Pharmacovigilance has grown more complex over the past decade with higher data volumes, changing regulations, rise of social media, and innovative digital advances. **Disclaimer: This article was previously published. Sciformix is now a Covance company.

1. About the Author
Supriya Desai MD, PGDBM,
is a clinical research and
pharmacovigilance executive
with over 16 years of experience
in clinical practice and in
various leadership roles in the
healthcare industry including
clinical research, drug safety,
and PV. In her current role as
Medical Director and Practice
Head at Sciformix, she provides
scientific and operational
leadership to a global medical
team (across India, Philippines
and US); and is involved in
medical review activities across
pharmacovigilance, safety
writing, signal management
and allied safety surveillance
activities, spanning diverse
therapeutic areas.
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on quality-of-life. Thus, one
of the key areas of influence
is to establish social media
as a safety reporting channel
by expanding its existing use
and unlock its potential as a
value-add for companies’ PV
strategies.
FDA draft guidance for AE
reporting and GVP(2)
, states
that valid ICSRs, which
qualify for reporting, should
consist of an identifiable
patient, identifiable reporter,
suspect product, and adverse
event. GVP also states, when
collecting reports of suspected
ADRs via the internet or digital
media, the term “identifiable”
refers to the possibility of
verification of the existence
of a reporter and a patient
(VI.B.1.1.4).
Key issues around patient
self-generated reports on
social media are credibility
and origin of reports and
concerns around inadequate,
inconsistent data, requiring
additional follow-up.
Confirmation of “identifiability”
of both patient and reporter,
and validation of reports with
focus on company-managed
social websites, becomes
critical to decrease chances
of incomplete/duplicate
AEs from different online
reporting channels. Allowing
posts/shares on company
Pharmacovigilance has
grown more complex over
the past decade with higher
data volumes, changing
regulations, rise of social
media, and innovative digital
advances. Whilst digital media
is used by biopharmaceutical
companies for patient
awareness initiatives, clinical
trial enrollments, and patient
support programs, the use
of the Internet and social
media has progressed slower
in Product Safety/Product
Vigilance (PV). This presents
the industry with opportunities
to leverage social media for
detection, assessment, and
prevention of adverse events
(AEs). Moving away from
traditional systems towards
more patient-centric PV
models would allow swift and
open communication between
companies, health care
providers (HCPs) and patients.
However, careful evaluation
and assessment of the use of
social media as a PV tool is
required before it becomes
usual practice.
REGULATORY GUIDANCE
AND FRAMEWORK
Companies operating in the
social media space have a
responsibility to document
and follow-up on potential
ADRs communicated
through these forums. Good
Pharmacovigilance Practices
(GVP) states that marketing
authorization holders (MAH)
should regularly screen the
Internet and/or digital media
under their management, for
potential reports of suspected
ADRs. The frequency of
screening should allow for
potential valid individual
case safety reports (ICSRs)
to be reported to competent
authorities within appropriate
timeframes based on the date
the information was posted
(VI.C.2.2.1)(1)
.
The US Food and Drug
Administration (FDA) product
promotion guidance on
social media and the internet,
by biopharmaceutical and
medical device companies,
addresses responses to off-
label inquiries (including
from digital platforms)
(2)
, provision of benefit-
risk information on digital
platforms with character space
limitations, e.g., Twitter(3)
,
addressing misinformation
about company products(4)
and fulfillment of company
post-marketing regulatory
requirements for submission
of “interactive promotional
media” for their FDA-approved
products(5)
. These documents
are an important first step
towards providing guidance
for companies to develop and
implement their social media
strategies for PV.
USING SOCIAL MEDIA FOR
SAFETY DATA REPORTING
Today, biopharmaceutical
companies manage social
media platforms that solicit,
capture, monitor, and report
safety data. Safety reports
obtained via social media
offers distinct advantages
such as faster, potentially
richer reports closer to real-
time data than reports filtered
through HCPs. Furthermore,
these reports can provide
significant data on off-label
use and impact of treatments
UNLEASHING THE POTENTIAL OF
SOCIAL MEDIA IN DRUG SAFETY
EXPLORING THE INCREASING
USE OF DIGITAL FORUMS IN
PHARMACOVIGILANCE
Supriya Desai, MD

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Special Section
monitored websites after user
registration (recording basic
user information) can help PV
teams verify reported data,
confirm case validity, and
follow-up with any additional
questions.
Processing of personal data
for PV needs to comply with
applicable data protection
laws supported by transparent,
robust processes. Data
protection notice on company-
sponsored sites, should explain
rationale and benefits for
collection of user-generated
safety information [AE or
product complaint (PC)] to
meet legal obligations and
protection of public health.
Regular training in data
protection requirements is
recommended for all company
staff involved in PV(6)
.
CHALLENGES IN DIGITAL &
BIG DATA ANALYTICS
Social media is a promising
source for safety data,
however, this data is
unstructured and lacks
governing data quality
standards and specific
business area orientation.
Retrieval and analysis of this
rapidly changing big data
requires extra workload
and additional resources.
Furthermore, it is challenging
to integrate social media
safety reports with those
obtained from more standard
sources.
Another concern is the
potential bias due to the
reporter population. Of the
many social media users,
only a small percentage (1%)
actually report AEs, while most
others occasionally contribute
or observe. Many elderly
individuals, constituting a large
demographic of prescription
medication users, do not use
social media, creating a strong
user bias for PV. Additional
technical challenges include
duplicate safety information,
mapping multi-lingual data
to standard ADRs, effective
data cleaning to mitigate
risk of spreading false safety
concerns and global diversity
challenges (7)
.
SOCIAL MEDIA INITIATIVES
IN PV
The biopharmaceutical
industry and regulators now
recognize the benefits of
automation tools for big data
analytics. Google Insights for
Search is a tool that measures
public safety concerns,
based on web traffic but with
limited precision(6)
. The FDA
is currently exploring multiple
such social media-based tools
and strategies. In Europe,
the WEBAE (Web Adverse
Events) project aims to form
a specialist public-private
consortium to enable adoption
of data mining methodologies
and algorithms for publicly
available web and social media
content to find emerging,
self-reported medical insights
such as AEs associated
with medicines and medical
devices(7)
.
RISK COMMUNICATION VIA
SOCIAL MEDIA
Social media presents an
effective digital tool for
proactive risk management
and communication, helping
companies to connect and
engage with patients and
HCPs to raise awareness, build
trust and ultimately improve
health outcomes (Figure 1).
SUMMARY
The fundamentals of social
media (listening, broadcasting
and engaging) are well-
aligned with the principles of
PV practice. Social media can
become a new-age tool to
monitor data in real-time, for
early indication of potential
safety issues requiring further
investigation and to help
generate more robust product
safety profiles by leveraging
the additional social media
data. Appropriate engagement
of consumers and HCPs
through social media, holds
the promise of better safety
outcomes for patients and
companies alike (Figure 2).
Figure 2: Social media promises better outcomes
References
1. European Medicines Agency 2013. Good pharmacovigilance practices Module
VI, Section VI.B.1.1.4.
2. Guidance for Industry Responding to Unsolicited Requests for Off-Label
Information About Prescription Drugs and Medical Devices (FDA Draft
Guidance) (FDA Draft Guidance December 2011).
3. Guidance for Industry Internet/Social Media Platforms with Character Space
Limitations—Presenting Risk and Benefit Information for Prescription Drugs
and Medical Devices (FDA Draft Guidance June 2014).
4. Guidance for Industry Internet/Social Media Platforms: Correcting
Independent Third-Party Misinformation About Prescription Drugs and
Medical Devices (FDA Draft Guidance June 2014).
5. Guidance for Industry Fulfilling Regulatory Requirements for Post-marketing
Submissions of Interactive Promotional Media for Prescription Human and
Animal Drugs and Biologics (FDA Draft Guidance Jan 2014).
6. Ralph Edwards and Marie Lindquist, 2011. Social Media and Networks in
Pharmacovigilance: Boon or Bane? I. Uppsala Monitoring Centre, Uppsala,
Sweden.
7. WEBAE. Leveraging Emerging Technology for Pharmacovigilance (Internet)
http://www.imi.europa.eu/webfm_send/912 [Accessed 11/06/2015]
Figure 1: Using social media to engage and improve
awareness about product safety
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