Decision No. 03/2005/QD-BYT on issuing the List of Main Medicines for Use at Medical Examination and Treatment Facilities

DECISION OF THE MINISTER OF HEALTH

Regarding the issuance of the List of Main Medicines for Medical Treatment

primarily used at medical examination and treatment facilities

THE MINISTER OF HEALTH

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Treatment Department, the Director of the Traditional Medicine Department, and the Director of the Vietnam Drug Administration,

DECISION:

Article 1. Now hereby promulgating with this Decision the List of Main Medicines for Medical Treatment primarily used at medical examination and treatment facilities, including the following main contents:

1. Objectives, principles for selecting medicines and regulations on using the List of Medicines

2. The List of Medicines includes:

- The List of Modern Medicines

- The List of Traditional Medicines

Article 2. The List of Main Medicines for Medical Treatment primarily used at medical examination and treatment facilities serves as a legal basis for:

1. Medical examination and treatment facilities to select and build specific Lists of Medicines for their units; Ensuring adequate supply of quality medicines and rational use of medicines;

2. Social Insurance to pay medicine costs for patients participating in Health Insurance according to the Government's Health Insurance Regulations.

Article 3. This Decision takes effect 15 days from the date of publication in the Official Gazette. All previous provisions contrary to this Decision shall be abolished.

Article 4. You, Mr./Mrs.: Director of the Office, Director of the Treatment Department, Director of the Traditional Medicine Department, Director of the Vietnam Drug Administration, relevant Departments of the Ministry of Health, Health Inspectorate; Directors of Provincial/Municipal Health Services under the Central Government, health sectors, and hospitals and institutes with beds directly under the Ministry of Health are responsible for implementing this Decision./.

LIST OF MAIN MEDICINES FOR MEDICAL TREATMENT

USED AT MEDICAL EXAMINATION AND TREATMENT FACILITIES

(Issued together with Decision No. 03/2005/QĐ-BYT dated January 24, 2005)

I. Objectives, Principles for Selecting Medicines and Regulations on Using the List

1.1. Objectives

- Ensuring rational use of medicines (including safety and efficacy);

- Meeting treatment requirements for patients;

- Ensuring patients' rights to medical treatment medicines who participate in Health Insurance;

- Being appropriate to patients' economic capacity and Health Insurance fund payment capacity.

1.2. Principles for Selecting Medicines in the List

Main medicines for medical treatment primarily used at medical examination and treatment facilities are selected based on the following principles:

1.2.1. Medicines ensuring therapeutic effectiveness and safety

- The main list is built on the basis of the current Essential Medicines List of Vietnam and the World Health Organization;

- Medicines must have clear efficacy in treatment (based on scientific and medical evidence);

- Medicines must be approved for circulation in Vietnam (having valid registration numbers, being approved) and frequently used at medical examination and treatment facilities;

- Not included in the list: Medicines recommended not to be used by the World Health Organization. Outdated medicines that many countries do not use. Medicines used abroad but not widely used in Vietnam;

- For Traditional Medicines, additional criteria include: Prioritizing medicines produced in Vietnam; traditional formulas and those with long-standing reputation on the market; medicines with formulas in the Vietnamese Pharmacopoeia. Medicines maintaining traditional preparation methods while ensuring suitable forms for use, storage, and distribution.

1.2.2. Medicines being appropriate to patients' payment capacity and Health Insurance fund. Medicines having a reasonable balance between treatment efficacy and cost.

1.2.3. Names of medicines in the list

- For modern medicines: Generic names (generic Name); Prioritizing original generic drugs (generic Drug is off-patent), single-component drugs, domestically-produced drugs meeting quality standards, and drugs from domestic pharmaceutical companies meeting Good Manufacturing Practice (GMP) standards;

- For Traditional Medicines: Formulations named after traditional prescriptions and common names; Specific names for formulations without common names. Names of medicinal ingredients and their scientific names follow the Vietnamese Pharmacopoeia.

1.3. Regulations on Using the List

The List of Main Medicines for Medical Treatment primarily used at medical examination and treatment facilities is applicable to hospitals (including those with beds under the Ministry), multi-specialty clinics, and healthcare facilities with doctors. Healthcare facilities without doctors use the current Essential Medicines List.

1.3.1. Medicines in the List

- For modern medicines: Using medicines according to hospital classification regulations; Specialty medicines are used according to management levels and medical practice guidelines;

- Special medicines for leprosy, mental illness, epilepsy, infertility, and vaccines not listed here are used according to program guidelines;

- For Traditional Medicines, they are used across all levels of medical examination and treatment;

- Consultation required when using the following medicines:

+ Modern Medicines List: Medicines marked with (*) are reserve and restricted use medicines. They can only be used when other medicines in the group are ineffective and require consultation;

+ Traditional Medicines List: Ginseng, Lingzhi-San preparations.

1.3.2. Medicines outside the List

- Permission granted to use specialty medicines of assured quality prepared by hospitals;

- For modern medicines: Combination medicines may be used if they are permitted for circulation and all single components are listed;

- For Traditional Medicines: Substitute formulations may be used if they have valid registration numbers, similar formulas, or similar functions to the medicines needed to replace them in the list.

1.3.3. Selection of specific finished product names for use in hospitals

- Based on this List of Medicines, and taking into account the disease profile and budget of the hospital (including state budget, part of hospital fees, and Health Insurance), the hospital director selects specific finished product names of medicines according to the aforementioned principles to serve medical examination and treatment at the hospital (encouraging the use of medicines from domestic manufacturers meeting Good Manufacturing Practice (GMP) standards).

- The hospital director coordinates with the director of the Social Insurance agency to settle the drug costs for patients participating in health insurance (including drugs from programs, if the hospital has not been supplied drugs by the program).

2. Drug List

2.1. List of New Drugs

- The list of new drugs includes 646 drugs;

- Drugs are arranged according to the ATC classification (Anatomical-Therapeutic-Chemical);

- The drug list consists of six columns: I, II, III, IV, V, VI. The contents of each column are as follows:

I. Serial number assigned according to the drug name/active ingredient; for drugs/active ingredients combined with other components, they are numbered a, b, c following the sequence of the drug/active ingredient. For repeated drugs (starting from the second occurrence), no serial number is assigned (to avoid multiple listings of the same drug);

II. Drug name (generic name)/active ingredient;

III. Route of administration, form, dosage, preparation form;

IV. Used in Level 1 and 2 hospitals;

V. Used in Level 3 and ungraded hospitals;

VI. Used in multi-specialty clinics and healthcare facilities with doctors.

- Pain relievers, anti-inflammatory drugs, antibiotics, antiviral drugs, and antifungal drugs are grouped together and not listed separately for each specialty to avoid repetition.

2.2. List of Traditional Medicine Drugs

- The list of prepared traditional medicine drugs includes 91 drugs divided into 11 groups based on the pharmacological effects of the drugs. The list consists of five columns:

I. Serial number of the drug in the list;

II. Serial number of the drug within its group;

III. Drug name (common name for traditional prescriptions and drugs with common names; specific name for drugs without common names);

IV. Preparation form;

V. Route of administration.

- The list of medicinal herbs includes 210 herbs divided into 25 groups based on their pharmacological effects. The list consists of five columns:

I. Serial number;

II. Serial number of the herb in the list;

III. Herb name;

IV. Origin (northern, southern);

V. Scientific name of the plant, animal, or mineral used as medicine.

This list will be amended and supplemented if there are changes in actual drug usage needs./.