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Impact of Social Media adverse event reporting
 

Impact of Social Media adverse event reporting

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A “back of the envelope“ analysis of how many more adverse events could potentially be reported via online communities ...

A “back of the envelope“ analysis of how many more adverse events could potentially be reported via online communities

All calculations done on the example of Copaxone patients within patientslikeme

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    Impact of Social Media adverse event reporting Impact of Social Media adverse event reporting Presentation Transcript

    • Impact of social media on adverse event reporting Example: Potential Copaxone AE cases on patientslikeme By SiljaChouquet Owner and managing director of whydot Basel, April 21st, 2009 -1-
    • Capturing AEs via online communities will help to increase patient safety Patientlikeme rationale for reporting AEs Definition of Adverse Event (AE) “Patients like you are becoming more and An adverse event is any undesirable experience associated with the use of a more influential in their treatment decisions. No medical product in a patient. The event is longer are you simply consumers of serious and should be reported when the pharmaceuticals and medical products, you patient outcome is: are customers. In this emerging world, you •Death have become better educated about your •Life-Threatening treatment options, the risk and benefits of •Hospitalization (initial or prolonged) different treatments, and your overall quality of •Disability health. Now you have the opportunity to tell •Congenital Anomaly. the FDA if you’ve had an adverse event.” •Requires Intervention to Prevent Permanent Impairment or Damage David S. Williams III Founding Executive, Marketing and Business Development Patientslikeme • FDA estimates that AEs are currently under reported with only 10% of serious and 2-4% of non-serious AEs getting captured  Is the systematic reporting of AEs via online communities going to improve the amount and quality of cases reported? Source: www.fda.gov,, http://blog.patientslikeme.com/2009/04/15/patientslikeme-offers-adverse-event-reporting-for-ms-patients/ whydotpharma presentation – www.whydotpharma.com -2-
    • Copaxone number one MS treatment on patientslikeme Top 5 prescription drugs in patientslikeme MS community n= number of patients Copaxone 2129 Baclofen 1413 Gabapentin 903 Avonex 820 Provigil 757 0 500 1000 1500 2000 2500  Therefore, used Copaxone as example to analyze impact on number and type of potential AEs Source: http://www.patientslikeme.com/multiple-sclerosis/treatments/ whydotpharma presentation – www.whydotpharma.com
    • Majority of Copaxone AE cases in FDA database have been reported by patients Example 63% of AE cases Copaxone are # of Copaxone cases reported in FDA database by … currentlyreported by patients N= 2854 2000 1788 1500 # of Cases 822 1000 500 110 100 89 38 12 4 3 0 Representative Professional Study Literature User Facility Distributor Other Consumer Foreign Company Health Source: fdablecopaxone AE report whydotpharma presentation – www.whydotpharma.com
    • Currently patients report mainly via pharma and HCPs HCPs HCPsreport AEs on a voluntary* basis to the appropriate source, most often regulatory responsibility for Patient the manufacturer. ensuring the safety of all marketed medical products. Patient experiences adverse event (AEs) Pharma Source:http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und *Note: AE reporting by an individual Healthcare professional is voluntary, except for specified vaccines **as well as distributors of FDA approved pharmaceuticals (drugs and biologics) and medical devices, plus pharmaceutical packers and device user facilities whydotpharma presentation – www.whydotpharma.com 5
    • Patientslikeme opens up a new “AE reporting channel” for patients Will FDA require pharma to collaboratewith site on AE reporting? How HCPs willphysiciansreact to patients reportingAEs? Patient Pharma Patient experiences adverse event (AEs) helps patients submit treatment- related AEs directly to the FDA through their site. Source: http://blog.patientslikeme.com/2009/04/15/patientslikeme-offers-adverse-event-reporting-for-ms-patients/ whydotpharma presentation – www.whydotpharma.com 6
    • Patientslikeme has more patients on Copaxone than the product’s label data Number of patients on Copaxone Example (glatiramer acetate) Copaxone 2129 Patientslikeme 1601 528 Discont’d Currently treated Label 900 0 500 1000 1500 2000 2500 • AEs in Copaxone label based on data from 900 patients, but 2129 patientslikeme members have taken the product  Will the data captured in patientslikeme impact the current label? Source: http://www.patientslikeme.com/multiple-sclerosis/treatments/show/823-copaxone, Copaxonelable, http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und whydotpharma presentation – www.whydotpharma.com
    • Potentially, reporting via patientslikeme could increase AE cases by up to 23% for Copaxone Number of Copaxone (glatiramer acetate) AE cases Example Copaxone 4000 3521 3500 484-667* potential additional AE cases= 3000 17-23%* increase 2500 Patientslikeme 2000 Moderate SE on treatment 1500 2854 Severe SE on treatment 1000 Discontinuation due to sever SE 500 0 Current FDA database Number of Adverse events  How is a sudden 23% increase of AE cases going to be perceived by FDA? Source: http://www.patientslikeme.com/multiple-sclerosis/treatments/show/823-copaxone, Copaxonelable, http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und *Note: not sure whether discontinued patients were counted in side-effect analysis whydotpharma presentation – www.whydotpharma.com
    • A potential 7% increase of cases could come from patients thatdiscontinuedtreatment due to severeSEs Example Copaxone 2129 •Currently, 2854 CopaxonerelatedAEs have been reported to FDA •36% or 198 of Copaxone patients on patientslikemediscontinued due to severesideeffects, representing a potential 7% increase in reportable AEs Source: http://www.patientslikeme.com/multiple-sclerosis/treatments/show/823-copaxone, Copaxonelable, http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und whydotpharma presentation – www.whydotpharma.com
    • Another 16% increase of AEs could come from severe and moderate side-effects reported by patients Example Copaxone Side effects captured by patients in patientslikeme community • 22% of Copaxonepatientslikeme members report severe or moderate side-effects • If severe side-effects can be seen as a proxy for serious AEs, while moderate side-effects can be taken as a proxy for non-serious AEs •Please note that only 299 out of 2129 patients on Copaxone within patientslikeme community chose to disclose details about their side effects, percentages were then applied to entire Copaxonepatientlikeme population Source: http://www.patientslikeme.com/multiple-sclerosis/treatments/show/823-copaxone, Copaxonelable, http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und whydotpharma presentation – www.whydotpharma.com 10
    • Open questions on impact • Under reporting: Actual increase in AE cases reported dependent on transformation rate of severe and moderate side-effects to a reported AE. How many AE cases will patients report, especially the non-serious ones? • Biases: patientlikeme population might not be representative of total patient population Are inherent biases in patientlikeme population (ie. Age, educational level etc.) likely to skew the AE reported? • Clinical impact: new AE cases reported might reveal new or more reactions than currently captured Will increase of AE cases have an impact on Copaxone current label? Are patients going to report reactions currently not part of label? Are they going to report more on certain reactions vs. others? whydotpharma presentation – www.whydotpharma.com
    • What does this mean for pharma? • For right now, only one social media online community is reporting AEs, but many more will follow, if patientslikeme pilot is successful Set up social media monitoring now to find out about side-effects and AEs discussed online • If large number of online communities start to report AEs, FDA might turn to Pharma to • check AEs for accuracy and quality as it done for HCPs reported events • evaluate impact and need for follow up studies Be proactive and start setting up processes to deal with FDA request Get data on how many of your patients are active in online communities and what the potential impact could be Talk to online communities and FDA about potential implications of patient-driven AE reporting whydotpharma presentation – www.whydotpharma.com
    • Contact SiljaChouquet Owner and managing director of whydot GmbH Bloggerwhydotpharma E-mail: siljachouquet@whydot.net whydotpharma presentation – www.whydotpharma.com