporting• To one that captures trends in patient communities that triggers further analysis 30
  • 31. • I.T. advances will facilitate data collection• Opportunities for Vendors• Specific inclusions in EU & Global guidelines• Patients will become more educated about their disease because of Pharma’s S.M. engagement• Web based technology will surpass all other routes for reporting AEsThe Future 31
  • 32. Take Home.• Communication platform of today• Be the change• But one size does not fit all so caution• PV is a key stakeholder• Drug & Patient Safety can benefit 32
  • 33. Digital & Social Media is HERE & NOW. 33
  • 34. Questions. Thank you for your time. “ The only constant is change ”.Rishi Kiran ChopraE. rishi@pharmertalk.comW. www.pharmertalk.com “ DriveL. http://uk.linkedin.com/in/rishikiranchopra change, get results ”. 34