Ask anyone in the healthcare industry if adverse drug event information is important and they will most certainly tell you YES. Ask them why it is important and hopefully their answer will be PATIENT SAFETY. Now ask them what is the IMPACT and they will probably either make something up, or look at you quizzically.

When a drug is approved for marketing, surprisingly little is known about its safety profile. In clinical trials, relatively speaking the sample size is small, the duration of the trial is short, and the demographics are homogenous. This combination makes constant detecting, diagnosing, and reporting such side effects post approval vital for making the best prescribing decisions that have a direct impact on the general public. Learn more in our comprehensive guide to FAERS. 


Related Read: Should Adverse Drug Event Reporting by Healthcare Providers be Mandatory?


During clinical trials, an average of 48 adverse events per drug come to light. At the time of approval an average of 70 adverse events per label.

How many adverse events per drug are seen in real world reporting?

What are the outcomes of these adverse events?

What are the costs of these adverse events?

The IMPACT is what is important [INFOGRAPHIC]

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Kerry Anne Fraser

Kerry Anne Fraser

Inbound Marketing Specialist

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Topics: Drug Safety

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.