Circular No. 05/2014/TT-BYT on the use of medicinal materials and traditional medicine formulas in medical examination and treatment facilities

CIRCULAR

Regulations on the use of traditional medicine herbs and drugs in medical examination and treatment facilities.h

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This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Traditional Medicine Management Department;

The Minister of Health shall issue a Circular to regulate the use of traditional medicine herbs and drugs in medical examination and treatment facilities.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular regulates the use of traditional medicine herbs and drugs (hereinafter referred to as drugs) in medical examination and treatment facilities.

Article 2. Interpretation of Terms

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

1. are raw herbal medicines, preliminarily processed herbal medicines, or herbal medicines that have been manufactured and can be used as medicines. are natural raw materials from animals, plants, or minerals for making drugs.

2. AND STORAGE SERVICES FOR HERBAL MEDICINES (also known as traditional medicine drugs) are herbs processed and prepared according to the theories of traditional medicine for disease prevention and treatment.

Chapter II

QUALITY OF TRADITIONAL MEDICINE HERBS AND DRUGS

Article 3. Quality of traditional medicine herbs and drugs

1. Must meet quality standards as prescribed: for herbs according to current Pharmacopoeia regulations (if applicable) or according to the standard established by the unit.

2. Packaging labels must comply with the labeling guidelines for drugs issued by the Ministry of Health.

Article 4. Quality inspection of traditional medicine herbs and drugs

1. Traditional medicine herbs and drugs supplied to medical examination and treatment facilities must have a test certificate or a certified copy of the test results.

2. All traditional medicine herbs and drugs must be inspected and admitted through the hospital's Admission Committee or the admission department of other medical examination and treatment facilities. Traditional medicine herbs and drugs can only be admitted into medical examination and treatment facilities if they meet quality requirements. Inspection results must be recorded in the admission logbook according to the model specified in Appendix 1 attached hereto.

3. The Admission Committee in hospitals operates according to Circular No. 22/2011/TT-BYT dated June 10, 2011, of the Ministry of Health on the organization and operation of Hospital Pharmacy Departments; the admission department of other medical examination and treatment facilities is established by the head of the facility, including at least the head of the pharmacy department, accountant, warehouse manager, and supply staff.

4. The head of the medical examination and treatment facility is responsible for organizing regular inspections at least once every three months and spot checks when necessary regarding the quality of traditional medicine herbs and drugs within the facility. After inspection, a record must be made.

5. In cases where there is doubt about the quality of traditional medicine herbs and drugs, the head of the medical examination and treatment facility must inspect and, if necessary, send samples to competent authorities for testing. They may only be used after receiving satisfactory test results.

Article 5. Regulations on storage of traditional medicine herbs and drugs

1. The warehouse storing traditional medicine herbs and drugs must ensure the following conditions:

a) Adequate space, well-ventilated, safe, and convenient for entry, exit, and transportation;

b) Ceilings, walls, and roofs of the warehouse must be designed and constructed to ensure hygiene, ventilation, dryness, sufficient lighting, and a high, flat, smooth floor;

c) Prevent the intrusion of insects, rodents, and other harmful animals; prevent the growth of mold and pests;

d) Reasonably arrange areas for tasks such as receiving, storage, special storage, and drug dispatching. Herbs and drugs containing essential oils must be stored in sealed packaging to avoid absorption by other items.

2. Equipment

a) Have shelves for stacking herbs and drugs, not allowing direct contact with the ground; there must be sufficient space between shelves for cleaning and handling;

b) Have appropriate equipment for transporting goods;

c) The warehouse must have adequate equipment for storing herbs and drugs such as fans, air conditioners, dehumidifiers, thermometers, hygrometers;

d) Equipment used to monitor storage conditions must be calibrated regularly;

đ) Control relative humidity not exceeding 70%;

e) Have sufficient fire protection equipment in accordance with the law.

3. Storage activities

a) Packages and boxes must have labels and be arranged properly to ensure ventilation;

b) Ensure warehouse sanitation work;

c) Maintain complete records for tracking entry and exit, processing work, and the basic standards of traditional medicine herbs and drugs according to the models specified in Appendices 2 and 3 attached hereto;

d) Regularly monitor quality, expiration dates, and traditional medicine herbs and drugs; when signs of non-compliance with quality standards are detected, they must be placed in special storage areas.

Chapter III

GUIDANCE FOR USE

Article 6. Guidelines for the use of medicines

1. Medicines used for patients must meet the following requirements:

a) They must be prepared in accordance with the regulations of the Ministry of Health;

b) The combination of herbal ingredients and traditional medicine components in each prescription must be consistent with the principles of traditional medicine theory;

c) There must be a preparation process for the production of formulations within healthcare facilities; this must be approved by the Scientific Council (if applicable) and submitted to the Head of the Healthcare Facility for approval;

d) They must be compatible with other medications used concurrently, without adverse interactions;

đ) Medication should not be overused.

2. The indication for medication shall be recorded according to the prescription regulations for traditional medicine.

3. The route of administration shall be selected based on the patient's condition, the severity of the disease, and the characteristics and nature of the medicine to issue an appropriate medical order.

4. Any unintended effects of the medicine (if any) shall be advised to the nursing staff monitoring and the patient (or the patient's family).

5. For toxic medicinal herbs used as medicine:

a) Strict control over dosage, usage subjects, routes of administration, and processing in accordance with the regulations of the Ministry of Health is required;

b) Prescription for treatment must be made under the examination, consultation, and follow-up of a physician.

Article 7. Organization of decoction and distribution of medicines

1. Depending on the conditions of each healthcare facility, the Pharmacy Department or Traditional Medicine Department or specialized unit shall be responsible for decocting and distributing medicines for use by patients.

2. To prevent confusion when decocting medicines: numbering must be done on prescriptions, slips, decoction pots, and containers before and after decoction; there must be shelves to distinguish between un-decocted, partially decocted, and fully decocted medicines.

3. Medicines shall be distributed daily and as supplements according to medical orders. Distribution must be timely to ensure that patients can use their medicines.

4. The person responsible for decocting medicines must have a minimum of a mid-level professional qualification in traditional medicine and continuously update knowledge about medicinal herbs and traditional medicine components.

5. Daily records must be kept to record the number of prescriptions received, distributed, and remaining in stock according to the model specified in Appendix 4 issued together with this Circular.

6. The decoction area must be clean and organized.

7. Decoction procedures must comply with the provisions of Decision No. 26/2008/QĐ-BYT dated July 22, 2008, regarding the issuance of technical procedures for traditional medicine.

8. After decoction, medicines must be filtered to remove residue and coarse particles.

9. For prescriptions containing toxic medicinal herbs and traditional medicine components: after decoction, the residue must be stored separately for each patient for at least 24 hours from the time of dispensing the medicine for possible review if necessary.

Article 8. Control of the process of distribution and decoction of medicines

1. The person responsible for decocting medicines must sign off with the person delivering the medicines on those requiring decoction and be responsible for the quantity and quality of the prescriptions received for decoction.

2. The head of the unit must conduct surprise or regular inspections of the distribution and decoction processes in healthcare facilities.

Article 9. Reporting System

1. In case of adverse events or medication errors, the healthcare facility must handle them immediately and report to the direct superior management authority.

2. Adverse drug reactions must be reported to the direct superior management authority and the National Center for Drug Information and Adverse Reaction Monitoring in accordance with the law.

3. Healthcare facilities under the Ministry of Health, other ministries (except the Ministry of Defense), and private hospitals must report traditional medicine activities annually by October 15 to the Ministry of Health (Traditional Medicine Management Department) according to the model specified in Appendix 5 issued together with this Circular and report promptly when requested.

4. Healthcare facilities in the locality, except as provided for in Clause 3 of this Article, must report traditional medicine activities annually by October 15 to the Provincial Health Department according to the model specified in Appendix 5 issued together with this Circular and report promptly when requested. The Provincial Health Department is responsible for summarizing and reporting to the Ministry of Health by November 30 each year.

Chapter IV

IMPLEMENTING PROVISIONS

Article 10. Effective Date

This Circular takes effect from April 1, 2014.

Article 11. Responsibility for Implementation

1. The officials: Director of the Ministry of Health’s Office, Director of the Traditional Medicine Management Department, Inspector General of the Ministry of Health, Heads of Departments, Directors of Provincial Health Departments, and Heads of Traditional Medicine Healthcare Facilities are responsible for implementing this Circular.

2. The Traditional Medicine Management Department is responsible for directing and coordinating with Provincial Health Departments and related agencies in supervising the implementation of this Circular.

During the implementation, if there are difficulties or obstacles, organizations and individuals are advised to promptly reflect these issues to the Ministry of Health (Traditional Medicine Management Department) for guidance and resolution./.