Comments on: 166 Reportable Adverse Events Equals One Red Herring http://www.doseofdigital.com/2009/11/166-reportable-adverse-events-equals-one-red-herring/ Improving Healthcare Through Digital Technology -- Effectively using digital technology and social media in pharma and healthcare Tue, 24 Jan 2012 00:11:00 +0000 hourly 1 http://wordpress.org/?v=3.3.1 By: Healthcare Agencies and Social Media: Start Here « Impactiviti blog http://www.doseofdigital.com/2009/11/166-reportable-adverse-events-equals-one-red-herring/#comment-9689 Healthcare Agencies and Social Media: Start Here « Impactiviti blog Tue, 14 Dec 2010 13:29:45 +0000 http://www.doseofdigital.com/?p=1716#comment-9689 [...] Oh – and about those reportable adverse events… [...] [...] Oh – and about those reportable adverse events… [...]

]]> By: Jonathan Richman http://www.doseofdigital.com/2009/11/166-reportable-adverse-events-equals-one-red-herring/#comment-8937 Jonathan Richman Thu, 12 Aug 2010 17:40:36 +0000 http://www.doseofdigital.com/?p=1716#comment-8937 Good question. First, just for clarity and to make sure I get what you're asking, 1 in 500 posts will have all four of the criteria to be considered "reportable" by the FDA. You said "will have a response" a few times and wanted to clarify what you meant. I'm assuming you mean "are reportable." That said...<br><br>First, if you don't monitor every site out there (or however many your monitoring tools actually cover), then you really won't have to worry about sifting through comments about your brand because you won't see them. That's obvious. Now when it comes to your own sites, that's a different story. You're absolutely responsible for monitoring and reporting on the sites you own. You can't argue that you didn't see a comment with an AE on your own website. Having said that, I wouldn't worry too much about the volume. The vast majority of pharma-controlled sites don't have any comments from anyone. They just aren't that well trafficked and people are talking about these products on third party sites. Take the JNJBTW blog, for example, I looked at their blog at one point and they had 13 comments total on their last 10 posts. That's not a lot to monitor. <br><br>Check out this post to get a better idea of how many posts you'll actually have to review if you're talking about third party sites and how much work it'll take. I think you'll see that it's quite manageable: <a href="http://www.doseofdigital.com/2009/12/monitoring-adverse-events-social-media-pharmas-biggest-brands/" rel="nofollow">http://www.doseofdigital.com/2009/12/monitoring...</a><br><br>Also, check out my recent post that includes commentary from one pharma brand manager regarding YouTube comments and how they manage them including the total number and number of AEs: <a href="http://www.doseofdigital.com/2010/07/pharma-successfully-manages-youtube/" rel="nofollow">http://www.doseofdigital.com/2010/07/pharma-suc...</a><br><br>Hope this helps. If not, click the Contact link at the top of the page to get in touch with me to discuss. Good question. First, just for clarity and to make sure I get what you're asking, 1 in 500 posts will have all four of the criteria to be considered “reportable” by the FDA. You said “will have a response” a few times and wanted to clarify what you meant. I'm assuming you mean “are reportable.” That said…

First, if you don't monitor every site out there (or however many your monitoring tools actually cover), then you really won't have to worry about sifting through comments about your brand because you won't see them. That's obvious. Now when it comes to your own sites, that's a different story. You're absolutely responsible for monitoring and reporting on the sites you own. You can't argue that you didn't see a comment with an AE on your own website. Having said that, I wouldn't worry too much about the volume. The vast majority of pharma-controlled sites don't have any comments from anyone. They just aren't that well trafficked and people are talking about these products on third party sites. Take the JNJBTW blog, for example, I looked at their blog at one point and they had 13 comments total on their last 10 posts. That's not a lot to monitor.

Check out this post to get a better idea of how many posts you'll actually have to review if you're talking about third party sites and how much work it'll take. I think you'll see that it's quite manageable: http://www.doseofdigital.com/2009/12/monitoring…

Also, check out my recent post that includes commentary from one pharma brand manager regarding YouTube comments and how they manage them including the total number and number of AEs: http://www.doseofdigital.com/2010/07/pharma-suc…

Hope this helps. If not, click the Contact link at the top of the page to get in touch with me to discuss.

]]> By: Jonathan Richman http://www.doseofdigital.com/2009/11/166-reportable-adverse-events-equals-one-red-herring/#comment-8938 Jonathan Richman Thu, 12 Aug 2010 17:40:36 +0000 http://www.doseofdigital.com/?p=1716#comment-8938 Good question. First, just for clarity and to make sure I get what you're asking, 1 in 500 posts will have all four of the criteria to be considered "reportable" by the FDA. You said "will have a response" a few times and wanted to clarify what you meant. I'm assuming you mean "are reportable." That said...<br><br>First, if you don't monitor every site out there (or however many your monitoring tools actually cover), then you really won't have to worry about sifting through comments about your brand because you won't see them. That's obvious. Now when it comes to your own sites, that's a different story. You're absolutely responsible for monitoring and reporting on the sites you own. You can't argue that you didn't see a comment with an AE on your own website. Having said that, I wouldn't worry too much about the volume. The vast majority of pharma-controlled sites don't have any comments from anyone. They just aren't that well trafficked and people are talking about these products on third party sites. Take the JNJBTW blog, for example, I looked at their blog at one point and they had 13 comments total on their last 10 posts. That's not a lot to monitor. <br><br>Check out this post to get a better idea of how many posts you'll actually have to review if you're talking about third party sites and how much work it'll take. I think you'll see that it's quite manageable: <a href="http://www.doseofdigital.com/2009/12/monitoring-adverse-events-social-media-pharmas-biggest-brands/" rel="nofollow">http://www.doseofdigital.com/2009/12/monitoring...</a><br><br>Also, check out my recent post that includes commentary from one pharma brand manager regarding YouTube comments and how they manage them including the total number and number of AEs: <a href="http://www.doseofdigital.com/2010/07/pharma-successfully-manages-youtube/" rel="nofollow">http://www.doseofdigital.com/2010/07/pharma-suc...</a><br><br>Hope this helps. If not, click the Contact link at the top of the page to get in touch with me to discuss. Good question. First, just for clarity and to make sure I get what you're asking, 1 in 500 posts will have all four of the criteria to be considered “reportable” by the FDA. You said “will have a response” a few times and wanted to clarify what you meant. I'm assuming you mean “are reportable.” That said…

First, if you don't monitor every site out there (or however many your monitoring tools actually cover), then you really won't have to worry about sifting through comments about your brand because you won't see them. That's obvious. Now when it comes to your own sites, that's a different story. You're absolutely responsible for monitoring and reporting on the sites you own. You can't argue that you didn't see a comment with an AE on your own website. Having said that, I wouldn't worry too much about the volume. The vast majority of pharma-controlled sites don't have any comments from anyone. They just aren't that well trafficked and people are talking about these products on third party sites. Take the JNJBTW blog, for example, I looked at their blog at one point and they had 13 comments total on their last 10 posts. That's not a lot to monitor.

Check out this post to get a better idea of how many posts you'll actually have to review if you're talking about third party sites and how much work it'll take. I think you'll see that it's quite manageable: http://www.doseofdigital.com/2009/12/monitoring…

Also, check out my recent post that includes commentary from one pharma brand manager regarding YouTube comments and how they manage them including the total number and number of AEs: http://www.doseofdigital.com/2010/07/pharma-suc…

Hope this helps. If not, click the Contact link at the top of the page to get in touch with me to discuss.

]]> By: Matthew http://www.doseofdigital.com/2009/11/166-reportable-adverse-events-equals-one-red-herring/#comment-8935 Matthew Thu, 12 Aug 2010 00:00:28 +0000 http://www.doseofdigital.com/?p=1716#comment-8935 My concern isn't AEs being reported it is having to monitor for that one in 500 posts. If it's my site, or my fan page, or my channel, or I'm sponsoring it, that (in the opinion of my legal counsel) makes it my responsibility if someone reports something (as opposed to a random comment on a blog where I had no expectation of seeing it). So while it may be true that only 1 in 500 posts will have a response, that doesn't mean that I don't have to have someone reading all 500 and making that judgment call . . .or does it? My concern isn't AEs being reported it is having to monitor for that one in 500 posts. If it's my site, or my fan page, or my channel, or I'm sponsoring it, that (in the opinion of my legal counsel) makes it my responsibility if someone reports something (as opposed to a random comment on a blog where I had no expectation of seeing it). So while it may be true that only 1 in 500 posts will have a response, that doesn't mean that I don't have to have someone reading all 500 and making that judgment call . . .or does it?

]]> By: The Beginner's Guide to Pharma Social Media | Dose of Digital - Digital Marketing in Pharma and Healthcare http://www.doseofdigital.com/2009/11/166-reportable-adverse-events-equals-one-red-herring/#comment-8291 The Beginner's Guide to Pharma Social Media | Dose of Digital - Digital Marketing in Pharma and Healthcare Thu, 01 Jul 2010 12:44:44 +0000 http://www.doseofdigital.com/?p=1716#comment-8291 [...] [...] [...] [...]

]]> By: Strategic Marketing Solutions » Using Social Media Tools in a Regulated Industry http://www.doseofdigital.com/2009/11/166-reportable-adverse-events-equals-one-red-herring/#comment-7620 Strategic Marketing Solutions » Using Social Media Tools in a Regulated Industry Fri, 14 May 2010 15:43:27 +0000 http://www.doseofdigital.com/?p=1716#comment-7620 [...] [...] [...] [...]

]]> By: Top three reasons why Biotech Companies should use Social Media « The RIC Blog http://www.doseofdigital.com/2009/11/166-reportable-adverse-events-equals-one-red-herring/#comment-3556 Top three reasons why Biotech Companies should use Social Media « The RIC Blog Thu, 17 Dec 2009 11:28:28 +0000 http://www.doseofdigital.com/?p=1716#comment-3556 [...] [...] [...] [...]

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