Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting

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By now, we’ve all seen this slide a hundred times, so I’m not going to explain it again. I will share the specific objection I get regarding this slide when I do share it with pharma clients. They don’t question the way Nielsen collected the data or analyzed it (nor do I). However, they question if this is really where their responsibility ends.

This is an actual example I pulled from iGuard. Assuming this was seen by a pharma employee, does this meet the criteria for “reportable”? If not, what information is missing and how far would the pharma company need to go to get this information?

Piece number one is an identifiable patient. There is no name here, but no name is required on form 3500.

So, if you don’t have a name, does it matter?

Is a combination of these bits of data good enough?

Piece two is an identifiable reporter. Since the reporter and patient are the same here, the answer to question one would answer this one? That is, how we treat the answer to if it’s an identifiable patient will also answer the reporter question. However, what if someone submitted it on behalf of someone else?

This is from MedHelp with “billieboy” asking about a potential AE on behalf of his father. Is billieboy good enough of an identifiable reporter? What about if we add in this profile information as scarce as it may be?

This one is, of course, one of the easiest of find, as it’s almost always mentioned when people are referring to a specific incident, but from time to time they don’t know the name or the suggest it but don’t mention it.

There’s not much to write about if there isn’t an adverse event included. The definition of an adverse event and what needs to be reported quickly to FDA is fairly clear, however, from personal experience there is a fair amount of confusion precisely what this means. Additional clarification could be helpful here

There was a time when physicians primarily were the ones collecting adverse events and there certainly weren’t message boards all over the place for people to talk about their conditions and experiences and potentially generate and adverse event report. When it was primarily the doctor, he or she could always make sure they gathered all the necessary information.

How do we handle a case like this? It looks like we might have all the pieces. Or do we?

How far do we peek into “billieboy’s” comment and profile? Can we just use his “handle” or do we need more and how far do we go to get it? Do we contact by email or direct message (if it’s available)? Do we contact the hosting site asking for this information? As more and more people go by handles in places like Twitter and in forums and blog comments, is this good enough for identifiable?

What if HealthGuy doesn’t include a name or link in his account? What if he includes a link to a blog? How long do we have to dig through it to find the person’s real name?

Perhaps we need new guidance or new acceptable limits or definitions for “identifiable” and other terms.

Do we need a new Form 3500 to account for how we gather the information?

Which of these do we need to reevaluate as companies are exposed to adverse events in completely new channels? We still want to capture legitimate events, but we also don’t want to create duplicates, which only confound the data.

1 Group

Joerg Kurt Wegner, Scientist at commercial drug design, added this to the group Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools

Dose of Digital FDA Pharma Social Media Hearing Testimony - Adverse Event Reporting - Presentation Transcript

Are pharma companies supposed to be private investigators? Jonathan Richman Director of Strategic Planning, Bridge Worldwide Author, Dose of Digital
- Required for reporting:
- an identifiable patient
- an identifiable reporter
- a specific drug or biologic involved in the event
- an adverse event or fatal outcome
- Only 1 in 500 posts have all this info.
Is this a reportable adverse event?
1. An Identifiable Patient Is this “identifiable”?
1. An Identifiable Patient
1. An Identifiable Patient
2. An Identifiable Reporter
2. An Identifiable Reporter
3. a specific drug involved in the event I can't remember the name it was something with a R. I got the shakes so bad that I had to take beta blockers to stop them.
4. An adverse or fatal outcome I ‘m beginning to wonder if the Parkinson-like movement of my left hand is related to taking Lipitor
In the “Old Days”...
A New Reality 1
- an identifiable patient
- an identifiable reporter
- a specific drug or biologic involved in the event
- an adverse event or fatal outcome
2 3 4
A New Reality HealthGuy
New Guidance Needed?
- an identifiable patient
- an identifiable reporter
- a specific drug or biologic involved in the event
- an adverse event or fatal outcome
New Guidance Needed?
- an identifiable reporter
New Guidance Needed?
New Guidance Needed?
- an identifiable patient
- an identifiable reporter
- a specific drug or biologic involved in the event
- an adverse event or fatal outcome
Jonathan Richman Director of Strategic Planning, Bridge Worldwide Author, Dose of Digital