Thông tư 44/2018/TT-BYT về kê đơn thuốc cồ truyền, thuốc cổ truyền với thuốc hóa dược

THE MINISTRY OF HEALTH 

CircularNo. 44/2018/TT-BYT dated December 28, 2018 of the Ministry of Health on stipulating prescription of traditional drugs, herbal drugs and combination of traditional drugs, and herbal drugs and modern drugs in prescriptions

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

Pursuant to the Law on Medical Examination and Treatment No. 40/2009/QH12 dated November 23, 2009;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director of the Traditional Medicine Administration of Vietnam, the Minister of Health promulgates a Circular stipulating the prescription of traditional drugs, herbal drugs, and combination of traditional drugs, herbal drugs and modern drugs in prescriptions.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

1.This Circular provides regulations on prescription of traditional drugs, herbal drugs, and combination of traditional drugs, herbal drugs and modern drugs in prescriptions in inpatient treatment, day treatment and outpatient treatment at health facilities.

2.This Circular applies to authorities, organizations and individuals involved in the prescription of traditional drugs, herbal drugs, and combination of traditional drugs, herbal drugs and modern drugs in prescriptions.

Article 2. Interpretation of terms

For the purpose of this Circular, the terms below are construed as follows:

1.“Oriental drug”is a type of traditional drugs which is comprised of one or several traditional ingredients combined together according to traditional medicine theories or experiences and prepared in dosage-based packages.

2.“Finished drug”refers to a form of traditional drugs which have gone through all production stages, including packaging and labeling by adopting traditional or modern methods, and are provided in the following dosage forms: tablets, liquid form, teas, powder form, bone glue and others.

Chapter II

PRESCRIPTION OF TRADITIONAL DRUGS AND HERBAL DRUGS

Article 3. Prescribers

1.The following persons who hold medical examination and treatment practicing certificates (hereinafter referred to as “practitioners”) are allowed to make up prescriptions for oriental drugs, and finished drugs integrating with oriental drugs:

a) Traditional medical doctors and doctors who has completed a traditional medicine-oriented training course with the course duration of at least 6 months;

b) Holders of bachelor’s degree in traditional medicine, who have completed training programs equivalent to those of doctors;

c) Traditional medical assistants;

d) Herbalists.

2.The following persons are allowed to make up prescriptions for herbal drugs:

a) The entities mentioned in Point a, Point b and Point c Clause 1 of this Article;

b) Doctors in specialties other than traditional medicine;

c) General physician assistants.

3.The following persons are allowed to make up prescriptions for finished drugs:

a) The entities mentioned in Clause 2 of this Article;

b) Herbalists.

4.Holders of practicing certificates in family remedies are only allowed to make up prescriptions for family medicines certified by competent authorities.

Article 4. Forms of prescribing traditional drugs and herbal drugs

1. Prescribing oriental drugs, finished drugs and herbal drugs separately.

2.Prescribing family remedies.

3.Prescribing finished drugs integrating with oriental drugs.

Article 5. Principles for prescribing traditional drugs and herbal drugs

1.Practitioners shall make up prescriptions only after having results of medical examination and diagnosis.

2.A prescription must be conformable with medical diagnosis results and the severity of illness.

3.A prescription given to a patient may include oriental drugs and finished drugs whose composition or formula has same ingredient(s).

4.If contents of a prescription are changed, the prescriber’s signature must be appended next to such changed contents.

5.If a prescription contains toxic herbal ingredient(s) on the List of toxic herbal ingredients enclosed with the Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Minister of Health, the quantity of toxic herbal ingredient(s) must be specified in both figures and words. A zero (0) must be used before any numbers lower than 10 (ten).

6.A prescription shall not contain information or advertising, marketing, prescribing, counseling or labeling contents or instructions that non-medicinal products can be used for prevention, treatment, diagnosis, alleviation of diseases or regulating human physiological functions, except for medical equipment.

Chapter III

COMBINATION OF TRADITIONAL DRUGS, HERBAL DRUGS AND MODERN DRUGS IN PRESCRIPTIONS

Article 6. Prescribers of traditional drugs, herbal drugs integrated with modern drugs

1.Practitioners who are allowed to make up prescriptions of traditional drugs/ herbal drugs integrated with modern drugs include:

a) Traditional medical doctors who are allowed to make up prescriptions for modern drugs within the scope of internal medicine specialty;

b) General practitioners who have completed traditional medicine-oriented training courses whose length is not shorter than 6 months.

2.The following persons are allowed to make up separate prescriptions for modern drugs:

a) General practitioners who have completed traditional medicine-oriented training courses whose length is not shorter than 6 months;

b) Traditional medical doctors are allowed to make up prescriptions within the scope of internal medicine specialty in conformity with medical conditions of patients as well as technical level and list of medical operations of their health facilities;

c) Traditional medical assistants are allowed to prescribe and use modern drugs which are used for emergency treatment at health facilities in emergency cases.

3.Traditional medical assistants who work in areas facing social – economic difficulties or serious social – economic difficulties in which doctors are not available are allowed to make up prescriptions for modern drugs within the scope of internal medicine specialty for treating a number of common diseases during the combination of traditional drugs, herbal drugs and modern drugs after they are licensed in writing by Directors of relevant Provincial Departments of Health.

4.Doctors in specialties other than traditional medicine and general physician assistants are allowed to make up prescriptions for finished drugs and herbal drugs.

Article 7. Forms of prescribing traditional drugs, herbal drugs integrated with modern drugs

1.Combination of oriental drugs and modern drugs.

2.Combination of finished drugs and modern drugs.

3.Combination of oriental drugs, finished drugs and modern drugs.

In case prescriptions for traditional drugs, herbal drugs integrated with modern drugs are given to outpatients, the prescription of oriental drugs shall be made using the form of prescription for oriental drugs used in outpatient treatment provided in the Appendix enclosed herewith, and modern drugs, finished drugs and herbal drugs shall be prescribed in accordance with the Circular No. 52/2017/TT-BYT dated December 29, 2017 of the Minister of Health.

Article 8. Principles for prescribing traditional drugs, herbal drugs integrated with modern drugs

1.The prescription of modern drugs in outpatient treatment shall adhere to the Circular No. 52/2017/TT-BYT.

2.If prescriptions contain modern drugs used in inpatient treatment, the duration of using modern drugs shall comply with applicable regulations on prescription of modern drugs.

Chapter IV

EXPRESSION OF PRESCRIPTIONS, INSTRUCTIONS FOR PATIENTS AND VALIDITY OF PRESCRIPTIONS

Article 9. Expression of prescriptions

1.General regulations on expression of prescriptions:

a) Drug s name must be clearly and exactly written out in Vietnamese; all items already printed in a prescription, patient’s medical book or treatment form in medical records must be filled;

b) The patient’s place of permanent or temporary residence must be specified exactly;

c) If a patient is a child aged less than 72 months, the number of months of age and full name of the child s parent must be specified;

d) The unused blank in a prescription from below the prescription contents to the prescriber s signature must be crossed out; the prescriber s signature and full name are compulsory.

2.Writing out prescriptions for traditional drugs and herbal drugs:

a) When prescribing oriental drugs, their common names, dosage and units must be specified; names of traditional ingredients cannot be abbreviated; specific instructions for decoction, administration route and time must be also specified;

b) Dosage, usage and administration route must be specified;

c) With regard to finished products which have been self-manufactured by health facilities, their manes approved by Provincial Departments of Health or Ministry of Health (except health facilities managed by the Ministry of National Defence) for internal use shall be specified; If finished drugs are allowed to sell nationwide, their names to which registration numbers have been granted by the Ministry of Health are specified;

d) If a prescriber gives his/her patient a dosage over a usual dosage as defined in the professional process adopted by the Ministry of Health or the treatment regimen, it must be confirmed by the prescriber’s signature.

3.Sequence of prescription drugs in a prescription and medical record:

a) Sequence of prescription traditional drugs and herbal drugs: Oriental drugs, finished drugs.

Finished drugs are prescribed in the following sequence: Tablets, liquid form, teas, powder form, bone glue and others;

b) Sequence of drugs in a combined prescription: Modern drugs are prescribed first, then traditional drugs and herbal drugs.

Article 10. Drug use duration written in prescriptions

1.Prescription for outpatient treatment:

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

b) Other diseases: The quantity of drugs in each prescription must be enough for use up to 10 days. With regard to remote regions, border regions, island regions or regions facing social – economic difficulties or serious social – economic difficulties, the quantity of drugs in a prescription may be enough for use up to 30 days.

2.Prescription for inpatient treatment and day treatment:

a) At least two prescriptions are given within 10 days;

b) With regard to the prescription of oriental drugs, during the inpatient or day treatment, if both indications for treatment and previously prescribed oriental drugs are kept unchanged, such previously prescribed drugs may be repeated by specifying the phrase “Bài thuốc hoặc đơn thuốc của ngày, tháng, năm” (“Using drugs or the prescription given on……………[date]”) but such prescription is repeated once only. If such oriental drugs continue to be used, new prescriptions must be given.

Article 11. Prescription by health facilities applying information technology in outpatient treatment

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

2.Health facilities that apply information technology must ensure the retention of the given prescriptions for tracing purpose or printing out when necessary.

3.Electronic medical records are employed in accordance with applicable laws.

Article 12. Validity of a prescription

1.A prescription shall be valid for buying/receiving drugs within 05 days from the prescription date.

2.Prescriptions for traditional drugs and herbal drugs are kept for 03 months. Prescriptions which contain toxic traditional ingredients on the list of toxic ingredients enclosed with the Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Minister of Health must be kept for 06 months.

Chapter V

IMPLEMENTATION

Article 13. Effect

1.This Circular takes effect on March 01, 2019.

2.The Circular No. 01/2016/TT-BYT dated January 05, 2016 of the Minister of Health shall be null and void from the effective date of this Circular.

Article 14. Terms of reference

If legislative documents referred to herein are superseded or amended, the new ones shall apply.

Article 15. Implementation organization

1.The Traditional Medicine Administration of Vietnam shall play the leading role and coordinate with the Drug Administration of Vietnam and the Administration of Medical Examination and Treatment affiliated to the Ministry of Health in organizing, inspecting and assessing the implementation of this Circular.

2.Departments of Health of provinces or central-affiliated cities and health agencies of Ministries/regulatory bodies shall:

a) Instruct and organize the implementation of this Circular within their management regions;

b) Inspect and evaluate the implementation of this Circular within their management regions.

3.Health facilities and drug retailers shall comply with regulations in this Circular.

4.Prescribers shall:

a) Implement regulations on prescription in this Circular and assume responsibility for their prescriptions given to patients;

b) Provide instructions for use of drugs, advice on diet and daily activities for patients during their use of prescription drugs; request the patients or their representatives to immediately inform the prescribers or nearest health facilities when patients have any abnormal signs or symptoms after taking medicines.

5.Patients and their representatives must comply with regulations in this Circular.

Article 16. Responsibility for implementation

Chief of the Ministry s Office, Director of the Traditional Medicine Administration of Vietnam, Director of the Administration of Medical Examination and Treatment, Director of the Drug Administration of Vietnam, Chief Inspector of the Ministry, General Directors/ Directors of departments/agencies/administrations affiliated to the Ministry of Health, Directors of hospitals/ institutions providing inpatient treatment affiliated to the Ministry of Health, Directors of Departments of Health of provinces or central-affiliated cities, heads of health agencies affiliated to regulatory ministries, heads of relevant organizations and relevant individuals shall be responsible for implementing this Circular.

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

For the Minister

Deputy Minister

Nguyen Viet Tien