As part of the 20th anniversary celebration of its MedWatch program, we previously reported that the Food and Drug Administration (FDA) rolled out new consumer-friendly forms and web-based learning tools to make it easier for consumers to report adverse events related to drugs and medical devices. As a compliment to the new Consumer Form – Form FDA 3500B – the FDA is also supporting a consumer mobile application (app) called MedWatcher.
What MedWatcher Means for Consumers
MedWatcher is a free tool that allows patients and physicians to submit “adverse event” reports to the FDA via smartphone or tablet (MedWatcher.org). MedWatcher is a project out of Boston Children’s Hospital and Harvard Medical School, created in collaboration with the FDA Center for Devices and Radiologic Health. According to the FDA, “the app makes it easier and faster for healthcare professionals, patients and caregivers to send voluntary reports of medical device problems to the FDA, compared to the traditional reporting methods – mail, phone or online.” Although the FDA only refers to the app in its online guidance for reporting problems with medical devices, MedWatcher’s stated goal is to make drugs, devices, and vaccines safer. Indeed, consumers can use the app to report side effects for all FDA-regulated products.
“The app drastically simplifies and expedites the reporting process by providing users with a brief 4-step form that is submitted electronically to the FDA,” said MedWatcher staff member Carrie Pierce.
According to the FDA, the app also allows users to upload photographs of medical devices, which can help identify visible problems with a device, such as breakage or corrosion. When users submit a report via MedWatcher, the information is formatted and sent directly to the FDA. MedWatcher then de-identifies and publishes the report on its own page, enabling other MedWatcher users to view these reports — somewhat like a “consumer reports” page for medical products.
The FDA emphasizes that confidentiality is an important part of the app reporting mechanism, including a strong firewall for incoming reports, so that information contained in the report is not vulnerable to unauthorized access after the FDA has received it. Moreover, the MedWatcher app does not store personal information from the user’s mobile device, nor does it store adverse event reports once they have been submitted.
The FDA encourages healthcare professionals, patients and caregivers to report the following types of problems, even when they are not certain that the device caused the problem:
- Serious adverse events that might be associated with a medical device, especially events that are not listed in the product labeling. “Serious” means fatalities, hospitalizations, and medically significant events.
- Therapeutic failures where the device failed to work as it should.
- Use errors with devices, including situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.
- Product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.
Physicians and patients can use the device for more than filing a report with the FDA. Users can also create a “Watch List” to generate a news feed providing updates on their selected prescriptions/devices, including FDA MedWatch safety alerts, fellow consumer reports, updates about the drug or device, recall information, relevant articles, and other information on specific medical products of interest.
What MedWatcher Means for Manufacturers
By law, companies are required to report to FDA certain serious problems that may have been caused by their products, including cases where consumers report suspected problems to the company. Currently, the vast majority of more than 900,000 MedWatch reports a year are funneled to FDA through companies. Nevertheless, the FDA clearly states that MedWatcher is not intended to fulfill mandatory reporting requirements for manufacturers. In addition to manufacturer self-reporting, the FDA relies on consumer reports of serious problems with medical devices and other products as another important way to conduct post-market surveillance to help identify and better understand the risks associated with these products. MedWatcher supports the FDA’s efforts to receive timely, higher quality reports from consumers, which, in turn, help the FDA identify and respond to safety signals and public health emergencies more efficiently and effectively. These reports, along with data from other sources, can provide critical information that can lead to improved patient safety.
PR Newswire previously reported about the development of the MedWatcher app, quoting app developers: “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), who co-led the development of the application with Clark Freifeld, research software developer at 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 Freifeld.
The crowdsourcing aspect of MedWatcher can benefit manufacturers as well as government agencies and consumers. Manufacturers who choose to monitor consumer reports on their own devices and drugs on the MedWatcher site may gain early insight and ability to respond to post-market concerns. The MedWatcher system is run by Epidemico, a Boston Children’s spin-out company. As a compliment to MedWatcher, Epidemico has created a new social media monitoring and analytics platform that can identify, aggregate, classify and visualize adverse events for drugs, devices and vaccines. Epidemico monitors social media avenues including Facebook, Twitter, online news outlets, and online patient communities.
Epidemico reports that “the system can be programmed to automatically alert users when reports reach frequency or statistical thresholds,” and it “minimize[s] false positives with sophisticated algorithms and expert curation.” Social analytics represent a new way manufacturers can track the impact of their own products. Companies looking to customize their use of MedWatcher for Enterprise can find more information on the MedWatcher website.
Download the MedWatcher Mobile App