go-Digital Blog on Digital Marketing

Most Social Media Mentions Do Not Constitute Reportable Adverse Events

Most social media mentions and content do not meet the 4 criteria set forth by the FDA to determine whether the adverse event is reportable.

FDA’s Four Adverse Event Reporting Criteria

Our team of social scientists analyzed each post in the sample set to ultimately determine how many met the FDA’s criteria for Adverse Event Reporting:

1. Identifiable Patient: The post contains information sufficient to believe a specific patient was involved, such as “I experienced” or “my brother experienced,” but did not contain general statements such as “many people.”
2. Identifiable Reporter: The post contains sufficient information to follow up with the person reporting, such as an email address, telephone number or physical address.
3. Specific Medication: The post mentions a specific medication by brand or the chemical name of a medication where that compound is unique to one specific brand. (Note:  For this project, only brand names were used.)
4. Adverse Event: The post describes a reaction that a “reasonable person” would consider an adverse experience such as death, hospitalization, vomiting, swelling or a side effect that is not known or expected with the medication.

Data publshed by Visible Technologies based on their study of  ”257,177 posts mentioning one or more of the 224 brand names” showed that, quote: ”

• Only 0.3 percent actually contain a report of an AE experience
• 14 percent of those posts have an identifiable full name and contact method (through site* or email).”

SOURCE: http://www.visibletechnologies.com/resources/white-papers/adverse-events/

Excerpt: “ To put some perspective on these figures, during the 30-day research period, the most talked about antacid brand online had just over 11,000 posts—nearly six times the volume of any other antacid brand studied.  Of those posts, only five met the criteria required to trigger filling out an Adverse Event Report.  This small number of AERs is also significant because this brand had nearly twice the AE reporting rate of the other antacid brands, yet still yielded just five posts meeting the criteria.

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