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Thursday, January 5, 2017

FAERS Report Sources Almost Non-Existent These Days

Yesterday's post is admittedly boring. I mean, AERS / FAERS reports have been going up over time (for the most part) with occasional "pauses" but is there anything more interesting in this gross analysis of the FAERS database?

Mayyyyyybe.

First, another boring bit.

Each FAERS report received by the FDA usually lists multiple medications (not a big surprise--many people take multiple medications). Each medication listed in a FAERS report gets its own record. So, we can ask:

Has the # of reported medications per report changed over time?

Short answer: probably not.

Below is a chart of the # of drug entries per quarter (blue line).
You can see that it roughly correlates with the # of reports per quarterly release (red line).


You can be a little more rigorous and plot the mean number of drug entries per report (per quarter) [see chart below]. I don't want to do the statistics on this, but my suspicion is that the regression line would be relatively flat, which means the # of reported meds per report hasn't changed much over time.

It looks as though there are about 3.5 medications listed per FAERS report and that's held steady.

I guess that's good. Maybe that means that there hasn't been a shift in adverse events related to the sheer number of drugs taken (per patient) over the past 20 or so years. I know that's a really speculative conclusion, but I suspect there's a kernel of truth in there.



But there's more information included in FAERS reports!

For example, each report can indicate the source of the adverse information. This is formally known as the Report Source. Some possible report sources include:
  • Health Professionals (physicians, etc.)
  • Company Representatives (the pharmacovigilance department let's the FDA know)
  • Scientific Literature (information is published in a medical journal)
  • Pharmaceutical Distributor
  • etc. etc.
The chart below shows the number of sources listed per FAERS report over time and it indicates that the report source information is essentially dead. . These days, less than 1 FAERS report out of 40 contains report source information. This doesn't seem like absolutely critical information for the FDA to publish, but I'm still surprised that it's fallen by the way-side.


You can download data and code here: https://github.com/pdanese/faers_counts_Q3_2016