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DigiPharm Europe 2010: Reportable Adverse Events on the World Wide Web

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At DigiPharm Europe 2010 Conference in London on 29 September, Paul Grant and Daniel Ghinn presented the highlights of a global study into reportable adverse events found online by therapeutic area, …

At DigiPharm Europe 2010 Conference in London on 29 September, Paul Grant and Daniel Ghinn presented the highlights of a global study into reportable adverse events found online by therapeutic area, brand and territory.

The research was one of the most extensive studies of its kind ever conducted, and was carried out by nine of Creation Healthcare's international team of consultants based in seven countries.

The DigiPharm session included some interesting dialogue with conference participants, who shared their own experiences of adverse events monitoring.

The session concluded with a challenge to pharmaceutical professionals in marketing, communications and pharmacovigilence to collaborate, using these insights to develop appropriate strategies in their own companies.

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  • Creation Healthcare is a global, research-led healthcare engagement strategy consultancy.Our team of experts on the ground in 15 countries provides local insights to shape strategies worldwide.Creation Healthcare’s Discovery Methodology provides a system for successful healthcare engagement for professionals in healthcare organizations.
  • At Creation Healthcare we are constantly developing the knowledge in our team.In the changing healthcare engagement landscape, we know that we don’t have all the answers.A key component of our commitment to global healthcare engagement strategy consultancy is to continue to grow our understanding of the differences between cultures, languages, and countries, so our team can be better equipped to help our clients develop long-lasting local & global strategies.
  • In August 2008, Nielsen Online published research into social media messages, indicating that 1 in 500 messages were reportable adverse events.Who’s seen this?This was an excellent report, and in this presentation we’re not going to go over the ground it already laid.But as with all research like this, answering a set of questions raises many more questions.So we were left with lots of questions after reading Nielsen report. Weren’t you too?
  • If you’re involved in monitoring social media conversations, what’s your experience?Is the 1 in 500 figure indicative of what you are seeing?Do you also find that you have many other questions?What kinds of questions do you find yourselves asking about this?
  • Feedback collected by DigiPharm after last year’s conference put regulation at the top of delegates’ wish list for 2010. Specific regulatory challenges identified included:- Concerns about lack of regulatory guidance- Fears about compliance issues Uncertainty about what is possible within regulations
  • We wanted to study drug mentions in context, to answer some of the questions about mentions of adverse drug reactions / adverse events / side effects.
  • Context is key
  • Our research focused on ‘adverse drug reactions’ (or adverse events) resulting from prescription only medication (POM).We studied the following therapy areas, globally:AnemiaArthritisAsthmaBreast CancerCardiovascularDeep Vein ThrombosisGastrointestinalMental HealthOsteoporosisType II DiabetesWe looked for ‘potentially reportable adverse events’, which would require further manual assessment to determine whether they were reportable.We defined our criteria as mentions that met the UK’s ABPI guidelines (noting that these are more stringent than those of most regulators):“The minimum information required for collecting and forwarding the AE/PC [product complaint] to the Pharmaceutical Company is the name of the drug concerned and the AE/PC experienced.”(Medcalf, Rachel (2009-11-01). “GUIDELINES for COLLECTING ADVERSE EVENTS and PRODUCT QUALITY COMPLAINTS from MARKET RESEARCH PROGRAMMES”, ABPI)
  • We wanted to answer the questions you were asking: What kind of social media conversations are likely to result in reportable adverse events? Are there variations in the prevalence of reportable adverse events online by therapeutic area, platform, country or language? How can pharmaceutical companies choose the most effective digital engagement channels to suit their approach to handling reportable adverse events?
  • Our research was designed to prove or disprove this hypothesis:“In conversations on the worldwide web, the volume of reportable adverse events vs product mentions varies by therapy area, channel, and language”
  • Let’s take a brief look at the scope of this research workWe started by setting some parameters for our study:1 week in July 2010;Ten major therapy areas;Five major products in the biggest therapy area;Detailed analysis in the biggest product
  • We had conversations with regulators in many of the countries of our study, in both the developed and developing worldE.g. Danish Medicines Agency in CopenhagenWe wanted to understand variations in regulatory parameters, attitudes and procedures
  • We used a number of automated and manual tools to search for and monitor conversations and online contentWe were looking for the relative volume of possible reportable adverse events between countries & languages, therapeutic areas, brands & productsin order to inform strategy development
  • Let’s explore three key insights. Consider how they affect you.
  • Spam is a big issue in social media monitoring and can add lots of noise!We’re talking here specifically about social media spam – unwanted, irrelevant marketing messages sent indiscriminately via social media platforms
  • How much of our monitored content in social media (NB not email) would you expect to be spam?20% or less?50%?80% or higher?What’s your experience?
  • The volume of spam in certain countries can lead to a distortion in the monitoring of product, brand or therapy area mentionsNote that much content appearing to originate in the US may in fact be from elsewhere, such as global content hosted in the US
  • Here we see that around 90% of mentions in the US were in fact spam. In France it was much lower; in Brazil we found almost 100% spam in our study.
  • Removing spam reveals the true picture.France is revealed as the country with the most mentions of the therapy areas / brands / products in our study, after the US.
  • Potentially reportable adverse events by therapy area.Would you expect the number of adverse events to vary by therapy area?Over what sort of range? E.g. Would the % of potential adverse events mentioned in the most active therapy area vary by a factor of twice the least active? Or more / less?
  • The volume of spam in certain countries can lead to a distortion in the monitoring of product, brand or therapy area mentionsNote that much content appearing to originate in the US may in fact be from elsewhere, such as global content hosted in the USWhat does this mean for you? At first glance, it tells you something about the scale of plans you should put in place to handle possible adverse event reporting. But again, there’s more to this story...
  • Further analysis of our data revealed some external factors affecting the results during our study week.External stories skewing results included news about Avandia; Lindsay Lohan; and Chewable Lipitor.
  • Adjusting for anomalies shows a significant difference, moving Type II Diabetes from rank 9 to rank 2.The range of potentially reportable side effects is now from 14% to 42%, with Arthritis at the top.
  • Potentially reportable adverse events by brand name / product in cardiovascular therapy area.Would you expect the number of adverse events to vary by brand / product?Over what sort of range?We studied the following brands/products:DiovanIscoverLipitorNorvascPlavix
  • This chart shows potentially reportable adverse events by product, including references to the active ingredient.
  • What kinds of platforms are reportable adverse events most likely to be found in?Let’s explore what our research found, and look at a hypothetical exampleBut first, in what kinds of platforms would you expect to find the most adverse event mentions? E.g. Microblogging, or forums?
  • This chart simply shows the total number of mentions we found, by platform.Our study showed that forums and platforms with a strong sense of community are more likely to include mentions of adverse events, than microblogging platforms.Is this your experience?However, this finding considers only single mentions. What happens if you consider a complete picture built up over a period via microblogging?
  • Here we see the breakdown by platform for cardiovascular therapy area.
  • OK, here’s a hypothetical example from Twitter.
  • Assume Norforlordor is one of your brands, a cardiovascular drug launched across Europe this year.Do you think Thomas Jefferson is his real name?Is this a reportable adverse event?
  • On its own, is this a reportable adverse event?What if you now know about both tweets?
  • What’s he saying here, in this tweet 3 weeks ago?He mentions the brand, and then says something else made him dizzy.Is it a reportable adverse event?It looks like this is a response to somebody else... Should we follow that conversation?
  • OK here’s the incoming message, also 3 weeks ago...Is it a reportable adverse event yet?
  • And here’s another piece of the puzzle...
  • Here’s his first mention of this headache...Is it a reportable adverse event yet?
  • Let’s look at the whole thing in sequence...Does a whole conversation count?Over how long would be relevant? 1 day? 1 month? 1 year?If they’re telling an individual other party, and not you, what’s your responsibility?Whose responsibility is it to report?Who would you report to?
  • So what should you do in the light of all this?
  • The solution is in applying Creation Healthcare’s Discovery Methodology.Discover: Find out what to expect in your therapeutic area or product. It’s not rocket science and it will enable you to Determine what your approach should be.Put in place a Discovery system that automates as much as possible and leaves you with manual decisions that you are prepared for.Then you will be equipped to Define an informed engagement strategy based on your goals.Take the lead; collaborate with colleagues. Bring Direction to pharmacovigilence in digital engagement.
  • It’s your strategy, so you must answer these questions for yourself.By taking the initiative on pharmacovigilence you can develop successful engagement strategies without a stalemate.The first steps aren’t always easy; sometimes it requires organisational change.
  • Transcript

    • 1. Reportable Adverse Events on the World Wide Web
      29th September 2010
      Daniel Ghinn & Paul Grant
    • 2. Creation Healthcare’s Global Team
    • 3. Why this research?
    • 4. Source: Listening to Consumers in a Highly Regulated Environment
      Melissa Davies, Nielsen Online, August 2008
      Previous research raised new questions
    • 5. What’s your experience?
    • 6. You asked for it
    • 7. We wanted to study conversations in context
    • 8.
    • 9. Reportable Adverse Events
    • 10. We wanted to answer the questions you were asking
      The big questions
      • What kind of social media conversations are likely to result in reportable adverse events?
      • 11. Are there variations in the prevalence of reportable adverse events online by therapeutic area, platform, country or language?
      • 12. How can pharmaceutical companies choose the most effective digital engagement channels to suit their approach to handling reportable adverse events?
    • Our hypothesis:
      “In conversations on the worldwide web, the volume of reportable adverse events versus product mentions varies by therapy area, channel, and language”
      We wanted to prove or disprove this hypothesis
    • 13. What did we do?
    • 14. Conversations with regulators in countries
    • 15. Online monitoring & analysis
    • 16. 3 key insights
      what do they mean for you?
    • 17. Image: Flickr cobalt123
      Source: http://www.flickr.com/photos/cobalt/247564799/
    • 18. How muchsocial media spam?
      Image: Flickr cobalt123
      Source: http://www.flickr.com/photos/cobalt/247564799/
    • 19. Volume of therapy area / brand / product mentions, without spam filtering
      Top 10 amongst countries monitored
      Creation Healthcare: Reportable Adverse Events on the World Wide Web
      Unfiltered mentions
    • 20. Creation Healthcare: Reportable Adverse Events on the World Wide Web
      How much spam?
      % spam amongst mentions of therapy area / brand / productTop 10 countries by overall volume of mentions
    • 21. The true picture, spam removed
      Volume of therapy area / brand / product mentions
      Top 10 countries
      Creation Healthcare: Reportable Adverse Events on the World Wide Web
    • 22. Potentially reportable adverse events by therapy area
    • 23. % of potentially reportable adverse events,
      by therapy area studied
      Creation Healthcare: Reportable Adverse Events on the World Wide Web
      By therapy area
      26%
      5%
    • 24. But there’s more to this story...
      Therapy area mention spikes caused by external factors
      Creation Healthcare: Reportable Adverse Events on the World Wide Web
    • 25. % of potentially reportable adverse events amongst mentions,
      by therapy area studied, after adjusting for spam and anomalies
      Creation Healthcare: Reportable Adverse Events on the World Wide Web
      After adjusting for anomalies
      42%
      14%
    • 26. Potentially reportable adverse events bybrand or product
    • 27. % of potentially reportable adverse events amongst mentions,
      by product in cardiovascular therapy area
      Creation Healthcare: Reportable Adverse Events on the World Wide Web
      By product - cardiovascular
    • 28. Platforms
      Image: Flickrsheilaellen
      Source: http://www.flickr.com/photos/sheilaellen/111377949/
    • 29. Share of mentions, by platform type
      Overall % share of mentions of therapy areas, brands and products in study
      Creation Healthcare: Reportable Adverse Events on the World Wide Web
    • 30. Share of mentions, by platform type
      % share of mentions by platform in cardiovascular
      Creation Healthcare: Reportable Adverse Events on the World Wide Web
    • 31. Safe to Twengage?
      Image: Twitter
    • 32.
    • 33.
    • 34.
    • 35.
    • 36.
    • 37.
    • 38. Location?
      Contact info?
      Name?
    • 39. What to do?
    • 40. Creation Healthcare’s Discovery Methodology
    • 41. It’s your strategy
      • What can you expect from your territory, therapeutic area(s), or product(s) ?
      • 42. Will you monitor real-time engagement?
      • 43. Will you take a global view, even in country or regional engagement?
      • 44. How will you collaborate with colleagues across marketing, communications, pharmacovigilence?
      • 45. Set thresholds and make it manageable
    • Reportable Adverse Events on the World Wide Web
      What kind of social media conversations are likely to result in reportable adverse events?
      Are there variations in the prevalence of reportable adverse events online by therapeutic area, platform, country or language?
      How can pharmaceutical companies choose the most effective digital engagement channels to suit their approach to handling reportable adverse events?
      Comprehensive 75-page report available from Creation Healthcare
    • 46. http://engagementstrategy.tv
      The e-journal for business leaders and communicators in healthcare
    • 47. More information
      Daniel Ghinndaniel.ghinn@creationhealthcare.com
      Paul Grantpaul.grant@creationhealthcare.com
      http://creationhealthcare.com
      London, UK
      90 Long Acre
      London
      WC2E 9RZ
      United Kingdom
      +44 (0)207 849 3167
      london@creationhealthcare.com
      Tokyo, Japan
      Shinjuku Park Tower
      30th Floor
      3-7-1 Nishi-Shinjuku
      Shinjuku-ku
      Tokyo 163-1030
      Japan
      +81-3-5326-3369
      tokyo@creationhealthcare.com