Decision No. 1847/2003/QĐ-BYT on Issuing the Regulation on Prescribing Medicines and Selling Medicines Based on Prescriptions

Pursuant to …;

Regarding the issuance of the Prescription Drug Writing and Selling Regulation

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Based on the Law on People's Health Protection issued on July 11, 1989 and the Pharmaceutical Regulations for Preventive and Curative Medicines for People issued together with Decree No. 23/HĐBT dated January 24, 1991 of the Council of Ministers;

Based on Decree No. 68/CP dated October 11, 1993 of the Government stipulating the functions, tasks, authorities, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Treatment Department, the Director of the Vietnam National Medicine Administration Bureau,

DECISION:

Article 1The Prescription Drug Writing and Selling Regulation is hereby promulgated along with this Decision.

Article 2. The Prescription Drug Writing and Selling Regulation applies to the writing of prescriptions and selling of medicines based on prescriptions for outpatient treatment, but does not apply to the writing of prescriptions for inpatient treatment and traditional medicine prescriptions.

Article 3This Decision takes effect fifteen days from the date of publication in the Official Gazette and replaces Decision No. 488/BYT-QĐ dated April 8, 1995 of the Minister of Health on the temporary issuance of the Prescription Drug Writing and Selling Regulation.

Article 4. The Heads of the Office, Inspectorate, Treatment Department of the Ministry of Health, the Director of the Vietnam National Medicine Administration Bureau, the General Director of the Vietnam Pharmaceutical Corporation, the Directors of hospitals and institutes under the Ministry, the Directors of Provincial Health Departments, and the heads of health sectors at central cities and provinces are responsible for implementing this Decision.

Prescription Drug Writing and Selling

REGULATIONS

(Issued pursuant to Decision No. 1847/2003/QĐ-BYT dated May 28, 2003)
Doctors may prescribe treatment instructions for patients on prescription forms or medical records, collectively referred to as drug prescriptions. Prescription forms are medical documents indicating the doctor's prescription for medication for patients; they serve as the legal basis for prescribing, selling, and dispensing medications according to prescriptions.

Chapter 1:

GENERAL PROVISIONS

Article 1Article 2. Scope of regulation and applicability.

1. Scope of regulation: Writing prescriptions and selling or dispensing medications based on prescriptions for outpatient treatment.

Doctors practicing at state-owned, private, semi-state, public welfare, charitable, foreign-invested healthcare facilities.

第二条 组织和实施奖励工作的支出水平，如政府第152/2025/NĐ-CP号决定关于分级授权和奖励领域的分权规定

Pharmacists selling medications at state-owned and private pharmaceutical establishments.

Article 3. Conditions for those who write prescriptions and sell medications based on prescriptions:

1. Those who write prescriptions must meet the following conditions:

Practicing at a state facility with a bachelor's degree in medicine and assigned by the head of the facility to provide medical services.

Practicing at a private, semi-state, public welfare, foreign-invested (non-state) healthcare facility that meets the conditions for providing medical services as stipulated by the Private Medical and Pharmaceutical Practice Ordinance and related regulatory documents, and assigned by the head of the facility to provide medical services.

2. Pharmacists: In accordance with current regulations on pharmaceutical practice guidelines issued by the Ministry of Health.

3. For provinces with mountainous, remote, highland, and far-flung island areas lacking sufficient medical personnel.

The Health Department shall issue a delegation letter authorizing the director of the district health center to designate individuals to write prescriptions and sell medications suitable to local conditions.

Private healthcare facilities shall follow the guidelines for medical and pharmaceutical practice issued by the Ministry of Health.

Article 4. Groups of drugs requiring prescriptions and sale based on prescriptions:

1. Narcotic drugs.

2. Psychotropic drugs and precursors used as drugs.

3. Toxic drugs A and B.

4. Antibiotics.

5. Hormonal drugs (excluding contraceptive drugs).

6. Cardiovascular drugs.

7. Infusion solutions.

PRESCRIPTIONS AND DRUG PRESCRIPTIONS

Chapter 2:

PRESCRIPTION DRUGS AND FILLING PRESCRIPTIONS

Article 5. Medical facilities must have the following forms and registers:

1. Prescription form for regular drugs, toxic drugs, psychotropic drugs, and precursor substances used as drugs.

(Annex 1: according to model number MS: 17D/BV-01 issued together with Decision 4069/QĐ-BYT dated September 28, 2001 on issuing medical record models).

2. Prescription form for addictive drugs (Annex 2).

3. Chronic disease treatment register (Annex 3). For outpatients with schizophrenia and epilepsy, it shall be implemented according to model number MS: 03D/BV-01 issued together with Decision 4069/QĐ-BVT dated September 28, 2001 on issuing medical record models.

4. Report form (Annex 4).

Article 6. The person prescribing drugs must be responsible for prescriptions issued to patients and strictly comply with the following regulations: 1. Only prescribe drugs for diseases assigned for diagnosis and treatment or within the scope of practice stated in the certificate of eligibility for practice issued by competent state management agencies.

2. Only prescribe drugs after directly examining the patient.

3. Be fully aware of indications, contraindications, usage methods, dosages, interactions, incompatibilities, unwanted effects, and harmful reactions of the prescribed drugs.

4. Do not prescribe drugs in the following cases:

Not for preventive or curative purposes.

At the unreasonable request of the patient.

Article 7. Regulations on writing prescriptions:

1. Fill in all items printed on the prescription. Prescriptions must be written in ink or ballpoint pen. Writing must be clear and legible.

2. For children under 24 months old: Record the age in months and write the name of the father or mother.

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

4. Write the drug name according to the international nonproprietary name (INN) for single-component drugs; write the brand name correctly for multi-component drugs.

5. Record the drug name, dosage, quantity, single dose, daily dose, and usage method for each drug.

6. Quantity of Class A toxic drugs and addictive drugs must be written in capital letters.

7. Quantity of Class B toxic drugs and psychotropic drugs, and precursor substances used as drugs must be preceded by the digit "0" if the quantity is a single digit.

8. Sign next to the prescription if prescribing an overdose or making corrections.

9. Addictive drugs must be prescribed separately (Annex 2) with two copies, one for the patient to keep and one for the pharmacy to retain, while the original copy is kept by the medical facility.

10. Cross out unused blank spaces on the prescription. Sign and clearly indicate academic title, full name, and stamp of the clinic or hospital (if they have separate stamps).

Article 8. Prescribing quantities of drugs exceeding the specified duration is prohibited:

Seven (07) days for addictive drugs.

Morphine chloride 10mg/ml vials for cancer patients using more than 30 mg/day should not exceed five (05) days.

Ten (10) days for Class A and B toxic drugs and psychotropic drugs.

For chronic diseases requiring long-term specific drug therapy, use the outpatient chronic disease treatment register (Annex 3) instead of prescriptions. Doctors can prescribe enough medication for one month.

For self-purchasing tuberculosis patients, prescriptions and sales follow the same procedures as for chronic diseases. For tuberculosis patients using program-supplied drugs, prescriptions and drug distribution follow national tuberculosis control program guidelines.

Article 9. For mentally ill patients in remote areas with difficult transportation, prescriptions can cover up to one month (30 days). Family members or commune health stations, workplace health centers of mentally ill patients are responsible for purchasing or collecting drugs and must sign and clearly indicate their full name and ID number on the retained prescription. Whether mentally ill patients can collect their own drugs is decided by the treating doctor.

Article 10Prescriptions are valid for purchasing drugs within ten days from the date of issuance and can be used at all legal drug-selling establishments nationwide.

Article 11Health Departments assign drug-selling establishments for patients with addictive drugs. Medical facilities must register doctors' signatures for addictive drug prescriptions annually with drug-selling establishments.

Article 12. Addictive drug prescriptions can only be purchased from registered drug-selling establishments.

Article 13SELLING DRUGS BASED ON PRESCRIPTIONS

Drug-selling establishments must print complete registers for addictive drugs, toxic drugs, psychotropic drugs, and precursor substances used as drugs, as stipulated by the Ministry of Health, and comply with the following regulations:

Chapter 3:

1. Strictly manage from printing, distribution to usage of registers.

Article 14. 2. Immediately report loss to the direct supervisory agency.

3. Retain registers and prescriptions for addictive drugs for at least five years from the last page's usage date.

Upon expiration of retention periods, units establish a committee and issue minutes for destroying registers and prescriptions.

Drug sellers may only sell drugs approved by the Ministry of Health for circulation and must not sell prescription drugs without a doctor's prescription.

Drug sellers must sell drugs strictly according to prescriptions. They cannot substitute drugs arbitrarily. If drugs have the same active ingredient, dosage, concentration, and formulation but different brand names, substitution is allowed with the buyer's or prescriber's consent and the substituted drug details must be noted on the prescription.

Article 15. The seller may only sell drugs that have been permitted for circulation by the Ministry of Health and must not sell prescription drugs without a prescription from a doctor.

Article 16. The seller must fill prescriptions accurately. If the prescription is unclear regarding the name of the drug, concentration, dosage, or quantity, the seller must inquire with the prescriber to avoid confusion. The seller has the right to refuse to sell drugs according to a prescription in the following cases:

1. The prescription is invalid.

2. The prescription contains errors or raises doubts.

3. The prescription is not intended for medical treatment purposes.

Article 17. The seller must dispense drugs strictly according to the prescription; they may not substitute drugs arbitrarily. In cases where drugs have the same active ingredients, the same dosage, concentration, and form of preparation but different brand names, the seller may substitute upon agreement of the buyer or prescriber and must record the substituted drug's name, dosage, concentration, and quantity on the prescription.

Article 18. The seller of drugs may sell certain psychotropic drugs and precursor substances for medicinal use according to the medical record book: 1. Ephedrine tablets 10 mg each time not exceeding 10 tablets

2. Ephedrine ampules 10 mg each time not exceeding 5 ampules

3. Phenylpropanolamine 25 mg/tablet each time not exceeding 10 tablets

Not to sell the above drugs to children under 15 years old

Article 19. After selling drugs, the seller must:

1. Clearly record the quantity of drugs sold on the prescription or medical record book. If the full range of drugs in the prescription is not available, record the quantity sold on the prescription so that the patient can purchase the remaining drugs elsewhere.

2. Record the drug export ledger for addictive drugs, toxic drugs A, toxic drugs B, and psychotropic drugs and precursor substances for medicinal use (model export/import ledger for addictive drugs, toxic drugs A, B, and psychotropic drugs as prescribed by the Ministry of Health)

3. Retain the original copy of the prescription for prescriptions for addictive drugs.

. Doctors shall not sell drugs. Strictly prohibit healthcare facilities from buying and selling drugs outside the emergency drug quota as specified.

Article 20. The subjects specified in Article 2 of this Regulation must be subject to inspection and audit by the Ministry of Health, Provincial Department of Health, and Municipal Departments of Health directly under the Central Government. Depending on the severity of the violation, they will be disciplined, administratively fined, or criminally prosecuted if damage is caused, and must compensate according to the law.

Chapter 4

IMPLEMENTING PROVISIONS

Article 21. Healthcare facilities and drug sellers must immediately report to the direct management authority when there is a violation of the prescription writing and drug sale regulations (Annex 4).

Article 22The Director of the Treatment Department, the Director of the Vietnam Drug Administration, and the Inspector General of the Ministry are responsible for guiding the implementation and inspecting and auditing the implementation of this Regulation nationwide. The Director of the Provincial Department of Health and Municipal Departments of Health directly under the Central Government are responsible for organizing the implementation and inspecting and auditing the implementation of this Regulation within their respective localities.

Article 23. During the implementation of the drug prescription regulation and drug sale based on prescriptions, if difficulties arise, local units must report to the Ministry of Health (Treatment Department, Vietnam Drug Administration) for timely research, amendment, and supplementation to ensure compliance./.

Article 24. During the implementation of the Prescription Drug Filling Regulations, if there are difficulties, local units must report to the Ministry of Health (Department of Treatment, Vietnam Drug Administration) for timely research, revision, and supplementation to ensure compliance./.