{"id":6995,"date":"2009-09-25T15:04:00","date_gmt":"2009-09-25T15:04:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/uncertainties-regarding-reporting\/"},"modified":"2019-02-21T01:22:34","modified_gmt":"2019-02-21T01:22:34","slug":"uncertainties-regarding-reporting","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/uncertainties-regarding-reporting\/","title":{"rendered":"Uncertainties Regarding Reporting Adverse Events Found on Social Media Sites: Survey Says&#8230;"},"content":{"rendered":"<p>In preparation for FDA&#8217;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 &#8220;<a href=\"http:\/\/pharma-mkting.com\/blog\/2009\/09\/lets-respond-to-fdas-questions.html\">Let&#8217;s Respond to FDA&#8217;s Questions Regarding Its Regulation of Social Media<\/a>&#8220;). These questions are included in my ongong online survey\/questionnaire, which you can access <a href=\"http:\/\/www.surveymonkey.com\/s.aspx?sm=8z8Z5WIRtwRusyTPCE4UIw_3d_3d\">here<\/a>.<\/p>\n<p>I am following the results of this survey closely and will provide updates. Here, I focus on this question:<\/p>\n<p>What <b>uncertainties<\/b> are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?<\/p>\n<p>The survey asks respondents to choose one or more of the following responses (and\/or add additional comments):<\/p>\n<ul>\n<li>Usually, there is uncertainty regarding the true identity of the reporter (anonymous source) <\/li>\n<li>Usually, there is uncertainty regarding the true identity of the patient (no patient named) <\/li>\n<li>Usually, there is uncertainty regarding the identity of the drug (eg, reporter refers to &#8220;sleep pill&#8221; rather than brand name of drug) <\/li>\n<li>Usually, there is uncertainty regarding the seriousness of the event reported <\/li>\n<li>None of the above<\/li>\n<\/ul>\n<p>The image below shows how respondents answered this question. <\/p>\n<p>\n<img loading=\"lazy\" decoding=\"async\" alt=\"AE Reporting Uncertainties\" height=\"325\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/fdaSM_AE_UncertaintiesChart.jpg\" width=\"500\" \/><\/p>\n<p><a href=\"http:\/\/bit.ly\/dhsqes\" track=\"on\"><img loading=\"lazy\" decoding=\"async\" alt=\"WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media\" border=\"0\" height=\"91\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/banners\/FDAQuestionsSurvey_Banner-528x91.jpg\" width=\"528\" \/><\/a><br \/>\n<a href=\"http:\/\/bit.ly\/dhsqes\">SPECIAL REPORT: FDA Regulation of Social Media<\/a><\/p>\n<p>Find links to more preliminary results <a href=\"http:\/\/www.surveys.pharma-mkting.com\/fdaSMsurvey.htm#Resources\">here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In preparation for FDA&#8217;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 &#8220;Let&#8217;s Respond to FDA&#8217;s Questions Regarding Its Regulation of Social Media&#8220;). These questions are included in my ongong online survey\/questionnaire, which [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":13101,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[112,44,182],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Uncertainties Regarding Reporting Adverse Events Found on Social Media Sites: Survey Says... - Pharma Marketing Network<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/uncertainties-regarding-reporting\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Uncertainties Regarding Reporting Adverse Events Found on Social Media Sites: Survey Says... - Pharma Marketing Network\" \/>\n<meta property=\"og:description\" content=\"In preparation for FDA&#8217;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 &#8220;Let&#8217;s Respond to FDA&#8217;s Questions Regarding Its Regulation of Social Media&#8220;). These questions are included in my ongong online survey\/questionnaire, which [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/uncertainties-regarding-reporting\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Marketing Network\" \/>\n<meta property=\"article:published_time\" content=\"2009-09-25T15:04:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2019-02-21T01:22:34+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/03\/pmn-logo-intro-post-1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"744\" \/>\n\t<meta property=\"og:image:height\" content=\"419\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Pharma Guy\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Pharma Guy\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/uncertainties-regarding-reporting\/\",\"url\":\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/uncertainties-regarding-reporting\/\",\"name\":\"Uncertainties Regarding Reporting Adverse Events Found on Social Media Sites: Survey Says... - 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