Social Media Considerations In Pharmacovigilance Visiongain 20110317 (Sandeep Bhat)

Social Media Considerations in Pharmacovigilance

Sandeep Bhat, MSE

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.)

Disclaimer

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

Business Challenge Need Potential Solution Type

Tools/Enablers

Data DelugeEnormous volume of data

Sharing of knowledge and collaboration (internally, locally and globally and externally with partners

Data and knowledge management

•Semantic Enablement•Mining algorithms•Metadata Management

Business ProcessMultiple disparate workflows leading to information in silos

Need for consolidation and channeling of the workflows with effective mining of volumes of data

Automated workflow and tracking

•BPM•Automation tools

Disparate ChannelsEmergence of various sources

Need to monitoring the progress

Need to harmonize both the work and its results

Dashboards and Visualization

• Portals • PV Project management suite

Newer TechnologiesEmerging new ways to perform research and investigation

Need for real-time decision making toolsNeed for seamless transition to newer technologies

Real-time decision-making

•Mobility•Enterprise Analytics•Cloud •*aaS solutions•HPC

Data Deluge Semantic Enablement

• SAP• REFDB

• NCBI

• GSM

• Manual Curation

• Legacy

Data DelugeMining Algorithms

Data DelugeMetadata Management

How Media Professionals look at it

Communities

(Blogs, Twitter, Wikis, Video,

Mashups, URLs)

Brand sponsored

Healthcare Professional

Societies

Patient Driven

Marketing Professionals

Others

Industry Observers

Caregivers

Social Media groups

(Facebook, Youtube, Twitter,

etc)

Individual Builders

(employees of Life sciences

firms, etc)

Social Media – Areas of Influence

•Product/Brand Managers•Business Unit, Therapy Area, etc.Brand Sponsored

•Medical Professional Societies, Conferences/Congresses •Clinical Associations

Healthcare Professional Societies

•Patients seeking some form of lifelong association•Patient Advocacy groupsPatient Driven•Healthcare Marketing Associations, Ad Agencies •Pure Promotion firmsMarketing Professionals

•New and unknown entrants/outlets,/channels, Academic medicine, Journals, etc•Parties with conflicting interest (Negative campaigns, etc) Others•Third-party advocates providing critical assessment of firms, industry, regulation•Industry Watchdogs and Independent CommunitiesIndustry Observers

•Patient supporters, families, those seeking information to share•Nursing groups, Home Healthcare groups, Assisted Patient Living groupsCaregivers•Facebook, Twitter, etc groups•Audio/Video Podcasts dedicated to topical areasSocial Media Groups

•Possibly employees of some healthcare or life sciences organization •Information brokers who many not necessarily represent an organization view Individual Builders

Social Media –Influence Channels

Gaining Support/Buy-InSponsors

ChampionsEna

blers

Shepherds/Stewards:• Financial Support• Business Direction• Executive Visibility• Management

Controllers/Operators:• Operationally• Technologically• Governance

Leaders/Connectors:• Drive the socialization• Ensure Visibility

Qualified Person PVMedical AffairsRegulatory Affairs

Stewards:

Information ManagementQuality and ComplianceLegal

Controllers:

Corporate CommunicationsHigh Profiled Individuals

Leaders:

People, Process, Tools

Process

PeopleTools

HowWhy

WhoWhat

Things to Think About

Should pharma harness social media for R&D?January 24, 2011 — 11:09am ET | By Tracy Statonhttp://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)

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

Earlier this year…(News about this… cont’d)

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

Looking for Guidance, Pharma Left WaitingIndustry Would Prefer Some Sort of Rulemaking for Social Media, but FDA DelaysMarch 07, 2011 – By: Rich Thomasellihttp://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)

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)

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."

Last Week(News about this … cont’d 2)

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.



Academic ArticleLinguistics and Text Mining

Academic ArticleLinguistics and Text Mining

IOM Presentation

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

[email protected]

http://www.linkedin.com/in/bhatsandeep