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Decision 2008/qd-Byt: About Issuing The Regulations Prescribe Drugs In Outpatient Treatment

Original Language Title: Quyết định 04/2008/QĐ-BYT: Về việc ban hành Quy chế kê đơn thuốc trong điều trị ngoại trú

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The decision on issuing the regulations prescribe drugs in outpatient treatment _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ MINISTER of health Medicinal pursuant to the law on June 14, 2005;
Pursuant to Decree No. 188/2007/ND-CP on December 27, 2007 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
At the suggestion of Director of Department of management of treatment-the Ministry of health, decision: article 1. Attached to this decision, "the regulations prescribe drugs in outpatient treatment".
Article 2. This regulation does not apply to the prescription drug in inpatient treatment and prescribe Oriental medicine. Article 3. This decision takes effect 15 days from the date the report. Annuls decision No 1847/2003/QD-BYT dated 28 May 2003 by the Minister of health on issuing regulations prescribe drugs and selling drugs.
Article 4. The He, she: Chief of the Department, Director of Department of management of treatment-the Ministry of health, Director of the drug administration, Chief Inspector, the Director of the hospital, the Institution has a hospital bed directly under the Ministry of health, the principal medical officer training school, Director of the provincial health department, central cities , Medical industry heads, the heads of the relevant unit, General Director of Vietnam Pharmaceutical Corporation is responsible for the implementation of this decision.

 



DEPUTY MINISTER signature (signed) Nguyen Thi Xuyen BYLAWS prescribe drugs in outpatient treatment (attached to decision No. 03/2008/QD-BYT October 2, 2008 by the Minister of health) _ _ _ _ _ _ chapter I GENERAL PROVISIONS article 1. Scope and objects 1. Prescribe, levels, sale and dispensing of drugs in outpatient treatment;
2. The examination and treatment in the clinical legal basis;
3. The person granting, selling the drug, dispensing medicine at the base hospital, base business legal drug;
4. The patient has prescriptions outpatient treatment.
Article 2. Explain the word prescriptions is legal base to sell drugs, medications, medicine processing and the use of drugs.
Article 3. The condition of people who prescribe drugs 1. In the basis of examination and treatment are legitimate medical university diploma and was the head of the facility assigned to examination and treatment;
2. for the province to have the mountains, deep, distant islands, the difficult and the unnamed doctor: the Health Department authorized in writing for the District Health Manager indicated the station's medical doctors replaced to suit the local situation. 
Article 4. Prescribed medications are prescribed according to the provisions in the drug prescription issued by the Ministry of health.
Chapter II PRESCRIPTIONS and PRESCRIPTION medications for 5. Forms and sample service prescription drug supply and drug sales, according to menu 1. The prescription: use for prescription drugs except medication addictive (annex 1 attached to this Regulation);
2. The prescription "N": use the addictive prescription (Appendix 2 attached to this Regulation);
3. Commitment to the use of morphine, ... for the sick (Appendix 3 attached to this Regulation);
4. chronic disease treatment Book (Appendix 3 attached to this Regulation);
5. examination Book (Appendix 5 attached to this Regulation);
6. Documents received by the addictive patients return (annex 6 attached to this Regulation);
7. report the implementation regulations prescribe drugs in outpatient treatment (annex 6 attached to this Regulation).
Article 6. Regulations for the prescribed prescribed Person must take responsibility for his prescription for sick people and stats make the following regulations: 1. Only prescribed medications for the disease was assigned to treatment or the disease within the scope of practice stated in the certificate of eligibility to practice by State administration authorities;
2. medication only after consultation directly;
3. Do not prescribe drugs the following cases: a) are not intended to prevent, cure;
b) unreasonable demand of the patient;
c) functional foods.
Article 7. Regulations on prescription records 1. Medication form, sample rules attached to this regulation;
2. burn enough items in the form; clearly written, easy to read, accurate; 
3. The address must accurately record the number of houses, streets or the countryside, communes;
4. With children below 72 months of age: record number of months old and named father or mother;
5. Write the name of the drug under the name international public (INN, generic name) or if credited to miscellaneous general international name in parentheses (unless smoking has many active substances);
6. Write the name of medication, the amount, amount, dosage, dosage of each medication;
7. number of addictive drugs are written with the letter, the first letter in uppercase;
8. The number of mental direction and precursor drugs used to write more zeros in front if the number has only one digit;
9. If any repair must sign, stating the full name, date of next;
10. Slash single part longer white paper. Signed, inscribed (or stamp) they name people.
Article 8. Prescription medications for chronic disease chronic disease need to specify long days treatment medication prescribed to treat chronic diseases, the number of drug users in a enough (01), or under the guidance of treatment of each disease.
Article 9. Prescription medication for tuberculosis treatment tuberculosis treatment tuberculosis treatment book or medical book, the number of days prescribed under the guidance of the national tuberculosis prevention programs.
Article 10. Medication mental direction and amount of substance use as smoking 1. For acute prescribing with enough doses do not exceed ten (10) days;
2. for patients with schizophrenia, epilepsy: prescribe drugs to treat chronic diseases, the number of days prescribed under the guidance of specialized mental treatment. Patients or health Stations, Township, Ward, the health of the body, the disease schizophrenia, epilepsy is responsible for purchasing/field and signed, specify the name of the medication level book medical Stations (sample under the guidance of the mental disciplines). The sufferer of schizophrenia have been the field themselves or not by the doctor drug treatment decisions. 
Article 11. Prescribe addictive drugs 1. Every year the basis of examination and treatment of registration signed by the person with addictive prescription drug sales base addictive;
2. Prescription medication form "N" to the base level, selling drugs, prescribed at the same time save on chronic disease treatment or consultation Windows to monitor and guide the patient use drugs;
3. Prescribe addictive drugs treat acute diseases with enough doses do not exceed seven (7) days.
Article 12. Prescription opioids to relieve pain for people with cancer and AIDS 1. Implementation of the provisions in clause 1, 2 of article 11;
2. Medical diagnosis determined people with cancer and AIDS patients chronic disease treatment book levels (designating opioids pain treatment) for the patient to serve as a basis for the unit online under specify analgesic opioids for patients;
3. The dose of opioids pain reliever analgesic needs of sick people.  Each time the specified drug not exceed one (1) month, but at the same time keep 3 for 3 treatments, each prescribed treatment not exceeding ten (10) days (specify the start and end of treatment). The prescription must guide the people sick: prescription treatment for sick people phase 2, phase 3 had been sold, while the attached confirmation of patient clinics communes, wards and towns; The time of purchase, the previous pills 1 day of treatment that (if the day is a holiday, then buy-in before the holidays); 
4. People with cancer and AIDS, the last stage is in the House, who was assigned by the authorized examination at clinics communes, wards and towns to visit and prescribe opioids for patients, each prescription does not exceed 7 days;
5. The prescription opioids requires committed patients using opioids true purpose and to be responsible before the law if the use of the drug misuse treatment for patients.
Article 13. Prescription time worth purchasing, smoking 1. Prescription drug purchase value within 5 days of prescription and be purchased in all the legal drug sales facility in the country;
2. addictive prescription buy time, smoking match day of the treatment stated in the menu. Buy, phase 2, 3 for opioids drug people with cancer and AIDS patients before 1 September of each treatment (if the day is a holiday, then buy, before the holidays) and can only be bought at drug sales base has registered prescribed person's signature or that of the Hospital where pharmacy prescription (if no local base selling addictive drug).
Chapter III The ORGANISATION Level, SELLING DRUGS And SAVE The DOCUMENT ABOUT The ADDICTIVE DRUG.
Article 14. Grassroots organization selling addictive drug by the Department of health is responsible for directing the Organization base selling addictive drug for the patient. The layout is not challenging the basis of selling addictive drugs, the hospital pharmacy must (according to the purchase price) addictive drug for the patient to ensure sufficient supply of medicines for the sick.
Article 15. Regulations for the granting, selling addictive drugs according to menu 1. Each level, selling addictive drug not so ten (10) days. The time of the sale of addictive prescription medication for burn treatments as defined in paragraph 3 of article 12;
2. The person granting, selling the medication record expiration of drugs sold on the single save (to save time tracking application) and save the full signature, indicate the name, address, identification number of the people who buy the drugs. Save more paper confirm the patient still alive of the communes, wards and clinics attached town treatment phase 2, phase 3;
3. Record the addictive drugs receive does not run out because of the patient's return. The minutes are made 2 copies (1 a save in place, sell drugs; a people filed back smoking keep). To receive the drug, preserved and processed in accordance with the provisions of the regulation on management of addictive drugs.
Article 16. Save the document on addictive drugs 1. Base treatment Root store prescription "N" in two (2) years from the date of the last page of the book used prescriptions "N"; Save the family's commitment to cancer, AIDS patients on the use of opioids in the two (2) years from the time of the final release of the year;
2. Business establishments, blending, grants, sale of addictive drug store prescriptions "N" as specified by regulations addictive drugs;

3. When the time limit save documents (original prescriptions, "N", "N" prescription, commitment of the patient on the use of addictive drugs) the unit Council cancel the document prescribed by regulations addictive drugs.
Article 17. Regulations on reporting clinical facility and level, to sell the drug under the single must periodically report and with direct management authority.