Decision No. 04/2008/QĐ-BYT on Issuing the Regulation on Prescribing Medicines for Outpatient Treatment

Pursuant to …;

On issuing the regulation on prescribing drugs for outpatient treatment

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THE MINISTER OF HEALTH

Pursuant to the Drug Law dated June 14, 2005;

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government 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 under the Ministry of Health,

DECISION:

Article 1. The attached Decision promulgates the "Regulation on Prescribing Drugs for Outpatient Treatment".

Article 2. This Regulation does not apply to prescribing drugs for inpatient treatment and traditional medicine prescriptions.

Article 3. This Decision takes effect fifteen days from the date of publication in the Official Gazette. It revokes Decision No. 1847/2003/QĐ-BYT dated May 28, 2003 of the Minister of Health on issuing the Regulation on Prescribing Drugs and Selling Drugs Based on Prescriptions.

Article 4. The Heads of the Ministry's Office, the Director of the Department of Medical Examination and Treatment under the Ministry of Health, the Director of the Department of Medicines, the Head of the Ministry's Inspectorate, Directors of hospitals and institutes with hospital beds under the Ministry of Health, Principals of medical staff training institutions, Directors of provincial health services under centrally governed cities, Heads of health sectors, Heads of related units, General Directors of Vietnam Pharmaceutical Corporation are responsible for implementing this Decision.

REGULATIONS

Prescribing drugs for outpatient treatment

(Issued together with Decision No. 04/2008/QĐ-BYT dated February 1, 2008)

of the Minister of Health)

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PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

1. Prescription, issuance, sale, and preparation of drugs for outpatient treatment;

2. Patients seeking examination and treatment at legally recognized healthcare facilities;

3. Persons issuing, selling, and preparing drugs at legally recognized healthcare facilities and pharmaceutical business establishments;

4. Patients with outpatient treatment prescriptions.

Article 2. Interpretation of Terms

A prescription is a legal basis for selling, issuing, and preparing drugs according to the prescription and using the drugs.

Article 3. Conditions for persons prescribing drugs

1. Practicing at a legally recognized healthcare facility with a bachelor’s degree in Medicine and assigned by the head of the facility to examine and treat patients;

2. In mountainous, remote, highland, distant island, and difficult areas where there are no doctors, the People's Committee of the province may issue a letter authorizing the Head of the Health Section of the district to designate a medical assistant at the Health Station to substitute appropriately based on local conditions.

Article 4. Prescription Required Drugs

As specified in the List of Prescription Drugs issued by the Ministry of Health.

Chapter II

PRESCRIPTIONS AND PRESCRIPTION WRITING

Article 5. Prescription form and record book for prescription writing, drug issuance, and drug sales based on prescriptions

1. Prescription: Used for writing prescriptions, except for narcotic drug prescriptions

(Annex 1 issued together with this Regulation);

2. Prescription "N": Used for writing narcotic drug prescriptions (Annex 2 issued together with this Regulation);

3. Commitment on the use of morphine, etc., for patients (Annex 3 issued together with this Regulation);

4. Chronic disease treatment record book (Annex 4 issued together with this Regulation);

5. Medical examination record book (Annex 5 issued together with this Regulation);

6. Receipt record for narcotic drugs returned by family members of patients (Annex 6 issued together with this Regulation);

7. Report on the implementation of the prescription writing regulation for outpatient treatment (Annex 7 issued together with this Regulation).

Article 6. Provisions for prescribers

The prescriber must be responsible for the prescriptions issued for patients and comply with the following provisions:

1. Only prescribe drugs for diseases within their assigned scope of examination and treatment or within the scope of practice indicated on the certificate of eligibility for practice issued by the competent authority;

2. Only write prescriptions after directly examining the patient;

3. Not to write prescriptions in the following cases:

a) Not for the purpose of preventing or treating diseases;

b) At the unreasonable request of the patient;

c) Functional foods.

Article 7. Prescription Recording Rules

1. Record prescriptions on the prescribed form or book as stipulated in this Regulation;

2. Fill in all items printed on the prescription clearly, legibly, and accurately;

3. The patient's address must be recorded accurately with house number, street, or village, commune;

4. For children under seventy-two (72) months old: record age in months and write the father’s or mother’s name;

5. Write the drug name according to the international nonproprietary name (INN, generic name), or if writing the brand name, enclose the INN in parentheses (except for drugs containing multiple active ingredients);

6. Record the drug name, dosage, quantity, dose, and method of administration for each drug;

7. The quantity of addictive drugs must be written in full letters, with the first letter capitalized;

8. The quantity of psychotropic drugs and precursors used as drugs should have a leading zero added if the quantity consists of only one digit;

9. If there are corrections to the prescription, sign and clearly write the full name and date next to the correction;

10. Cross out any blank spaces on the prescription. Sign (or stamp) the full name of the prescriber.

Article 8. Prescription for Chronic Disease Treatment

For chronic diseases requiring long-term specific treatment, prescribe on the chronic disease treatment book, with a quantity sufficient for one (01) month or as directed by the national tuberculosis control program.

Article 9. Prescription for Tuberculosis Treatment

Prescribe tuberculosis medication in the tuberculosis treatment book or outpatient medical record, with the prescription duration following the national tuberculosis control program guidelines.

Article 10. Prescription for Psychotropic Drugs and Precursors Used as Medications

1. For acute conditions, prescribe a sufficient dose not exceeding ten (10) days;

2. For patients with schizophrenia or epilepsy: prescribe medication in the chronic disease treatment book, with the prescription duration following the mental health specialty treatment guidelines. Family members of the patient or the commune health station, urban district health station, workplace health unit of the patient with schizophrenia or epilepsy are responsible for purchasing/receiving the medication and signing their full name on the medication distribution book of the health station (according to the mental health specialty guidelines). Whether a patient with schizophrenia can self-receive medication is decided by the treating physician.

Article 11. Prescription for Addictive Drugs

1. Annually, healthcare facilities register the signature of the prescriber of addictive drugs with the drug dispensing facility;

2. Record prescriptions on the "N" prescription form for the dispensing facility to retain, while also recording in the chronic disease treatment book or outpatient medical record for monitoring treatment and guiding patients on drug usage;

3. For acute conditions, prescribe a sufficient dose of addictive drugs not exceeding seven (07) days.

Article 12. Prescription for Opioids Pain Relief for Cancer Patients and AIDS Patients persons suffering from cancer and persons suffering from AIDS

1. Implement the provisions of Clause 1 and 2 of Article 11;

2. Healthcare facilities diagnose and issue a chronic disease treatment book (with opioid pain relief prescription) to cancer patients and AIDS patients for lower-level units to prescribe opioid pain relief medications;

3. The opioid pain relief dose is based on the patient's pain relief needs. Each prescription period does not exceed one (01) month, but three prescriptions for three treatment periods must be issued simultaneously, each period not exceeding ten (10) days (clearly indicating the start and end dates of each treatment period). The prescriber must instruct the patient's family: The second and third prescriptions can only be sold or dispensed when accompanied by a confirmation from the commune health station that the patient is still alive, purchased or received one day before the treatment period (if it falls on a holiday, purchase the day before the holiday);

4. For terminal cancer and AIDS patients at home, the authorized person assigned to examine and treat at the commune health station issues opioids prescriptions, each not exceeding seven (07) days;

5. The prescriber of opioids requires the patient's family to commit to using opioids for the intended purpose and to bear legal responsibility if used improperly for the patient's treatment.

Article 13. Duration for Prescription Validity for Purchasing Medicines

Clause 1. A prescription is valid for purchasing medicines within five (05) days from the date of issuance and can be used to purchase medicines at all legal pharmaceutical establishments nationwide.

Clause 2. For prescriptions for addictive drugs, the time for purchasing and receiving medicines shall be consistent with the treatment cycle indicated on the prescription. For the second and third cycles of opioid purchases for cancer patients and AIDS patients, they must be purchased or received one day prior to each treatment cycle (if it falls on a holiday, then it should be done before the holiday), and such purchases can only be made at pharmaceutical establishments that have registered the signature of the prescribing physician or the hospital pharmacy department where the prescription was issued (if there is no local pharmaceutical establishment for addictive drugs).

Chapter III

ORGANIZATIONS ISSUING, SELLING DRUGS AND MAINTAINING DOCUMENTATION ON ADDICTIVE DRUGS.

Article 14. Organizations Selling Addictive Drugs Based on Prescriptions

The Department of Health is responsible for directing the organization of pharmaceutical establishments selling addictive drugs to outpatients. In areas where it is difficult to establish such pharmaceutical establishments, the hospital pharmacy department must supply (at purchase price) addictive drugs to outpatients to ensure adequate drug supply for patients.

Article 15. Provisions for Issuing and Selling Addictive Drugs Based on Prescriptions

Clause 1. Each cycle of issuing and selling addictive drugs shall not exceed ten (10) days. The sale of drugs based on prescriptions indicating a treatment cycle shall follow the provisions set forth in Clause 3 of Article 12.

Clause 2. The person issuing and selling drugs shall record the expiration date of the sold drugs on the retained prescription (to monitor the retention period) and the retained prescription must include full signatures, clearly stating the buyer's name, address, and ID number. Additionally, a certificate confirming the patient's survival from the commune health station, ward, or town must be attached to the treatment prescription for the second and third cycles.

Clause 3. Record the return receipt for unused addictive drugs submitted by the patient’s family. The receipt shall be made in two copies (one copy retained by the issuing and selling entity; one copy kept by the returning party). Returned drugs shall be stored separately, preserved, and disposed of according to the regulations stipulated in the Management Regulations for Addictive Drugs.

Article 16. Retention of Documentation on Addictive Drugs

Clause 1. Medical examination and treatment facilities shall retain the original prescription "N" for two (02) years from the date of using the last page of the prescription book "N"; retain the commitment of the patient's family regarding the use of opioids for two (02) years from the latest date in the year.

Clause 2. Pharmaceutical businesses, compounding, issuing, and selling establishments shall retain prescription "N" in accordance with the Management Regulations for Addictive Drugs.

Clause 3. When the retention period for documentation (original prescription "N", prescription "N", commitment of the patient's family regarding the use of addictive drugs) expires, the relevant units shall establish a committee to destroy the documents in accordance with the Management Regulations for Addictive Drugs.

Article 17. Reporting Requirements

Medical examination and treatment facilities and those issuing and selling drugs based on prescriptions must report periodically and urgently to the direct management authority.