Thông tư 52/2017/TT-BYT đơn thuốc và kê đơn thuốc hóa dược sinh phẩm trong điều trị ngoại trú

CIRCULAR

PROVIDING FOR PRESCRIPTION OF MODERN DRUGS AND BIOLOGICALS IN OUTPATIENT TREATMENT

Pursuant to the Law on Pharmacy in 2016;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 defining Functions, Tasks, Powers and Organizational Structure of Ministry of Health;

At the request of the Director of the Administration of Medical Examination and Treatment,

Minister of Health promulgates a Circular providing for prescription of modern drugs and biologicals in outpatient treatment.

Article 1. Scope

This Circular provides regulations on prescription of modern drugs and biologicals in outpatient treatment at health facilities.

Article 2. Regulated entities

1. Doctors who possess legal practicing certificates and have registered for practice in medical examination and treatment at health facilities in accordance with regulations of the Law on medical examination and treatment.

2. Medical assistants who possess legal practicing certificates and have registered for practice at level-4 health facilities in accordance with regulations of the Circular No. 43/2013/TT-BYT dated December 11, 2013 by Minister of Health providing for division of levels of health facilities.

3. Health facilities that have unexpired licenses to provide healthcare services in accordance with regulations of the Law on medical examination and treatment.

4. Drug retailers and chief pharmacists of drug retailers as defined in the Law on Pharmacy.

5. Patients and their representatives who have prescriptions.

6. Other authorities, organizations and individuals that involved in prescription.

Article 3. Prescription forms

The following prescription forms are enclosed with this Circular.

1. Appendix I: Prescription form

2. Appendix II: Prescription form for “N” drugs (narcotic drugs)

3. Appendix III: Prescription form for “H” drugs (psychotropic drugs and precursor drugs)

Article 4. Prescription principles

1. Prescriptions are made up after having results of medical examination and diagnosis.

2. The prescription must be conformable with medical diagnosis results and the severity of illness.

3. Making up prescriptions must be safe, rational and efficient. Prescription of single-substance drugs or generic drugs is given priority.

4. Prescription must be conformable with one of the following documents:

a) Clinical guidelines on diagnosis and treatment or clinical guidelines on HIV/AIDS treatment and care promulgated or recognized by the Ministry of Health; Clinical guidelines on diagnosis and treatment formulated by health facilities in accordance with regulations in Article 6 of the Circular No. 21/2013/TT-BYT dated August 08, 2013 by Minister of Health on organization and operation of drug and treatment councils in hospitals in cases where the Ministry of Health’s clinical guidelines on diagnosis and treatment are unavailable.

b) Package inserts enclosed with drugs licensed for sale.

c) National Pharmacopoeia of Vietnam;

5. The quantity of drugs in a prescription shall conform to clinical guidelines on diagnosis and treatment mentioned in Point a Clause 4 of this Article or must be enough for use up to 30 (thirty) days, except the cases mentioned in Articles 7, 8 and 9 herein.

6. If a patient has undergone medical examination at three specialties of a health facility in a day or more, the health facility’s head or his/her authorized person (head of outpatient department or clinical department) or the person in charge of prescription of the health facility shall base on medical examination results given by such specialties to make up a prescription or designate a doctor of appropriate specialty to make up a prescription for that patient.

7. Doctors and medical assistants working at level-4 health facilities may provide general medical examination and treatment and make up prescriptions for all specialties in the list of medical technical services at level-4 health facilities (which has been approved by a competent authority).

8. In case of emergencies, doctors and medical assistants mentioned in Clauses 1, 2 Article 2 herein may make up prescriptions for dealing with such emergencies according to medical state of patients.

10. The information specified in Clause 15 Article 6 of the Law on Pharmacy is not written out in prescriptions. To be specific:

a) Medicines or substances that are not used for medicinal purposes;

b) Medicines which are not licensed for sale in Vietnam;

c) Functional foods;

d) Cosmetics.

Article 5. Forms of making up prescriptions

1. Prescriptions given to patients who have medical examination and treatment at health facilities:

A prescriber shall write prescription drugs in the patient’s prescription form or medical record according to the form stated in Appendix IV enclosed herewith, and record drugs to be dispensed in health facility’s medical book or patient management software.

2. Prescription for outpatients:

A prescriber writes prescription drugs in the patient's medical record and the health facility's outpatient medical record or patient management software.

3. Prescription for patients upon the completion of inpatient treatment:

a) If a prescriber anticipates that the patient needs taking medicines for a period from 01 (one) to 07 (seven) days, the prescriber shall continue writing out prescription drugs in the patient’s prescription form or medical record and the health facility’s inpatient medical record or patient management software.

b) If a prescriber anticipates that the patient needs taking medicines for a period longer than 07 (seven) days, the prescriber shall make up prescription for that patient in accordance with regulations in Clause 2 of this Article or carry out procedures for referral of that patient to an appropriate health facility for further treatment.

4. Making up prescriptions for narcotic drugs, psychotropic drugs and precursor drugs shall be governed by the regulations in Articles 7, 8 and 9 of this Circular.

Article 6. General requirements on prescription contents

1. Clearly and exactly complete every item printed in the prescription form or medical record of the patient.

2. Exactly specify the patient's permanent or temporary address, including house number, street, residential group or hamlet/village, commune/ward/town, district, province/city.

3. Specify the child’s months of age, full name and ID or Citizen Identity Card’s number of the child's parent or guardian if patient is a child aged under 72 months.

4. Write out prescription drugs as follows:

a) Single-active ingredient drugs:

- Write drug names according to the international nonproprietary names (INN, generic);

E.g.: If drug contains 500mg of active ingredient Paracetamol, the drug name shall be written out as: Paracetamol 500mg.

- Write drug names according to the international nonproprietary names + (trade name).

E.g.: If drug contains 500mg of active ingredient Paracetamol and is known under the trade name A, the drug name shall be written out as: Paracetamol (A) 500mg.

b) For drugs containing multiple active ingredients or biologicals: their trade names shall be specified.

5. Write drug name, concentration/content, quantity/volume, dosage, administration route and time for taking each type of drug. Toxic drugs must be written out before other drugs in a prescription.

6. Specify the quantity of narcotic drugs in words with the first letter capitalized.

7. Write “0” in front of the one-digit number indicating the quantity of drug (i.e. smaller than 10).

8. Append the prescriber’s signature next to altered contents (if any).

9. Cross the blank from the bottom left of prescription contents to the top right of the prescriber’s signature; prescriber must sign and write his/her full name (or affix his/her signature stamp).

Article 7. Prescription for narcotic drugs

1. “N” prescription form is used for making up prescriptions for narcotic drugs at health facilities having patient beds and made into 03 copies: 01 copy of the “N” prescription is retained at the health facility, 01 copy is attached to the patient’s medical record and the other (which has been stamped by the health facility) is kept by the facility where prescription drugs are dispensed or sold. If prescription drugs are dispensed or sold by the health facility, the prescription does not require that health facility’s stamp.

2. The quantity of narcotic drugs in a prescription for an acute disease shall not exceed 07 (seven) days.

3. In case of prescription for narcotic drugs, the prescriber must instruct the patient or his/her representative (if the patient is unable to come the health facility or the patient is not capable of civil acts) to make a commitment on the use of narcotic drugs. This commitment is made according to the form stated in the Appendix V enclosed herewith and made into 02 copies of same contents, among which one copy is retained at the health facility and the other is given to the patient or his/her representative.

4. The health facility must prepare a list of sample signatures of prescribers for narcotic drugs and send it to relevant departments of the health facility.

Article 8. Prescription of narcotic drugs for pain relief in patients with cancer or AIDS

1. If a patient is diagnosed with cancer or AIDS, the health facility shall make outpatient medical record for that patient. The prescriber shall instruct the patient or his/her representative in completing the commitment on the use of narcotic drugs in accordance with regulations in Clause 3 Article 7 herein. Narcotic drugs shall be prescribed for use up to 30 (thirty) days provided that 03 prescriptions must be given at the same time for 03 consecutive treatment stages, in which the quantity of drugs in each prescription shall not exceed 10 (ten) days (the dates of starting and ending each treatment stage must be specified).

2. In case of prescription for narcotic drugs for pain relief in a patient with terminal cancer or AIDS at home (the patient is unable to come to the health facility): The patient must present a certificate granted by the head of medical station of commune, ward or town where the patient resides to certify that he/she needs using narcotic drugs to relieve his/her pain according to the form stated in the Appendix VI enclosed herewith, and the summarized medical record as prescribed in Point c Clause 4 Article 59 of the Law on Medical Examination and Treatment, which is granted by the health facility where the patient receives the final treatment. Doctor of the health facility having patient beds shall base on this certificate and summarized medical record to make up prescription for that patient. The quantity of narcotic drugs to be dispensed in each prescription shall not exceed 10 (ten) days.

Article 9. Prescription for psychotropic drugs and precursor drugs

1. “H” prescription form shall be used to prescribe psychotropic drugs or precursor drugs and made into 03 copies, among which 01 copy of the “H” prescription is retained at the health facility, 01 copy is attached to the patient’s medical record and the other (which has been stamped by the health facility) is retained at the facility where prescription drugs are dispensed or sold. If prescription drugs are dispensed/ sold by the health facility, the “H” prescription does not require the health facility’s stamp.

2. The quantity of drugs to be written out in a prescription for an acute disease shall not exceed 10 (ten) days.

3. With regard to diseases requiring long-term treatment (chronic diseases): The prescription shall be given in conformity with the Ministry of Health’s guidelines for medical diagnosis and treatment or with the quantity of drugs enough for use up to 30 (thirty) days.

4. Patients with mental illness or epilepsy:

a) The prescription is made up according to the guidelines for medical diagnosis and treatment of relevant specialty;

b) The patient's representative or staff of the medical station of commune, ward or town where the patient resides shall be responsible for receiving prescription drugs with signature and full name specified in the medical station’s record of drug delivery (using the form regulated by the Ministry of Health for each specialty);

c) The prescriber shall decide whether a patient with mental illness may himself/herself receive prescription drugs or not.

Article 10. Prescription in health facilities applying information technology

1. The prescription shall be made up by computer aid and saved in software of the health facility. “N” prescriptions and “H” prescriptions must be printed out and delivered to patients, and also kept by health facilities.

2. Health facilities must ensure the retention of given prescriptions for data retrieval in case of need.

Article 11. Validity of a prescription

1. A prescription shall be valid for buying/receiving drugs within 05 days from the prescription date.

2. Prescription drugs may be purchased from any licensed drug retailers nationwide.

3. The time limit for buying or receiving narcotic drugs shall correspond with the treatment stage specified in the prescription. Narcotic drugs of the second or third treatment stage of a patient with cancer or AIDS must be bought or received at least 01 (one) to 03 (three) days before each treatment stage (if such days fall into public holidays, Saturday or Sunday, prescription drugs must be bought or received in days preceding or following the day off).

Article 12. Return of unused narcotic drugs, psychotropic drugs and precursor drugs

1. Patients or their representatives must return unused narcotic drugs, psychotropic drugs or precursor drugs to the facilities dispensing or selling them. These facilities must make records of receipt of returned drugs. To be specific:

a) The facility dispensing drugs shall make record of receipt of returned drugs according to the form stated in the Appendix VII enclosed herewith. The record shall be made in 02 copies (01 copy is retained at the facility dispensing drugs and the other is delivered to the person returning drugs).

b) A drug retailer shall make record of receipt of returned drugs in accordance with regulations of the Circular No. 20/2017/TT-BYT dated May 10, 2017 by the Minister of Health elaborating some Articles on drugs and medicinal ingredients subject to special control of the Law on Pharmacy and the Government's Decree No. 54/2017/ND-CP dated May 08, 2017.

2. Returned narcotic drugs, psychotropic drugs and precursor drugs must be separately stored and handled in accordance with regulations of the Law on Pharmacy in 2016.

Article 13. Retention of prescriptions and drug-related documents

1. Health facilities must retain all prescriptions for 01 (one) year from the date on which a prescription is given.

2. Health facilities must retain “N” prescriptions, written commitments on use of narcotic drugs and “H” prescriptions for 02 (two) years from the prescription date.

3. Facilities preparing/dispersing/retailing narcotic drugs, psychotropic drugs and precursor drugs must retain all “N” prescriptions and “H” prescriptions for 02 (two) years from the drug expiration date.

4. Facilities preparing/dispersing/retailing drugs must retain prescriptions which contain antibiotics or anti-retroviral drugs for 01 (one) year from the prescription date. The retention of prescriptions shall be made in one of the following forms:

a) Retaining the original or copied prescriptions;

b) Retaining information about each prescription, consisting of: health facility’s name and address, prescriber’s full name, the patient’s full name and permanent address, names of antibiotics or anti-retroviral drugs, content, quantity, dosage and administration route.

5. When the retention period of documents about narcotic drugs, psychotropic drugs and precursor drugs, relevant facilities must establish document destruction councils in accordance with regulations of the Circular No. 20/2017/TT-BYT dated May 10, 2017 by the Minister of Health elaborating some Articles on drugs and medicinal ingredients subject to special control of the Law on Pharmacy and the Government's Decree No. 54/2017/ND-CP dated May 08, 2017. Documents to be destructed: “N” prescriptions, “H” prescriptions, written commitments on use of narcotic drugs, records of receipt of returned narcotic drugs, Certificates certifying that patients needs using narcotic drugs for pain relief made by medical stations of communes, wards or townlets (if any).

Article 14. Implementation

1. The Administration of Medical Examination and Treatment affiliated to the Ministry of Health and shall assume responsibility to instruct, organize, inspect and evaluate the implementation of this Circular.

2. Departments of Health of provinces or central-affiliated cities and health agencies of Ministries/regulatory bodies shall:

a) Instruct and organize the implementation of this Circular within their management regions;

b) Inspect and evaluate the implementation of this Circular within their management regions;

3. Health facilities and drug retailers shall:

a) Implement regulations herein;

b) Receive narcotic drugs, psychotropic drugs and precursor drugs returned by patients or their representatives, and handle them in accordance with regulations of the Circular No. 20/2017/TT-BYT dated May 10, 2017 by the Minister of Health elaborating some Articles on drugs and medicinal ingredients subject to special control of the Law on Pharmacy and the Government's Decree No. 54/2017/ND-CP dated May 08, 2017.

c) Drug retailers are only allowed to sell drugs which are not in the list of OTC drugs enclosed to the Circular No. 07/2017/TT-BYT dated May 03, 2017 by the Minister of Health on promulgation of the list of OTC drugs to buyers who are given with prescriptions as referred to in this Circular;

d) Narcotic drug retailers must sell narcotic drugs to patients when they have “N” prescriptions as referred to in Articles 7 and 8 of this Circular.

4. Prescribers shall:

a) Implement regulations on prescription in this Circular and assume responsibility for their prescriptions given to patients;

b) Provide instructions for use of drugs, advice on diet and daily activities to patients or their representatives; request the patients or their representatives to immediately inform the prescribers or nearest health facilities when patients have any abnormal signs or symptoms after taking medicines.

5. Patients and their representatives must comply with regulations in this Circular.

Article 15. Effect

1. This Circular shall come into force from March 01, 2018.

2. The Circular No. 05/2016/TT-BYT dated February 29, 2016 on prescription for outpatient treatment shall be null and void from the date of entry into force of this Circular.

Article 16. Terms of reference

In case the legislative documents and regulations cited in this Circular are changed or replaced, the new ones shall apply.

Article 17. Responsibility for implementation

Chief of the Ministry's Office, Chief Inspector of the Ministry, General Directors/ Directors of Departments affiliated to the Ministry of Health, Directors of Departments of Health of provinces or central-affiliated cities, heads of relevant agencies/ organizations and relevant individuals shall be responsible for implementing this Circular.

Difficulties that arise during the implementation of this Circular should be promptly reported to the Ministry of Health (via the Administration of Medical Examination and Treatment) for consideration./.

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