Personal Injury Law

FDA Presents Ten Years Of Summary Statistics For Its Adverse Event Reporting System (AERS)

By Tom Lamb

Information Current As Of December 31, 2008; FDA Says It Will Provide Quarterly Updates For This AERS Data

(Posted by Tom Lamb at DrugInjuryWatch.com)

In early April 2009 the FDA released its Adverse Event Reporting System (AERS) Statistics as of December 31, 2008.

From that document, found on the FDA's web site, we get this contextual information:

The Adverse Event Reporting System (AERS) contains over four million reports of adverse events and reflects data from 1969 to the present. Data from AERS are presented here as summary statistics. These summary statistics cover data received over the last ten years. These data are presented at the individual report level; some of the numbers may reflect duplicate reporting due to factors such as follow-up reports received on a case or different persons reporting on the same patient case.

This summary of AERS statistics from the FDA is presents four different ways:

Reports Received and Reports Entered into AERS by Year (1999 - 2008)

Number of Domestic (U.S.) and Foreign Reports in AERS (1999 - 2008)

Reporting by Healthcare Providers and Consumers by Year (1999 - 2008)

Patient Outcomes by Year (1999 - 2008)

The third statistical analysis, which provides some breakdown on the type of person who submitted the adverse event (AE) report to FDA -- or submitted the AE report to the manufacturer which, in turn, sent the report to FDA -- was the one that I found most interesting. 

From this third analysis, Reporting by Healthcare Providers and Consumers by Year, we learn that in 2008 about 54% of the almost 500,000 AE reports were submitted by healthcare providers.  And for the 269,765 AE reports that were made in 2008 by healthcare providers, we get this further breakdown:

• Physicians: 154,044 AE reports in 2008
• Pharmacist: 27,070 AE reports in 2008
• Other types of providers (includes nurses, dentists, etc.): 88,651 AE reports in 2008

Any person who made an AE report to the FDA and who is not documented in the report as a healthcare provider was categorized as a "consumer".  About 46% of the 2008 AE reports were made by this group of reporters.

One might also look at the first analysis, Reports Received and Reports Entered into AERS by Year, to see the general trend upward for AE reports in the the past six years.

We look forward to receiving the quarterly updates to this summary of AERS statistics from the FDA in the future.

Full post as published by Drug Injury Watch on April 08, 2009 (boomark / email).