藥物警訊（藥師週刊 第1713期）

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental Overdose

AUDIENCE: Pharmacy, Oncology, Pain Management

Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the high potency 100 mg/5mL product. In most of these cases, morphine sulfate oral solutions ordered in milligrams (mg) were mistakenly interchanged for milliliters (mL) of the product. The approval of this product is part of FDA’s unapproved drugs initiative. Prior to the recent approval, Roxane marketed a morphine sulfate oral solution with the strength expressed as 20 mg/mL, using a container label and carton labeling that had brown lettering on a white background. The newly approved product labeling and packaging feature revisions intended to reduce the risk of medication errors.

BACKGROUND: Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for relief of moderate to severe acute and chronic pain in opioid-tolerant patients.

RECOMMENDATION: See Roxane's "Dear Healthcare Professional Letter" for a complete description and photos of labeling and product packaging changes. Changes include:

* A warning stating “ONLY FOR USE IN PATIENTS WHO ARE OPIOID TOLERANT” is displayed in a box to highlight that the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant patients only. The 100 mg per 5 mL concentration of morphine sulfate may cause fatal respiratory depression when administered to patients not previously exposed to opioids.

* The strength is presented as 100 mg per 5 mL followed by a less prominently displayed concentration of (20 mg/mL). The intent of this designation is to help differentiate this product from the 20 mg/5 mL morphine sulfate product.

* A bright yellow background is used on multiple sides of this product to differentiate the morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL) from other morphine sulfate oral solutions marketed by Roxane with a white background.

* The drug name, strength and concentration are displayed in white lettering on a red background as an additional means of differentiating this product from other concentrations of morphine sulfate oral solutions.

* A reminder is presented to the pharmacist to dispense the product to each patient with the enclosed Medication Guide.

* Both the 30 mL and 120 mL bottles of morphine sulfate 100 mg per 5 mL (20 mg/mL) oral solution are packaged with a calibrated oral syringe to provide accurate dose measurements. Healthcare providers should read the instructions in the Medication Guide that describe the correct use of the oral syringe in order to help prevent medication errors from occurring.

* Healthcare providers should discuss the correct use of the oral syringe with their patients.

Read the MedWatch safety alert, including links to the Dear Healthcare Professional Letter and product Prescribing Information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

Roxane實驗室及FDA提醒醫護人員，因morphine sulfate口服液劑意外過量造成的嚴重藥物不良反應事件及死亡，特別是使用高效價100 mg/5 mL的產品，大部份的事件是以mg開方，卻誤以mL給藥，此產品原是FDA未經核准藥物計畫的其中一個品項，在近期核准之前Roxane上市的20 mg/mL morphine sulfate口服液劑，其容器及紙盒外以白底棕色字體標示，而最新核准的產品變更標示及包裝以降低用藥錯誤的風險。

Morphine Sulfate 100 mg/5 mL (20 mg/mL)的口服液劑核准用於耐受鴉片類藥物的病人緩解中至重度急性和慢性的疼痛。產品變更包含下列事項：

* 在外盒標示” 限耐受鴉片類藥物的病人使用”，因為若先前未接受過鴉片類藥品的病人使用濃度100 mg/5 mL的morphine sulfate可能會造成致命性的呼吸抑制。

* 用100 mg/5 mL的標示代替20 mg/mL，以區別20 mg/5 mL的產品。

* 外盒用明亮的黃底取代原本的白底標示，以區別100 mg/5 mL的產品與Roxane其他morphine sulfate的產品。

* 外盒的藥名、強度及濃度以紅底白字標示，以區別其他濃度的morphine sulfate口服液劑。

* 容器標示提醒字樣，以提醒藥師在調劑藥品給每一位病人時應交付用藥指引。

* 30 mL及120 mL瓶裝的morphine sulfate 100 mg/5 mL (20 mg/mL)口服液劑都有附給藥針筒，以精確測量劑量。健康照護者應詳讀用藥指引中口服給藥針筒的正確使用方法以免給藥錯誤。

* 健康照護者也應與病人討論口服給藥針筒的正確使用方法。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

[Posted 01/10/2011]

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