Thông tư 31/2011/TT-BYT

CIRCULAR

ISSUING AND GUIDING THE IMPLEMENTATION OF THE LIST OF ESSENTIAL MEDICINES USED AT MEDICAL FACILITIES AND COVERED BY THE HEALTH INSURANCE FUND.

Pursuant to the Law on Medical examination and treatment dated November 23^rd 2009;

Pursuant to the Law on Pharmacy dated June 14^th 2005; the Government's Decree No. 79/2006/NĐ-CP dated August 09^th 2006, specifying the implementation of a number of articles of the Law on Pharmacy;

Pursuant to the Law on Health insurance dated November 14^th 2008; the Government's Decree No. 62/2009/NĐ-CP dated July 27^th 2009, specifying and guiding the implementation of a number of articles of the Law on Health insurance;

Pursuant to the Government's Decree No. 188/2007/NĐ-CP dated December 27^th 2007, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to the Joint Circular No. 09/2009/TTLT-BYT-BTC dated August 14^th 2009 of the Ministry of Health and the Ministry of Finance, guiding the health insurance;

The Ministry of Health issues and guided the List of essential medicines at medical facilities covered by the health insurance fund (hereinafter referred to as the list of medicines) as follows:

Article 1. Issuing the list of medicines

Promulgated together with this Circular the “List of essential medicines used at medical facilities and covered by health insurance, including:

1. The List of medicines.

2. The List of radiopharmaceuticals and tracers.

Article 2. List structure

1. The list of medicines.

a) The list comprises 900 medicines or active ingredients, sorted by the Anatomical Therapeutic Chemical classification system (ATC code); named according to international names, and in accordance with the Vietnam’s National Pharmacopoeia. An active ingredient that has more than one ATC code or indication shall be classified into the most suitable group to avoid duplication.

b) The medicine list has 8 columns:

- Column 1 indicates ordinal numbers according to the names of medicines or active ingredients;

- Column 2 indicates ordinal numbers of the medicines or active ingredient in the list;

- Column 3 indicates names of medicines and active ingredients;

- Column 4 indicates routes of administration dosage forms

- Column 5 indicates the use for hospitals in special class and 1^st class;

- Column 6 indicates the use for hospitals in 2^nd class;

- Column 7 indicates the use for hospitals in 3^rd class and 4^th class;

- Column 8 indicates the use for private clinics and other medical facilities.

2. The list of radiopharmaceuticals and tracers include 57 active ingredients, named after international names, sort by alphabetical order, and has 5 columns, including:

- Column 1 indicates the ordinal numbers;

- Column 2 indicates the names of radiopharmaceuticals and tracers;

- Column 3 indicates the routes of administration;

- Column 4 indicates the dosage form;

- Column 5 indicates the unit;

Article 3. The use of the medicine list

1.  Medicines.

a) Medicines are used in accordance with the class of hospitals. Specialized medicines are used in accordance with the management decentralization and medicine practice.

b) The medicines marked with (*) are backup drugs, restricted from use. These medicines are only used when other medicines in the group are not effective, and medical consultation is compulsory (except for emergency treatment);

c) The medicines that are used to treat the diseases in another group shall be covered by the health insurance fund if the indication is given as registered in the issued medicine registration dossier;

d) The medicines classified as antineoplastic drugs, immunosuppressive drugs

- The medicines indicated to treat cancer, including the medicines not in the list of the Ministry of Health are only used at medical facilities licensed to treat cancer, and indicated by the doctors that have been trained in oncology;

- The medicines indicated to treat other diseases other than oncology shall be used at the hospitals or clinic wards other than cancer ward according to the treatment regimen provided by the hospital. The consultation with oncologists is required to ensure the safety and treatment efficiency.

dd) The medicines that treat leprosy, mental illness, epilepsy in the Medicine list promulgated together with this Circular that provided in the programs and projects may be used as guided by the programs and projects.

2. Radiopharmaceuticals and marking compounds in the list shall be subject to special control. The supply, use, and management of them must be conformable with the regulation on medicines, and the law on radiation control and safety.

Article 4. Compilation of the List of medicines in medical facilities

1. According to Article 2 and Article 3 of this Circular; the technical classification, the illness models, and the hospital budget, the Director of the hospital shall appoint the Treatment and Medicine Panel to compile the internal List of Medicines, and make plans for supplying medicines that satisfy the treatment demand in accordance with the laws on bidding for medicine supply. The Director of the Service of Health shall direct the compilation of the List of medicines used for commune medical stations.

2. The finished medicines shall be selected as follows: generic medicines, mono-substance medicines, medicines produced at home, medicines produced by the facilities that follow the Good manufacturing practices (GMP) shall be preferred.

3. The medical facilities shall ensure the prompt and adequate supply of medicines, avoid patients buying medicines themselves, including anti-cancer drugs, immunosuppressive drugs that are not in the list but covered by the health insurance fund as prescribed.

Article 5. The patients’ payment for medicines

1. For the list of medicines.

a) The health insurance shall cover other chemical forms of a pharmaceutical substance if they have the same indication;

b) A medicine shall be covered if its route of administration and dosage form is provided in the list. The sublingual or medicines that are sucked, chewed, or sublingually administered shall be covered by the health insurance fund similarly to orally administered medicines; the medicines that are externally rubbed or adhered shall be covered similarly to topically administered medicines; The medicines of which the routes of administration are intramuscular injection, intradermal injection, intravenous injection, intravenous infusion, intra-articular injection, and intracavitary injection shall be covered similarly to the medicines of which the route of administration is injection.

c) When a medicine combines multiple active ingredients, and such combination is not provided in the List, it shall be covered by the health insurance fund if all active ingredients are present in the form of mono-substances, and the route of administration, the class of hospital are conformable (not applicable to the group of medicines being mixtures of vitamins);

d) When a hospital provide technical services of a hospital in a higher class, the medicines used by the latter may be used.

2. The specialized medicines produced by the hospitals must ensure the quality as prescribed. The medicine prices shall be covered by the health insurance fund based on the prices of ingredients provided by the Director of the hospital. The Director shall be responsible for before law for such ingredient prices.

3. For non-public medical facilities, depending on the list of technical services approved by competent agencies, the list of medicines shall be compiled under an agreement with the social insurance agency for paying the cost of medicines for the patients that have health insurance as prescribed.

4. The expenditure on medicine included in the price of technical services (such as desensitizers, anaesthetics, and infusion fluid used during surgeries, procedures, or radiocontrast media in medical imaging) shall not be paid again. The medicines in XV group – Disinfectants and antiseptics shall be paid together with the technical services and, not be paid separately.

5. If the patient only uses part of the dosage in the smallest unit under professional indication (e.g. paediatric medicines, oncological medicines), and the residual amount is not used (e.g. no patient, not enough dose, the medicines are expired), the health insurance fund shall pay the cost of the smallest unit.

6. The health insurance fund only pay for a number of medicines with the following indications:

a) Interferon and peginterferon used to treat hepatitis C in accordance with the treatment regimen.

b) Rituximab used to treat Non-Hodgkin Lymphoma with positive CD20.

c) Sorafenib used to treat developing liver cancer and kidney cancer;

d) Cerebrolysin, citicolin used to treat acute cerebrovascular accident, traumatic brain injury;

dd) Nimodipin used to treat meningeal hemorrhage due to cerebral aneurysm or injuries.

Article 6. The order and procedure for requesting the amendment, supplementation, and revision of the list of medicines

1. Annually, depending on the need for treatment, the medical facilities shall suggest the amendment, supplementation, and revision of the List of medicines to suit the practice in accordance with the following targets and rules:

a) Target:

- Ensure the safe, reasonable, and effective use of medicines;

- Satisfy the need for treatment of patients;

- Ensure the entitlement to medicines of the patients that have health insurance;

- Suitable for the financial capability of patients and the health insurance fund.

b) Rules:

- The medicines suggested to the List of medicines are conformable with the List of essential medicines of Vietnam and WHO;

- The medicines are effective in treatment;

- Do not suggest the list of medicines not recommended by WHO, the Ministry of Health, or medicines that are obsolete and have many side effects to the List of medicines;

- The amendment, supplementation, and revision must be suggested by the Treatment and Medicine Panel of the hospital.

2. The medical facilities shall send written request (according to the Annex enclosed with this Circular) to the Ministry of Health (The Department of Medical Examination And Treatment Management) or the provincial Services of Health for considering the amendment, supplementation, or revision.

Article 7. Implementation responsibilities

1. The list of medicines promulgated together with this Circular is the basis for medical facilities to select medicines, and satisfy the need for treatment and medicine payment of patients.

2. The social insurance agency and medical facilities shall cover the cost of medicines for the patients that have health insurance as prescribed in this Circular..

Article 8. Effects

This Circular takes effect on August 25^th 2011. The List of medicines, the List of radiopharmaceuticals and tracers, and the guide to the List of essential medicines used at medical facilities promulgated together with the Decision No. 05/2008/QĐ-BYT dated February 01^st 2008 of the Minister of Health, on the promulgation of the List of essential medicines used at medical facilities, are annulled The Circular No. 02/2010/TT-BYT dated January 15^th 2010 of the Minister of Health, promulgating the list of supplementary medicines used for children under 6 years old and covered by the health insurance fund is annulled.

During the implementation, the organizations are recommended to report the difficulties to the Ministry of Health for consideration and settlement./.

ANNEX

(Application form for amending and supplementing the List of Medicines promulgated together with the Circular No. 31/2011/TT-BYT dated July 11^th  2011 of the Minister of Health)

The Ministry of Health (or the Service of Health).……………

Hospital:……………………

APPLICATION FOR REVISING, AMENDING AND SUPPLEMENTING THE LIST OF ESSENTIAL MEDICINES USED AT MEDICAL FACILITIES

To: ………………………………………………………………………………

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