embase webinar: building searches for drug safety and post market device surveillance 26 nov 2014

Embase® is a registered trademark of Elsevier BV.

Presented by Sherry Winter

and Ian Crowlesmith

26 November 2014

[email protected]

[email protected]

Building searches for drug safety and

device postmarket surveillance


AGENDA

1. Introduction

2. Finding adverse reactions for drugs

3. Post marketing surveillance for

medical devices

4. Drug safety and risk

5. Conclusion



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Pharmacovigilance

• Pharmacovigilance (PV) is

defined as the science and

activities relating to the

detection, assessment,

understanding and prevention

of adverse effects or any other

drug-related problem.

• Increasingly important in

today’s world of big data

analysis and regulation

Sherry Winter & Ian Crowlesmith | 26 November 2014 |

Drug safety and post-marketing surveillance for devices

4

A. Good reporting PracticeSpontaneous case reports of adverse events submitted to the sponsor and FDA, and reports from other sources, such as the medical literature or clinical studies, may generate signals of adverse effects of drugs. The quality of the reports is critical for appropriate evaluation of the relationship between the product and adverse events. FDA recommends that sponsors make a reasonable attempt to obtain complete information for case assessment during initial contacts and subsequent follow-up, especially for serious events, and encourages sponsors to used train…

VI.B.1.1.2. Literature reportsThe scientific and medical literature is a significant source of information for the monitoring of the safety profile and of the risk benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues. Marketing authorization holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week. The marketing authorization holder should ensure that the literature review includes the use of reference databases that contain the largest reference of articles in relation to the medicinal product properties

What Are Governments Doing?

Marketing authorization holders are therefore

expected to maintain awareness of possible

publications through a systematic literature

review of widely used reference databases

(e.g. Medline, Excerpta Medica or Embase)

no less frequently than once a week.

Growing regulatory pressure and focus on literature monitoring in EU & US

The quality of the reports is critical for

appropriate evaluation of the relationship

between the product and adverse events.



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The Increasing Volume of Literature Is Making Adverse

Event Monitoring a More Difficult Challenge

• Reliable tools for finding adverse events are needed

• Complex search strategies need to be employed to find the most relevant articles among the

thousands that are published each year

Embase, October 2014

1975

1980

1985

1990

1995

2000

2005

2010

2011

2012

2013

0 5 10 15 20 25

30Millions



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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

Our Framework

Elsevier provides the capabilities necessary for Pharmacovigilance and Drug

Safety groups to be more efficient, stay compliant and mitigate risk



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EMBASE FOCUSES ON DETECTING ADVERSE EVENTS IN THE SCIENTIFIC LITERATURE

Every year >1,000,000 biomedical articles and 300,000 conference papers are published

Of all adverse events reported, 14% comes from the literature




AGENDA

1. Introduction



medical devices


5. Conclusion



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FINDING ADVERSE REACTIONS FOR DRUGS

TOPICS COVERED



• Searching with drug subheadingsUsed for: fully indexed records

• Searching with free text (keywords)Used for: automatically indexed records

• Saving search strategies• Setting up Email alerts

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POSTMARKET SURVEILLANCE FOR MEDICAL DEVICES

SEARCH OPTIONS



• Searching with device subheadingsUsed for: fully indexed records from 2014

• Searching with keywords and other termsUsed for: automatically indexed AND older records


AGENDA

1. Introduction



medical devices


5. Conclusion



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Output Analysis: Risk Mitigation

Key Challenges

• 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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EMBASE & PHARMAPENDIUM

IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORING

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



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By accessing regulatory data as well as published literature, you can:

• Link critical post marketing findings to the drug and validate its relevance in the

context of the studies that were performed as part of the drug approval process

• Look at post marketing findings and understand how they could be relevant

across different drugs and drug classes

• Go directly to a study that was done to find ways in which study designs could be

optimized in order to reduce the chance of seeing those same events take place

with a drug that you are currently developing

• Develop risk mitigation strategies that establish inclusion and exclusion criteria

for patients who wish to participate in trials (for example by predicting the

effect of drug-drug interactions with medications they are already on)

EMBASE & PHARMAPENDIUM



IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORING

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IDENTIFY AE REPORTED IN LITERATURE

FIND AE ON ROFECOXIB IN EMBASE (SHOWN BY IAN)



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ACCESS INFORMATION FROM REGULATORY DATA

DELVE INTO MORE DETAILS WITH THE FDA APPROVAL PACKAGE



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FIND DRUG-DRUG INTERACTIONS

E.g., search for drug interactions

to find those identified with

existing drugs.



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FIND ADVERSE EVENTS REPORTED IN FDA/EMAPACKAGE

Search the FDA package

for mentions of reported

adverse events



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ACCESS AE DATA AND AERS REPORTS

Access Preclinical and

Clinical data on adverse

events and Post-marketing

(AERS reports)



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• Post-market surveillance of drugs

• Post-market surveillance of medical devices

• For drug safety/risk mitigation during drug development

• Other

POLL – WHAT IS YOUR MAIN REASON FOR SEARCHING FOR ADVERSE EVENTS IN EMBASE?



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Embase supports your pharmacovigilance workflow by:

Finding adverse events in the literature

Comprehensive content, deep drug, device and disease indexing and dedicated

search tools mean you will avoid missing critical information

Unique access to regulatory data

Manage the risk of late stage failure by making more informed risk

management/mitigation decisions with information reported in the literature as

well as adverse events and drug-drug interactions reported in FDA/EMA documents

IN CONCLUSION…



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• Q&A will be sent to you by email and for more information and

questions please contact your regional office

• Our next Embase webinar will take place January 2015 and will focus

on Systematic Reviews.

• Please click on at Embase.com for all Embase training materials

and a webinar overview

THANK YOU

SEE YOU NEXT TIME!

Please fill out the survey that appears on your

screen after leaving the webinar.



THANK YOU

ANY QUESTIONS?

23

Sherry Winter

Product Marketing Manager

[email protected]

Ian Crowlesmith

Sr Product Manager, Content Development

[email protected]



embase webinar: building searches for drug safety and post market device surveillance 26 nov 2014

Health & Medicine

safety profile

literature monitoring

adverse reactions

emerging safety issues

medical literature

preventionof adverse

serious events

postmarketing surveillance