Information is power, and as of this month, there’s a new power source of information about drug effects.

openFDA.gov is an initiative of the U.S. Food and Drug Administration to expand access to and use of reports of problems associated with drugs. Although the public is welcome to plumb the database assembled from other federal reporting systems, it’s a bit wonky, and requires experience with certain documents and databases to get the most out of it.

There are tutorials, but it’s still tough stuff. The feds have geared it toward researchers, web developers, industry representative and anyone seeking depth as well as transparency.

The dataset includes nearly 4 million records from 2004 to 2013 regarding:

  • Adverse Events: reports of events and medication errors submitted to the FDA concerning all regulated drugs;
  • Recalls: information gathered from public notices about enforcement and certain recalls of FDA-regulated products;
  • Documentation: detailed product label information on many FDA-regulated products.

We’ve referred readers to various adverse events resources, including the Institute for Safe Medication Practices (ISMP), and the FDA’s MedWatch. That’s the voluntary adverse event reporting and safety information program whose database is known as FAERS--Adverse Event Reporting System. For most people, they are sufficient for finding what you want to know.

 

 

Topics:  Adverse Events, Databases, FDA, FOIA, HHS, Labeling, openFDA, Pharmaceutical, Prescription Drugs

Published In: Administrative Agency Updates, Consumer Protection Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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