Circular No. 44/2018/TT-BYT on prescribing traditional medicine prescriptions, herbal drugs, and combined traditional medicine and herbal drug prescriptions with chemical drugs

 

CIRCULAR

REGULATIONS ON PRESCRIBING TRADITIONAL MEDICINE AND HERBAL DRUGS

AND COMBINING THE PRESCRIPTION OF TRADITIONAL MEDICINE AND HERBAL DRUGS WITH CHEMICAL DRUGS

||| BASED ON PHARMACY LAW NO. 105/2016/QH13 dated April 6, 2016;BASED ON THE MEDICAL EXAMINATION AND TREATMENT LAW NO.40/2009/QH12 dated November 23, 2009;

BASED ON DECREE NO. 75/2017/NĐ-CP dated June 20, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health AT THE PROPOSAL OF THE DIRECTOR OF THE DEPARTMENT OF TRADITIONAL MEDICINE AND PHARMACY MANAGEMENT, THE MINISTER OF HEALTH ISSUES THIS CIRCULAR TO REGULATE THE PRESCRIPTION OF TRADITIONAL MEDICINE AND HERBAL DRUGS AND THE COMBINED PRESCRIPTION OF TRADITIONAL MEDICINE AND HERBAL DRUGS WITH CHEMICAL DRUGS.ARTICLE 1. This Circular regulates the prescription of traditional medicine and herbal drugs, and the combined prescription of traditional medicine and herbal drugs with chemical drugs for inpatient treatment, day hospital treatment, and outpatient treatment at medical facilities. ARTICLE 2. This Circular applies to agencies, organizations, and individuals related to the prescription of traditional medicine and herbal drugs and the combined prescription of traditional medicine and herbal drugs with chemical drugs.ARTICLE 3. Traditional decoction is a form of traditional medicine consisting of one or more traditional medicinal herbs combined according to the theory of traditional medicine or folk experience, packaged by a physician according to the dosage for use. ARTICLE 4. Finished traditional medicine is a form of traditional medicine that has undergone production processes, including packaging and labeling, using traditional or modern methods, belonging to one of the following forms: pills, liquids, tea, powder, extract, and other forms.

PRESCRIPTION OF TRADITIONAL MEDICINE AND HERBAL DRUGS ARTICLE 3. Persons authorized to prescribe traditional medicine and herbal drugs "d) The original or a certified copy of the discharge summary or a summary of the medical record as prescribed in Appendix 3 and Appendix 4 issued together with this Circular. If the worker has not been hospitalized or treated as an outpatient, they must have documents related to the examination and treatment of occupational injuries or diseases corresponding to the time of the accident and the injury for which assessment is requested.;

1. Persons holding a certificate for practicing medical examination and treatment (hereinafter referred to collectively as practitioners) may prescribe traditional decoctions, finished traditional medicines, and combined prescriptions of finished traditional medicines and traditional decoctions:a) Specialist doctors in traditional medicine, doctors with a certificate in specialized training in traditional medicine for a minimum of six months;b) Bachelor's degree holders in traditional medicine who have been trained equivalently to a doctor's degree;c) Assistant doctors in traditional medicine;d) Traditional doctors.2. Persons authorized to prescribe herbal drugs:a) The subjects specified in Points a, b, and c of Clause 1 of this Article; b) Doctors not specializing in traditional medicine;

PART I

GENERAL PROVISIONS

       Article 1. Scope of Regulation and Applicability

       c) Assistant doctors in general practice.

       3. Persons authorized to prescribe finished traditional medicines:

       Article 2. Interpretation of Terms

       In this Circular, the following terms are understood as follows:

       a) The subjects specified in Clause 2 of this Article;

       b) Traditional doctors.

Chapter II

4. Persons holding a certificate for hereditary prescriptions may only prescribe hereditary prescriptions that have been approved by the competent authority.

       ARTICLE 4. Forms of prescribing traditional medicine and herbal drugs

       1. Prescribing individual traditional decoctions, finished traditional medicines, and herbal drugs.

       2. Prescribing hereditary prescriptions.

       3. Prescribing combined finished traditional medicines and traditional decoctions.

       ARTICLE 5. Principles of prescribing traditional medicine and herbal drugs

       1. Practitioners may only prescribe medicine after obtaining examination results and diagnosing the disease.

       2. Prescriptions must be appropriate to the diagnosis and condition of the disease.

       3. It is permissible to prescribe a combination of traditional decoctions and finished traditional medicines on the same patient where there is overlap in some ingredients or formulas.

       4. In cases where the content of the prescription is modified, the prescriber must sign immediately next to the modified content.

       5. If the prescription contains toxic herbal drugs listed in the Herbal Drug Toxicity List issued together with Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Minister of Health (hereinafter referred to as Circular No. 42/2017/TT-BYT), the quantity must be clearly stated in both figures and words, and if the quantity is less than ten (ten), a zero (zero) must be placed before it.

       6. Information, advertising, marketing, prescription, advice, labeling, and usage instructions for products that are not medicines shall not be included in the prescription unless they are medical devices.

       COMBINED PRESCRIPTION OF TRADITIONAL MEDICINE, HERBAL DRUGS WITH CHEMICAL DRUGS

       b) Traditional physician.

       4. Persons holding a practice certificate for family herbal prescriptions may only prescribe such family herbal prescriptions that have been permitted by the competent authority.

       Article 4. Forms of prescribing traditional medicine and medicinal herbs

       1. Prescribing individual decoctions, finished medicines, and medicinal herbs.

       2. Prescribing family herbal prescriptions.

       3. Prescribing a combination of finished medicines and decoctions.

       Article 5. Principles of prescribing traditional medicine and medicinal herbs

       1. A practitioner may only prescribe medicine after obtaining the results of a medical examination and diagnosis.

       2. The prescription must be appropriate to the diagnosis and condition of the illness.

       3. It is permissible to prescribe a combination of decoctions and finished medicines on the same patient where there is overlap of certain ingredients in their formulas.

       4. In cases where the content of the prescription is amended, the prescriber must sign next to the amended content.

       5. If the prescription contains toxic medicinal herbs listed in the Catalogue of Toxic Medicinal Herbs issued together with Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Minister of Health (hereinafter referred to as Circular No. 42/2017/TT-BYT), the quantity must be clearly stated both numerically and in words; if the quantity is less than ten (10), a zero (0) must be placed before the number.

       6. Information, advertising, marketing, prescription, advice, labeling, and usage instructions for non-medicines products that claim to prevent, treat, diagnose, alleviate, or adjust physiological functions of the human body shall not be included in the prescription, except for medical devices.

Chapter III

COMBINED PRESCRIPTION OF TRADITIONAL MEDICINE,

MEDICINAL HERBS WITH CHEMICAL DRUGS

       Article 6. Persons authorized to prescribe traditional medicine, herbal medicine combined with chemical drugs

       1. Practitioners authorized to prescribe traditional medicine, herbal medicine combined with chemical drugs.

       a) Traditional Medicine Specialists may prescribe chemical drugs within the scope of internal medicine.

       b) General Practitioners with a certificate in specialized training in Traditional Medicine for at least six months.

       2. Persons authorized to prescribe only chemical drugs.

       a) General Practitioners with a certificate in specialized training in Traditional Medicine for at least six months;

       b) Traditional Medicine Specialists may prescribe within the scope of internal medicine, appropriate to the patient's condition and the technical level of the healthcare facility, and the technical directory of the medical examination and treatment facility;

       c) Traditional Medicine Attendants may prescribe and use emergency chemical drugs at healthcare facilities for emergency treatment.

       3. Traditional Medicine Attendants working in areas with difficult economic and social conditions, or particularly difficult conditions where there is no specialist physician authorized to prescribe internal medicine chemical drugs to treat common diseases during the combination of traditional medicine, herbal medicine with chemical drugs, may do so after obtaining written permission from the Director of the Department of Health.

       4. Non-specialist physicians in Traditional Medicine and General Attendants may prescribe finished medicines and herbal medicines.

       Article 7. Forms of prescribing traditional medicine, herbal medicine combined with chemical drugs

       1. Combination of decoctions and chemical drugs.

       2. Combination of finished medicines and chemical drugs.

       3. Combination of decoctions, finished medicines, and chemical drugs. In cases where prescriptions include the combination of traditional medicine, herbal medicine with chemical drugs for outpatients, the prescription of decoctions shall be carried out according to the Outpatient Decoction Prescription form attached to this Circular, while the prescription of chemical drugs, finished medicines, and herbal medicines shall follow Circular No. 52/2017/TT-BYT dated December 29, 2017 issued by the Minister of Health on drug prescriptions, and the prescription of chemical drugs and biological products in outpatient treatment at medical examination and treatment facilities (hereinafter referred to as Circular No. 52/2017/TT-BYT).

       Article 8. Principles of prescribing traditional medicine, herbal medicine combined with chemical drugs.

       1. Prescribing chemical drugs for outpatient treatment shall be carried out in accordance with the provisions of Circular No. 52/2017/TT-BYT.

       2. For prescriptions combining chemical drugs in inpatient treatment, the duration of using chemical drugs shall comply with the legal regulations on prescribing chemical drugs.

Chapter IV

RECORDING OF PRESCRIPTIONS, USE OF MEDICINES AND THE VALIDITY PERIOD OF PRESCRIPTIONS

AND THE VALIDITY PERIOD OF THE PRESCRIPTION

       Article 9. Guidelines for recording prescriptions

       1. General rules for recording prescriptions

       a) The name of the drug must be written in Vietnamese, accurately and clearly, filling all sections printed in the prescription, patient's medical record book, and treatment sheet in the medical file;

       b) Accurately record the address of the patient's residence or temporary residence;

       c) For children under 72 months old, their age in months and the name of either parent must be recorded;

       d) Cross out any blank space below the prescription content up to above the prescriber's signature; sign and write the full name of the prescriber.

       2. Recording prescriptions for traditional medicine and herbal medicine.

       a) When prescribing decoctions, record the common name, specify the dosage, unit of measurement, and do not abbreviate the name of traditional medicine ingredients; provide specific instructions on how to prepare and take the decoction;

       b) Clearly specify the dosage, method of administration, and route of administration:

       c) For finished medicines produced by medical examination and treatment facilities, record according to the name approved for internal circulation by the Department of Health or the Ministry of Health (except for units managed by the Ministry of Defense); for medicines circulating nationwide, record the name according to the registration number issued by the Ministry of Health;

       d) If the prescriber allows the patient to use a dose exceeding the usual dose according to the Ministry of Health's professional procedures or treatment guidelines, they must sign confirmation next to it.

       3. Order of listing medicines in prescriptions and medical records

       a) Order of listing traditional medicine and herbal medicine: Decoctions, finished medicines. For finished medicines, list in the following order: Tablets, liquids, tea, powder, paste, and other forms;

       b) Order of listing combined medicines: List chemical drugs first, followed by traditional medicine and herbal medicine.

       Article 10. Duration of Medication Prescription

       1. Outpatient medication prescription

       a) Chronic diseases requiring long-term treatment: Each prescription shall not exceed thirty days or according to the treatment guidelines for each disease;

       b) Other diseases: Each prescription shall not exceed ten days. For remote areas, border regions, islands, and economically disadvantaged areas, prescriptions may extend up to thirty days.

       2. Inpatient and day-care inpatient medication prescription

       a) At least two prescriptions shall be issued within ten days;

       b) For decoction prescriptions, during inpatient and day-care inpatient treatment, if there is no change in the treatment regimen and the previous prescribed formula remains unchanged, it can be renewed by noting "Prescription or formula of date, month, year" only once. If the formula is continued in subsequent prescriptions, it must be re-recorded.

       Article 11. Medication Prescription at Healthcare Facilities Applying Information Technology for Outpatient Prescriptions

       1. The prescription shall be recorded in the computer once, then printed out and signed by the prescriber, and given to the patient one copy to keep in their medical record book or long-term treatment record book.

       2. Healthcare facilities applying information technology must ensure the storage of prescriptions for retrieval or printing as necessary data.

       3. Electronic medical records shall be implemented in accordance with the provisions of the law.

       Article 12. Validity Period of Prescriptions for Purchasing and Collecting Medications and Storage of Prescriptions

       1. Prescriptions are valid for purchasing and collecting medications for a maximum period of five days from the date of issuance.

       2. The storage period for traditional medicine prescriptions and herbal medicine prescriptions is three months. However, for prescriptions containing toxic traditional medicines listed in Circular No. 42/2017/TT-BYT dated November 13, 2017, issued by the Minister of Health on the List of Toxic Herbs Used as Medicine, the storage period is six months.

Chapter V

IMPLEMENTING PROVISIONS

       Article 13. Effective Date

       1. This Circular takes effect from March 1, 2019.

       2. Circular No. 01/2016/TT-BYT dated January 5, 2016, issued by the Minister of Health regarding Traditional Medicine Prescriptions and Combined Traditional Medicine and Modern Medicine Prescriptions in healthcare facilities, shall cease to be effective from the date this Circular takes effect.

       Article 14. Cross-referencing Provisions

       In cases where referenced documents in this Circular are replaced or amended, they shall be applied according to the replacing or amended documents.

       Article 15. Implementation Organization

       1. The Department of Traditional Medicine and Pharmaceutical Management shall take the lead in coordinating with the Department of Drug Administration, the Department of Medical Examination and Treatment, and the Ministry of Health to organize the implementation, inspection, and evaluation of this Circular.

       2. Provincial Departments of Health under the central government, health departments of ministries and sectors shall have the responsibility to:

       a) Direct and organize the implementation of this Circular within their jurisdiction and managed units;

       b) Inspect and evaluate the results of implementing this Circular within their jurisdiction and managed units.

       3. Healthcare facilities and retail pharmacies shall have the responsibility to implement the provisions of this Circular.

       4. Prescribers shall have the responsibility to:

       a) Implement the prescription regulations stipulated in this Circular and bear responsibility for prescriptions issued to patients;

       b) Guide patients on the use of medications, provide dietary and lifestyle advice during medication use, and instruct patients or their family members to immediately inform the prescriber or visit the nearest healthcare facility if they experience any unusual symptoms after taking the medication.

       5. Patients and their representatives shall have the responsibility to comply with the provisions of this Circular.

       Article 16. Responsibility for Implementation

       Gentlemen and Ladies: Heads of the Ministry's Office, Director of the Department of Traditional Medicine and Pharmaceutical Management, Director of the Department of Medical Examination and Treatment, Director of the Department of Drug Administration, Head of the Ministry's Inspectorate, General Directors, Directors of Institutes and Hospitals under the Ministry of Health, Directors of Provincial Health Departments under the central government, Heads of Health Sectors, related organizations, and individuals shall be responsible for implementing this Circular. Any difficulties or issues encountered during implementation should be promptly reported to the Ministry of Health (Department of Traditional Medicine and Pharmaceutical Management) for review and resolution.

       During implementation, any difficulties or issues should be promptly reported to the Ministry of Health (Department of Traditional Medicine and Pharmaceutical Management) for review and resolution./.