Adverse event reporting: What pharmaceutical companies need to know
But let’s look a little closer. As pharma companies know, there are four very specific criteria that must be met in order to constitute filing a report with the FDA. If a report does not contain all four elements, it will be returned as insufficient. The FDA’s four parameters for submitting information about adverse experiences are:
- Identifiable reporter
- Identifiable patient
- An adverse event or fatal outcome
- A suspect drug or biological product
“In other words, if any of these basic elements remain unknown after being actively sought by the applicant, manufacturer, or licensed manufacturer, a report on the incident should not be submitted to the FDA because reports without such information make interpretation of their significance difficult, at best, and impossible, in most instances,” according to the FDA and US Department of Health and Human Services.
When you look more closely at conversations happening online you will find that people are not typically speaking about adverse events, but rather they are seeking support and sharing information on lifestyle, experiences and tips. In order to get to the bottom of the realities of adverse events in social media, Visible Technologies recently tracked 224 pharmaceutical brands, then collected and analyzed more than 257,000 posts across social media sites during a 30-day period.
Some of the key findings include:
• 0.3 percent of all posts contained an adverse event (AE) experience.
• Only 14 percent of posts that contained an AE had an identifiable name and contact method to enable pharmaceutical marketers to fill out required paperwork.
• On average, during the 30-day period, each brand received a total of three posts that met the requirements for AE reporting.
With these findings, pharma companies can rest assured that the benefits and opportunities of engaging in online conversations far outweigh the negatives. Yes, there will be the occasional adverse event that will require reporting. But that is certainly not enough reason to avoid it all together and miss out on the chance to build a community among customers and cultivate brand advocates.
To learn more, read our social report, “Adverse Event Reporting in Social Media.”
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