This is my testimony that I will present to the FDA at the upcoming hearings on the use of social communications in pharma. This specifically will address their question regarding adverse event monitoring and reporting
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Dealing with side effects is reported by patients as the second most frustratiin part of their treatment experience (PwC 2013 Customer Exerience Radar Research). This presentation looks at
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- social media as a medium to discover and report adverse events
- recent research on the occurence of reportable adverse events in social media space
- regulatory agencies (FDA, EMA) pharmacovigilance activities in Social Media
- algorithm to track adverse events with industry standard social media monitoring tools
- possible engagement with the patients to address side effects and increase treatment adherence within regulatory boundaries
Users of synthetic drugs have reported impaired perception, reduced motor control, disorientation, extreme paranoia, and violent episodes. The use of these illicit products is reportedly more popular between individuals whose ages range between 20 and 29 years old.
Social Media and Adverse Events Reporting / Pharma Customer Experience Manage...Piotr Wrzosinski
Dealing with side effects is reported by patients as the second most frustratiin part of their treatment experience (PwC 2013 Customer Exerience Radar Research). This presentation looks at
- regulatory obligations of pharmaceutical firms in AER and DTC communication
- social media as a medium to discover and report adverse events
- recent research on the occurence of reportable adverse events in social media space
- regulatory agencies (FDA, EMA) pharmacovigilance activities in Social Media
- algorithm to track adverse events with industry standard social media monitoring tools
- possible engagement with the patients to address side effects and increase treatment adherence within regulatory boundaries
Users of synthetic drugs have reported impaired perception, reduced motor control, disorientation, extreme paranoia, and violent episodes. The use of these illicit products is reportedly more popular between individuals whose ages range between 20 and 29 years old.
While the pharma and healthcare world waits for the FDA to issue guidelines that may never come, there are still a lot of marketing activities that you can do today that are legal and appropriate (and might just be successful).
While pharma and healthcare companies may be limited by regulatory rules about what they can do with social media marketing, there is plenty they can and many companies have already jumped ahead. Here are some case studies of the best and why they work.
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This is my testimony that I will present to the FDA at the upcoming hearings on the use of social communications in pharma. This specifically will address their question regarding "what parameters should apply to the posting of corrective information on Web sites controlled by third parties?"
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TiVo, iPod, and blogging have something more in common than the right technology at the right time. They provide the same old media in new and interesting ways. This not only changes consumer behavior, but forever shifts consumer attitude. Greedy for content and equipped with almost magical abilities to control media delivery, we have armed a very intelligent consumer.
“If you build it they will come” may have worked in Field of Dreams, but times have changed. There is too much competition for consumers’ attention online allowing them to choose from any one of millions of other sites. Consumers now spend less and less time on “traditional” websites and instead find themselves spending hours with social media instead. These days, in order to ensure consumers receive, understand and are engaged in your brand message; you must bring it to them rather then hope they find you. No longer can pharmaceutical brand exist on just one site, have just one presence, one URL.
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Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
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1. Are pharma companies supposed to be private investigators? Jonathan Richman Director of Strategic Planning, Bridge Worldwide Author, Dose of Digital
9. 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.
10. 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
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.
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.