{"id":5698,"date":"2017-03-20T17:53:00","date_gmt":"2017-03-20T17:53:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/how-many-adverse-event-reports-are\/"},"modified":"2019-02-21T01:14:39","modified_gmt":"2019-02-21T01:14:39","slug":"how-many-adverse-event-reports-are","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/how-many-adverse-event-reports-are\/","title":{"rendered":"How Many Adverse Event Reports Are Submitted to the FDA? Whatever the Answer, It&#8217;s at an All-Time High!"},"content":{"rendered":"<p>I&#8217;ve been tracking the number of adverse event reports (AERs) submitted to the FDA over the years based on data supplied by the FDA <a href=\"http:\/\/bit.ly\/6mK0y\">here<\/a>. The latest update of that data was made in November 2015 showing the number of AERs FDA received in the first quarter (Q1) of 2015.<\/p>\n<p>If you assume that the submission rate seen in Q1 of 2015 remained constant throughout the year, you get the following trend chart based on FDA&#8217;s summary data table:<\/p>\n<table align=\"center\" cellpadding=\"0\" cellspacing=\"0\" class=\"tr-caption-container\" style=\"margin-left: auto; margin-right: auto; text-align: center;\">\n<tbody>\n<tr>\n<td style=\"text-align: center;\"><a href=\"https:\/\/2.bp.blogspot.com\/-Y1-2NLkU_S4\/WNARgHnKrjI\/AAAAAAAAJFo\/FQKTmLWPw34X7_YE4NmhqrBNpVeIQfGuQCLcB\/s1600\/AE-Reports-Trend.jpg\" imageanchor=\"1\" style=\"margin-left: auto; margin-right: auto;\"><img loading=\"lazy\" decoding=\"async\" border=\"0\" height=\"455\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2017\/03\/AE-Reports-Trend-1.jpg\" width=\"500\" \/><\/a><\/td>\n<\/tr>\n<tr>\n<td class=\"tr-caption\" style=\"text-align: center;\">Click on image for enlarged view.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>According this analysis, about 2.25 million AERs were submitted by healthcare professionals (HCPs) and consumers in 2015. An analysis by the <i>Milwaukee Journal Sentinel<\/i> and <i>MedPage Today<\/i>, however, yields drastically different numbers.<\/p>\n<p><a name='more'><\/a>According to that analysis only 1.19 million AERs were submitted to the FDA in 2015 (see embedded story at the end of this post). That&#8217;s only half of what I find based on my analysis.<\/p>\n<p>Perhaps the <i>Sentinel<\/i> analysis is only looking at reports submitted by HCPs, which would make its results jibe with my estimate. However, the <i>Sentinel<\/i> says there were 206,000 AERs submitted in 2006. FDA data on the page I cite at the beginning of this post indicates that there were 311,156 AERs submitted by HCPs <i>and<\/i> consumers in 2006 (184,238 of these were submitted by HCPs).<\/p>\n<p>I&#8217;m not sure why there is this discrepancy. Perhaps the <i>Sentinel<\/i> analyzed the raw quaterly data files found <a href=\"https:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/Surveillance\/AdverseDrugEffects\/ucm082193.htm\">here<\/a>. But that doesn&#8217;t make sense because 2016 data are available on that page, but the Sentinel said &#8220;Numbers aren\u2019t final for 2016,&#8221; which implies it did not use the quarterly data.<\/p>\n<p>Whatever! Adverse event reporting is at an all-time high and growing.<\/p>\n<p>\u201cWe are concerned,\u201d said Michael Carome, deputy director of Public Citizen\u2019s Health Research Group. \u201cIt reflects that the FDA has allowed drugs to come to market without adequately ensuring safety.\u201d<\/p>\n<div id=\"scoopit-container-4076701982\">\n<a href=\"http:\/\/www.scoop.it\/t\/pharmaguyevents\/p\/4076701982\/2017\/03\/20\/more-than-1-million-adverse-event-reports-were-sent-to-fda-in-2015-only-the-tip-of-the-iceberg\">More Than 1 Million Adverse Event Reports Were Sent to FDA in 2015 \u2013 Only the Tip of the Iceberg<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>I&#8217;ve been tracking the number of adverse event reports (AERs) submitted to the FDA over the years based on data supplied by the FDA here. The latest update of that data was made in November 2015 showing the number of AERs FDA received in the first quarter (Q1) of 2015. If you assume that the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":12333,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[112,113,44,128],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How Many Adverse Event Reports Are Submitted to the FDA? 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