Background: FDA Black Box warnings for psychiatric medications are important for both prescribing and non-prescribing mental health professionals. The information on Black Box warnings is available; but not available in one reference that can be quickly and easily reviewed. This gap in the reference literature may contribute to lack of awareness of Black Box warnings.
As an example, if most clinicians were told that one mental health medication carries a life-threatening risk for QTc prolongation they might, understandably, guess that it is Citalopram. Actually, it’s not Citalopram. (See below for the correct answer*.)
Methods: The author attempted address this reference gap by designing, programming an animated, touch-screen app for Apple and Android mobile phones and tablets. The author attempted to publish this reference app free-of- charge on the associated app stores.
The author used FDA materials on psychiatric medications to aggregate all the various Black Box warnings into one quick reference. The medications and their warnings are organized around psychiatric diagnosis. The app is touch-screen operated and color-coded so the user can instantly toggle between medications with one touch.
Results: For Android, the top countries for download are (in order): United States, India, United Kingdom, Canada, Ghana. For Apple, there have been 262 downloads. The top 5 countries for use are: United States, Australia, Canada, United Kingdom, India.
Conclusion: Unfortunately, results of this attempt to increase awareness of Black Box warning can only be described as incomplete and mixed. On the hand the author was able to program and publish the touch-screen mobile app on FDA Black Box warnings and the mobile-app could be consider a novel reference tool for clinicians. This app also can be said to be available globally for download and access, free of charge.
On the other hand, available data indicates that many users who downloaded the app did not maintain it on their device. Additionally, though user reviews have been universally positive, the numbers of review are far too low to draw any conclusions.
*Correct answer: Methadone
Hello, my name is Matthew Lally. I’m a psychiatrist. And thank you for clicking on this audio file. The name of my Mysell Day poster presentation is The Black Box Warning Mobile App. That is The Black Box Warning Mobile App. In summary, I spent about a year designing, programming and publishing a mobile app for mental health professionals. The idea is that this app would be for both prescribing and potentially for non-prescribing mental health professionals. The spirit of this is that I consider mental health professions to be my peers. And I tried to create something that I hope, and my ultimate goal, is that it could be useful to my peers in mental health, and useful, hopefully, in providing care to patients with mental health issues. It’s not clear that I’ve achieved that goal. In fact, I don’t think I have, but that was the goal in the first place.
In creating this app, I tried to take two different ideas and combine them into one project. On the one hand, I tried to create an academic reference that was evidence-based and clinically reliable. To that goal, I use a lot of information from the FDA, including black box warning information and dosing information. And I also used references from psychiatric and medical journals. And I’ve included those references in the app. You simply touch upon the number of the citation, and the information for the citation will appear immediately on your screen.
So, in addition to try to making the app have the kind of integrity and evidence of a true clinical reference, I also tried it to combine it with the look and design and functionality of a video game. I know that’s a strange juxtaposition, and somewhat unusual, and some people may not approve that, but that was the goal I was going for. The reason I wanted it to have the look and functionality of a video game is for the following reasons. I wanted the app to be very user friendly. In fact, I wanted it to be pleasant for the user. So, I made it touchscreen. I made it animated. I made it instantaneous, and I tried to make it self-explanatory. So, as soon as the user opens the app, within a moment or two, they understand entirely how it works and where they should go to get the information that they need, and that they can move around very quickly from place to place. And it’s very easy to use and very easy to understand.
So, combining the evidence of a clinical reference with the look and functionality of a video game is what I was going for. Ultimately, the app has not made much clinical impact. Very few people have found the app. Very few people have downloaded the app. And even people that have downloaded the app have uninstalled the app. So, it has not been successful in terms of the original goal of becoming a reference that mental health professionals utilize. If you’re interested in seeing this app or trying this app, do not search The Black Box Warning Mobile App. That is just the title of this Mysell Day presentation to emphasize the black box warning component. The actual title of the app is different. And I apologize for that discrepancy. The actual title of the app is Everybody’s Guide to Psych Meds. That is Everybody’s Guide to Psych Meds. If possible, I would go back and change the title, but it’s very hard for me to do that, especially with the Apple App Store. So, if you want to look for it, that would be the title to search.
Thank you so much for your interest. I hope you have a great day. And I’m sorry we can’t communicate in person, but if you’d like to reach me or ask me a question, please feel free to do so. Thank you so much.
Live Zoom Session – April 21st
Matthew Lally, MD