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)



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.



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.

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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 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



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 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




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



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 efficientstay 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 InputAutomated Literature Monitoring

Case ProcessingAutomated Literature Triage

Case Output

Integration with case reporting systems

and audit trails

Our Framework



Case Input: Literature MonitoringKey Challenges

Output Analysis


Strategies



Case Output


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


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


Strategies



Case Output


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


Strategies



Case Output


and audit trails



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



Output Analysis: Risk MitigationKey Challenges

Output Analysis


Strategies



Case Output


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 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

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 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

Thank you!www.elsevier.com/pharmacovigilance

Health & Medicine

Minimizing Risk in Pharmacovigilance