Access to Information About Drugs for Dogs is Complex

Published in the March 2019 issue of Whole Dog Journal was an article headlined, “Reporting Dogs’ Adverse Reactions is Your Duty.” In the article, longtime WDJ contributor Barbara Dobbins discussed the various reasons that dog owners and veterinarians should report any sort of adverse event or negative side effects they observe in their dogs or their clients’ dogs to the agency that provides oversight of whatever substance they think has caused harm.

Dobbins also provided instruction on and links for sending adverse event reports to the appropriate agencies; for example, animal drugs are regulated by the Food & Drug Administration’s Center for Veterinary Medicine (FDA CVM); topical pesticides are monitored by the Environmental Protection Agency (EPA); animal vaccines are regulated by the U.S. Department of Agriculture Center for Veterinary Biologics (USDA CVB).

We complained about one thing in that article – that the CVM’s cumulative database of adverse drug event (ADE) summaries offers only reports that were collected by the agency from 1987 through April 30, 2013. More recent reports have been collected electronically – and ironically, these more technologically modern reports have not been made available to the interested public, except through a Freedom of Information Act (FOIA) request.

The problem, as it was explained on the CVM’s website, was that the project of collating the (old) paper reports with the newer, electronically submitted reports was not complete. A note on the CVM website stated, “We anticipate having updated adverse event information available in late 2017 or early 2018.” (But the note, and not the updated adverse event reports, was still present on the website in January 2019!)

On April 3, 2019, the FDA issued a press release, announcing that it is making the adverse event reports related to animal drugs and medical devices used in animals available online – including all the reports going back some 30 years. The reports “will be available electronically onopenFDA.gov, an agency-run digital platform used by researchers, statisticians and other academics to access large, valuable public health datasets collected by the FDA.”

Hurray! The project is complete! This giant new step in transparency makes it possible for a dog owner or veterinarian to research what sorts of adverse effects to a certain drug (for example) have been experienced by dogs, and how many dogs have been affected in those ways! Wow! Cool!

But before we celebrate our new ability to check out the past ADEs, we will have to master some new and tricky (although certainly not impossible) application programming interfaces (APIs).

What the Heck is An API?

According to Wikipedia: “In computer programming, an application programming interface (API) is a set of subroutine definitions, communication protocols, and tools for building software. In general terms, it is a set of clearly defined methods of communication among various components.”

The computer programmers among our readers may just be as happy with this news as my dog Woody with his Planet Dog Squeak ball. Alas, I am not a computer programmer, and my initial excitement over the FDA news release has been thoroughly squashed by the hour or so I spent trying to learn about APIs and how to construct queries and, oh, by the way, when doing so, please note that the system makes use of British English spellings of words like “diarrhoea.”

My squashing, I hope, is temporary. I’m sure I know someone who can walk me through and past this technological challenge – perhaps to a point where I could explain to others how to access all of this valuable information on animal drugs. If you think that person might be you, take a look at the launch site, and get back to me?