Minimizing Risk in Pharmacovigilance

1Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Minimizing Risk in
Pharmacovigilance

Key Challenges in
Pharmacovigilance

Challenge
• Development of a common platform
across different geographic locations,
functional groups, product lines.
• Integration of data — a single database to
include data across the entire product life
cycle (pre and post-market). Challenge:
multiple databases may contain similar
information but are not linked/linkable to
each other.
• Implementation of work flow
management technology — identify and
distribute information to stakeholders
according to a predetermined set of rules.
Ensure only the appropriate employees
receive the data required to inform the
decisions they are authorized to make.
How to Standardize Processes and Data Management
“We don’t view drug safety from a postmarket or
premarket perspective but, rather, as a continuum
from the time the compound is identified and the time
of animal studies on through when companies are
hoping to get approval...”
Alan Goldhammer, Associate vice president of regulatory
affairs for the Pharmaceutical Research and
Manufacturers of America (PhRMA) (source: PWC report)

Challenge
Implement Proactive Risk Management
• Development of a risk
management action plan
Establish risk scoring and
mitigation processes to
evaluate external risk
factors (regulatory,
reputation, product liability)
and internal (portfolio,
strategic and financial risk).
• Dashboard
Summarize safety
information across the
product portfolio in real
time. Identify the types
of data that should/should
not be used in drug safety
decision making.
• Implementation of data
mining techniques
Assess the patterns, time
trends and events
associated with drug-
drug interactions.

Challenge: Run PV Operations Cost Effectively
• Growing amount of data
causes important safety
signals to be missed — how
to deal with the data storm?
Embase, October 2014
• Savings from outsourcing PV
operations can be negated with
costs from the manual review of
records. Tools that better target
relevant literature can prevent
this.
• Signal identification must not
be lost due to segmentation of
the analysis by different parties.
1975
1980
1985
1990
1995
2000
2005
2010
2011
2012
2013
0 5 10 15 20 25 30
Millions of Records
Increasing number of records added to Embase

Once Articles Are Captured, the Review and Triage
Process Has Additional Challenges
Too much time is wasted
looking at the same article
multiple times
Challenges Needs
Some outsourced systems
are unable to meet the rigid
regulatory demands
Existing in-house systems are
becoming outdated, and
maintenance & replacement
costs are high
Need to be sure all articles are
captured and reviewed
A coordinated workflow to
manage the article pipeline
Capture metrics behind article
reviews in case of audits

Elsevier Can Create a Unifying Structure that Can Be
Used to Promote Best Practices
Adapted from Zhengwu Lu, Information technology in pharmacovigilance: Benefits, challenges, and
future directions from industry perspectives, Drug Health Patient Saf. 2009; 1: 35–45.
Tested and Proven Cloud-Based Tools
Set up a
coordinated
workflow to
manage the
article pipeline
Be sure all
articles are
captured
and reviewed
Capture metrics
behind article
reviews in case
of audits
Ensure
accessibility
of safety
information
Organizational
Alignment
Operations
Management
Data
Management
Risk
Management

Cloud Based
Solution
Pharma company was using a combination
of a cloud-based solution and SharePoint
to monitor literature for adverse events.
Pharma company reviewed captured
articles and submitted serious cases to
regulatory agencies
However, not all articles were appearing in
SharePoint, and important articles are missed,
resulting in a warning from the regulatory agency
Regulatory
Agency
Issues
Warning
Pharma
Company
What Can Go Wrong in Large Pharma
A Gap in Literature Monitoring
Published Literature
Literature
Monitoring
System

Published Literature
Literature
Monitoring
System
Elsevier implemented a complex search
strategy into its biomedical literature
database [Embase] to ensure that relevant
information was captured.
Elsevier also provided a tool that alerted the
customer about unread articles to make
sure all materials were reviewed.
Seamless
Literature
Triage
Largest Journal
and Conference Coverage
+
Specialist-Developed
Search Strategy
Regulatory
Agency
ICSRs
Pharma
Company
What Can Go Wrong in Large Pharma
A Gap in Literature Monitoring

Additional Sub-optimal Processes in Pharma Companies…
• Under-staffed literature screening teams
– Some global pharma companies have as few as one person screening literature for
adverse events.
– This is a tremendous workload that results in too much time being taken to discover
serious ADRs, or possibly missing them entirely.
• Use of Reference Management tools to manage literature
– Reference Management tools do not allow searching of full text articles.
– This results in a highly manual process that requires additional time to read the
article for mentions of adverse events.

Addressing the Challenges in
Pharmacovigilance

Our Mission in Pharmacovigilance
Elsevier provides the capabilities necessary for
Pharmacovigilance and Drug Safety groups to be:
more efficient
stay compliant
and mitigate risk

1. Avoid missing critical
information
2. Save time with better
article pipeline
management
3. Connect literature
to broader ecosystem
4. Manage risk of
late-stage failure
Output
Analysis
Regulatory Data for
Risk Mitigation
Strategies
Case
Input
Automated
Literature
Monitoring
Case
Processing
Automated
Literature
Triage
Case
Output
Integration with case
reporting systems
and audit trails
Our Framework

Case Input: Literature Monitoring
Key Challenges
Output
Analysis
Regulatory Data for
Risk Mitigation
Strategies
Case
Input
Automated
Literature
Monitoring
Case
Processing
Automated
Literature
Triage
Case
Output
reporting systems
and audit trails
• How thorough is your existing
literature monitoring process?
Are you at risk of missing
articles that report AEs?
• Are you wasting valuable
time sifting through
duplicate articles?
• Are you increasing cost by
purchasing the full-text articles
multiple times?

Centralized
Document
Repository for
Drug Safety
Published
Literature
Avoid missing critical information
Case Input: Literature Monitoring
More confidently
find adverse
events in the
literature
Find information
not available in
other tools
Increase the
likelihood of early
signal detection
Save time reviewing,
reduce the risk of
double-counting
Most
comprehensive
journal coverage
and indexing
available
Most
comprehensive
coverage of
conference
proceedings
Custom
development of
complex
searches
Automatic
deduplication of
articles

Case Processing: Literature Triage
• Are the appropriate employees
receiving the required data to inform
the decisions they are authorized
to make?
• Are you working with multiple
databases that contain similar
information but are not linked/linkable
to each other?
• Are you wasting valuable time sifting
through duplicate articles?
• Are you increasing cost by purchasing
the full-text articles multiple times?
Key Challenges
Output
Analysis
Regulatory Data for
Risk Mitigation
Strategies
Case
Input
Automated
Literature
Monitoring
Case
Processing
Automated
Literature
Triage
Case
Output
reporting systems
and audit trails

Case Processing: Literature Triage
Regulatory
Reports
Centralized
Document
Repository
Save time with better article pipeline management
Seamless
centralized
triage tool
Text mining of
articles
Alerts about
unread articles
Triage articles
faster
Find AEs faster by
reviewing the most
relevant articles
Be more confident
that information
isn’t missed

Case Output: Integration With Case Reporting System
• Can you effortlessly export your
data to existing
analysis/reporting tools?
• Are you wasting valuable
resources on manual
processing of data?
• In the event of an audit, will you
be able to clearly demonstrate
that the review process was
done correctly?
Key Challenges
Output
Analysis
Regulatory Data for
Risk Mitigation
Strategies
Case
Input
Automated
Literature
Monitoring
Case
Processing
Automated
Literature
Triage
Case
Output
reporting systems
and audit trails

Case Output: Integration With Case Reporting System
Connect literature process to the broader ecosystem
Pharmacovigil
ance Signal
Detection and
Reporting
Ecosystem
Centralized
Document
Repository
Review process
tracked for
reporting
Literature
pre-formatted
for case reports
Automated
exporting of
data to case
management
systems
Be better prepared
for audits
Save time and effort
Reduce manual steps
when integrating
triage results

Output Analysis: Risk Mitigation
Key Challenges
Output
Analysis
Regulatory Data for
Risk Mitigation
Strategies
Case
Input
Automated
Literature
Monitoring
Case
Processing
Automated
Literature
Triage
Case
Output
reporting systems
and audit trails
• How can we better manage risk?
• Are we gathering all available
safety/AE data about a drug/
class of drugs?
• Are we leveraging best practices
from precedent preclinical/
clinical studies?
• Have all the potential and
unanticipated risks been captured?

Output Analysis: Risk Mitigation
Make better informed risk management and mitigation decisions
Reduce
regulatory
cycling
Improve REMS
planning and
approval
processes
Detect emerging
risks not observed
in the clinic
Identify key areas of
surveillance
Understand how to tailor
standards to specific risks
Find best practices in
designing and
implementing REMS
intervention
Comparative drug
safety data across
preclinical, clinical
and post market
Precedent REMS
plans and
regulatory context
Precedent
standards and
regulatory context
for patient and
HCP
communication
plans
Post market
data from
regulatory
documents and
literature
Searchable
FDA/EMA drug
approval
documents,
biomedical
literature and
FDA AERS

The Elsevier Life Science Solutions (ELSS) Portfolio
• Workflow specific decision tools that
support key use cases and
research outcomes in Life
Sciences
• Working as a portfolio — Evolving
from ‘point solutions’ to tools that
work together to support integrated,
cross-domain workflows
• Using our capabilities to provide
services that address ‘custom’ use
cases, changing how organizations
manage R&D data
Text Mining &
Data Integration

Embase & Pharmapendium
A single drug search in Embase seamlessly
links to PharmaPendium to deliver:
• Comprehensive information that better
informs a risk management /
pharmacovigilance strategy
• Drug safety information reported
in the literature
• FDA/EMA approval and drug review
reports that provides insights into
historical regulatory precedents
• A direct link to preclinical and clinical
observations and reported adverse
events (AERs) to better monitor and
anticipate safety risks
23
Improving biomedical literature search and risk monitoring

QUOSA
A combination of software and services that
allows customers to reduce risk, remain
compliant and ensure that workgroups have
the latest scientific literature
•Pharmacovigilance — Monitor literature for
adverse drug events
•Medical Affairs — Collect and share the
latest information for Key Opinion Leaders
and healthcare providers
•Medical Devices — Conduct post-market
surveillance for adverse events reporting and
pre-market approval
•Information Management — Collect,
organize and share key documents for your
stakeholders
24
Improving biomedical literature search and risk monitoring

To Summarize…
• Key trends in Pharmacovigilance include:
–greater standardization of processes and data management
–implementation of proactive risk management
–reduction/management of costs
• Elsevier provides the capabilities necessary for Pharmacovigilance and Drug
Safety groups to be more efficient, stay compliant and mitigate risk
–Automated literature monitoring — avoid missing critical information
–Fast and effective literature triage — save time with better article
pipeline management
–Seamless integration with existing case reporting systems — connect
literature to a broader ecosystem
–Unique access to regulatory data — manage the risk of late stage failure
by making more informed risk management/mitigation decisions

Thank you!

Minimizing Risk in Pharmacovigilance

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