Best practices for AEs on social media
4 tips for reporting AEs from Twitter and other platforms
Eventually, it will happen. If you're following HCPs on social media, you will eventually find an AE.
Here’s an example from Twitter:
So what should you do? How do you respond? What are your regulatory and other responsibilities?
Read on for answers...
First, let's review what is reportable per FDA guidelines. Before reporting to the FDA, you'll need these details:
Patient: sufficient information to believe a patient had an adverse event
Reporter: contact information to follow up with the reporter
Medication: a biological or pharmaceutical product
Adverse event: an AE or death suspected due to the product
If you’re a biotech or pharma employee, you must report within 24 hours.
If the AE was serious and unexpected, your organization must file with the FDA within 15 days. Other AEs may be reported quarterly or annually, depending on your product’s time on market.
How the FDA regards AE reports from social media
Per FDA guidance, AE reports from social media should be treated as spontaneous reports. Spontaneous reports are unsolicited communications that mention AEs. The FDA uses the same review process for spontaneous and other reports.
Challenges with reporting AEs from social media
With 500 million posts every day on Twitter alone, the volume of social media can complicate this process. However, a closer look shows a low number of reportable AEs.
See this quote from IQVIA:
The real challenge is not the total volume of adverse events, but being able to quickly identify the relatively small number of adverse events from large amounts of data. You see about 2% of conversations will have reportable adverse events...across all disease states.
Complications also include incomplete reports and potential duplicates:
Incomplete reports. Many social media posts do not sufficiently describe the patient's symptoms to confirm a diagnosis or condition.
Potential duplicates. If an AE is serious enough to justify a post, it's likely the patient’s provider has already reported to the FDA.
For more guidance, see this Social Media Regulatory Affairs presentation.
How you should handle AEs on social media
To report AEs from social media, here are four recommendations:
Share with your PV team
Send a screenshot and a link to your PV team. Include specifics on the patient, reporter, medication and AE.
Use current PV processes
Leverage your audit, reconciliation and training processes. This provides consistency across channels and alignment with regulatory requirements.
Allow PV to respond if appropriate
Enable your PV team to reply to the original post with options to continue the conversation via private channels. This lets you collect details and answer questions while respecting privacy.
Include your Compliance team
As with any new process, be sure to ask for guidance from Compliance so they can support your initiatives.
For more tips, check out this C3i infographic (click to view):
Got questions about AEs and social media? Share below!