Pharma’s Social MediaRubik’s Cube:A Hands-on SolutionPhil Baumann, RN BSN, Social Media Strategist

A Division of Telerx

Agenda

2

Regulatory Recap

Adverse Event / Product QualityComplaint Process for SocialMedia

Social Media Technologies

Question and Answer Session

Photo credit: https://commons.wikimedia.org/wiki/User_talk:Booyabazooka

Key Considerations

3

Training

DocumentedProcess

Reconciliation

Audit

ValidationStaffingNon-HCP

HCP

SecurityTechnology

Adverse Events & Social Media

UNDERSTANDCHALLENGES

MANAGE WITHWELL-DEVELOPED

PROCESSES

USE TECHNOLOGYAS AN ALLY

TRANSITION TOEXISTING PVPROCESSES

REGULATORYRECAP

Regulatory Recap

Regulatory Guidance is in Evolution

Keep the Principles in Mind:

– On label vs off label

– Solicited vs unsolicited

– Consider the missions/objectives of regulatory agencies

– Safety first!

June, 2014: Correcting Independent Third-PartyMisinformation, FDA

June, 2014: Internet/Social Media Platforms withCharacter Limitations – Presenting Risk andBenefit Information, FDA

FDA Is Getting Serious About AE Detection in Social Media

7

Mock Example of FDA Compliant Tweet

8

The FDA-Compliant Tweet

9

Why Collaboration, Due Diligence, and Technological Understanding Are Important

*Based on a review , conducted n July 2014 by Phil Baumann RN, of 38 prescribing information highlights of pharmaceutical products for 8 different disease states across various drugclassifications. See appendix for further details.

16%

24%60%

Compliancy of Promotional Tweets*

Likely Compliant

Debatably Compliant

Not Compliant

ADVERSE EVENT /PRODUCTQUALITYCOMPLAINTPROCESS FORSOCIAL MEDIA

Collaboration: A Crucial Element in Social Media

Pharmacovigilance

CustomerServiceVendors

InvestorRelations

LegalMarketing

Agency

PublicRelations /

Affairs

11

PLAYBOOK – PROCESS ALIGHMENT

COORDINATION

TECHNOLOGY

PLAYBOOK – PROCESS ALIGHMENT

COORDINATION

TECHNOLOGY

Adverse Event Monitoring Process

12

High Level Social Intake Process

• Training• Social media search

inclusions andexclusions

• Training• Social media search

inclusions andexclusions

• Monitor social media• Identify potential AEs• Monitor social media• Identify potential AEs

• Complete triage,investigation and duediligence for all AEs

• Complete triage,investigation and duediligence for all AEs

• Obtain source doc• Create case• Obtain source doc• Create case

• Capture AE detailsfrom social media postin source document

• Capture AE detailsfrom social media postin source document

• Send source documentto PV data team viasecure fax or validatedsystem

• Send source documentto PV data team viasecure fax or validatedsystem

PrerequisitesPrerequisites AE IdentificationAE IdentificationDocument Critical AE

DetailsDocument Critical AE

Details

• Respond to/@consumer with 800# toreport further detailsby phone

• Respond to/@consumer with 800# toreport further detailsby phone

Initial Outreach viaSocial Media

Initial Outreach viaSocial Media

Triage Post to PV TeamTriage Post to PV TeamBook-InBook-InCase ProcessingCase Processing

Legend:• Social Media Specialist, Non-HCP• Safety Data Associate, Non-HCP• Drug Safety Team Member, HCP

• Identified AE reportingelements to clientand/or regulatoryauthorities

• Identified AE reportingelements to clientand/or regulatoryauthorities

Reporting & Reg FilingReporting & Reg Filing

• Identified AEoperational reportingelements

• Identified AEoperational reportingelements

Operational ReportingOperational Reporting

Social Media Interaction

13

Sample Recommended Adverse Event Responses

(name) Thank you for your comment. We take product safetyseriously and would like to know more about yourexperience. Please contact our (Medical Information team) at(800.555.5555) so we can gather additional information.

(@username) Thank you for bringing this toour attention. We’re interested in learningmore. Please call us at (800.555.5555).

(@username) We’re interestedin learning more about yourexperience. Please call us at800.555.5555.

RESPONSE TO COMMENT

ON YOUR FACEBOOK

PAGE

DIRECT

RESPONSE TO TWEET

@YOUR COMPANY

DIRECT

RESPONSE TO TWEET

MENTIONING YOUR

PRODUCT

INDIRECT

Handling High Volume

14

Limit Monitoringto a Pre-set

Limit of EventsPer Day?

Limit Monitoringto a Pre-set

Limit of EventsPer Day?

CrisisManagement:

Recall;Label Change;

Black BoxWarning;

Viral Detraction

CrisisManagement:

Recall;Label Change;

Black BoxWarning;

Viral Detraction

ContinueMonitoringContinue

Monitoring

DiscontinueMonitoringTemporarily

DiscontinueMonitoringTemporarily

Adjust / ExcludeRelated Keywords

(“Dial Down”)

Adjust / ExcludeRelated Keywords

(“Dial Down”)

OR

OR

TECHNOLOGYOVERVIEW

Social Technology Vendors

16

Social Media Technology

17

Allies in Identification and Triaging

NativePlatform

TechnologyPlatformBenefits

Native Platform

3rd Party Tools

Limited functionality and administration

Consolidate, enable and streamlineinteraction, monitoring, reporting andoperational activities Monitoring

QueryDevelopment

Tagging

ReportingEngagement

Identification of AEs/PQCs - Where

18

BrandedProperties

Broad SocialSpace

PrivateCommunities

Corporate Facebook page Blogs, forums, websites, socialmedia platforms

Closed physician communities

AutomatedProcess

&Manual Review

Identification of AEs/PQCs - How

19

OtherTags

PQC

AE

Results

“NotWorking”

Infection

AcmeRx

ExistingDrug SafetyProcesses

Giving Definition and Structure to Tags

20

Source Author Behavior Type Topic Sentiment

Platformsource of postor comment(e.g. Twitter,Facebook,blog, forum,online journal,etc.)

Attribute oforiginalposter - helpsto definedemographic,influence,specialty. Ex:Consumer,HCP

Conduct orpattern ofauthor’saction. Ex:Educate,Recommend,Prescribe,Detract, etc.

Characteristicof the kind ofcontentposted. Ex:inquiry;complaint;praise;adverseevent

Descriptiveelement thatfurthercategorizes apost. Ex:Cancer,Treatment

Tone of apost. Ex:Positive,Negative,Mixed, orNeutral

Subject

Main focus ofa post orcomment.Examples:Oncology;BrandedProduct

Examples of Applying Tags

Category Source Author Type Subject Topic Sub-topic Sentiment

Tags Twitter(Query)

Physician Inquiry Diabetes PrescribingInformation

Indication

SafetyProfile

Neutral

Tags FacebookBrandedPage

Consumer AdverseEvent

Inquiry

BrandedProduct

Cost

Immunity

PAP Neutral

Tags BrandedBlog

KOL Praise BrandAdvocacy

TV Commercial Positive

Tags YouTube PatientAdvocate

InfoSharing

Cancer Misinformation DiseaseState

Negative

21

Social Media Technology Dashboard

22

Social Technology – Adding Layers of Value

23

Reporting and Insights(Sample Generic Dashboard)

24

QUESTIONS

26

PHIL BAUMANN, RN BSNPHILIP.BAUMANN@C3IHC.COM@HEALTHISSOCIAL ON TWITTER

Appendix

*Based on a review , conducted n July 2014 by Phil Baumann RN, of 38 prescribing informationhighlights of pharmaceutical products for 8 different disease states across various drugclassifications.

Compliancy determined on best-effort judgment, based on:

Character length of brand and generic names, indication(s), and major risks

Compliancy defined as likelihood of prescribing information’s ability to summarized within140 characters pursuant to FDA’s guidance..

No claim is made that results are representative of larger sample sizes.. No formal, rigorousmethodologies (randomized, double-blinded selections, etc.) were applied to this informalresearch.