Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA

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  1. 1. Developments in Medical Big Data Research: United States and China ISPOR 20th Annual International Meeting May 19, 2015
  2. 2. Page 2 Mobile Apps and Social Media Impacts on Adverse Event Reporting to the FDA Nabarun Dasgupta, Ph.D. Epidemico May 19, 2015 The WEB-RADR project is supported by the Innovative Medicines Initiative Joint Undertaking (IMI JU) under grant agreement n 115632, resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and EFPIA companies in kind contribution.
  3. 3. Page 3 Mobile Apps and Social Media Impacts on AE Reporting Drug Interactions May Be Difficult to Capture May 19, 2015 Source: Larry Risen at BioTrak Its just temporary. Next time, dont take your Rogaine and Viagra at the same time.
  4. 4. Patients are speaking Shouldnt we be listening? Beyond informing the public about the importance of adverse event reporting, we can take steps to encourage patients to report. 01 02 03 Meet patients where theyre at Protect their privacy Give them easy-to-use tools
  5. 5. Data flow for detecting adverse drug reactions in social media data. 5 DATA PROCESSING Acquire Filter Curate Causation Describe Collect social media data Detect Proto- AEs, translate vernacular Reduce false positives Descriptive statistics Synthesis of information
  6. 6. Bayesian classifier identifies posts with resemblance to adverse events Dictionary translates vernacular to MedDRA Multiple copies of posts are consolidated and PII removed 01 02 03 50 million posts that mention a medical product have been collected. The classifier has been trained with 360,000 manually coded posts. 6 AUTOMATED FILTERING 68% Research-ready data available daily. PRECISION [+ predictive value] 88% RECALL [sensitivity]
  7. 7. Vernacular-to-Regulatory Translation 7
  8. 8. Spelling VariationsCombined or invented wordsImplied phrasesInternet Vernacular Translation lost their eyesight seeing weird color seeing weird colour doublevision uldnt see double vision blind googley eyed blurry vision changes in viscross eyed seeing weird vision change blindness cross visionvisual snow googly eyed seeing doub making me eat like a mouse anorexic st appetite #notevenhungry appetite is nonexistent apetite surpressed didnt get hungry dont want to eat killed my apetite miss feeling hung killed my appetite cant eat lost apetite lost my appetite no appetitey lack of apetite stomach small lost teh appetite never hnever want to eat cant eat coucrosseyed blurry apetite surpressed killed my apetite lost apetite lack of apetite lost teh appetite Typos seeing weird color seeing weird colour googley eyed googly eyed #notevenhungry no appetitey making me eat like a mouse never want to eat
  9. 9. Visual impairment MedDRA 10047571 Visual impairment SNOMED 397540003 Decreased appetite MedDRA 10061428 Loss of appetite SNOMED 79890006 making me eat like a mouse anorexic st appetite #notevenhungry appetite is nonexistent apetite surpressed didnt get hungry dont want to eat miss feeling hung killed my appetite cant eat lost apetite lost my appetite no appetitey lack of apetite stomach small lost teh appetite never hnever want to eat cant eat lost their eyesight seeing weird color seeing weird colour doublevision uldnt see double vision blind googley eyed blurry vision changes in viscross eyed seeing weird vision change blindness cross visionvisual snow googly eyed seeing doub coucrosseyed blurry killed my apetite
  10. 10. Victoza - liraglutide [rDNA origin] injection Diabetes indication (Does not include Dec 2014 US approval for Saxenda for chronic obesity) UK, US, IN, CN, EU, JP, DE, DK, NL, IE, SE, FR, MY, SG UK approval: 30 Jun 2009 Public Social Media (FB & Twitter): Jan 1, 2014 to March 9, 2015 English language only MHRA Drug Analysis Print & FDA FAERS (county-limited, non-duplicated) 10 DESCRIPTIVE METHODS
  11. 11. 11 MENTIONS & PROTO-AEs 6360 4098 29 411 TWITTER All mentions FACEBOOK All mentions TWITTER Proto-AEs FACEBOOK Proto-AEs 01 02 03 04
  12. 12. 12 SOC Comparison to UK & US Spontaneous Reports
  13. 13. 13 KNOWN FREQUENCY ADVERSE EVENTS 1:10k+1:1000 1:10k1:1001:10 10 10 0 1k VERY COMMON decreased blood sugar levels, diarrhoea, nausea COMMON bronchitis, constipation, abdominal distension, faster heart rate, feeling dizzy, flatulence, gastritis, gastro- oesophageal reflux, headaches, indigestion, inflammation of nose/throat, injection site problems, loss of appetite, antibodies to Victoza, skin rash, stomach pain, tiredness, toothache, vomiting UNCOMMON dehydration, malaise, itching, kidney problems, urticaria RARE / VERY RARE anaphylaxis, angioedema, GI problems; pancreatitis, hypersensitivity 10 k SOURCE emc+ Medicine Guide, Jan 16, 2015, Datapharm medicines.org.uk Medicine Guide Preferred terms appearing in social media and not appearing
  14. 14. 2 23 21 158 TWITTER MHRA spontaneous reports FDA spontaneous reports (w/o multiplicate reduction) FACEBOOK 14 REPORTING BURDEN PER MONTH ? True Incidence Rate? How does social media volume for Victoza (liraglutide) compare to traditional pharmacovigilance? Can patterns be detected sooner? What does social media contribute? Twitter & Facebook: Jan 14 Mar 15 MHRA Drug Analysis Print: Jun 09 Mar 15 FDA FAERS: Oct 12 Mar 14
  15. 15. Why do Patients Report Adverse Drug Reactions? Data from The Netherlands Jan 2008 Mar 2009, Top 4 responses, N=999 33%Not mentioned in patient information leaflet The adverse drug reaction was severe I wanted to share my experiences The possibility for reporting just exists 54% 48% 35% Van Hunsel, F 2010. Eur J Clin Pharmacol
  16. 16. Essure Implantable, permanent birth control for women Coils made of polyester fibers, nickel-titanium and stainless steel, implanted into fallopian tubes US FDA approved 2002 5-year fail rate: 0.27% 750,000 implanted Potential market 20% of married women using birth control Copyright Conceptus, credit Wikipedia
  17. 17. Methods Outreach to Facebook group Essure Problems 15,000 members Work with group administrators to promote AE reporting via mobile app Krystal Donahue & Melanie Goshgarian 1,349 ICSRs analyzed from publicly redacted versions at medwatcher.org WHO-UMC VigiGrade completeness scores
  18. 18. Mobile App vs. Traditional PharmacovigialnceComparison of Essure mobile app submissions with WHO-UMC database Average Time for Submission App users submitted in 8.5 minutes (104 words average) compared to 40 minutes via traditional forms Average VigiGrade Score Mobile app submissions were more complete than the global average in VigiBase. Well-documented Reports Reports from mobile app were considered well-documented 3x more often than global average in VigiBase 40 min 0.45 Bergvall T 2013 Drug Safety 8.5 min 0.80 56% 24% HCP 13% overall
  19. 19. Essure Reports per Month 7 per month FDA MAUDE 132 months marketing authorisation 103 per month MedWatcher Mobile App 19 months collaboration with patient community

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