Công văn 14167/QLD-ĐK năm 2015 về cập nhật thông tin dược lý đối với thuốc chứa docetaxel do Cục Quản lý Dược ban hành

On October 29, 2014, the Drug Administration issued the Official Dispatch no. 18443/QLD-TT to warn health workers about the risk of ethanol poisoning which involves the use of docetaxel (for cancer treatment) containing ethanol, which helps dissolve active ingredients in order to be used intravenously, may cause patients to have symptoms of ethanol poisoning or to feel drunk during and after treatment.

Following this, the US Food and Drug Administration (FDA) has required that producers of docetaxel containing ethanol must include the warning of the risk of ethanol poisoning in the package inserts. Pursuant to the conclusion of the Drug Registration Board - Ministry of Health towards docetaxel containing ethanol; in order to ensure the using purpose of docetaxel in a reasonable, safe and effective way, below are instructions from Drug Administration:

I. Responsibilities of departments of health of provinces and central-affiliated cities and hospitals, institutions having patient beds under the management of the Ministry of Health:

Keep informing all local medical facilities, and medicine traders about recommendations of FDA stated in the Official Dispatch no. 18443/QLD-TT dated October 29, 2014 of the Drug Administration; intensify the monitoring of adverse effects of docetaxel when in use and in circulation; send the ADR report (if any) to the National Drug Information and Adverse Drug Reaction Monitoring Centre (DI & ADR Centre) (13-15 Le Thanh Tong, Hanoi) or Local Drug Information and Adverse Drug Reaction Monitoring Centre  in HCMC (201B Nguyen Chi Thanh, District 5, HCMC).

II. Responsibilities of companies that register or produce docetaxel:

1. Regarding docetaxel containing ethanol licensed to be freely sold in the market

Within 03 months from the day on which this Official Dispatch is signed, these companies must update on the package inserts as follows:

Add information about the content of ethanol in the drug where suitable.

1.2. Add the following information in the “Thận trọng và cảnh báo” (Warning and Caution):

“This drug contains ethanol: reported poisoning relating to some docetaxel products due to ethanol therein. The content of ethanol in an injection of docetaxel may affect on the central nervous system and it should be taken into account when prescribing docetaxel for patients in whom alcohol intake should be avoided or minimized. Take into consideration the content of ethanol in docetaxel injections regarding the abilities to drive or operate machinery immediately after injection."

1.3. Instructions on information update are provided in clause 4 article 9 in the Circular no. 44/2014/TT-BYT dated November 25, 2014 of the Ministry of Health providing on medicine registration.

2. Regarding docetaxel containing ethanol for which applications are yet to be approved

The Drug Administration will only issue the registration number after the applicants have submitted documents about addition of pharmaceutical information stated in point II.1.1 and II.1.2 of this Official Dispatch and such information is verified and accepted.

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