藥物警訊

Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors

AUDIENCE: Infectious Disease, Pharmacy

ISSUE: FDA is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active ingredients (i.e., 2.5 gram). To prevent medication errors, FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.

Since Avycaz's approval in February 2015, FDA received reports of three medication error cases related to confusion on how the strength was displayed on the Avycaz vial and carton labels. Two cases stated that the errors occurred during preparation of the dose in the pharmacy. The third case described concern about the potential for confusion because the strength displayed for Avycaz differs from how the strength is displayed for other beta-lactam/beta-lactamase drugs. Based on the information provided in the reports, FDA is aware that at least one of the patients received a higher-than-intended dose of Avycaz. No adverse events were reported.

BACKGROUND: Avycaz is approved for intravenous administration to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen in patients with limited or no alternative treatment options.

RECOMMENDATION: Due to reports of medication errors associated with Avycaz, the vial and carton labels have been revised to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA發布藥物安全警訊，抗微生物藥品AvycazTM注射劑含有兩種主要成分ceftazidime和 avibactam，其瓶身及外盒之含量標示為將兩種主要成分分開(2 g/0.5 g)，但此藥品之給藥劑量是使用兩種成分之加總(2.5 g)來計算。美國FDA提醒醫療人員應小心勿混淆藥品瓶身或外盒之含量標示，而造成給藥劑量錯誤。

AvycazTM自2015年2月上市以來，美國FDA已接獲3起與給藥劑量相關之用藥錯誤報告。由報告中資訊得知，至少一名病人被給予了超過預期之劑量，目前尚未有副作用案例報告。

AvycazTM為用於治療複雜性泌尿道感染或與metronidazole合併用於不適用其他藥物治療之複雜性腹腔感染。

為了避免再次發生相關錯誤，AvycazTM將更改其標示為：每瓶AvycazTM含有2.5 g，相當於每瓶含有ceftazidime 2 g及avibactam 0.5 g。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

[Posted 09/22/2015]

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