{"id":10252,"date":"2025-03-01T14:03:17","date_gmt":"2025-03-01T19:03:17","guid":{"rendered":"https:\/\/www-test.dhss.delaware.gov\/dph\/dhan283\/"},"modified":"2025-09-10T16:17:39","modified_gmt":"2025-09-10T21:17:39","slug":"dhan283","status":"publish","type":"page","link":"https:\/\/www-test.dhss.delaware.gov\/dph\/homepage\/about\/sections\/emsps\/php\/alerts\/alertshan2012\/dhan283\/","title":{"rendered":"Delaware Health Alert Network #283"},"content":{"rendered":"<div data-swiftype-index=\"true\">\n<div id=\"main_header\" class=\"container\">\n<p><!-- BEGIN readspeaker div --><\/p>\n<div id=\"readspeaker_button1\" class=\"rs_skip rsbtn rs_preserve\">\n<p><span class=\"rsbtn_left rsimg rspart\"><span class=\"rsbtn_text\">Listen<\/span><\/span><\/p>\n<\/div>\n<p><!-- END readspeaker div --><\/p>\n<header class=\"pull-left\">\n<h1>Delaware Health Alert Network #<!--[type=EDIT name=\"DHAN Number\"]-->283 <!--[END]--><\/h1>\n<h2><!--[type=EDIT name=\"DHAN Date\"]-->November 5, 2012 8:31 am <!--[END]--><\/h2>\n<\/header>\n<\/div>\n<div class=\"container\">\n<div class=\"row\">\n<div id=\"leftCol\" class=\"col-md-3\">\n<div id=\"accordion\" class=\"panel-group\">\n<div class=\"panel sectionmenu_panel\">\n<div class=\"panel-heading\">\n<p class=\"panel-title\"><a class=\"agency_nav\" href=\"#collapseOne\" data-parent=\"#accordion\" data-toggle=\"collapse\"><strong><i class=\"fa fa-align-justify fa-fw\"><\/i> Public Health Menu<\/strong><\/a><\/p>\n<\/div>\n<div id=\"collapseOne\" class=\"panel-collapse collapse in\">\n<div id=\"clf_nav\" class=\"panel-body\">\n<ul id=\"agency_sidebar\" class=\"nav nav-stacked nav-pills-clf\">\n<li><a href=\"\/dph\/\"><br \/>\n<\/a><\/p>\n<h2>Home <i class=\"fa fa-home fa-fw\"><\/i><\/h2>\n<\/li>\n<li class=\"toplevel\"><a href=\"#HomeMenu\" data-parent=\"#agency_sidebar\" data-toggle=\"collapse\"><br \/>\n<\/a><\/p>\n<h2>About <i class=\"fa fa-caret-right fa-fw\"><\/i><\/h2>\n<ul id=\"HomeMenu\" class=\"panel-collapse collapse\">\n<li><a href=\"\/dph\/about.html\">About DPH<\/a><\/li>\n<li><a href=\"\/dph\/sections.html\">Sections &amp; 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Specifically,<\/p>\n<ol>\n<li>FDA provides list of facilities that received products shipped from the New England Compounding Center (NECC). Visit below forfacilities\u2019 list:\n<p>http:\/\/www.fda.gov\/Safety\/MedWatch\/SafetyInformation\/SafetyAlertsforHumanMedicalProducts\/ucm323946.htm.<\/li>\n<li>CDC Issues Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated SteroidProducts. Please find detailed guidance at: <a href=\"http:\/\/emergency.cdc.gov\/HAN\/han00330.asp\">http:\/\/emergency.cdc.gov\/HAN\/han00330.asp<\/a>.<\/li>\n<\/ol>\n<p>It is important to note that <strong>no facilities in Delaware received the contaminated lots of methylprednisolone acetate (PF) 80mg\/ml<\/strong><\/p>\n<p>(the steroid injection). Facilities in Delaware did receive other products from the New England Compounding Center (NECC) that<\/p>\n<p>are included in the FDA expanded recall.<\/p>\n<p>Background<\/p>\n<p>On October 4, 2012, FDA advised medical professionals that all products produced by NECC should be retained, secured, and withheld from<\/p>\n<p>use. On October 6, NECC announced a voluntary recall of all its products currently in circulation that were compounded at and distributed<\/p>\n<p>from its Framingham, Massachusetts facility. On October 15, 2012, FDA further advised healthcare providers to follow-up with patients who<\/p>\n<p>were administered any NECC injectable product <strong>on or after May 21, 2012<\/strong>, including an ophthalmic drug that is injectable<\/p>\n<p>or used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC.<\/p>\n<ol>\n<li><strong>FDA provides NECC Customer List<br \/>\n<\/strong> FDA made publicly available two lists of facilities that received products that<\/p>\n<p>were shipped on or after May 21, 2012 from NECC\u2019s Framingham, MA facility. The lists were prepared based on information provided<\/p>\n<p>by NECC, and FDA cannot vouch for the completeness or accuracy of the lists. Products shipped by NECC may be missing from the list and<\/p>\n<p>facility information may be incomplete. Nevertheless, this is the best information that FDA has available to help inform facilities and<\/p>\n<p>healthcare providers.<\/p>\n<p>The following is a list of Delaware facilities, publicly released by FDA, that received any NECC products shipped on or after May 21,<\/p>\n<p>2012. The NECC customer lists can be accessed at: <a href=\"https:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/FungalMeningitis\/UCM325467.pdf\">https:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/FungalMeningitis\/UCM325467.pdf<\/a><\/p>\n<p>and <a href=\"https:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/FungalMeningitis\/UCM325466.pdf\">https:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/FungalMeningitis\/UCM325466.pdf<\/a>.<\/p>\n<p>Advanced Eye Care PA<\/p>\n<p>Anesthesia Providers<\/p>\n<p>Bayhealth Medical Center<\/p>\n<p>Beebe Medical Center<\/p>\n<p>Richard Bonder, MD, PA<\/p>\n<p>Christiana Health System<\/p>\n<p>Christiana Spine ASC<\/p>\n<p>Glasgow Medical Center<\/p>\n<p>Lewes Surgery Center<\/p>\n<p>Pain Center of Delaware<\/p>\n<p>St. Francis Hospital<\/li>\n<li><strong>CDC Issues Guidance on Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated<\/strong>\n<p>Steroid Products.<br \/>\nThe information in the CDC health alert below is specific to patients who received epidural and<\/p>\n<p>paraspinal injections with the contaminated recalled lots of methylprednisolone acetate and who are asymptomatic (i.e. showing no signs<\/p>\n<p>or symptoms of disease).<\/p>\n<p>CDC analysis suggests that the period of greatest risk for development of fungal meningitis among patients who received epidural or<\/p>\n<p>paraspinal injections with contaminated products (referring to the 3 contaminated recalled lots of methylprednisolone acetate) is<\/p>\n<p>during the first 6 weeks (42 days) after injection; therefore, additional monitoring of these patients should be considered.<\/p>\n<p>Accordingly, CDC provides guidance for asymptomatic patients who received epidural or paraspinal injections with contaminated steroid<\/p>\n<p>product within the last 6 weeks (42 days), and those who received such products longer than 6 weeks (42 days) ago. For specific details<\/p>\n<p>about the updated guidance, see <a href=\"http:\/\/www.cdc.gov\/hai\/outbreaks\/clinicians\/guidance_asymptomatic_persons.html\">Guidance on<\/a><\/p>\n<p>Management of Asymptomatic Patients Who Received Epidural or Paraspinal Injections with Contaminated Steroid Products (<a href=\"http:\/\/www.cdc.gov\/hai\/outbreaks\/clinicians\/guidance_asymptomatic_persons.html\">http:\/\/www.cdc.gov\/hai\/outbreaks\/clinicians\/guidance_asymptomatic_persons.html<\/a>).<\/p>\n<p>CDC does <strong>not<\/strong> recommend initiation of antifungal treatment in the absence of diagnostic test results indicating fungal<\/p>\n<p>meningitis in exposed patients who are asymptomatic. Currently available data do not suggest an added benefit to this approach in<\/p>\n<p>comparison to the strategies outlined in the updated guidance, and patients may experience serious adverse drug events associated with<\/p>\n<p>treatment.<\/li>\n<\/ol>\n<p>Recommendations<\/p>\n<ol>\n<li>FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditionsare met:\n<p>-The medication was an injectable product purchased from or produced by NECC<strong>,<\/strong> including an ophthalmic drug that is<\/p>\n<p>injectable or used in conjunction with eye surgery, or a cardioplegic solution,<\/p>\n<p>-The medication was <strong>shipped by NECC on or after May 21, 2012<\/strong>, and<\/p>\n<p>-The medication was administered to patients on or after May 21, 2012.<\/li>\n<li><strong>Advice to NECC Customers<\/strong>\n<p>Customers identified on these lists should check their stocks to identify whether they have any products from the New England<\/p>\n<p>Compounding Center (NECC), and they should immediately isolate any identified product from their drug supplies. All NECC products are<\/p>\n<p>subject to voluntary recall. Customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain<\/p>\n<p>instructions on how to return products to NECC.<\/li>\n<li><strong>Advice to Patients<\/strong>\n<p>Patients who believe they received an injection or other product that was shipped <strong>by NECC on or after May 21, 2012<\/strong><\/p>\n<p>should remain vigilant for the signs and symptoms of infection, and contact their health care provider if they are concerned. The<\/p>\n<p>meningitis outbreak has occurred in patients who received injections near the spine (back or neck). The signs and symptoms of<\/p>\n<p>meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status.<\/p>\n<p>Symptoms for infections following other types of injections at other body sites may vary, and are not limited to meningitis. Other<\/p>\n<p>possible infections at other parts of the body (e.g., peripheral joints) may include fever; swelling, increasing pain, redness, warmth<\/p>\n<p>at an injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site<\/p>\n<p>(infection within the chest).Patients should contact their healthcare provider if they have any of these signs or symptoms.<\/p>\n<p>Patients who received an NECC product prior to May 21, 2012 and who have not experiencing symptoms of infection to date are at less<\/p>\n<p>risk of infection because of the amount of time that has elapsed since that date. FDA is not recommending these patients follow-up with<\/p>\n<p>their healthcare providers unless they are experiencing symptoms of infection.<\/li>\n<li><strong>Advice to Healthcare Professionals<\/strong>\n<p>FDA advises healthcare professionals to follow-up with patients who have been administered an injectable product <strong>shipped by<\/strong><\/p>\n<p>NECC on or after May 21, 2012, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a<\/p>\n<p>cardioplegic solution. FDA does not urge patient follow-up at this time for NECC products of lower risk such as topicals (for example,<\/p>\n<p>lotions, creams, eyedrops not used in conjunction with surgery) and suppositories, or for patients who may have received an NECC<\/p>\n<p>product in these categories before May 21, 2012. Patients who received an NECC product prior to May 21, 2012 and who have not<\/p>\n<p>experienced symptoms of infection to date are at less risk of infection because of the amount of time that has elapsed since that date.<\/p>\n<p>FDA is not recommending that healthcare providers follow-up with these patients unless they have reported symptoms of infection.<\/p>\n<p>Health care professionals should retain and secure all remaining products purchased from NECC. All NECC products are subject to<\/p>\n<p>voluntary recall. Clinics or customers with product on hand should contact NECC at 1-800-994-6322 or via fax at 508-820-1616 to obtain<\/p>\n<p>instructions on how to return products to NECC.<\/p>\n<p>Clinicians and patients are also requested to report any suspected adverse events following use of these products to FDA\u2019s<\/p>\n<p>MedWatch program at <strong>1-800-332-1088<\/strong> or <a href=\"http:\/\/www.fda.gov\/medwatch\">www.fda.gov\/medwatch<\/a>.<\/li>\n<\/ol>\n<p>Additional Information<\/p>\n<ul>\n<li><a href=\"http:\/\/www.cdc.gov\/hai\/outbreaks\/meningitis.html\">Multistate Fungal Meningitis Outbreak Investigation<\/a> (<a href=\"http:\/\/www.cdc.gov\/hai\/outbreaks\/meningitis.html\">http:\/\/www.cdc.gov\/hai\/outbreaks\/meningitis.html<\/a>)<\/li>\n<li><a href=\"http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/mm61e1012a1.htm?s_cid=mm61e1012a1_w\">MMWR Early Release: Multistate Outbreak of<\/a>\n<p>Fungal Infection Associated with Injection of Methylprednisolone Acetate Solution from a Single Compounding Pharmacy \u2014 United<\/p>\n<p>States, 2012. <span style=\"text-decoration: underline;\">(<\/span> <a href=\"http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/mm61e1012a1.htm?s_cid=mm61e1012a1_w\">http:\/\/www.cdc.gov\/mmwr\/preview\/mmwrhtml\/mm61e1012a1.htm?s_cid=mm61e1012a1_w<\/a><\/p>\n<p><span style=\"text-decoration: underline;\">)<\/span><\/li>\n<li><a href=\"http:\/\/www.bt.cdc.gov\/HAN\/han00328.asp\">CDC HAN Advisory: Update: Multistate Outbreak of Meningitis and Stroke Associated with<\/a>\n<p>Potentially Contaminated Steroid Medication (<a href=\"http:\/\/www.bt.cdc.gov\/HAN\/han00328.asp\">http:\/\/www.bt.cdc.gov\/HAN\/han00328.asp<\/a>)<\/li>\n<li><a href=\"http:\/\/www.cdc.gov\/fungal\/\">CDC Website on Fungal Diseases<\/a> (<a href=\"http:\/\/www.cdc.gov\/fungal\/\">http:\/\/www.cdc.gov\/fungal\/<\/a>)<\/li>\n<li><a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm322734.htm\">FDA Statement on Fungal Meningitis Outbreak<\/a> (<a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm322734.htm\">http:\/\/www.fda.gov\/Drugs\/DrugSafety\/ucm322734.htm<\/a>)<\/li>\n<li>Delaware Division of Public Health, Bureau of Epidemiology (24\/7): 1-888-295-5156<\/li>\n<li>Delaware Division of Public Health Webpage on meningitis: <a href=\"\/wp-content\/uploads\/sites\/12\/dph\/pdf\/meningocfaq.pdf\">http:\/\/dhss.delaware.gov\/dph\/files\/meningocfaq.pdf<\/a><\/li>\n<\/ul>\n<p>***************<\/p>\n<p>You are receiving this message because you are a registered member of the Delaware Health Alert Network. If you are not a member and<\/p>\n<p>would like to subscribe, please register at <a href=\"https:\/\/healthalertde.org\">https:\/\/healthalertde.org<\/a><\/p>\n<p><!--[END]--><\/p>\n<div class=\"panel panel-danger\">\n<div class=\"panel-heading\">\n<h2>Categories of Health Alert messages:<\/h2>\n<\/div>\n<div class=\"panel-body\">\n<ul>\n<li><strong>Health Alert:<\/strong> Conveys the highest level of importance; warrants immediate action or attention.<\/li>\n<li><strong>Health Advisory:<\/strong> Provides important information for a specific incident or situation; may not require immediate action.<\/li>\n<li><strong>Health Update:<\/strong> Provides updated information regarding an incident or situation; unlikely to require immediate action.<\/li>\n<\/ul>\n<div><strong>NOTE: This page is for informational purposes only and dated material (e.g. temporary websites) may not be available.<\/strong><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p><!-- \/container --><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Listen Delaware Health Alert Network #283 November 5, 2012 8:31 am Public Health Menu Home About About DPH Sections &amp; Programs Office Locations Contact Info Calendar Services A-Z Services Air &amp; Water Quality Birth, Death, &amp; Marriage Records Clinics Health Data &amp; Statistics Emergency Preparedness Health &amp; Wellness Healthy Homes Healthy Workplaces Laboratory Restaurant Inspections [&hellip;]<\/p>\n","protected":false},"author":9,"featured_media":0,"parent":10494,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-10252","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www-test.dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10252","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www-test.dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www-test.dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www-test.dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/www-test.dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/comments?post=10252"}],"version-history":[{"count":21,"href":"https:\/\/www-test.dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10252\/revisions"}],"predecessor-version":[{"id":28097,"href":"https:\/\/www-test.dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10252\/revisions\/28097"}],"up":[{"embeddable":true,"href":"https:\/\/www-test.dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10494"}],"wp:attachment":[{"href":"https:\/\/www-test.dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/media?parent=10252"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}