Circular No. 52/2017/TT-BYT promulgates the Circular on prescription forms and the issuance of chemical drugs and biological products prescriptions for outpatient treatment.

CIRCULAR

PROVISIONS ON PRESCRIPTIONS AND THE ISSUE OF PRESCRIPTIONS FOR CHEMICAL DRUGS AND BIOPRODUCTS IN OUTPATIENT TREATMENT

Pursuant to the Drug Law of 2016;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of Medical Examination and Treatment,

The Minister of Health issues this Circular prescribing provisions on prescriptions and the issue of prescriptions for chemical drugs and bioproducts in outpatient treatment.

Article 1. Scope of Regulation

This Circular prescribes provisions on prescriptions and the issue of prescriptions for chemical drugs and bioproducts in outpatient treatment at medical examination and treatment facilities. (hereinafter referred to as issuing prescriptions).

Article 2. Applicability

1. Physicians who have a practice certificate for medical examination and treatment and who have registered their practice at a medical examination and treatment facility in accordance with the Medical Examination and Treatment Law.

2. Medical assistants who have a practice certificate and who have registered their practice at a fourth-tier medical examination and treatment facility as prescribed in Circular No. 43/2013/TT-BYT dated December 11, 2013, issued by the Minister of Health detailing the classification of technical specialties within the medical examination and treatment system.

3. Medical examination and treatment facilities that have been granted a permit for medical examination and treatment activities in accordance with the Medical Examination and Treatment Law.

4. Retail pharmacies and persons responsible for pharmaceutical matters at retail pharmacies in accordance with the Drug Law.

5. Patients and representatives of patients holding prescriptions.

6. Other agencies, organizations, and individuals involved in prescription-related activities and issuing prescriptions.

Article 3. Prescription Forms

This Circular hereby promulgates the following prescription forms:

1. Appendix I: Prescription Form

2. Appendix II: Prescription Form "N" (Prescription form for addictive drugs)

3. Appendix III: Prescription Form "H" (Prescription form for psychotropic drugs and precursor substances)

Article 4. Principles for Issuing Prescriptions

1. Prescriptions may only be issued after obtaining examination results and making a diagnosis.

2. Prescriptions must be appropriate to the diagnosis and severity of the disease.

3. The issuance of prescriptions must achieve safety, rationality, and effectiveness. Priority should be given to single-component drugs or generics.

4. The issuance of prescriptions must comply with one of the following documents:

a) Diagnosis and treatment guidelines or HIV/AIDS care and treatment guidelines issued or recognized by the Ministry of Health; diagnosis and treatment guidelines established by medical examination and treatment facilities in accordance with Article 6 of Circular No. 21/2013/TT-BYT dated August 8, 2013, issued by the Minister of Health regarding the organization and operation of the Hospital Pharmacy and Treatment Council in cases where there are no diagnosis and treatment guidelines issued by the Ministry of Health.

b) Medication usage instructions accompanying drugs that have been approved for circulation.

c) The National Pharmacopoeia of Vietnam.

5. The quantity of drugs prescribed shall be carried out in accordance with the diagnosis and treatment guidelines specified in Point a Clause 4 of this Article or sufficient for use but not exceeding thirty days, except in cases stipulated in Articles 7, 8, and 9 of this Circular.

6. For patients requiring consultation from three or more specialties in one day, the head of the medical examination and treatment facility or a person authorized by the head of the medical examination and treatment facility (head of the outpatient department, head of the clinical department) or a specialist in charge of the medical examination and treatment facility shall review the examination results from the relevant specialties and either issue the prescription themselves or assign a physician with the appropriate specialty to issue the prescription for the patient.

7. Physicians and medical assistants at fourth-tier medical examination and treatment facilities are permitted to conduct general medical examinations and treatments and issue prescriptions for all specialties within the fourth-tier technical scope (technical scope of the medical examination and treatment facility which has been approved by the competent authority).

8. In emergency situations involving patients, physicians and medical assistants as prescribed in Clauses 1 and 2 of Article 2 of this Circular shall issue prescriptions for emergency treatment that are appropriate to the patient's condition.

10. It is prohibited to include in prescriptions the contents specified in Clause 15, Article 6 of the Drug Law, specifically:

a) Drugs and substances not intended for disease prevention or treatment;

b) Drugs not legally approved for circulation in Vietnam;

c) Nutritional supplements;

d) Cosmetics.

Article 5. Form of Prescription

1. Prescription for patients seeking medical examination at healthcare facilities:

The person issuing the prescription shall record the prescription on the Prescription form or the patient's medical record book (medical passport) according to the model prescribed in Appendix IV issued together with this Circular and the medical examination tracking number or the patient management software of the healthcare facility.

2. Prescription for outpatients:

The person issuing the prescription shall issue treatment instructions in the patient's medical record book (medical passport) and outpatient treatment medical records or the patient management software of the healthcare facility.

3. Prescription for patients immediately after completing inpatient treatment:

a) In cases where the patient is expected to continue using medication from 01 (one) to 07 (seven) days, the prescription (treatment instruction) shall be continued on the Prescription form or the patient's medical record and the inpatient treatment medical record or the patient management software of the healthcare facility.

b) In cases where the patient is expected to continue treatment for more than 07 (seven) days, the prescription shall be made in accordance with Clause 2 of this Article or referred to another suitable healthcare facility for continued treatment.

4. Prescription for addictive drugs, psychotropic drugs, and precursor drugs shall be implemented in accordance with Articles 7, 8, and 9 of this Circular.

Article 6. General Requirements for Prescription Content

1. Record all items printed in the Prescription form or in the patient's medical record clearly and accurately.

2. Record the address of the patient's place of permanent or temporary residence: house number, street, residential ward or village/hamlet/commune, district/town/city, province/city.

3. For children under 72 months old, record their age in months, and record the name and identification card number or citizen identity card number of the father or mother or guardian of the child.

4. Prescribe medications according to the following rules:

a) Medication with one active ingredient

- By the international nonproprietary name (INN, generic);

Example: If the active ingredient is Paracetamol with a dosage of 500mg, the drug name should be recorded as follows: Paracetamol 500mg.

- By the international nonproprietary name + (trade name).

Example: If the active ingredient is Paracetamol with a dosage of 500mg and the trade name is A, the drug name should be recorded as follows: Paracetamol (A) 500mg.

b) Medication with multiple active ingredients or medical products, record by the trade name.

5. Record the drug name, concentration/dosage, quantity/volume, dose, route of administration, and time of administration for each type of drug. If the prescription includes toxic drugs, they must be recorded before other drugs.

6. The quantity of addictive drugs must be written in words, with the first letter capitalized.

7. If the quantity of a drug is a single digit (less than 10), write a zero before it.

8. In case of corrections to the prescription, the prescriber must sign next to the corrected content.

9. Cross out any blank space on the paper from below the prescription content to above the prescriber's signature, from top to bottom and left to right; sign and write (or stamp) the prescriber's full name.

Article 7. Prescription for Addictive Drugs

1. The "N" Prescription form is used to prescribe addictive drugs at healthcare facilities with hospital beds and is made in three copies: 01 "N" Prescription form retained at the healthcare facility; 01 "N" Prescription form retained in the patient's medical record book; 01 "N" Prescription form (with the seal of the healthcare facility) retained at the pharmacy supplying the drug. In cases where the drug is supplied by the prescribing healthcare facility itself, there is no need for the seal of that healthcare facility.

2. Prescription for addictive drugs for acute treatment shall not exceed a quantity sufficient for 07 (seven) days of use.

3. When prescribing addictive drugs, the prescriber shall guide the patient or the representative of the patient (in cases where the patient cannot attend the healthcare facility or does not have full civil capacity) to write a commitment to use the addictive drug. The commitment shall be written according to the model prescribed in Appendix V issued together with this Circular, made in two identical copies, of which: 01 copy is retained at the healthcare facility, 01 copy is given to the patient or the representative of the patient.

4. Healthcare facilities must establish a list of sample signatures of prescribers of addictive drugs from their own facility and send it to relevant departments within the healthcare facility for their knowledge.

Article 8. Prescription for narcotic drugs to relieve pain for cancer patients or AIDS patients

1. Medical examination and treatment facilities, upon diagnosing a cancer patient or an AIDS patient, shall issue an outpatient treatment medical record for the patient. The prescriber shall guide the patient or the representative of the patient to write a commitment on the use of narcotic drugs in accordance with Clause 3, Article 7 of this Circular. Each prescription shall be valid for a maximum of thirty (30) days, and must simultaneously include three (3) prescriptions for three consecutive treatment periods, each not exceeding ten (10) days (clearly stating the start and end dates of each treatment period).

2. In cases where a prescription for narcotic drugs to relieve pain for terminal cancer patients or AIDS patients who are at home and unable to visit a medical facility: The patient must have a confirmation letter from the head of the commune health station where the patient resides, confirming that the patient requires continued pain relief treatment using narcotic drugs according to the model specified in Appendix VI attached to this Circular, along with a summary of the medical record file according to Point c, Clause 4, Article 59 of the Law on Medical Examination and Treatment from the last medical facility treating the patient, as a basis for the doctor at the medical facility with inpatient beds to prescribe the drug; each prescription shall not exceed ten (10) days of medication usage.

Article 9. Prescription for psychotropic drugs and precursor chemicals

1. The "H" prescription is used to prescribe psychotropic drugs and precursor chemicals and consists of three copies: One copy of the "H" prescription is kept by the medical examination and treatment facility; one copy of the "H" prescription is kept in the patient's medical record book; one copy of the "H" prescription is kept at the drug dispensing and selling facility with the stamp of the medical examination and treatment facility. In cases where the drug dispensing and selling facility is the same as the medical examination and treatment facility that issued the prescription, there is no need for the stamp of the medical examination and treatment facility.

2. For acute diseases: Prescribe a quantity of drugs not exceeding ten (10) days of usage.

3. For chronic diseases requiring long-term treatment: Prescribe drugs according to the diagnostic and treatment guidelines of the Ministry of Health or prescribe a quantity of drugs not exceeding thirty (30) days of usage.

4. For mental illness patients and epilepsy patients:

a) Prescribe drugs according to the diagnostic and treatment guidelines of the specialty.

b) The patient's representative or staff of the commune health station where the patient resides shall be responsible for collecting the drugs and signing their full name in the commune health station's drug distribution ledger (according to the model provided by the Ministry of Health for each specialty).

c) The prescriber decides whether a mentally ill patient can collect their own drugs or not.

Article 10. Prescription by medical examination and treatment facilities applying information technology

1. The prescription is entered into a computer once and stored in the software at the medical examination and treatment facility. For "N" prescriptions and "H" prescriptions, they must be printed out for the patient and kept at the medical examination and treatment facility.

2. Medical examination and treatment facilities must ensure the storage of prescriptions to extract data when necessary.

Article 11. Validity period of prescriptions for purchasing and collecting drugs

1. A prescription is valid for purchasing or collecting drugs within a maximum of five (5) days from the date of issuance.

2. Prescriptions can be purchased from legitimate retail pharmacies nationwide.

3. The time for purchasing or collecting narcotic drugs should align with the treatment period indicated on the prescription. For the second or third treatment period of cancer patients and AIDS patients, purchase or collection should occur one (1) to three (3) days before each treatment period (if it falls on a public holiday, Saturday, or Sunday, then purchase or collection should take place on the nearest working day before or after the holiday).

Article 12. Returning Narcotic Drugs, Psychotropic Substances, and Precursors Due to Non-use or Incomplete Use.

1. The patient or the representative of the patient must return unused or partially used Narcotic Drugs, Psychotropic Substances, and Precursors to the entity that issued or sold the drugs. The entity shall record the returned drugs as follows:

a) For entities issuing drugs, the record of returned drugs shall be made according to the form prescribed in Appendix VII attached to this Circular. The record shall be made in two copies (one copy retained at the issuing entity, one copy given to the person returning the drugs).

b) For retail drug sellers, the record of returned drugs shall be made in accordance with Circular No. 20/2017/TT-BYT dated May 10, 2017, issued by the Minister of Health detailing certain provisions of the Drug Law and Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government on Narcotic Drugs, Psychotropic Substances, and Precursors under special control.

2. Returned Narcotic Drugs, Psychotropic Substances, and Precursors shall be stored separately and handled in accordance with the provisions of the Drug Law 2016.

Article 13. Retaining Prescriptions and Documents Related to Drugs.

1. Medical examination and treatment facilities, compounding entities, and drug dispensing entities shall retain prescriptions for all drugs requiring prescriptions for a period of one year from the date of issuance.

2. Medical examination and treatment facilities shall retain Prescription "N", the Patient's Commitment to Use Narcotic Drugs, and Prescription "H" for a period of two years from the date of issuance.

3. Compounding entities, dispensing entities, and retail sellers of Narcotic Drugs, Psychotropic Substances, and Precursors shall retain all Prescription "N" and Prescription "H" for a period of two years from the expiration date of the drugs.

4. Compounding entities, dispensing entities, and retail sellers of drugs shall retain prescriptions containing antibiotic and antiviral medications for a period of one year from the date of issuance. The retention may be carried out in one of the following forms:

a) Retaining the original or a copy of the prescription;

b) Retaining information about the prescription including: name and address of the medical examination and treatment facility, name of the prescriber, patient's name, patient's permanent address, name of the antibiotic or antiviral medication, dosage, quantity, route of administration.

5. When the retention period for documents related to Narcotic Drugs, Psychotropic Substances, and Precursors expires, the entity shall establish a Committee to destroy the documents in accordance with Circular No. 20/2017/TT-BYT dated May 10, 2017, issued by the Minister of Health detailing certain provisions of the Drug Law and Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government on Narcotic Drugs, Psychotropic Substances, and Precursors under special control. The destroyed documents include: Prescription "N"; Prescription "H"; Commitment to Use Narcotic Drugs for Patients; Record of Returned Narcotic Drugs; Confirmation of the need for continued pain relief treatment using Narcotic Drugs from the Commune Health Station (if applicable).

Article 14. Implementation Organization

1. The Department of Medical Examination and Treatment under the Ministry of Health is responsible for guiding, organizing implementation, inspecting, and evaluating the implementation of this Circular.

2. Provincial Departments of Health under the central government, health departments of ministries and sectors shall have the responsibility to:

a) Directing and organizing the implementation of this Circular within their jurisdiction or unit.

b) Inspecting, auditing, and evaluating the implementation results of this Circular within their jurisdiction or management unit.

3. Medical examination and treatment facilities and retail drug sellers shall be responsible for:

a) Implementing the provisions of this Circular.

b) Accepting the return of Narcotic Drugs, Psychotropic Substances, and Precursors from patients or their representatives and handling the drugs in accordance with Circular No. 20/2017/TT-BYT dated May 10, 2017, issued by the Minister of Health detailing certain provisions of the Drug Law and Decree No. 54/2017/NĐ-CP dated May 8, 2017, of the Government on Narcotic Drugs, Psychotropic Substances, and Precursors under special control.

c) For drugs not included in the List of Over-the-Counter Medicines issued together with Circular No. 07/2017/TT-BYT dated May 3, 2017, issued by the Minister of Health, retail drug sellers may only sell such drugs when the buyer has a prescription in accordance with this Circular.

d) Retail sellers of Narcotic Drugs must sell Narcotic Drugs to patients based on Prescription "N" issued in accordance with Articles 7 and 8 of this Circular.

4. Prescribers shall have the responsibility to:

a) Implement the prescription regulations stipulated in this Circular and bear responsibility for prescriptions issued to patients;

b) Providing guidance on the use of drugs, nutritional advice, and lifestyle recommendations to patients or their representatives; guiding patients or their representatives to immediately inform the prescriber or visit the nearest healthcare facility if they experience any unusual symptoms after taking the drugs.

5. Patients and their representatives shall be responsible for complying with the provisions of this Circular.

Article 15. Effective Date

1. This Circular takes effect from March 1, 2018.

2. Circular No. 05/2016/TT-BYT dated February 29, 2016, on Prescription Writing for Outpatient Treatment, shall cease to be effective from the date this Circular takes effect.

Article 16. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 17. Responsibility for Implementation

The Director of the Ministry's Office, the Inspector General of the Ministry, the Director of the General Department, the Heads of Departments under the Ministry of Health, the Directors of Provincial Health Departments, and other relevant agencies, organizations, and individuals shall be responsible for implementing this Circular.

During implementation, if there are difficulties or obstacles, the agencies, organizations, and individuals concerned are requested to promptly report to the Ministry of Health (Department of Medical Examination and Treatment) for consideration and resolution./.