The MedWatcher Application:
Mobile Phones and Crowdsourcing for Drug Safety Surveillance

John S. Brownstein, PhD, Clark C. Freifeld MS, Nabarun Dasgupta MPH

1. Computational Epidemiology Group, Children’s Hospital Informatics Program at the Harvard-MIT Division of Health Sciences and Technology, Children’s Hospital Boston, Boston, MA
2. Department of Pediatrics, Harvard Medical School, Children’s Hospital Boston, Boston, MA
3. Department of Epidemiology, Gillings Schools of Global Public Health, University of North Carolina, Chapel Hill, NC

Traditionally, public health information flows through a hierarchical structure, originating with a patient, being reported by healthcare providers, and assessed by public health authorities. Results of this information exchange are communicated to healthcare providers via the medical literature and targeted communications, while the general public receives sporadic and uncoordinated reports usually conveyed by news media. This highlights an important information gap between government and the general public. Meanwhile, broad adoption of the Internet and mobile phone around the world has enabled a new class of real time participatory systems and “crowdsourcing”. In the health field, online patient communities have provided a forum for patients to share their experiences, collect information, and inform biomedical researchers. These new systems represent a departure from the careful control and verification of traditional structures, but often provide advantages in scalability, coverage, timeliness, and transparency. Engaging the public transforms users from passive recipients of information to active participants in a collaborative community, helping to improve their own health as well as the health of those around them.

Here, we focus on the potential role of public participation in drug safety surveillance, where the information gap between government and the public is arguably widest. Currently, the identification of safety problems with marketed drugs is dependent on the FDA's Adverse Event Reporting System (AERS), which collects voluntary reports that are limited by under-reporting and inconsistent ascertainment. The system was designed in a previous era when its role was to identify major dramatic adverse events (e.g., birth defects and thalidomide). As drugs have become safer and regulatory mechanisms to mitigate risk have become stronger, today’s safety concerns include subtle increases in rates of already occurring diseases. Notably, in the earlier part of the decade, it would have been very unlikely that a clinician would report a myocardial infarction associated with rofecoxib to AERS, even if they suspected it was related. The wisdom of crowds can be used to improve adverse event reporting for drug safety. Patients and the general public are routinely left out of the process because it is incorrectly assumed that healthcare professionals are the only ones capable of identifying drug interactions or associated adverse events. Without a known prior association, crowdsourcing can be an important adjunct to existing pharmacovigilance to generate hypotheses about candidate medication risks, especially for widely prescribed medicines.

We attempt to improve upon the drug safety process through our MedWatcher App for the iPhone. The application is designed to engage users (both the public and healthcare practitioners) in issues of drug safety and real-time pharmacovigilance. The system has two main functions: alerting and reporting. First, the application alerts users about new drug warnings through both official FDA channels (such as MedWatch Alerts) and through informal channels (such as news media). Second, using forms tailored separately to the public and clinicians, we provide a user-friendly tool for reporting information about drug side effects. Serious adverse events from clinicians are automatically submitted to FDA, while public discourse between patients creates a sense of community, as well as a source of information for hypothesis generation for researchers. (See screenshots below)

We believe these early efforts represent an important step in engaging the public as participants in the public health process and empowering individuals to make the informed decisions on which our healthcare model is predicated. Mobile applications for health are likely to be a successful tool in engaging Americans to understand important public health topics, while improving the performance of drug safety surveillance.