Should There be an App for Reporting Adverse Events?

Today the United States Department of Agriculture (USDA) announced the launch of a new app for smartphones that will alert consumers to the latest recall information in one spot, allowing them to track and actually see recalled products.  This means that a consumer doesn't have to navigate a difficult and cumbersome Web site, or number of Web sites, to get the latest consumer information. Fro example, the information in the app collects information from several sites, including the FDA.  

But there is something else in the app that is extremely provocative.  The app also has a "report incident" function that allows for a consumer to submit a report about a product that might be unsafe.  

The latter is a daring feature and one that is not without risk.  But USDA apparently figures that the benefit outweighs the risk, or at least is willing to find out.  

The agencies of the federal government are rolling out more and more apps.  What if an app from FDA provided the latest drug information?  If it were geared to patients directly, would that be too much? Would patients be reporting an AE every time they felt just a little funny after taking a medication?  Would a patient app be too readily available for reporting where there was in fact, no basis.  Would it overwhelm resources?  

What if it were an app for physicians only?  The success of Ortho-McNeil-Janssen's Black Bag app for physicians is only one of many examples of how health care professionals are embracing new technologies in the practice of medicine.  

Right now, the reporting of an adverse event on the FDA Web site looks something like this.  You go to the very busy FDA landing page.  There are a lot of options.  In the lower right hand corner there is a box "Report a Problem".  You see a choice for "Drugs and Medical Devices".  You click on that (CLICK 1).  


You come to another very busy page.  Where to go?  There is nothing that prompts you in terms of priority.  In the upper left hand corner, there is a box "Medwatch The FDA Safety Information and Adverse Event Reporting Program" which is also the title of the center of the page.  The left hand box though has a link to "Reporting Serious Problems to the FDA".  But underneath that, is another box.  There is a link there – "Reporting a Serious Medical Product Problem Online".  Is that a how-to resource?  Should I click there first, or on the Reporting Serious Problems link?  How do I know if my problem is classified as serious?  I opt for the "Reporting a Serious Medical Product…" link.  (CLICK 2) Here is what I get. 

Ae's 2 

There is a link to report a problem, but I am a consumer and there is also a link for reporting by consumers.  Which do I click?  It also tells me I could report a counterfeit product here, but would I have defined that as a "serious medical problem" before I got to this page.  

Say you click on "Reporting by Consumers", (CLICK 3) you will come to yet another landing page, but still nothing that is a form that is collecting your information.  There you will click on yet another link (CLICK 4) that will take you to an electronic form.  You can type in the answers on this form, but you then have to print it and fax it to the FDA (NO MORE CLICKS?).  

Maybe an app that is in the hands of consumers on their phones would create chaos by making the reporting of an AE too easy and whimsical.  But there has to be something between an app, and a succession of links through busy web pages, to facilitate the reporting of an adverse event.  

In April 2010, the California Healthcare Foundation released a report entitled "How Smart Phones Are Changing Healthcare for Consumers and Providers" that provides an excellent overview of how apps are being applied so far today.  We need as well, to think about the blueprint for tomorrow.  

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2 Responses to Should There be an App for Reporting Adverse Events?

  1. RachelW says:

    I just downloaded an FDA Recalls app yesterday to my iPad (although it’s designed for a phone, so is small size), but I just checked and it’s not actually from the FDA itself; see

  2. Mark Senak says:

    Thanks Rachel! Very intersting. Appreciate the note.

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