Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US
Epidemico and representatives from a patient group, Essure Problems, co-authored a publication describing the use of Facebook outreach and the MedWatcher app to encourage adverse event reporting to the US FDA for Essure, a hysteroscopic sterilization device. Over 1,300 valid reports were received through the app over approximately 19 months, which amounts to over 15 times more reports than through traditional channels. Further, these reports were more than 4 times as likely to be “well-documented” according to WHO’s VigiGrade standards. A report took on average 11 minutes to submit, compared to 40… Read More
MedWatcher Social: Online Listening for Adverse Events
In just the past week, we have seen a flurry of news about FDA-approved acid reflux drugs and possible associations with increased heart attack risk. Media and regulatory attention demand that manufacturers find innovative solutions for monitoring and managing messaging about their products. Epidemico offers a post-market surveillance solution, MedWatcher, a suite of tools aimed to help industry better understand patient experience, and navigate adverse event reporting. MedWatcher Social (MWS) is a GxP-validated social media monitoring platform, offering assurance that MedWatcher complies with strict regulatory standards and practices. 5 of the top 12 pharmaceutical… Read More
The revolution will not be televised, but it may be posted on Twitter and Facebook
We are pleased to announce that our social media monitoring and analytics platform, MedWatcher Social, has been featured in an article on The Pink Sheet, “Adverse Events In Social Media: FDA Expects Signal Detection ‘Revolution.’” Sarah Karlin describes how the FDA expects to expand on its traditional adverse event collection process by utilizing data from social media spaces like Facebook and Twitter to assist in post-market surveillance. Karlin also discusses how our team at Epidemico has worked with the FDA to provide them with the necessary technology for such surveillance using our… Read More
FDA post-market evaluation results, 2013
All drugs, devices and vaccines must undergo several phases of clinical trials before they are approved and brought to market; the process of evaluating a medical product’s safety profile, however, does not stop at approval. The FDA conducts what are called post-market evaluations to determine if any unforeseen side effects occur once a drug has been used by the general population either 18 months after approval or by the time the the drug has been used by 10,000 individuals (whichever is later). The data for several drugs were evaluated in 2013. While… Read More
ICYMI: FDA’s biggest announcements from 2013
January – lowers recommended dose for certain sleep drugs containing zolpidem (e.g. Ambien, Zolpimist); approves 3 new drug txs for type 2 diabetes (Nesina, Kazano, Oseni); approves new orphan drug Kynamro to treat inherited cholesterol disorder February – approves first retinal implant for adults with rare genetic eye disease; approves new treatment Kadcyla for late-stage breast cancer March – approves Invokana to treat type 2 diabetes, Tecfidera new tx for MS; TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients April – approves Plan B One-Step emergency… Read More
Why Report via MedWatcher?
When you report your side effects to MedWatcher, you’re not only formally documenting your experience with the FDA but you’re also letting other MedWatcher users know, anonymously. We work in real-time, sharing adverse event reports with the MedWatcher community as soon as we can format them. Your knowledge of side effects could provide valuable information to other users who may be researching a new prescription or wondering if a side effect they’re experiencing themselves is common or not. When you report to MedWatcher, you’re also reporting to the MedWatcher community.
Why Report? (part 2)
Many reports describing a single side effect experienced from the same product by different people can signal a problem to the FDA. This signal could lead to further investigation which in turn could lead to label changes, dose modifications or even a product recall, leading to increase patient safety.
When a drug is being developed, it goes through several clinical trials. These trials typically test the safety and efficacy of the drug on a smaller, more homogenous population than that which actually ends up using the drug when it is approved. Post-market surveillance helps provide a more complete understanding of a product’s safety profile and what side effects might occur.
The MedWatcher App – How It Works
You can use MedWatcher to report a side effect or adverse event for any drug, device or vaccine. When you submit a report using our mobile app or website, we verify and format your information so that it can be sent to the FDA. We also publish a de-identified version of your report to MedWatcher so that other users can learn about your side effects. When you submit a report via MedWatcher, you’re helping increase transparency around medical products and improving the safety profiles of drugs, devices and vaccines!