Vietnam: Drug labels must guides the treatment for overdose

Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Ministry of Health of Vietnam provides for information on labels, methods for labeling and package inserts of drugs and medicinal ingredients sold on the market; change of expiry dates of labeled drugs because of national defense and security, epidemic control or disaster recovery need.

A notable content of this Circular is that package insert is an integral part of the drug label and contained in the secondary package. If a drug does not have the secondary package, the package insert must be printed or affixed on the primary package.

Compulsory information on a label of drug or medicinal ingredient and the package insert must be written in Vietnamese language, except for some contents which may be written in other Romance languages.

Labels of controlled medicinal ingredients (including controlled semi-finished drugs): The following texts must be specified on secondary labels of medicinal ingredients which are active ingredients, herbal ingredients or semi-finished drugs containing active ingredients or herbal ingredients on the Lists of narcotic active ingredients, psychotropic ingredients, drug precursors, toxic medicinal ingredients, toxic herbal ingredients and radioactive medicinal ingredients: “Nguyên liệu gây nghiện” (“Narcotic active ingredients”), “Nguyên liệu hướng thần” (“Psychotropic ingredients”), “Nguyên liệu tiền chất làm thuốc” (“Drug precursors"), “Nguyên liệu độc” (“Toxic medicinal ingredients”), “Dược liệu độc” (“Toxic herbal ingredients”) or “Nguyên liệu phóng xạ” (“Radioactive medicinal ingredients”).

Circular No. 01/2018/TT-BYT also specifies the following contents: Presentation of names of drugs and medicinal ingredients; precautions and recommendations; composition of drugs and semi-finished drugs; indications; dose and usage instructions; contraindications; warnings and cautions; using drugs during pregnancy and breastfeeding; influence of the drug on ability to drive or operate machinery; drug interactions and incompatibilities; adverse drug reactions; overdose and treatment; etc.

A notable content is the requirements for information regarding overdose, and treatment therefor. Circular No. 01/2018/TT-BYT requires to specify the symptoms and signs of overdose, in particular, symptoms and signs of acute poisoning and possibility to cause permanent injuries (if any). If the information about drug overdose is unavailable, the text “Không có dữ liệu về sử dụng thuốc quá liều, không dùng quá liều chỉ định của thuốc” (“There is no record of drug overdose. Do not use this medicine in larger amounts than recommended”) shall be specified.

Regarding treatment for overdose, specify the measures or treatment for overdose, including monitoring and using adrenergic agonists, antagonists, antidotes, or enhanced drug excretion. If such information is not available or not sufficient, there must be the text “Tích cực theo dõi để có biện pháp xử trí kịp thời” ("Keep monitoring to respond in time"). Concurrently, provide information for special users such as: elderly people, pregnant and breastfeeding women, children, patients having kidney failure, liver failure, or other diseases (if any).

Circular No. 01/2018/TT-BYT also specifies cases of change of expiry dates of labeled drugs because of national defense and security, epidemic control or disaster recovery need. Specifically, the Minister of Health may decide to change the expiry dates of labeled drugs and stipulate the way to express the expiry date in each specific case on the basis of drug quality, comparison between benefits and risks or lack of domestic supply of drugs.

Circular No. 01/2018/TT-BYT of the Ministry of Health of Vietnam takes effect from June 01, 2018.

Source: Bao Thoi dai Online

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE