|
Fungal Meningitis Outbreak
FDA provides NECC Customer List
FDA is making available two lists of customers (consignees) who received products that were shipped on or after May 21, 2012 from New England Compounding Center's Framingham, MA facility. The first list includes customer names and addresses, organized by state. The second list contains the same basic information as the first list, but is organized alphabetically by customer name and also includes the specific products shipped, the quantities of product shipped, and the shipping date. The lists were prepared based on information provided 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 facility information may be incomplete. Nevertheless, this is the best information we have available, at this time, to help inform facilities and healthcare providers of NECC products shipped to their facilities since May 21, 2012.
FDA is reiterating and updating its previous recommendation that follow-up with patients be done when the following three conditions are met:
* The medication was an injectable product purchased from or produced by NECC, including an ophthalmic drug that is injectable or used in conjunction with eye surgery, or a cardioplegic solution,
* The medication was shipped by NECC on or after May 21, 2012, and
* The medication was administered to patients on or after May 21, 2012.
Since the May 21, 2012 date is the date the first of three lots of methylprednisolone acetate implicated in the current outbreak was produced, products produced and shipped by NECC on or after May 21, 2012 are believed at this time to be of greatest risk of contamination. Now that we have shipping information available, we are updating FDA's recommendation to health care providers so that they can focus their attention on following up with the patients who are believed to be at greatest risk of receiving a contaminated product.
Read the MedWatch Safety Alert, including links to the FDA update and the NECC Customer Lists, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm
FDA已建立兩份收到NECC於2012/5/21之後出貨的產品之承銷人清單。
第一份清單包含承銷人姓名和地址，以州劃分。第二份清單基本上跟第一份的內容相同，但為按承銷人姓名的字母順序排列，也包含了個別的出貨產品、數量及日期。
此清單由NECC提供，FDA無法確保其完整性與正確性，可能會有漏列之情況且機構資訊也許不完整。
儘管如此，此為目前可用之最佳資訊來幫助醫療機構了解哪些為自2012年5月21日(含)之後出貨到該機構之NECC產品。
FDA重申和更新之前的建議，當病人符合以下三項條件時需密切觀察：1. 藥品為向NECC購買或由其調製之注射劑，包含可用於注射或眼部手術中配合使用之眼用藥品，或心臟麻痺溶液。2. 此藥品為NECC於2012年5月21日(含)以後出貨之產品。3. 病人於2012年5月21日(含)以後使用此藥品。
因2012年5月21日為最先被認為與近期發生之感染有關連之三批methylprednisolone acetate的製造日期，由此之後NECC出貨之產品皆被認為具有相當大的汙染風險。
目前我們已可取得相關出貨資訊，將更新FDA之前之建議以便醫療機構密切注意這些可能已使用了疑似受汙染之產品的病人。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm323946.htm
[Posted 10/22/2012]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
|
資料來源：藥師週刊（第1802期）
