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New England Compounding Center (NECC) Potentially Contaminated Medication: Fungal Meningitis Outbreak
AUDIENCE: Surgery, Anesthesia, Neurology, Healthcare Professionals
ISSUE: FDA has observed fungal contamination by direct microscopic examination of foreign matter taken from a sealed vial of methylprednisolone acetate collected from New England Compounding Center (NECC). FDA is in the process of conducting additional microbial testing to confirm the exact species of the fungus.
Investigation into the exact source of the outbreak is still ongoing, but the outbreak is associated with a potentially contaminated medication. That product is preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid produced and distributed by New England Compounding Center (NECC) in Framingham, Massachusetts. CDC’s interim data show that all infected patients received injection with this product.
BACKGROUND: FDA was been working closely with CDC, several state health departments, and the Massachusetts Board of Pharmacy to investigate the scope and cause of the outbreak of fungal meningitis. FDA inspectors in the New England District Office, in cooperation with the Massachusetts Board of Registration in Pharmacy have been conducting an inspection of the New England Compounding Center. The firm voluntarily ceased all operations and surrendered its license to the Massachusetts Board of Registration in Pharmacy on October 3, 2012.
RECOMMENDATION: Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. In addition, FDA requests that health care professionals retain and secure all remaining products purchased from NECC until FDA provides further instructions regarding the disposition of these products.
Although the investigation into the source of the outbreak is still ongoing, if you have purchased a product from NECC, FDA is advising?not to use it at this time. This includes all products compounded and distributed at NECC; not just the ones that have been recalled. Please see the CDC website for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, incliding links to the FDA statement, Q&As, and list of recalled products, at:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm322849.htm
FDA發現由新英格蘭藥品調劑中心(NECC)出產之密封包裝methylprednisolone可能受真菌汙染。FDA將再進行額外的微生物測試確認此真菌的種類。
疫情的確切來源仍在調查中，但此疫情和潛在性的藥物汙染有關。此產品為無添加防腐劑的類固醇注射劑methylprednisolone acetate (80 mg/mL)，由位於美國麻薩諸塞州(Massachusetts)的新英格蘭藥品調劑中心(NECC)配製。美國疾病管制與預防中心(CDC)的臨時數 據顯示，所有被感染的病人皆注射過此藥物。
FDA目前正與CDC、麻州藥政單位一同密切調查爆發真菌性腦膜炎的真正原因。FDA之調查員與麻州藥政單位已開始對NECC進行調查，該公司於2012/10/3已主動停止作業且交出許可證給麻州藥政單位。
謹慎起見，FDA建議醫療機構與消費者目前先不要使用任何由NECC調製的產品。除此之外，FDA請所有醫療機構先保留所有向NECC購買的產品，直到FDA提供有關此產品處置的方式。
雖然此疫情的來源仍在調查中，若有購買任何由NECC調製的產品，FDA建議先暫時不要使用。包含所有由其調劑跟分裝的產品，並非只有被回收的品項。請參閱CDC網站以獲得更多的資訊。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm322849.htm
[Posted 10/05/2012]
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
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資料來源：藥師週刊（第1799期）