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Friday, September 25, 2009

Uncertainties Regarding Reporting Adverse Events Found on Social Media Sites: Survey Says...

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?
The survey asks respondents to choose one or more of the following responses (and/or add additional comments):
  • Usually, there is uncertainty regarding the true identity of the reporter (anonymous source)
  • Usually, there is uncertainty regarding the true identity of the patient (no patient named)
  • Usually, there is uncertainty regarding the identity of the drug (eg, reporter refers to "sleep pill" rather than brand name of drug)
  • Usually, there is uncertainty regarding the seriousness of the event reported
  • None of the above
The image below shows how respondents answered this question.


AE Reporting Uncertainties




WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more preliminary results here.

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