Thông tư 01/2016/TT-BYT

CIRCULAR

PROVIDING FOR PRESCRIPTION FOR TRADITIONAL MEDICINES, AND PRESCRIPTION FOR TRADITIONAL MEDICINES INTEGRATED WITH MODERN MEDICINES IN HEALTH FACILITIES

Pursuant to the Government's Decree No. 63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of Ministry of Health;

At the request of Director of Traditional Medicine Administration of Vietnam;

Minister of Health promulgates a Circular providing for the prescription for traditional medicines and the prescription for traditional medicines integrated with modern medicines in health facilities.

Article 1. Scope

This Circular provides for conditions to be satisfied by prescribers, prescription scope, principles and forms, and specific regulations on the prescription for traditional medicines and the prescription for traditional medicines integrated with modern medicines in health facilities.

Article 2. Integration of terms:

In this Circular, these terms shall be construed as follows:

1. Traditional medicine (including traditional ingredients and oriental medicines) means a medicine whose contents are herbal ingredients which are processed, prepared or combined by adopting traditional medicine theories and methods or experiences into preparations with traditional or modern dosage form.

2. Traditional ingredient means a herbal ingredient that is processed by adopting traditional medicine theories and methods, and is used for production of traditional medicines or prevention or treatment of diseases.

3. Oriental medicine is a type of traditional medicines, which is comprised of one or several traditional ingredients based on traditional medicine theories or experiences, and packed under dosages.

4. Finished traditional medicinal products (oriental medicine and herbal medicine) refer to traditional medicines which have gone through all production stages, including packing and labeling, and come in several different forms: tablets, liquid form, teas, powder form, bone glue and other dosage forms.

Article 3. Conditions to be satisfied by prescribers and scope of the prescription for traditional medicines and the prescription for traditional medicines integrated with modern medicines

1. Prescribers must be practitioners in health facilities which are established under the law, and possess medical examination and treatment practicing certificates in conformity with the law on medical examination and treatment.

2. Specialized doctors and specialty-oriented doctors of traditional medicine are allowed to make up prescriptions for all types of traditional medicines and prescriptions for traditional medicines integrated with modern medicines within the scope of their professional competence.

3. General practitioners, other specialty doctors and general physicians shall only make up prescription for finished traditional medicinal products when combining traditional medicines with modern medicines in their prescriptions.

4. Traditional medicine physicians who work at State-owned district health facilities or health clinics of communes/wards/towns or school health facilities may make up prescriptions for all types of traditional medicines within the scope of their professional competence.

5. Traditional medicine physicians who work at regions with difficult or extremely difficult social – economic conditions in which doctors are not available may make up prescription for traditional medicines and those integrated with modern medicines after having obtained letters of assignment from directors or heads of health facilities in such regions.

6. Herbalists shall only make up prescription for traditional medicines within the scope of their practicing certificates. Herbalists are not allowed to make up prescription for traditional medicines integrated with modern medicines.

7. Holders of family remedies shall only make up prescription for family medicines of which certificates have been granted by competent authorities as regulated.

Article 4. Principles for making up prescription for traditional medicines and prescription for traditional medicines integrated with modern medicines

1. Prescriptions are given to patients only after they have been directly examined, diagnosed and given with symptom-based remedies by taking traditional medicines or combining traditional medicines and modern medicines.

2. The prescription must ensure correct types of medicines, dosage and correspond with medical diagnosis and disease progression.

3. The following items are not written out in a prescription:

a) Medicines that are not used to prevent and treat diseases;

b) Medicines which are not allowed to sell in Vietnam;

c) Functional foods;

d) Cosmetics;

dd) Medicines suggested by patients.

Article 5. Forms of making up prescription for traditional medicines and prescription for traditional medicines integrated with modern medicines

1. Forms of making up prescription for traditional medicines:

a) Prescription for oriental medicines;

b) Prescription for finished traditional medicinal products;

c) Prescription by combining types of traditional medicines, including finished traditional medicinal products and oriental medicines;

d) Making up prescription according to family remedies.

2. Forms of making up prescription for traditional medicines integrated with modern medicines:

a) Integration between oriental medicines and modern medicines;

b) Integration between finished traditional medicinal products and modern medicines;

c) Integration between oriental medicines, finished traditional medicinal products and modern medicine.

If prescriptions for traditional medicines integrated with modern medicines are given to outpatients, the prescription for oriental medicines shall follow the “Prescription for outpatient’s oriental medicines” form stated in the Annex herein, and the prescription for modern medicines and finished traditional medicinal products shall follow Minister of Health’s Circular providing for the prescription for outpatients.

Article 6. Guidelines for making up prescriptions

1. General regulations on the prescription

a) Writings must be clear, accurate and sufficient according to items already printed in the prescription or patient's medical book or treatment forms in medical records;

b) Patient's address must be exactly written out in accordance with administrative regulations on place-names, including house number, street, residential group or hamlet/village, commune/ward/town;

c) If patient is a child aged under 72 months, the number of months of age and full name of child's father or mother must be specified;

d) If a prescription is adjusted, the prescriber must sign and specify his/her full name and adjustment date alongside the adjusted contents;

dd) The unused blank in the prescription must be crossed out from the point under the prescription contents to the point above the prescriber’s signature; prescriber’s signature and full name are required.

2. Prescription for traditional medicines:

a) Medicine’s name must be clearly and exactly written out in Vietnamese. When prescribing oriental medicines, their common names shall be used. The prescription shall include dosage and unit. Names of traditional ingredients are not abbreviated;

b) Dosage, usage and administration are specified.

With regard to the prescription for oriental medicines in the course o the inpatient treatment, if indications for treatment and previously prescribed medicines are unchanged, the previously prescribed medicines may be repeated by specifying the phrase “Bài thuốc hoặc Dơn thuốc của ngày, tháng, năm” (“Using medicines or the prescription given on………………..[date]) but the prescription is repeated for one time only;

c) Specific instructions for decoction, administration route and time must be given;

d) Finished traditional medical products which are self-manufactured by health facilities shall be prescribed under the names approved by competent authorities for internal use. If medicines are allowed to sell nationwide, their names to which registration number has been granted by Ministry of Health shall be specified;

dd) If a prescriber for traditional ingredients gives his/her patient a dosage over an usual dosage as defined in the professional process adopted by Ministry of Health or the treatment regimen, or corrects any contents in the prescription, he/she must confirm by affixing his/her name next to the corrected contents.

3. The prescription for modern medicines shall be made in accordance with the Circular adopted by Ministry of Health providing for the prescription for outpatient treatment and current regulations on the prescription for modern medicines.

4. Sequence of prescription medicines in a prescription or medical record

a) Sequence of prescription traditional medicines: Oriental medicines, finished traditional medicinal products. Finished traditional medicinal products shall be prescribed in the following sequence: Tablets, liquid form, teas, powder form, bone glue and other dosage forms;

b) Sequence of prescription modern medicines: Intravenously administered medicines, orally administered medicines, suppositories, topically administered medicines and medicines administered under other routes;

c) Sequence of the integrated prescription for traditional and modern medicines: Modern medicines shall be prescribed first, then traditional medicines;

d) The prescription for toxic traditional medicines on the list of toxic herbal ingredients used in Vietnam, enclosed to the Circular No. 33/2012/TT-BYT dated December 28, 2012 by Minister of Health, must be given upon decision of Director or the individual authorized by Director of health facility.

Article 7. Regulations on use duration of medicines written in inpatient and outpatient prescriptions

1. Prescription for outpatient treatment

a) Chronic diseases (requiring long-term treatment): The quantity of medicines in each prescription must be enough for use up to 30 days or according to specific treatment indications for each disease;

b) Other diseases: Each prescription must include sufficient doses but use duration shall not exceed 7 days;

With regard to remote regions, border regions, island regions or regions with difficult or extremely difficult social – economic conditions in which traditional medicine doctors and physicians are not available, the use duration of medicines in a prescription may be up to 30 days but only the prescription for traditional medicines is allowed.

2. Prescription for ipatient treatment

a) Acute diseases: At least two prescriptions are given within 7 days.

b) Chronic diseases: A prescription shall only include sufficient dosages and use duration of medicines shall not exceed 10 days.

3. If a prescription includes the combination of traditional medicines and modern medicines, the use duration of modern medicines shall be governed by applicable regulations on the prescription for modern medicines.

Article 8. Forms of prescriptions for traditional medicines and prescriptions for traditional medicines integrated with modern medicines

1. Prescriptions for oriental medicines given to outpatients shall follow the form stated in the Annex herein.

2. If an outpatient is given with a prescription for traditional medicines integrated with modern medicines, the prescription for modern medicines and finished traditional medical products shall comply with regulations on forms of outpatient prescriptions for modern medicines.

3. With regard to inpatients, prescriptions shall be included in their medical records in compliance with current regulations.

Article 9. Prescription by health facilities where information technology is applied to outpatient prescription

1. The prescription shall be made up by computer aid, then printed and signed by the prescriber, one copy of which shall be given to the patient in order to keep in his/her medical book or treatment book.

2. Health facilities that apply information technology to the prescription must retain given prescriptions for tracing or printing out in case of need.

Article 10. Effect

This Circular takes effect as of February 18, 2016.

Article 11. Terms of reference

If documents which are referred to in this Circular are replaced or amended, replacement or amendment documents shall apply.

Article 12. Implementation responsibility

Chief of Ministry's Office, Director of Traditional Medicine Administration of Vietnam, Director of Agency of Health Examination and Treatment, Ministry’s Chief Inspector, Director Generals, Directors or Heads of Ministry's affiliates, Directors of Hospitals or Institutes with patient beds affiliated to Ministry of Health, Directors of Health Departments of central-affiliated cities or provinces and heads of medical authorities shall be responsible for implementing this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (via Traditional Medicine Administration of Vietnam) for consideration./.