Circular 05/2014/tt-Byt: Regulating The Medicinal Use Of Herbs, Traditional Medicine In The Medical Facility, Healing

Original Language Title: Thông tư 05/2014/TT-BYT: Quy định việc sử dụng dược liệu, vị thuốc y học cổ truyền trong các cơ sở khám bệnh, chữa bệnh

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The CIRCULAR stipulated the use of medicinal herbs of traditional medicine in the medical facility, the cure _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ pursuant to Decree No. 63/2012/ND-CP on August 31, 2012 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
At the suggestion of the Director of medical management, traditional herbal medicine;
The Minister of Health issued a circular regulating the medicinal use of herbs, traditional medicine in the medical facility, healing.
Chapter I GENERAL PROVISIONS article 1. Scope this circular regulates the use of medicinal herbs, traditional medicine (hereinafter referred to as the drug) in the base doctor, healing.
Article 2. Explanation of terms In this circular, the terms below are interpreted as follows: 1. Medicinal herbs are medicinal ingredients of natural origin from animal, vegetable or mineral.
2. The traditional medicine (also called Oriental Medicine) is the medicinal herbs are processed, manufactured according to the reasoning of traditional medicine is used to prevent and cure disease.
Chapter II the QUALITY of MEDICINAL HERBS, HERBS for TRADITIONAL medicine article 3. The quality of medicinal herbs, traditional medicine 1. Must reach the prescribed quality standards: for medicinal herbs according to the current Pharmacopoeia regulations (if any) or by standard basis by the construction unit.
2. On packaging, packaging labels need to comply with the prescribed drug label instructions of the Health Ministry.
Article 4. Quality control of medicinal herbs, traditional medicine 1. The medicinal herbs of traditional medicine are offered on the basis of consultations, healing must have the vote tested or certified copies of test results.
2. The medicinal herbs, traditional medicine must be checked, enter through the check of the hospital Council or controller type of medical facility, healing others. Medicinal herbs, traditional medicine is only included in the base doctor, cure disease when satisfactory quality. The test results must be recorded on the check book import batches according to the form prescribed in annex 1 attached to this circular.
3. Enter the Control Board in the hospital performed as specified in circular 22/2011/TT-BYT on June 10, 2011 Ministry of Health regulates the organisation and operation of Hospital Pharmacy; Check parts imported by the head of the base doctor, healing others decided to set up a minimum charge include pharmacy, accounting, supply officer, storekeeper.
4. The head of the base doctor, cure has the responsibility to inspect periodically for at least 3 months and unscheduled inspections when needed on the quality of medicinal herbs of traditional medicine in the medical facility, healing. After the check to set the minutes.
5. where there is doubt about the quality of medicinal herbs, traditional medicine, the head of the base doctor, healing must check and when it is necessary to send the form to the relevant authorities for testing. Only to be used after the test results, quality standards.
Article 5. Regulations on the preservation of medicinal herbs, traditional medicine 1. Warehouses for preservation of medicinal herbs, traditional medicine must ensure the following conditions: a) Sufficient area, ventilation, safe, convenient for export, import and transport;
b) ceiling, wall, roof shed should be building design ensure sanitation, ventilation, dry, there is enough light, the warehouse must be high enough, flat, smooth;
c) against the invading species of insects, rodents and other invasive animal species; prevent the growth of mold, termites;
d) deployed to areas of work as: reception area, conservation area, separate storage area, the region exported medicinal herbs, herbs for traditional medicine. The medicinal herbs of traditional medicine that contains essential oils must be stored in sealed packaging to avoid absorption into other items.
2. a) has equipment reviews, shelf to medicinal herbs, herbs of traditional medicine, not to medicinal herbs, traditional medicine in direct contact with the ground; between the shelves to have about ways to facilitate cleaning and unloading;
b) Have means suit for shipping;
c) Warehouse has enough equipment to preserve medicinal herbs, traditional medicine such as exhaust fans, conditioner, dehumidifier, thermometers, humidity design;
d) the equipment used to monitor the condition of preservation must be periodically calibrations;
DD) controlled relative humidity not exceeding 70%;
e) have adequate equipment for the Fire Department, fire under the provisions of the law.
3. preservation activities a) sacks, crates must have labels and to the right category, must be streamlined ensure ventilation;
b) ensuring hygiene warehouses;
c) Have full books system for tracking records the import, processing, the standard basis of medicinal herbs, traditional medicine according to the form prescribed in Appendix 2 and Appendix 3 attached to this circular;
d) quality tracking, unlimited use, medicinal herbs and the traditional medicine regularly; When signs do not guarantee the quality, have to stay separate areas.
Chapter III article 6 MANUAL. Drug user guide 1. Medications used for patients who need to ensure the following requirements: a) are processed in accordance with the regulations of the Ministry of health;
b) combining medicinal herbs, herbs for traditional medicine article each drug must match the arguments of traditional medicine;
c) process patent for the manufacture of preparations in medical establishments; through the Science Council's (if any) and the head of the base doctor, healing;
d) collaboration in accordance with the form of the drug used, there is no adverse interaction;
DD) not abuse drugs.
2. Recording specify smoking follow prescribed prescription medicine.
3. selecting the way to use based on the patient's condition, level of Pathology, characteristics and properties of the drug for medical use appropriate commands output.
4. unwanted effects of medications (if any) are recommended for nursing care and the patient (or the patient's family).
5. for toxic medicinal use as drugs: a) To tight control of dosage, use objects, road users and must be processed in accordance with the regulations of the Ministry of health;
b) is indicated in treatment necessarily have the consultations, advice and follow-up of the physician.
Article 7. Excellent organization and allocate drugs 1. Depending on the condition of each patient base, healing, Pharmacy or medicine or traditional departments responsible, best medications to use for sick people.
2. Against the mistaken identity when conducting drug: into the elevator, the warm colors, the votes, the canister before and after drug identity; must have distinct arrangements price Cabinet yet, smoking is bad, sharp has done best.
3. the broadcasting organization of daily medication and supplement pills under the y command. Timely to ensure the medications the patient is taking the drug.
4. Person responsible for the decoction must have the level of expertise on traditional medicine from intermediate upwards, are continuously updated knowledge about medicinal herbs, traditional medicine.
5. import Windows every day to record the number of elevators received medication, were delivered and the remainder of the day according to the form prescribed in Appendix 3 attached to this circular.
6. Where colors smoking must ensure clean, tidy.
7. Best Way smoking made in accordance with decision 26/2008/QD-BYT on July 22, 2008 on the issuing of technical process of traditional medicine.
8. the filter must be done to remove outstanding Drug residue and residue.
9. With regard to the drugs that contain medicinal herbs of traditional medicine have toxicity: after having brilliantly done, excess drugs to save individual patients for at least 24 hours since the medications for the patient to recover save when necessary.
Article 8. Controlled drug, allocated 1. The person in charge of the drug must sign with outstanding delivery of smoking the drug needs and responsible for the ladders of number of drugs as well as the quality of the drug received.
2. Unit heads held unscheduled or recurring test allocation, colors in the base doctor, healing.
Article 9. Report mode 1. In the event of complications, confusion about the use of drugs, medical facility, healing must handle immediately and report about the superior administration directly.
2. The report of harmful drug reactions about the superior authority directly and the National Center of drug information and monitoring of harmful reaction of the drug as prescribed by law.
3. The basis of examination and treatment in the Health Ministry, in the other sets (except Defense) and private hospitals of traditional medicine work reports periodically every year to the Ministry of health (health care administration, traditional herbal medicine) before 15/10 according to the model specified in annex 5 attached to this circular and irregular reports when requested.
4. The base doctor, cure on the area, except in the case prescribed in clause 3 of this traditional pharmacy work report periodically on the Department of health, the central cities before 15/10 according to the model specified in annex 5 attached to this circular and irregular reports when requested. The Department of health are responsible for synthesis and reports on previous Health Ministry on November 30 annually.
Chapter IV the TERMS OF IMPLEMENTATION of article 10. Effective enforcement of this circular effect since 1 April 2014.
Article 11. Responsibility 1. The he, she: Chief of the Department, Director of medical management, traditional Medicine, Chief Inspector of the Ministry, General Director, Director, Director General, Ministry of health, Director of the provincial health department, central cities and heads of health sectors, the head of the base doctor, healing with traditional medicine is responsible for implementation of this circular.
2. Medical administration, traditional Medicine is responsible for directing, coordinating with the provincial health department, central cities and other agencies involved in testing, monitoring the implementation of this circular.
In the process if there are difficulties and obstacles, suggest the Agency, organization or individual should reflect timely Health Ministry (health care administration, traditional herbal medicine) for guidance, consider resolve./.