minimizing risk in pharmacovigilance
TRANSCRIPT
1Minimizing Risk in Pharmacovigilance |
www.elsevier.com/pharmacovigilance
Minimizing Risk in Pharmacovigilance
www.elsevier.com/pharmacovigilance
3Minimizing Risk in Pharmacovigilance |
www.elsevier.com/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)
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ChallengeImplement Proactive Risk Management
• Development of a risk management action planEstablish risk scoring and mitigation processes to evaluate external risk factors (regulatory, reputation, product liability) and internal (portfolio, strategic and financial risk).
• DashboardSummarize 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 techniquesAssess the patterns, time trends and events associated with drug-drug interactions.
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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.
19751980198519901995200020052010201120122013
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Millions of Records
Increasing number of records added to Embase
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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 systemsare 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
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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
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Cloud BasedSolution
Pharma company was using a combination of a cloud-based solution and SharePointto 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
RegulatoryAgency
IssuesWarning
PharmaCompany
What Can Go Wrong in Large PharmaA Gap in Literature Monitoring
Published Literature
LiteratureMonitoringSystem
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Published Literature
LiteratureMonitoringSystem
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.
SeamlessLiteratureTriage
Largest Journal and Conference Coverage
+ Specialist-Developed
Search Strategy
RegulatoryAgencyICSRs
PharmaCompany
What Can Go Wrong in Large PharmaA Gap in Literature Monitoring
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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.
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Our Mission in Pharmacovigilance
Elsevier provides the capabilities necessary for Pharmacovigilance and Drug Safety groups to be:
more efficientstay compliant
and mitigate risk
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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 InputAutomated Literature Monitoring
Case ProcessingAutomated Literature Triage
Case Output
Integration with case reporting systems
and audit trails
Our Framework
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Case Input: Literature MonitoringKey Challenges
Output Analysis
Regulatory Data for Risk Mitigation
Strategies
Case InputAutomated Literature Monitoring
Case ProcessingAutomated Literature Triage
Case Output
Integration with case 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?
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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
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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 InputAutomated Literature Monitoring
Case ProcessingAutomated Literature Triage
Case Output
Integration with case reporting systems
and audit trails
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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
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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 InputAutomated Literature Monitoring
Case ProcessingAutomated Literature Triage
Case Output
Integration with case reporting systems
and audit trails
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Case Output: Integration With Case Reporting System
Connect literature process to the broader ecosystem
Pharmacovigilance 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
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Output Analysis: Risk MitigationKey Challenges
Output Analysis
Regulatory Data for Risk Mitigation
Strategies
Case InputAutomated Literature Monitoring
Case ProcessingAutomated Literature Triage
Case Output
Integration with case 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?
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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
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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
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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 reportedin 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
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Improving biomedical literature search and risk monitoring
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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
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Improving biomedical literature search and risk monitoring
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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 articlepipeline 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