Automate your literature monitoring for more effective pharmacovigilance

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Automate your

literature monitoring

for more effective

Pharmacovigilance

Presented by Robin Fogel and Ian Crowlesmith

June 24, 2015

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Webinar control panel:

• ‘Ask a question’ for

questions and comments

• Option for full screen view

• Q&A at the end

Need to Know

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Presented By

Date

Ian Crowlesmith

24 June, 2015

Finding adverse reactions in Embase

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Setting up Email alerts on Embase for adverse reactions

• Embase content on adverse drug / device reactions

• Using subheadings (with a specific drug or device)

• Using free text to find adverse effects (or toxicity)

• Setting up an Email alert

Agenda

Embase content

on adverse drug /

device reactions

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Searching for "adverse" in Embase

0

20,000

40,000

60,000

80,000

100,000

1945 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015

In all fields As subheadings

Records

Per year

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Searching for "adverse" or "toxicity" in Embase

Records

Per year

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

1945 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015

In all fields As subheadings

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Searching subheadings on Embase: how to do it

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Searching subheadings on Embase: results

Using subheadings

with a specific drug

or device

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Searching subheadings for a specific drug

Goal: find records reporting adverse drug

reactions for plavix (clopidogrel)

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Step 1: find the Emtree term for the drug

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Step 2: take the query to drug search

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Step 3: select subheadings (ADR, TOX) and search

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Step 4: review results

Using free text to

find adverse effects

(or toxicity)

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Using free text to find adverse effects

Goal: extend results by searching for

records mentioning adverse drug

reactions that have not been

indexed using subheadings

Background:

(1) Include records that are automatically indexed and for which no subheadings have therefore been indexed

(2) Specifically include adverse effects of interest

(3) Include records which indexers may have missed, or which predate the introduction of subheadings (1987)

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Step 1: find keywords for “adverse” to search free text

You are free to use any terms you wish.

One approach is to scan abstracts retrieved

in a search with subheadings, and to select

relevant keywords.

Some possible terms are shown on the next

slide.

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Representative list of possible terms for “adverse”

Source: Webinar in 2013 - Searching Adverse Events on Embase: http://www.slideshare.net/rocheam/embase-webinar-ard-25-sep-2013

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Step 2: search using free text keywords

Setting up an Email

alert

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Setting up an Email alert

Goal: set up regular delivery of new

content selected by any search

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Step 1: choose Email alert option for selected search

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Step 2: edit Email alert parameters / set the alert

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Step 3: review Email alerts (1)

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Step 3: review Email alerts (2)

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Step 4: export history for an email alert (1)

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Step 4: export history for an email alert (2) This is the history of alert "Whole database" as exported on 24 Jun 2015 12:03 GMT. This alert was originally set up on 06 Oct 2014

06:49 GMT.

Alert name Event Search

query Date & time

(GMT) Records

included Frequency Recipients Status

Whole database Automatic run ? 24/06/2015 04:37 14352 Every day [email protected] On





















USING QUOSA TO AUTOMATE THE LITERATURE AND TRIAGE PROCESS |

Presented By

Date

Robin Fogel

24 June, 2015

Using QUOSA to automate the literature and triage process


Enter your questions in the chat box for Sherry will raise them at the end of the presentation

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We want to address your questions as we go!


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


About 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


QUOSA Solution for Pharmacovigilance

• Avoid wasted time looking at the same article multiple times

• Ensure all articles are captured and reviewed

• Automated addition of tagging

and organizing literature from searches


Receive Alerts as a First Step to Rapidly Identify Adverse Events in Literature


QUOSA Captures Literature Alert Emails

Embase

Email Provider

QUOSA Alert Parser

QUOSA Virtual Library

Server


Same Alert Emails Reviewed Manually Serve as QUOSA Input


Add the VL Address as an Alert Recipient


Subject Line Tagging Contributes to Orderly Review Process


Each Citation will be Captured…


As a Robust Fully Populated Record in QUOSA


Deduplication Merges the Same Record Found by Multiple Alerts






Deduplication Also Merges Ahead of Print and “Published” Citation


Audit Trail of Alert Emails to Validate that No Records are Missed


• Captures the citation for re-use and sharing

• Minimizes duplicate reviews while intelligently merging originals, updates and copies coming from multiple searches and databases

• Ahead of print seamlessly updated to print version

• Human and system edits intelligently preserved

• Provides confidence that all articles will be reviewed

• Sets the stage for orderly curation – tags are applied that will be used to organize product literature pipeline

• Flexible support for multiple content sources

Many Benefits to Alert Capture by QUOSA


Review and Annotate Articles from a Scalable Central Library


Example of a Coordinated Workflow to Manage the Article Pipeline

Metrics and alerts may be set on any process step but will almost always include alerts for documents needing review and those that are overdue


Reviewer Process May Begin with Automated Full Text Retrieval


Reviewer Process May Begin with Automated Full Text Retrieval


When in Doubt, Batch Highlighting Saves Time for Article Reviews

"heart infarction" or bleeding "acute coronary syndrome" "coronary artery disease" CAD hypertension thrombosis "diabetes mellitus" "cerebrovascular accident" "stent thrombosis" "cardiovascular disease"


When in Doubt, Batch Highlighting Saves Time for Article Reviews


Reviewer Edits Captured as Document Properties


A Different Record:Translation Requests with Clock Date Management


Benefits of QUOSA Triage Process

• Customized workflow aligned with your organization’s practices

• Make sure that no records are missed

• Ensure compliance

• Improve efficiency with better article backlog management


Use pre-formatted output to easily create reports


Audit Trail Presented for Each Record


Benefits of Storing PV Literature in QUOSA

• Ensure accessibility of safety information in the form of reports and also for direct access (e.g. for signal detection)

• Effortlessly export (avoid reformatting/manual processing)

• In the event of an audit, trail is included in each record


Embase and QUOSA for Literature Monitoring

• Monitor the most comprehensive source of high-quality biomedical information

• Ensure all articles are captured in a central library

• Automate the process of tagging and organizing literature from searches

• Ensure all relevant articles are reviewed

• Avoid wasted time looking at the same article multiple times

We’d be happy to review more details about QUOSA in a live demonstration. Let us know if you’d like to learn more in the post-webinar survey.

Thank you and

Questions


Thank you

Robin Fogel

Life Sciences Consultant

[email protected]

Ian Crowlesmith

Senior Product Manager

[email protected]

mailto:[email protected]

mailto:[email protected]

Automate your literature monitoring for more effective pharmacovigilance

Health & Medicine

adverse drug reactions

subheadings records

adverse drug device

drug search

adverse source

adverse events

embase records

email alert goal