Circular 05/2016/tt-Byt: Regulations On Prescription Drugs In Outpatient Treatment

Original Language Title: Thông tư 05/2016/TT-BYT: Quy định về kê đơn thuốc trong điều trị ngoại trú

Read the untranslated law here: https://www.global-regulation.com/law/vietnam/2952773/thng-t-05-2016-tt-byt%253a-quy-nh-v-k-n-thuc-trong-iu-tr-ngoi-tr.html

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The CIRCULAR regulates prescription drugs in outpatient treatment _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 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 Director of Department of management examination and treatment, the Minister of Health issued a circular regulating about prescription drugs in outpatient treatment.
Article 1. Scope 1. This circular regulates prescription drugs in outpatient medical establishments, the healing of State and private.
2. This circular does not apply to the following cases: a) prescription medicine, prescription drug combination of traditional medicine with medicine;
b) prescription drug substance addiction treatment by alternative medicine.
Article 2. Application object 1. Doctor, nurse practice certificate examinations, (hereinafter referred to as the doctor, nurse).
2. The basis of examination and treatment by a licensed doctor, healing activities (hereinafter referred to as the base doctor, healing) and retail establishments are eligible certificate of business (hereinafter referred to as the drug retail establishments).
3. The patient and the patient's outpatient prescriptions.
Article 3. Prescribed for the prescription drugs 1. Doctor.
2. Nurse prescription drugs when meets the following conditions: a) Are practice examinations, cure and are working at the base hospital, healing the State's District lines or stations y tẽ communes, wards and towns, health authorities, schools (hereinafter referred to as communal clinics);
b) Must have text assigned by the head of the base doctor, cure online district assigned doctor, cure according to the hierarchy of local health managers.
3. The doctor, the nurse at the medical stations allowed Township prescribe drugs for the disease in the corresponding specialty examination scope, General healing are decided within the expertise of the medical station and township of doctor, nurse.
4. In the case of emergency diseases that have yet to catch up with the admission procedures, the prescription of any specialties (including traditional medicine) are medication to handle emergencies consistent with the status of the disease.
Article 4. Medication guidelines 1. Only prescription medication after the examination, diagnosis of the disease.
2. Prescribe appropriate medications with diagnosis and severity of disease.
3. The number of prescription follow guide diagnosis and treatment of the Health Ministry or the full use of the maximum 30 (thirty) days, unless otherwise specified in articles 7, 8 and 9 of this circular.
4. the nurse is not medication coordinated form products containing the active substance, drug product format combined contain active ingredient and drug product mental direction form coordination containing no precursor in non-prescription drugs catalogue by the Minister of health.
5. Not to be listed on the prescription: a) The drugs, substances not intended to prevent, cure;
b) these drugs have not been allowed to circulate in Vietnam;
c) functional foods;
d) cosmetics.
Article 5. Medication form 1. Medication for the patient to the doctor at the base hospital, healing: The medication taken medication for a patient on prescription according to the form prescribed in annex No. 1 or consultation Windows according to the form prescribed in annex No. 2 attached to this circular and write the name of the drug content, quantity, number of days used in the consultation Book of medical facility, healing.
2. Prescribe drugs for patients outpatient treatment: medication out specified drug treatment in hospital outpatient treatment of sick people at the same time prescribe (star treatment) on the shared examination of the patient according to the form prescribed in annex No. 2 or Window treatment need lengthy treatment of the sick according to the form prescribed in annex No. 3 attached to this circular.
3. Prescribe drugs for people with the disease continue to outpatient treatment soon after the end of the inpatient treatment: a) the case of the medication patient prognosis to just continue using the drug from 1 (a) to 7 (seven) days shall prescribe the drug (treatment) on hospital inpatient treatment at the same time prescribe (star treatment) on the shared examination or Window treatment need lengthy treatment of sick people.
b) case of the medication patient prognosis should continue treatment on 7 (seven) days must then move to outpatient treatment (hospital outpatient) immediately after the end of treatment, the medication taken under the provisions of Paragraph 2 of this Article.
4. addictive prescription drugs and precursors under the mental direction made under the provisions of articles 7, 8 and 9 of this circular.
Article 6. General requirements to prescribe drugs 1. Write clearly and accurately enough, the items in the form of drugs or in consultation or Window treatment should treat the long days of sick people.
2. Write the address exactly where sick people are permanent or temporary stay: House number, street, city or Hamlet, Hamlet, a, communes, wards and towns.
3. for children below the age of 72, then you have to write, write the name and age of the child's mother or father.
4. Write the name of the drug under the name international public (INN, generic) except where the drug has many active substances. The case added to the name of the drug under the trade name are listed in parentheses after the trade name international.
For example: for the drug Paracetamol-Written under the name international joint drug name: Acetaminophen 500 mg.-drug name record cases under the trade name: Paracetamol 500 mg (Hapacol or Biragan or Efferalgan or Panadol, ...)
5. Write the name of the drug, the concentration/amount, amount, dosage, use, time of use of each drug.
6. number of addictive drugs are written with the letter, the first letter capitalized.
7. The amount of the drug: write more zeros in front if the number has only one digit (less than 10).
8. in case of repair the prescription must sign right next to the content of this page.
9. Slash paper section space from the bottom of the prescribed content to the top of the signature of the prescription; signed, inscribed (or stamp) they name people.
Article 7. Prescribe addictive drugs 1. Prescribed on the prescription "N" in the form prescribed in annex No. 4 attached to this circular and made into a 3:1 prescription "N" save the base doctor, healing; 1 prescription "N" save in the examination or treatment of Window treatment on the patient's long; 1 prescription "N" save at the facility level, selling drugs with the base's Hospital, healing. The case of the sale of drugs, patient base key, healing medication does not need the seal of the medical facility, healing it.
2. Medication treatment of acute drug use amount does not exceed the 7 (seven) days.
3. where the prescribed addictive drugs, the guidelines prescribe the patient or the patient's home (in case the patient cannot come to the base doctor, cure or sick person without capacity for civil acts full) written commitment to use addictive drugs. Commits are written according to the form prescribed in annex No. 5 attached herewith, be made into 2 a alike, including: 1 a save at the base hospital, healing, 1 a delivery to the patient or the patient's home.
4. The base doctor, healing must list the sample signature of the addictive prescription of his base to send the relevant parts in the base doctor, cure is known.
Article 8. Prescription drugs to ease the pain for people with cancer or AIDS 1. Basis of examination and treatment when determining the diagnosis of cancer or AIDS patients to outpatient treatment for people with the disease and the treatment Window level treatment on long. The patient's Guide to prescription or the patient's commitment to using addictive drugs for sick people to commit in page 2 Window treatment should cure (the content is committed to the provisions in annex No. 5 attached to this circular).
2. addictive dose for pain relief are prescribed according to the patient's pain relief needs, each time specifying the drugs up to 30 (thirty) days, but at the same time keep 3 for 3 consecutive treatment, each for a prescribed treatment does not exceed 10 (ten) days (specify the start and end of treatment).
3. where the prescribed addictive drugs to ease the pain for people with cancer or AIDS last stage located at home (sick people unable to visit the base doctor, healing): the patient must have the certificate of the Chief station for clinics where patients township residents identified the patient should continue to treat the pain with medication addictive according to the form prescribed in annex No. 6 attached to this circular to make bases for doctors in medical establishments and treatment medication, each prescription, the number of drug use do not exceed 10 (ten) days.
Article 9. Mental direction and prescribe drugs precursors 1. Prescribed on the prescription "H" in the form prescribed in Appendix No. 7 attached to this circular and made into 3 a in which: 1 prescription "H" to save the base doctor, healing; 1 prescription "H" in the patient Window or Window treatment need lengthy treatment of the patient; 1 prescription "H" at the facility level, selling drugs with the base's Hospital, healing. The case of the sale of drugs, patient base key, healing medication does not need the seal of the medical facility, healing it.
2. for acute diseases: prescription medication use quantities do not exceed 10 (ten) days.
3. For diseases treatment (chronic diseases): prescribe drugs under the guidance of diagnosis and treatment of the Ministry of health or prescription drug use numbers up to 30 (thirty) days.
4. For people with mental illness, epilepsy: a) prescribe drugs under the guidance of diagnosis and treatment of geriatric;
b) the sick person or the staff clinics where patients township residents are responsible to allocate, and signed, specify the name of the medication level book medical stations (sample under the guidance of a specialist);
c) the mentally ill have been drug or not because the field of self medication decision for each case.
Article 10. Prescription of medical establishments, there are healing applications of information technology in medication

1. Prescriptions on the computer once, then print out and sign the prescription, charged for sick people to save in a 1st consultation Window or in the treatment of long-day treatment of sick people.
2. The prescription "N" made in accordance with paragraph 1 article 7 of this circular and the prescription "H" made in accordance with paragraph 1 article 9 of this circular: printed 03 prescription corresponding to a single store.
3. Prescription "N" as defined in clause 2 article 8 this circular: printed 06 prescription a respectively for the 3 treatments per patient, including: 1 a respectively 3 treatments in hospital outpatient treatment of the patient; 3 the corresponding version 3 treatment given to a patient or the patient's home.
4. The base doctor, cure has the application of information technology to ensure the Save menu to data extraction when necessary.
Article 11. The time limit for prescriptions worth buying, smoking 1. The prescription drug, purchase value within a maximum of 5 days from the date of prescription.
2. The prescription to be bought at retail establishments nationwide legal drugs.
3. time to buy or the field of addictive prescription match day of the treatment stated in the menu. Buy or addictive drugs field phase 2 or phase 3 for people with cancer and AIDS patients before 01 (one) to 3 (three) days of each treatment (if on holidays, new year, Saturday, Sunday, the purchase or on the adjacent field before or after the holidays).
Article 12. Return the smoking addictive, mental direction and precursor drugs do not use or use not out 1. The patient or the patient's home to return the addictive drug, mental direction and drug precursors do not use or do not use most of the facility was granted or sold drugs.
2. Basis of the sale or supply of drugs established thereon received smoking addictive, smoking mental direction and precursor because the patient or the patient's return home according to the form prescribed in annex No. 8 attached to this circular. The minutes are made in 2 copies (1 a-level or place in medicine, 1 a the return of drugs).
3. Smoking causes addiction, mental direction and precursor drugs get back to, and processed in accordance with the provisions of the law on pharmacy.
Article 13. Save menu, documentation about the addictive drug, mental direction and precursor drugs used as medicines, prescriptions have listed antibiotics 1. The base doctor, cure save the save time prescription 1 (one) year from the date of prescription.
2. The base doctor, cure save the prescription "N", committed to paper using addictive drugs for the patient and the prescription of "H", the 2 (two) years, since expired medication use.
3. Basis of preparation, levels, addictive drug retail, drug money and the fluid direction the entire prescription "N" prescription, "H", the 2 (two) years, since expired medication use.
4. blending facility, level, retail drug store prescriptions have listed antibiotics during 1 (one) year from the date prescribed, the application can do one of the following forms: a) Save the original or a copy of the prescription;
b) stores information about prescriptions include: the name and address of the facility, healing, and the name of the medication, the patient's full name, permanent address of the patient, the name of antibiotics, the amount of content.
5. Upon expiry of document about smoking addictive, smoking mental direction and precursor, facility established the Council to cancel the document as specified in circular No. 19/2014/TT-BYT on June 2, 2014 addictive medication management rules, mental direction and precursor drugs used as medicines. Cancellation documents include: prescription "N"; The prescription "H"; Commitment to using addictive drugs for the sick; Addictive drugs received thereon; Confirmation should continue to treat the pain with medication addictive by the medical Stations (if available).
Article 14. Implementation 1. Examination administration, healing-the Ministry of health is responsible for guiding the Organization, deployment, testing, reviews the implementation of this circular.
2. the Department of health, the central cities, health ministries are responsible for: a) direction, the Organization implemented local circular, management unit;
b) testing, monitoring and evaluation of the results of the implementation of the circular in the local scope, Unit Manager;
c) directing the Organization of the addictive drug sales base for the patient. For the County, district, town, city in the province do not have the facility to sell addictive drugs, the Pharmacy Department of the local hospital must provide (in the purchase price) addictive drug for the patient to ensure sufficient supply of medicines for the sick.
d) notice for the base doctor, healing, the relevant unit in the list the base level, selling addictive drugs.
3. The base doctor, cure, drug retail establishments are responsible for: a) the implementation of the provisions of this circular.
b) get back smoking addictive, smoking mental direction and precursor because the patient or the patient's return home and proceed to destroy the drug as specified in circular No. 19/2014/TT-BYT on June 2, 2014 of the Minister of health prescribing addictive drugs management, mental direction and precursor drugs used as medicines.
c) for drugs not in the formulary does not prescribe attached to circular No. 23/2014/TT-BYT on June 30 2014 of the Minister of Health issued no prescription drug category, retail drug establishments only sold when the buyer had the prescription medications as prescribed in this circular;
d) addictive drug retail premises to sell addictive drugs to patients when prescriptions "N" are prescribed according to the provisions of article 7 and 8 of this circular.
4. Who prescribe drugs responsibly: a) the implementation of the rules on prescription drugs in this circular and take responsibility for his prescription for the disease statistics;
b) guide the use of medications, dietary advice, living mode for the patient or the patient's home; Guide to the patient or the patient's home to notify people who prescribe drugs or go to the nearest medical facility when abnormal signs after using the drug.
5. The patient and the patient's responsibility to implement the provisions of this circular.
Article 15. Effect 1. This circular is in effect from July 1, 2016.
2. decision No. 04/2008/QD-BYT October 2, 2008 by the Minister of Health issued regulations prescribe drugs in outpatient treatment expired from the date of this circular effect.
In the process, if there are difficulties and obstacles, suggest the Agency, held personal reflections about timely health (patient administration) to be considered solved./.