Featuring the Embase and PharmaPendium combined drug

safety solution

Your host: Ann-Marie Roche Your presenter: Pooja Jain

Welcome to our drug safety webinar!

About us

Need to know

• Your control panel:– Questions for asking the presenter a question or making a comment.– Option for full screen view

• Questions during the webinar and time for Q&A at the end.

Finding A Drug Safety Solution: Embase + PharmaPendium

Finding A Drug Safety Solution: Embase + PharmaPendium

Presented By: Pooja Jain, M.Sc., MBA

Date: Oct 25 2012

•Embase is an online information source of biomedical literature that serves pharmacovigilance reporting needs by broadly tracking adverse events from comprehensive high-quality sources.

•Embase records are deeply indexed using our Emtree thesaurus to make searching faster, more accurate and more specific. Emtree lists more than 60,000 preferred terms and over 260,000 synonyms, including generic and trade names of drugs.

•Compared to MEDLINE, Embase has over 2,000 more journals in addition to conference reports. In total Embase indexes over 7,000 journals.

•Embase is an online information source of biomedical literature that serves pharmacovigilance reporting needs by broadly tracking adverse events from comprehensive high-quality sources.

•Embase records are deeply indexed using our Emtree thesaurus to make searching faster, more accurate and more specific. Emtree lists more than 60,000 preferred terms and over 260,000 synonyms, including generic and trade names of drugs.

•Compared to MEDLINE, Embase has over 2,000 more journals in addition to conference reports. In total Embase indexes over 7,000 journals.

PharmaPendium is the only online resource to allow drug development teams to efficiently extract:

• Best-in-class drug development information

•All available FDA approvals since 1938 + EMA since 1995 + more

• More than 1.5 million pages of drug reviews

• More than 4,000 drugs covered

• Comparative exposure data

• Regulatory precedents

PharmaPendium is the only online resource to allow drug development teams to efficiently extract:

• Best-in-class drug development information

•All available FDA approvals since 1938 + EMA since 1995 + more

• More than 1.5 million pages of drug reviews

• More than 4,000 drugs covered

• Comparative exposure data

• Regulatory precedents

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Adverse event not reported in labeling

Adverse events reported to affect

patient compliance

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Could we have known about these

adverse events before the label was updated?

Did we actually find evidence of this in

the approval package? How do we mitigate risk

moving forward?

Indexing allows for easy to find information that

would otherwise be missed

PubMed returns less than one third of

results.

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

What information would you have missed that would pertain to critical post-

marketing events?

Search of “acarbose” in Embase

Search of “acarbose” in Embase, filtered based on adverse drug reaction

Filter further on “liver toxicity”

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Was there any evidence of this

before the drug was approved?

Summary

• 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

• Get directly to the study that was done and now find ways in which study designs could be optimized to reduce the chance of seeing those same events take place with a drug that you are currently developing

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Filter further on “liver toxicity”

Summary

• Found postmarketing adverse event reporting in the Japanese demographic

• Found drugs within the antidiabetic drug class which demonstrated similar adverse events in the Japanese demographic and were then able to do comparative adverse event analysis on those drugs

• Found extracted drug safety data in both preclinical and clinical studies across different drug classes

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Adverse event not reported in labeling

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Could we have known about these

adverse events before the label was updated?

Article: “Medical Management of Metabolic Dysfunction in PCOS”

2008 label

2011 label

Summary

• Found postmarketing adverse event reporting in the Japanese demographic

• Found drugs within the antidiabetic drug class which demonstrated similar adverse events in the Japanese demographic and were then able to do comparative adverse event analysis on those drugs

• Found extracted drug safety data in both preclinical and clinical studies across different drug classes

• Found adverse events not yet reported on the label

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Adverse event not reported in labeling

Adverse events reported to affect

patient compliance

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Could we have known about these

adverse events before the label was updated?

Did we actually find evidence of this in

the approval package? How do we mitigate risk

moving forward?

Was there any evidence of lack of patient compliance pre drug approval?

Summary

• Found evidence that patient compliance was an issue with acarbose due to its adverse events

• These concerns were clearly expressed in the approval package and should have been further considered before launching the drug on the market

• Now if you are facing similar adverse events in your clinical trials, what information can you find that can help you mediate that risk of patients withdrawing from your drug?

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Adverse event not reported in labeling

Adverse events reported to affect

patient compliance

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Could we have known about these

adverse events before the label was updated?

Did we actually find evidence of this in

the approval package? How do we mitigate risk

moving forward?

However a combinatorial drug therapy of acarbose and

metformin is not approved yet by the FDA or EMEA. Was this

ever tested before?

Where do we go from

here?

Summary

• Found evidence of acarbose plus metformin combination therapy in recent clinical studies

• However the same combination has been considered by the FDA before

• Gained insight into the risk factors of combining therapies where both drugs have similar adverse events

• Found a possible way of mitigating that risk of patient withdrawal if that type of combination therapy were to be explored again

Acarbose example“Acarbose” search in Embase

Filter by “adverse event”

Filter by “liver toxicity”

Identification of relevant articles

Identify any warning signs that there may

be drug induced liver toxicity

Reports of post-marketing adverse

events

Adverse event not reported in labeling

Adverse events reported to affect

patient compliance

Was there any evidence of this

before the drug was approved?

Can we find evidence of these adverse events at the preclinical and

clinical stages before drug approval?

Could we have known about these

adverse events before the label was updated?

Did we actually find evidence of this in

the approval package? How do we mitigate risk

moving forward?

• The Q&A will be sent to you by email.• For more information and questions please

contact bdtraining@elsevier.com• Check out upcoming and previous Embase and

PharmPendium webinars at http://www.embase.com/info/embase-webinars and http://www.pharmapendium.com/info/pharmapendium-webinars.

Please fill out the survey that appears on your screen after leaving the webinar.

Please fill out the survey that appears on your screen after leaving the webinar.