Social Media Considerations In Pharmacovigilance   Visiongain 20110317 (Sandeep Bhat)
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Social Media Considerations In Pharmacovigilance Visiongain 20110317 (Sandeep Bhat)

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Presented at the 6th Annual Pharmacovigilance Conference 2011 (London March 17th)

Presented at the 6th Annual Pharmacovigilance Conference 2011 (London March 17th)

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  • Heat map profiling of spontaneously reported adverse events for a single drug. This heat map is divided into different spaces according to MedDRA (the Medical Dictionary for Regulatory Activities) terms; the rectangles outlined in white and labeled are the system–organ classes. The smaller squares represent the 10,000 or so MedDRA preferred terms that are grouped with respect to the hierarchy of MedDRA. The heat map is interactive, and as a computer cursor is moved over these squares, information appears concerning where that square falls in the MedDRA grouping.SOURCE: DuMouchel, 2007.From: 8, PharmacovigilanceEmerging Safety Science: Workshop Summary.Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation.Washington (DC): National Academies Press (US); 2008.Copyright © 2008, National Academy of Sciences.NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

Social Media Considerations In Pharmacovigilance   Visiongain 20110317 (Sandeep Bhat) Social Media Considerations In Pharmacovigilance Visiongain 20110317 (Sandeep Bhat) Presentation Transcript

  • Social Media Considerations in Pharmacovigilance
    Sandeep Bhat, MSE
  • Disclaimer
    The following slides represent my thoughts, opinions, personal musings, attempts at using abstractions and creativity. They are are in no way representative of my employer MphasiS Ltd., or the company that represents its majority ownership (Hewlett-Packard Corp.)
  • Preview
    • Definition(s)
    • Types
    • Disparities/Commonalities
    • How “we” think
    • Technology, Media
    • Influencers, Getting “Buy In”
    • Things to consider (things to think about)
    • News, Implementation, Research
  • DefinitionsSocial Media Definition via Google
    •  media designed to be disseminated through social interaction, created using highly accessible and scalable publishing techniques. …
    en.wikipedia.org/wiki/Social_media
    • media that is created to be shared freely
    en.wikipedia.org/wiki/social_media
    • user-created video, audio, text or multimedia that are published and shared in a social environment, such as a blog, wiki or video hosting site.
    www.capilanou.ca/help/login-page/active-cms/glossary.html
    • website or web service that utilizes a 'social' or 'Web 2.0' philosophy. This includes blogs, social networks, social news, wikis, et
    webtrends.about.com/od/web20/a/web20-glossary_2.htm
    • any form of online publication or presence that allows end users to engage in multi-directional conversations in or around the content on the website
    www.onlinematters.com/glossary.htm
    • the use of technology combined with social interaction to create or co-create value
    www.no2pen.com/blog/2010/01/social-media-dictionary-for-small-businesses/
  • Types
    • Blog
    • Wiki
    • Twitter
    • Social Media Platforms
  • Types
    • Blog
    • www.doseofdigital.com
    • Wikipedia
    • www.wikipedia.org
    • Twitter
    • www.twitter.com
    • Platform Environments
    • Facebook, LinkedIn/Xing
  • DisparitiesCharacteristics
    Social Media
    Unstructured data
    Unstructured process
    Unregulated
    Uncontrolled
    Ungoverned
    “Not” Quality Driven
    Disruptive
    Non-specific orientation
    Business Area
    Pharmacovigilance
    Structured data
    Structured process
    Highly regulated
    Controlled
    Governed
    Quality Driven
    Purposefully nondisruptive
    Highly specific orientation
    Business Area
  • CommonalitiesCharacteristics
    Social Media
    Hot topic: A “Trend”
    Highly Visible in public
    Everyone has an understanding of the benefit
    Everyone has an understanding of the harm
    Rapid – almost real time!
    Global Phenomena
    Source is always from the field
    Pharmacovigilance
    Sensitive topic
    Can be Highly visible to public
    Everyone can easily understand the benefit
    Everyone can easily understand the historical precept of risk/harm
    Intention to be rapid
    Going to be global
    Source is from the field
  • How Technology Professionalslook at it
  • Data Deluge Semantic Enablement
    SAP
    Legacy
    REFDB
    GSM
    NCBI
    Manual Curation
  • Data DelugeMining Algorithms
  • Data DelugeMetadata Management
  • How Media Professionals look at it
  • Social Media – Areas of Influence
  • Social Media –Influence Channels
  • Gaining Support/Buy-In
    Shepherds/Stewards:
    • Financial Support
    • Business Direction
    • Executive Visibility
    • Management
    Stewards:
    Qualified Person PV
    Medical Affairs
    Regulatory Affairs
    Leaders/Connectors:
    • Drive the socialization
    • Ensure Visibility
    Controllers/Operators:
    • Operationally
    • Technologically
    • Governance
    Controllers:
    Leaders:
    Information Management
    Quality and Compliance
    Legal
    Corporate Communications
    High Profiled Individuals
  • People, Process, Tools
    How
    Why
    Who
    What
  • Things to Think About
  • Earlier this year…
    (News about this)
    Should pharma harness social media for R&D?
    January 24, 2011 — 11:09am ET | By Tracy Staton
    http://www.fiercepharma.com/story/should-pharma-harness-social-media-rd/2011-01-24#ixzz1GqT7HyK1 
    When pharma folks talk about social networking, it's usually in a marketing or public relations context. Using Twitter to generate traffic to a disease-awareness website or to report news about a new drug; launching iPad apps to help patients manage their diabetes; monitoring blog comments for accuracy and responding with the facts.
    But a Boston Globe op-ed suggests that social media could be a new frontier for drug development. If pharma companies could gather real-world data from prescribers, they might find new uses for existing drugs. As the authors point out, Viagra resulted from side-effect reports in a cardiovascular trial, and some psychotropic meds trace back to a tuberculosis study. Through physician postings online, drugmakers might identify other unintended benefits of their meds.
  • Earlier this year…
    (News about this… cont’d)
    So why doesn't Big Pharma set something up? It could be a thorny FDA problem, given the ban on off-label promotion. But a greater fear might be its unintended consequences. Set up a networking site to find unanticipated benefits, and you might come up with unexpected safety problems instead. Very public safety problems, given that the reports would be online and out in the open. And such unverified safety problems could spook patients .
    Such is the double-edged sword of social media--it's a means of spreading both good and bad news. And like everything else online, it can't be tightly controlled.
    FiercePharma article posted on Jan 24, 2011 http://www.fiercepharma.com/story/should-pharma-harness-social-media-rd/2011-01-24#ixzz1GqT7HyK1 
  • Lots of Information?
    Deluge of new information
    Uncontrolled context
    Unknown source
  • What you already do
    Active Surveillance Systems
    Expected, planned, monitored
    Spontaneous (unsolicited) event
    Unscheduled, Unknown
  • Truth?
    The question of accuracy?
    The question of truth?
    Source Data Verification
    Qualified and Educated Source
  • Temporally, when do you record
    A blog can list multiple parts of the same event
    Start, in the middle, at the end?
    How to you code a “Conversation”?
  • Feedback to the public
    Can Social Media be reasoning we can use to promote “good” communication (and eventual reporting) of safety concerns – back to the public audience?
    We seek to obtain at the onset 4 relevant fields
    Via the right outlets/channels, message are:
    VERY IMPACTFUL
    VERY RAPID
  • Last Week
    (News about this)
    Looking for Guidance, Pharma Left Waiting
    Industry Would Prefer Some Sort of Rulemaking for Social Media, but FDA Delays
    March 07, 2011 – By: Rich Thomaselli
    http://adage.com/article/news/drug-makers-wait-fda-ruling-social-media-dtc-ads/149214/
     
    The biggest regulatory issue involving the pharmaceutical and health-care industries is actually a lack thereof.
    The Food and Drug Administration has continually delayed the announcement of new advertising guidelines for online and social-media marketing -- despite holding public hearings on the topic more than 15 months ago -- leaving drug makers and health-care agencies alike in no-man's land with a lack of clearly defined principles for internet advertising.
  • Last Week
    (News about this … cont’d)
    Now, after anticipating changes that were hoped to be as broad as the landmark 1997 FDA guidelines regarding direct-to-consumer broadcast advertising of prescription drugs, the industry is preparing for little movement from the status quo when it comes to social media.
    Twice in February 2011, Tom Abrams, the head of FDA's Division of Drug Marketing, Advertising and Communications, suggested that little will change. On Feb. 8, speaking at the ePharma Summit in New York, Mr. Abrams conceded that the process is "taking longer than we thought," but added, "We owe it to you to get this right," according to Medical Marketing & Media.
    But part of the delay, he said, was concern on the part of FDA that social-media platforms such as Twitter and Facebook would not be around in the future. "We did not want the guidances to become quickly outdated," Mr. Abrams said.
  • Last Week
    (News about this … cont’d 2)
    On Feb. 22, speaking at the Drug Information Association's annual marketing meeting in Washington, D.C., Mr. Abrams said, "There will be guidance on some specific matters, but there will be no new regulations or new standards. Look at our recent Warning Letters involving social media, such as Facebook. These Warning Letters cite existing rules and do not make new policy.“
    "We took it as Tom Abrams saying there's going to be some social-media guidance but it's not going to change the rules," John Kamp, director of the Coalition for Healthcare Communication, told Advertising Age. "This is going to be a pretty serious disappointment to pharma companies hoping there would be some kind of change in DDMAC's attitude."
    "The problem," said one health-care ad-agency president, who asked not to be identified, "is that the digital space is so vastly different from traditional 30-second spot advertising that the [current] guidelines don't apply online. There needs to be significant change, and it doesn't appear there's going to be."
  • A reason for better communication?
    Can Social Media be used to promote good communication (and eventual reporting) of patient safety – back to the public audience?
    Professionals obtaining the relevant 4 fields
    Via the right outlets/channels, message are:
    VERY IMPACTFUL
    VERY RAPID
  • Impact
    Social Media already has impacted the community of medical practitioners
    www.sermo.com
    Social Media has impacted the community of patients:
    www.patientslikeme.com
    Social Media has impacted the community of medical education
    Social Media has impacted the community of medical care facilities
    Mayo Clinic
  • Scope
    This is a massive movement
    Potential immediate impact
    Large scale pandemic/epidemic/outbreak
    Vaccine “gone wrong”
    Use all your employees to be stewards
  • “Sample” Social Media Guideline
    Roche Social Media Principles (in short):
    7 Rules for PROFESSIONAL online activities Speaking “on behalf of” Roche
    Follow the Roche Group Code of Conduct and Communications Policy.
    Follow approval processes for publications and communication.
    Mind Copyrights and give credit to the owners.
    Use special care if talking about Roche products or financial data.
    Identify yourself as a representative of Roche.
    Monitor your relevant social media channels.
    Know and follow our Record Management Practices.
    7 Rules for PERSONAL online activities Speaking “about” Roche
    Be conscious about mixing your personal and business lives.
    You are responsible for your actions.
    Follow the Roche Group Code of Conduct.
    Mind the global audience.
    Be careful if talking about Roche. Only share publicly available information.
    Be transparent about your affiliation with Roche and that opinions raised are your own.
    Be a “scout” for sentiment and critical issues.
  • “Sample” Social Media Guideline
  • “Sample” Social Media Guideline
  • Academic Article
    Linguistics and Text Mining
  • Academic Article
    Linguistics and Text Mining
  • IOMPresentation
  • Review
    • Definition(s)
    • Types
    • Disparities/Commonalities
    • How “we” think
    • Technology, Media
    • Influencers, Getting “Buy In”
    • Things to consider (things to think about)
    • News, Implementation, Research
  • Thank you
    Sandeep Bhat
    Sandeep.bhat@mphasis.com
    http://www.linkedin.com/in/bhatsandeep