Scientific commentary on the criminal code Volume 4 - Dinh Van Que

The Head of the Department of Health of the Ministry of the Interior, the Director of the Railway Health Department, and the heads of health sectors must strictly implement this directive.

--------------------------------------------------------------------------------------

Maybe you are interested!

DECISION

OF THE MINISTER OF HEALTH NO. 939/BYT-QD DATED 6 MONTH

6 YEAR 1995

ON THE PROMULGATION OF REGULATIONS ON MANAGEMENT OF ADDICTIVE DRUGS AND LIST OF ADDICTIVE DRUGS

MINISTER OF HEALTH

- Pursuant to the Law on Protection of People's Health dated July 11, 1989;

- Pursuant to the Regulations on preventive and curative drugs issued together with Decree No. 23/HDBT dated January 24, 1991 of the Council of Ministers (now the Government);

- Pursuant to Decree No. 68/CP dated October 11, 1993 of the Government stipulating the functions, tasks, powers and organization of the Ministry of Health;

- Considering the proposal of the Director of the Department of Pharmacy;

DECISION

Article 1 : Hereby promulgate together with this Decision the Regulations on management of addictive drugs and the list of addictive drugs.

Article 2 : This Decision takes effect from the date of issuance, previous regulations contrary to the provisions of this Decision are annulled.

Article 3 : The Chief of Office, Director of the Department of Pharmacy, Heads of units under the Ministry, Directors of the Department of Health of provinces and centrally run cities are responsible for implementing this Decision.

RULES

ADDICTIVE DRUG MANAGEMENT

(Issued with Decision No. 939/BYT-QD dated June 6

1995

of the Minister of Health)

Among the drugs used in the medical field, there are some drugs that, if used incorrectly, will cause patients to become accustomed to the drug and become addicted. If these drugs are not strictly managed, they will have a negative impact on society.

To ensure patient health safety, the Ministry of Health issued regulations on management of addictive drugs.

CHAPTER I: GENERAL PROVISIONS

Article 1 : Concept of addictive drugs:

Addictive drugs are natural, synthetic, or semi-synthetic substances used in medicine (disease prevention, treatment, scientific research) but are easily abused for non-medical purposes.

Abuse can lead to addiction - a physical or mental dependence on the substance of abuse.

Addictive drugs used in the medical industry include those in the attached list.

From time to time, the Ministry of Health will add or remove certain drugs from the above list.

Article 2 : Purpose of use:

Addictive drugs are only used for the purposes of disease prevention, treatment, teaching at medical and pharmaceutical professional schools and scientific research.

CHAPTER II: PRODUCTION, MIXING, PACKAGING, LABELING, TRADING, IMPORT AND EXPORT.

Article 3 : Production - Preparation:

3.1. Only state-owned drug manufacturing enterprises licensed by the Ministry of Health are allowed to produce raw materials, semi-finished products and finished products of addictive drugs.

3.2. Hospital pharmacy departments are allowed to prepare finished products containing addictive drugs for dispensing to inpatients and outpatients according to pharmacopoeia formulas, formulas prescribed by the Ministry of Health or the hospital, and according to physician prescriptions.

3.3. Only university pharmacists are allowed to prepare narcotic drugs.

3.4. Do not produce or mix addictive drugs at the same time or in the same place as other drugs.

3.5. Compounding in industrial production must comply with the general provisions of the Good Manufacturing Practices (GMP) regulations. The dossier of addictive drug batches must be closely monitored, and each stage must be signed for handover. The recording of compounding, production, and management of addictive ingredients used to compound finished drugs with formulations consisting of many active ingredients in which the addictive ingredients only participate in a small amount or concentration is also applied according to this regulation.

Article 4: Packaging.

4.1. At the manufacturing plant, the packaging of narcotic drugs must comply with the general provisions of good pharmaceutical manufacturing practices.

4.2. In the hospital pharmacy department, when preparing addictive drugs according to prescriptions, according to formulas approved by the hospital director, fixed formulas in the pharmacopoeia, formulas approved by the Ministry of Health, after preparation and production, the university pharmacist must directly package and label the drugs immediately to avoid confusion.

4.3. For pharmaceutical businesses:

- Before preparing to deliver to the buyer, the warehouse department must base on the warehouse receipt to pack. If the quantity of addictive drugs is small, they must be put in a separate box with a packing slip with the name of the packer written on the outside of the box. In case the quantity of addictive drugs is not enough to put in a separate box, they can be packed in a box with other drugs but must be placed in a separate corner, and the box must have a packing slip.

Article 5: Label.

Follow label regulations.

Article 6: Trading.

Only state-owned pharmaceutical enterprises are allowed to trade and store addictive drugs according to the following specific regulations:

6.1. Central pharmaceutical companies are allowed to purchase, sell, and store raw materials, semi-finished products, and finished products of addictive drugs for distribution to pharmaceutical businesses under provinces and centrally run cities.

6.2. Pharmaceutical businesses in provinces and centrally run cities are allowed to purchase addictive drugs from central pharmaceutical companies to distribute to provincial and municipal hospitals or sell to pharmacies under the businesses, industry hospitals, industry medical facilities, nursing stations or areas for war invalids, and drug rehabilitation centers located in the province or city.

6.3. Pharmacies of drug trading enterprises under provinces and cities are allowed to purchase (or receive) addictive drugs from affiliated enterprises to distribute to district and county hospitals, district medical centers, and grassroots medical facilities within the scope of the assigned pharmacy and to retail directly to patients according to doctors' prescriptions.

6.4. Military medical units are allowed to purchase addictive drugs from the Central Pharmaceutical Company. The Director of the Military Medical Department shall prescribe and approve the budget for lower-level military medical units to purchase addictive drugs from one of the Central Pharmaceutical Companies. The Department of Health - Ministry of the Interior is allowed to purchase addictive drugs from the Central Pharmaceutical Company according to the budget approved by the Ministry of Health.

Article 7 : Import - Export:

7.1. Only enterprises designated by the Ministry of Health are allowed to export and import addictive drugs. Manufacturing enterprises licensed by the Ministry of Health are allowed to import addictive drug ingredients to serve the enterprise itself in producing approved products.

7.2. Every year, the Central Pharmaceutical Company establishes the demand for addictive drugs to be exported and imported for the Ministry of Health (Pharmaceutical Department) to review and issue a separate license (Form 2).

CHAPTER III: PLAN - PLAN APPROVAL.

Article 8: Provision:

Units that need to use addictive drugs every year must make a budget.

The deadline for submitting annual estimates is November 25 of the previous year. Additional estimates can be made during the year if necessary.

A separate table must be prepared for the purchase of addictive drugs (Form 3). When making a plan for drugs whose quantity exceeds the normal level compared to the previous year, there must be a clear explanation of the reason and purpose.

Article 9 : Approval of the project:

9.1. The Minister of Health authorizes the Director of the Pharmacy Department to approve the budget for Central Hospitals, Research Institutes, medical and pharmaceutical schools under the Ministry of Health, the Military Medical Department - Ministry of National Defense, and the Health Department - Ministry of the Interior.

- Non-health agencies that have special needs to serve scientific research must have an official dispatch explaining the reasons and be confirmed by the head of the agency at the Department or Bureau level or higher, and approved by the Ministry of Health (Pharmaceutical Department).

9.2. The Director of the Department of Health of a province or centrally-run city approves the budget for provincial and municipal hospitals, district and county hospitals, affiliated pharmaceutical businesses, nursing units for war invalids, drug rehabilitation facilities, hospitals, and industry clinics located in the province or city.

9.3. The director of the district health center approves the budget for the affiliated health station.

9.4. The head of the department, treatment room, and head of the general clinic signs and approves the receipt of addictive drugs for his/her department.

9.5. Annually or on an ad hoc basis, the Military Medical Department shall prepare a budget for narcotic drugs for use by military medical units. The budget must clearly state the quantity of each drug to be purchased from central pharmaceutical companies and submit it to the Ministry of Health for approval. The Director of the Military Medical Department shall base on the approved budget to approve it for lower-level military medical units according to the provisions in Section 6.4, Article 6.

CHAPTER IV: DELIVERY - TRANSPORTATION.

Article 10: Delivery - Receipt:

University pharmacists assigned to deliver and receive goods must carefully check and compare the drug name, concentration, content, quantity, batch number, expiry date, and quality. Upon delivery and receipt, both parties must sign the warehouse release form.

Article 11: Transportation :

University pharmacists assigned to receive narcotic drugs must have the necessary documents: letter of introduction, identity card. University pharmacists receiving narcotic drugs must be responsible for the quality, quantity, and type of drugs during transportation and must fully hand over to the warehouse keeper after bringing the drugs to the unit.

Article 12 : Storage

12.1. Addictive drugs must be stored in a separate warehouse. The warehouse for addictive drugs must be sturdy (built house, concrete ceiling, sturdy doors, good locks, equipped with ventilation system, air conditioner, cabinets, shelves, fire fighting equipment...).

- Units with small amounts of addictive drugs such as hospitals and district pharmacies must have separate cabinets for storage or must arrange addictive drugs in a separate area in the drug warehouse.

- In the on-call medicine cabinets and emergency medicine cabinets of clinical departments in hospitals, addictive drugs must be kept in a separate compartment or box to avoid

The amount of addictive drugs kept in the emergency medicine cabinet and emergency medicine cabinet as prescribed by the hospital director is just enough for one shift.

12.2. Business units from provincial level and above must assign university pharmacists to be responsible for management (organization of reception, preservation, issuance of documents, monitoring of books and documents, payment and settlement...).

- At district pharmacies, university pharmacists are directly in charge. Retail sales according to doctors' prescriptions can be assigned to secondary pharmacists. In case the university pharmacist is absent, the head of the unit can assign a secondary pharmacist to manage a quantity of medicine sufficient for one month.

- The on-duty medicine cabinets, emergency medicine cabinets in clinical departments, infirmary medicine cabinets, and dispensaries are kept by the on-duty nurse and dispensed according to the doctor's orders. When changing shifts, the books and medicines must be handed over to the nurse on duty for the next shift.

12.3. All establishments trading, using, and storing addictive drugs must make a record of handling poor quality or expired drugs (Form 6).

CHAPTER V: PRESCRIPTION - USE.

Article 13: Prescription.

Prescription of addictive drugs must be carried out in accordance with the regulations on prescription and sale of prescription drugs.

Article 14 : Distribution and use at treatment facilities.

- The hospital pharmacy department distributes medicine to departments and treatment rooms according to the drug receipt form (Form 8) and directly dispenses medicine to inpatients and outpatients as prescribed by the doctor.

CHAPTER VI: BOOKS - REPORTS

Article 15: Books.

15.1. Manufacturing and preparation facilities must open separate tracking books for addictive drugs (form 1)

15.2. When purchasing, selling, or distributing addictive drugs, a separate import and export logbook must be opened (form 4). A separate receipt for the release of addictive drugs must be written (form 5).

15.3. Books and documents must be kept for 5 years. When the storage period expires, the head of the unit will establish a council to destroy the documents and make a record.

Article 16: Report (Form 7).

16.1. Monthly report: Facilities under district and county health centers report to district and county health centers. Pharmacies under drug trading enterprises under provinces and cities report monthly to the enterprise, the report submission date is the 25th of each month.

16.2. Quarterly report: Provincial and municipal hospitals, district and county hospitals, and pharmaceutical businesses under the province or city report to the provincial and municipal Department of Health:

- Military medical units are regulated by the Military Medical Department.

- Units under the Ministry, provincial and municipal health departments report to the Ministry.

Medical.

- Report submission deadline is the 25th of the last month of the quarter.

16.3 Annual report: On December 25 of each year, every facility that uses

Those who use and trade in addictive drugs must take inventory and report to the direct superior management agency; units under the Ministry, provincial and municipal health departments must report to the Ministry of Health (Pharmaceutical Department). The Pharmaceutical Department is responsible for synthesizing reports nationwide, then making a report to the Minister of Health.

16.4. Unscheduled reporting: All establishments producing and trading in addictive drugs must urgently report to the direct management agency in the following cases: mistakes, poisoning, theft, loss due to any cause. The provincial and municipal health departments collect and urgently report to the Ministry of Health (Pharmaceutical Department).

16.5. Report on request for destruction of addictive drugs: when expired drugs or poor quality drugs need to be destroyed, a report must be made to the direct superior management agency. The report must clearly state the reason for destruction and the method of destruction. Drug destruction can only be carried out when approved by the direct superior management agency.

The head of the unit requesting to destroy drugs must establish a drug destruction council.

When the cancellation is completed, a report must be made to the immediate superior.

CHAPTER VII: INSPECTION - EXAMINATION - HANDLING OF VIOLATIONS.

Article 17: Inspection and examination.

17.1. Pharmaceutical inspectors of the Department of Health of provinces and cities are responsible for conducting surprise and periodic inspections of all units under the management of the province or city.

- The Ministry of Health Inspectorate is responsible for periodically or suddenly inspecting all facilities nationwide.

- The Director of the Military Medical Department shall specify the inspection for each military medical level.

- The Department of Health - Ministry of Home Affairs, the Department of Health - Ministry of Transport are responsible for regular or surprise inspections of health facilities under their management.

17.2. The Minister of Health authorizes the Director of the Pharmaceutical Department to organize periodic and surprise inspections of all establishments producing, trading and using drugs nationwide.

Pharmaceutical production and trading organizations are responsible for inspecting and urging units under their management.

- Heads of units and Directors of Provincial and Municipal Health Departments are responsible for inspecting and urging the implementation of regulations for units under their management.

Article 18 : Handling of violations

18.1. Individuals and groups that violate this regulation will be handled according to the law, depending on the severity of the violation.

18.2. Individuals and groups that trade, produce or use addictive drugs for non-medical purposes will be handled according to the provisions of law.

LIST OF ADDICTIVE DRUGS

(Issued with Decision No. 939/BYT-QD dated June 6, 1995 of the Minister of Health).

I. INGREDIENTS:

Acetorphine (3-O-acetyltetrahydro-7-(1-hydroxy-1-methylbutyl)-6,14- endoetheno-oripavine)

Acetyl-alpha-methylfentanyl (N-[1-(a-methylphenethyl)-4-piperidyl)

-4-piperidyl] acetanilide Acetyldihydrocodeine

Acetylmethadol (3-acetoxy-6-dimethylamino-4,4 diphenylheptane) Alfentanll (N-{1-{2-(4-ethyl-4,5 dihydro-5- oxo- 1 H-tetrazol-1 -yl)

ethyl] -4- (methoxymethyl) - 4 - piperidinyl}-N- phenylpropanamide monohydrochlorido)

Allylporodine (3-allnyl-1 -methyl -4-phenyl-4-propionoxypiperidine) Alphacetylmethadol (alpha-4-acetoxy-6-dimethylamino -4,4-

-diphenylheptane)

Alphameprodine (alpha-3-ethyl-1-methyl-4-propionoxypiperidine) Alphamethadol (alpha-6-dimethylamino-4,4-diphencyl-3-heptanol)

Scientific commentary on the criminal code Volume 4 - Dinh Van Que - 28

Comment