11 - 12 September 2017 | Boston, MA

Thursday, March 05, 2015

FDA Develops a Mobile App for Reporting Drug Shortages. But Wouldn't an App for Adverse Events Better Fit the Agency's Mission?

FDA/CDER launched its first and only mobile app on iTunes: DrugShortages (see logo on left).

The iTunes blurb suggests the public would find this information important:

"Access to drug shortage information is now easier and faster. FDA has developed an app that allows users to quickly identify current drug shortages, resolved shortages, and discontinuations of drug products. This app was developed to accelerate public access to important – and sometimes critical -- information about drug shortages. The application uses a searchable database to provide real-time information to key stakeholders, including health care practitioners and pharmacists."

I'm not sure how useful this app is for the public versus HCPs who definitely would like easy access to such information. According to the blurb, the app "helps health care practitioners make quick decisions about patient treatment."

More importantly, the app "provides information on how to report a shortage or supply issue, and links to other resources from FDA". Of course, the general public would not find this feature of the app very useful.

But an app that would be VERY useful for HCPs and patients is an app that provides easy access to adverse event data and that allows users to report adverse events. This, I believe, would better fulfill FDA's mission: to "protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices..."

What would such an app look like? I used the DrugShortages screen to create what I call "DrugAE," a concept for a mobile app that I hope the will FDA launch on iTunes soon. Here's my concept:



My concept for the DrugAE app home screen is on the right. The home screen of DrugShortages is shown on the left for comparison. Click on the image for an enlarged view.
The DrugAE iTunes blurb might look like this:

"Access to drug adverse event information is now easier and faster. FDA has developed an app that allows users to quickly search FDA's  current drug adverse event database. This app was developed to accelerate public access to important – and sometimes critical -- information about drug adverse events. The application uses openFDA technology, which is specifically designed to make it easier for the public to access and use the agency's searchable database to provide real-time information to key stakeholders, including health care practitioners, pharmacists, AND PATIENTS. The app:

  • helps health care practitioners make quick decisions about patient treatment 
  • allows users to search for a generic name or active ingredient, and browse by alphabetic list or therapeutic category 
  • provides information on how to report an adverse event or other drug safety issue, and links to other resources from FDA.

UPDATE: A colleague on Twitter informed me of MedWatcher, a mobile app created in collaboration with the US Food and Drug Administration (FDA) Center for Devices and Radiologic Health (CDRH). The iTunes blurb says you can use "MedWatcher to get news and official safety alerts for medical devices, as well as drugs and vaccines. MedWatcher is the only app that allows you to report bad side effects or adverse events directly to the FDA to make medical products safer for everyone."

I downloaded the app and registered by supplying my name and email address. BTW, I didn't notice any privacy policy. When I tried submitting an AE report for "flu vaccine" the app could not find it in the database. So I tried submitting a report for Cialis. Unfortunately, the app froze up with the "Your report is being submitted" displayed on the screen for the last ten minutes.

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