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wipro.com
Redefining #Pharmacovigilance
with Social Media
Enhance Patient Safety with a 4-Step Social Media Model
anti-inflammatory drug
withdrawn in 2004
attracted a whopping $6 billion in
financial damages. A similar drug
recalled in 2005 resulted in $2
billion in damages.
There have been several instances
where products were recalled for
severe risk factors leading to
penalties over a billion dollars. As
newer treatment options (new
chemical and biological entities)
are being developed for various
diseases, there is an increased
focus by regulators to provide
utmost safety to patients.
Question is, can these damages
be preempted and corrective
steps taken to save penalty and
provide better patient safety?
Drugs go through a rigorous
testing and evaluation mechanism
during clinical trial and post
market surveillance. Clinical trials,
limited to a few thousand patients,
do not provide enough
information on all potential side
effects of a particular drug. Data
generated during post market
surveillance directly from patients
and healthcare practitioners help
identify and evaluate associated
side-effects of the drugs.
However, this is at a stage where
the damage has already reached a
significant level. Clearly, there is a
need to bring a reform to identify
side-effects at an early stage
leading to increased patient safety
and decrease in losses.
Fortunately, a
proactive approach
using social media
to get real-time
insights to not only
identify risks but
also manage online
reputation can help
companies
minimize losses
Keeping this need in view,
regulatory bodies are
collaborating with websites and
applications such as MedWatcher
and PatientsLikeMe for safety
reporting. These platforms,
through free tools, give patients
and physicians the power to
submit adverse event reports to
the FDA. These tools also provide
rich information on drugs safety
parameters. In addition to this, the
safety ecosystem can further be
strengthened by using social
media based on availability of real
time information on it.
While regulatory bodies have not
yet structured the guidelines for
monitoring adverse drug
reactions (ADRs) using social
media, there are concerted efforts
in this direction. These bodies
have started viewing social media
as an important platform that
connects various stakeholders
including pharmaceutical
companies, researchers, doctors
and patients.
Companies need to develop their
own strategies for sustainable
engagement with consumers by
framing guidelines for online
interactions and messaging. An
effective social media model will
allow them to create a strategic
pharmacovigilance practice that is
less reactionary, process-intensive
or resource-heavy. It will help
them become a proactive agent
for patient safety. Specifically, it
will make them future-ready, once
social media policies are
mandated by regulatory bodies.
1
nonsteroidal
Pharmaceutical and biotechnology
companies can leverage the
growing popularity of social media
business intelligence in identifying
adverse events and respond in
time. It is an excellent tool to listen
into consumer conversations,
feedback and complaints and take
the right corrective action. Social
media is also a powerful medium
to educate consumers about
products regarding their benefits
as well as side effects. Such
awareness will only go on to build
trust and acceptance. Of course, all
the adverse event data collected
can be analysed to identify the key
unmet need of the market and help
research to identify areas to
improve or innovate the products.
Powering
pharmacovigilance
with social
media model
There are four main steps to
creating a sustainable engagement
with your consumers. The first is to
identify the right keywords that
your audience is using to search for
you. Next, listen into their
conversations and feedback
keenly, and this can be done
through social forums, blogs and
other literature. Thirdly, leverage
reporting and analytics on the
captured data and finally, respond
creatively and leverage this
medium to generate awareness
and address their problems.
2
The four pillars of social
media-powered pharmacovigilance
3
• Understand the buying psyche of patients and physicians and how they are
influenced by their peers
• Identify KPIs and list keywords that reflect product-related side effects
• Input keywords in technology platform, Google Alerts, social media mentions
Establish
Keywords
• Observe product related mentions and identify triggers
• Monitor real-time dashboards and segregate content
• Classify mentions into side effects and positives
• Identify opportunities to engage
• Participate in conversations
• Identify users who could be reached to gather additional information
• Address concerns and provide required product information (within SLA terms)
• Alert in case of escalation for early response and resolution
Engage
• Social CRM tracking
• Close to real time dashboards with intuitive insights and integrated view with
internal safety data
• Risk identification and signal detection
• Support in fine-tuning marketing strategy
Reporting
and
Analytics
Listen
How can
companies
benefit from the
model?
It is widely accepted that safety
and efficacy of products gives
companies a competitive
advantage to increase market
share. Engaging with consumers
directly to address their
complaints and issues regarding
adverse events will ultimately allow
companies to boost their patient
safety policies. This will help them
benefit from both, earning
credibility as well as commercial
aspects.
Simply put, adopting a social
media strategy ensures the
company’s future readiness to
meet the regulatory body’s
mandates for safety reporting,
while it also helps them protect the
brand’s reputation.
Identify early risk and signal
detection
• Access to real time information
related to product side effects,
trending topics, influencers and
competition actions
• Robust signal detection
process by providing additional
data from real world
Minimize online reputation risk
• Prompt identification and
collection of published
mentions across multiple
sources
• Minimization of potential of risk
magnification to threats though
prompt response
• Enhancing advocacy through
real time resolution of concerns
expressed
Manage Adverse Events
Converting side effects mentioned
to adverse events by gathering the
following additional information
and reporting to internal system:
• Identifiable patient
• Identifiable reporter
• A specific drug or biologic
involved in the event
• Adverse event or fatal outcome
Social media platforms are
designed to increase human
connections between companies
and consumers. Companies must
adopt an open approach that
focuses on listening, spreading
awareness, building trust, and
improving health outcomes. This
creates a win-win situation for
both, the companies receiving
signal detection as well as the
consumers who get more access
to information.
4
About the
author
5
Dheeraj Girdhani has over 12 years of pharmaceutical industry
experience in areas of operations, tech transfer, audits, and analytics
(Commercial & Safety). He leads HLS Analytics as a service for Wipro and
has contributed to engagements with leading pharma companies.
Dheeraj received his Post Graduate degree from IMT Ghaziabad and
Masters of Industrial Pharmacy from SGSITS Indore.
About Wipro
Wipro Ltd. (NYSE:WIT) is a leading information technology, consulting and
business process services company that delivers solutions to enable its
clients do business better. Wipro delivers winning business outcomes
through its deep industry experience and a 360 degree view of "Business
through Technology.” By combining digital strategy, customer centric
design, advanced analytics and product engineering approach, Wipro
helps its clients create successful and adaptive businesses. A company
recognized globally for its comprehensive portfolio of services, strong
commitment to sustainability and good corporate citizenship, Wipro has
a dedicated workforce of over 160,000, serving clients in 175+ cities across
6 continents. For more information, please visit wipro.com or write to us
on info@wipro.com
“No part of this booklet may be reproduced in any form by any electronic or mechanical means (including photocopying, recording and printing) without permission in writing from the publisher,
except for reading and browsing via the world wide web. Users are not permitted to mount this booklet on any network server.”
© Wipro LTD 2016 IND/INT/JAN-DEC2016
DO BUSINESS BETTER CONSULTING | SYSTEM INTEGRATION | BUSINESS PROCESS SERVICES

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Redefining pharmacovigilance-with-social-media

  • 1. wipro.com Redefining #Pharmacovigilance with Social Media Enhance Patient Safety with a 4-Step Social Media Model
  • 2. anti-inflammatory drug withdrawn in 2004 attracted a whopping $6 billion in financial damages. A similar drug recalled in 2005 resulted in $2 billion in damages. There have been several instances where products were recalled for severe risk factors leading to penalties over a billion dollars. As newer treatment options (new chemical and biological entities) are being developed for various diseases, there is an increased focus by regulators to provide utmost safety to patients. Question is, can these damages be preempted and corrective steps taken to save penalty and provide better patient safety? Drugs go through a rigorous testing and evaluation mechanism during clinical trial and post market surveillance. Clinical trials, limited to a few thousand patients, do not provide enough information on all potential side effects of a particular drug. Data generated during post market surveillance directly from patients and healthcare practitioners help identify and evaluate associated side-effects of the drugs. However, this is at a stage where the damage has already reached a significant level. Clearly, there is a need to bring a reform to identify side-effects at an early stage leading to increased patient safety and decrease in losses. Fortunately, a proactive approach using social media to get real-time insights to not only identify risks but also manage online reputation can help companies minimize losses Keeping this need in view, regulatory bodies are collaborating with websites and applications such as MedWatcher and PatientsLikeMe for safety reporting. These platforms, through free tools, give patients and physicians the power to submit adverse event reports to the FDA. These tools also provide rich information on drugs safety parameters. In addition to this, the safety ecosystem can further be strengthened by using social media based on availability of real time information on it. While regulatory bodies have not yet structured the guidelines for monitoring adverse drug reactions (ADRs) using social media, there are concerted efforts in this direction. These bodies have started viewing social media as an important platform that connects various stakeholders including pharmaceutical companies, researchers, doctors and patients. Companies need to develop their own strategies for sustainable engagement with consumers by framing guidelines for online interactions and messaging. An effective social media model will allow them to create a strategic pharmacovigilance practice that is less reactionary, process-intensive or resource-heavy. It will help them become a proactive agent for patient safety. Specifically, it will make them future-ready, once social media policies are mandated by regulatory bodies. 1 nonsteroidal
  • 3. Pharmaceutical and biotechnology companies can leverage the growing popularity of social media business intelligence in identifying adverse events and respond in time. It is an excellent tool to listen into consumer conversations, feedback and complaints and take the right corrective action. Social media is also a powerful medium to educate consumers about products regarding their benefits as well as side effects. Such awareness will only go on to build trust and acceptance. Of course, all the adverse event data collected can be analysed to identify the key unmet need of the market and help research to identify areas to improve or innovate the products. Powering pharmacovigilance with social media model There are four main steps to creating a sustainable engagement with your consumers. The first is to identify the right keywords that your audience is using to search for you. Next, listen into their conversations and feedback keenly, and this can be done through social forums, blogs and other literature. Thirdly, leverage reporting and analytics on the captured data and finally, respond creatively and leverage this medium to generate awareness and address their problems. 2
  • 4. The four pillars of social media-powered pharmacovigilance 3 • Understand the buying psyche of patients and physicians and how they are influenced by their peers • Identify KPIs and list keywords that reflect product-related side effects • Input keywords in technology platform, Google Alerts, social media mentions Establish Keywords • Observe product related mentions and identify triggers • Monitor real-time dashboards and segregate content • Classify mentions into side effects and positives • Identify opportunities to engage • Participate in conversations • Identify users who could be reached to gather additional information • Address concerns and provide required product information (within SLA terms) • Alert in case of escalation for early response and resolution Engage • Social CRM tracking • Close to real time dashboards with intuitive insights and integrated view with internal safety data • Risk identification and signal detection • Support in fine-tuning marketing strategy Reporting and Analytics Listen
  • 5. How can companies benefit from the model? It is widely accepted that safety and efficacy of products gives companies a competitive advantage to increase market share. Engaging with consumers directly to address their complaints and issues regarding adverse events will ultimately allow companies to boost their patient safety policies. This will help them benefit from both, earning credibility as well as commercial aspects. Simply put, adopting a social media strategy ensures the company’s future readiness to meet the regulatory body’s mandates for safety reporting, while it also helps them protect the brand’s reputation. Identify early risk and signal detection • Access to real time information related to product side effects, trending topics, influencers and competition actions • Robust signal detection process by providing additional data from real world Minimize online reputation risk • Prompt identification and collection of published mentions across multiple sources • Minimization of potential of risk magnification to threats though prompt response • Enhancing advocacy through real time resolution of concerns expressed Manage Adverse Events Converting side effects mentioned to adverse events by gathering the following additional information and reporting to internal system: • Identifiable patient • Identifiable reporter • A specific drug or biologic involved in the event • Adverse event or fatal outcome Social media platforms are designed to increase human connections between companies and consumers. Companies must adopt an open approach that focuses on listening, spreading awareness, building trust, and improving health outcomes. This creates a win-win situation for both, the companies receiving signal detection as well as the consumers who get more access to information. 4
  • 6. About the author 5 Dheeraj Girdhani has over 12 years of pharmaceutical industry experience in areas of operations, tech transfer, audits, and analytics (Commercial & Safety). He leads HLS Analytics as a service for Wipro and has contributed to engagements with leading pharma companies. Dheeraj received his Post Graduate degree from IMT Ghaziabad and Masters of Industrial Pharmacy from SGSITS Indore. About Wipro Wipro Ltd. (NYSE:WIT) is a leading information technology, consulting and business process services company that delivers solutions to enable its clients do business better. Wipro delivers winning business outcomes through its deep industry experience and a 360 degree view of "Business through Technology.” By combining digital strategy, customer centric design, advanced analytics and product engineering approach, Wipro helps its clients create successful and adaptive businesses. A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, Wipro has a dedicated workforce of over 160,000, serving clients in 175+ cities across 6 continents. For more information, please visit wipro.com or write to us on info@wipro.com
  • 7. “No part of this booklet may be reproduced in any form by any electronic or mechanical means (including photocopying, recording and printing) without permission in writing from the publisher, except for reading and browsing via the world wide web. Users are not permitted to mount this booklet on any network server.” © Wipro LTD 2016 IND/INT/JAN-DEC2016 DO BUSINESS BETTER CONSULTING | SYSTEM INTEGRATION | BUSINESS PROCESS SERVICES