MedWatch is the Food and Drug Administration’s (FDA) reporting system for adverse events. It was founded in 1993, and it’s focused on reporting adverse events related to medications.

Both health care professionals and patients have the ability to report events – using three methods: online, by phone 1-800-FDA-1088, or by mail and fax. Most would assume the online method would be extremely easy to find – not so.

Using Google, it took me more than 10 clicks and bouncing around multiple website pages to find the actual form that enables you to submit the adverse drug outcome form. This anecdotal example shows there has to be another easier solution.

A group of researchers from the University of North Carolina at Chapel Hill and Children’s Hospital Boston are trying to provide such a solution – in mobile form – and it had the potential to affect how drugs are recalled and to change the current paradigm of prescription drug surveillance.

The free app is called MedWatcher: Drug Safety Reporting, and it’s compatible on all iOS 4 devices [iPhone, iPod Touch, and the iPad]. The app allows patients and physicians to directly report adverse medication side effects to the FDA via their iOS 4 mobile device.

The main goal of the researchers is to lower the barrier of adverse drug effect reporting and make the process significantly more accessible:

“Traditional voluntary drug safety surveillance is limited by substantial under-reporting,” said John Brownstein, PhD, director of the Computational Epidemiology Group within the Informatics Program at Children’s Hospital Boston (CHIP)”

“Our hope is that through the release of MedWatcher, we will prompt increased participation in surveillance, empowering people to participate in the public health process but also potentially allowing us to ‘crowdsource’ problem drugs which will lead to better understandings of side effects of medicines, and possibly even bring about earlier detection and prevention,” said Clark Freifeld, research software developer at CHIP.

Providing Utility:

The app also provides a key utility for patients by allowing them to receive important notifications and updates pertaining to their current drug regimes. This aspect of the app gives value for patients and is essential in getting patients to download the free app.

Ease of Use:

After selecting a particular drug, the following are images of the user interface and how patient’s can report adverse drug events:

Overall the user interface is clean and navigation is simple, but there are some issues that will hopefully be worked out in subsequent updates.  One of the main ones being the lack of a good search tool when trying to add medications.  Having to scroll through and match the medications exactly is a function that will hopefully be simplified.

Mobile Format:

Having a reporting system accessible via mobile form provides real time data feedback.  This should not be overlooked and could be the main reason patient’s report more adverse outcomes – they always have their phone on them and won’t forget by the time the get home.  Prior stories we’ve written related to research being done with real time mobile medical reporting has been encouraging.

Game Changer:

The data collected from patients and health care professionals by this app will be analyzed by epidemiology researchers for trends, and then submitted to the FDA. If a large number of people download the app, it has the potential to change how fast a particular pharmaceutical drug might be recalled. This is where Crowd Sourcing comes into play – outsourcing a task, such as drug surveillance – to a large population.

With 120 million iOS 4 devices sold in just the last few years there is no doubt that if this app gains popularity it could have a significant affect on the current drug surveillance paradigm and even save lives by hastening the pace of drug recalls.

Source: University of North Carolina at Chapel Hill School of Public Health