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CIRCULAR

REGULATIONS ON MIXING DRUGS TO TREAT PATIENTS AT MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS

Pursuant to Law on Pharmacy No. 105/2016/QH13 dated April 6, 2016;

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of Government on functions, tasks, powers, and organizational structure of Ministry of Health;

At the request of Director General of Vietnam Administration of Medical Services,

The Minister of Health promulgates Circular on mixing drugs to treat patients at medical examination and treatment establishments.

Article 1. Scope

1. This Circular prescribes principles, professional standards, and technical standards required to ensure good practice in medicinal mixing (excluding herbal drug, traditional drug, and traditional ingredient) for treating patients at medical examination and treatment establishments (hereinafter referred to as “medical establishments”).

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Article 2. Scope of drug mixing

1. Drug mixing serving treatment of patients at medical establishments must conform to the scope of medical examination and treatment operations approved by competent authorities in accordance with medical examination and treatment.

2. Drug mixing shall use medicinal ingredients in case the drugs have not been licensed in Vietnam or the drugs have been licensed but have not been distributed or distributed without sufficing treatment demand.

3. Drug mixing shall use final product drugs to dilute, combine, separate doses, dilute and combine, dilute and separate doses, change route of administration depending on treatment demand.

Article 3. Scope of tasks of persons in charge, persons mixing, and persons inspecting drug quality

1. Persons in charge of mixing drugs are responsible for organizing and supervising activities relating to mixing drugs, reviewing dossiers, documents on quality control of drugs before, during, and after mixing. Medical establishments shall assign persons with at least university education in pharmacy to carry out these tasks.

2. Persons mixing drugs are responsible for following approved formula, complying with instructions relating to drug mixing, and compulsory regulations relating to mixing conditions, sanitation and safety, completing dossiers on drug mixing and control before distributing the drugs.

Medical establishments shall assign persons with at least university education in pharmacy to mix drugs in cases under Clause 2 Article 2 hereof and mix drugs from final product drugs that are addictive drugs; assign persons with at least college education in pharmacy to mix drugs in cases under Clause 3 Article 2 hereof.

3. Persons inspecting drug quality are responsible for controlling, supervising drug quality based on regulations, procedures for ensuring drug quality, and inspecting drug quality as per approved standards. Persons inspecting drug quality must not also be the persons in charge or persons mixing drugs. Medical establishments shall assign persons with at least university education with appropriate specialty (chemistry, biochemical, pharmacy, microbial) to carry out this task.

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Article 4. Drug mixing, preserving, and inspecting areas

1. Drugs mixing, preserving, and inspecting areas are designed to properly facilitate drug mixing, preservation, and inspection (if any). Mixing areas for toxic drugs, radioactive drugs must be design to reduce risk of contact for employees. To be specific:

a) Be located separately and have sufficient area for drug mixing;

b) Be arranged in reasonable manner depending on order of mixing activities, design mixing area in a unidirectional manner that is convenient for cleaning, maintaining sanitation, repair, maintenance, disease prevention, infection prevention;

c) Maintain temperature, humidity, and lighting suitable for each type of drug. Temperature and humidity must be closely monitored and fully recorded. Lighting equipment must be installed and inspected to provide sufficient lighting for all mixing operations;

d) Maintain clean water supply;

dd) Consult good manufacturing practice for drugs of WHO regarding level of clean environment and air pressure in order to control infection in mixing areas and preventing exposure for health workers;

e) Toxic drug and radioactive drug mixing areas must be properly labeled and have warning signs erected.

2. Preservation areas

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3. Drug quality inspection areas

a) Be located separately from mixing areas; have adequate area and design for controlling infection, avoiding confusion, and facilitating operations, preservation of samples, reference materials, solvents, reagents, and test dossiers;

b) Areas where biological, microbial tests are conducted must be separate from one another and have separate air treatment equipment;

c) Have adequate equipment, devices, chemicals, solvents, and reagents to inspect quality indicators of ingredients, semi-finished products, and finished products.

Article 5. Management and use of drug mixing equipment

1. Equipment must be suitable for mixing each type of drugs.

2. Mixing equipment must be maintained periodically according to recommendations of manufacturers to ensure safety, avoid infection and dust build-up, and prevent any impact on drug quality.

3. Scales and measuring instruments must be calibrated. Calibration results must be recorded and kept in accordance with Circular No. 07/2019/TT-BKHCN dated July 26, 2019.

4. Medical establishments must promulgate guidelines for using, cleaning, and maintaining equipment, comply with the guidelines, and property keep a record of use.

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Article 6. Sanitation

1. Medical establishments must promulgate regulations and procedures for sanitation and organize proper implementation. These regulations and procedures must be periodically reviewed and approved by heads of medical establishments.

2. Medical establishments must have sanitation regulations, procedures, and methods for mixing areas.

a) Equipment sanitation must depend on levels of clean environment, type of equipment, and drug mixing procedures;

b) Solutions are devised for treating wastes produced from mixing, waste containers are clearly marked, dumped, and cleaned regularly, at least once per day;

c) Sanitation regulations and procedures must be suitable for cleaning before and after mixing, changing drug type and batch.

3. Personal hygiene requirements

a) Employees mixing drugs must receive training and comply with sanitation regulations and procedures for sanitation of medical establishments; ensure sanitation conditions for mixing areas, equipment, tools, and personal hygiene;

b) Outfit of persons mixing drugs: protective goggles, non-powdered surgical gloves, disposable and watertight coats with long sleeves, hats, facemasks, shoe covers.

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1. Develop regulations and procedures for drug quality assurance

a) Medical establishments shall rely on regulations on drug quality management, labeling, biomedical waste, and good manufacturing practice for drugs of WHO to develop regulations on mixing drugs, regulations on drug quality assurance;

b) Regulations on mixing drugs must contain the following: mixing formula, standards and requirements of ingredients, mixing, packaging, inspecting, control procedures during mixing process, quality standards of finished products, labeling and preservation;

c) Drug mixing regulations and procedures, drug quality must be approved by councils for drugs and treatment of medical establishments (if any) and heads of the medical establishments.

2. Quality standards for mixing drugs are mentioned under Clause 2 Article 2 hereof.

a) Medical establishments must apply quality standards (base standards or Vietnamese Pharmacopoeia or any of the reference pharmacopoeia) to all mixed drugs at the establishment;

b) Quality standards are developed to meet drug quality control requirements and approved by heads of medical establishments or permitted for application.

3. Drug mixing dossiers

a) Drug mixing dossiers shall be produced on a case-by-case basis and contain the following primary contents: name of drugs, contents, concentration of products, date of mixing, formula, quantity of finished products, persons mixing drugs, and persons carrying out quality control;

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Article 8. Quality control during mixing process

1. For drugs mixed in accordance with Clause 2 Article 2 hereof, quality control shall be carried out as follows:

a) Initial ingredients for mixing drugs must be up to standards (not expired, attached by certificate of analysis, invoice, certificate of origin);

b) Packing materials and printed packages must be kept in separate areas and distributed depending on mixing demands;

c) Semi-finished products (if any) awaiting packaging shall be labeled and preserved as per the law before being subject to quality control and subsequent stages;

d) Control mixing process

- Control at weighing station for medicinal ingredients: before weighing and distributing ingredients, inspect sanitation, temperature, humidity, ensure clean weighing and distribution areas and accurate results. Sterile ingredients must be weighed and distributed in sterile areas;

- Control mixing process: have sufficient number of persons mixing drugs and have appropriate solutions for monitoring all actions during mixing process. All employees must wear proper PPE before mixing drugs; mixing environment and conditions must meet regulations. All mixing equipment must be inspected for sanitation conditions before use and during mixing process. All ingredients, packaging of semi-finished products, precision machinery, packing rooms and assembly lines in use must bear labels containing name of the drugs being mixed and batch number. Inspect, control, and record all inspection results during mixing process and environmental control as per mixing process.

dd) Control labeling and packaging activities: control primary packaging materials and pre-printed packaging before mixing, labeling and packaging activities must be physically separated to prevent any confusion, separate and safe preservation areas must be prepared for finished products awaiting distribution.

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a) All finished products before being mixed must be inspected visually and unexpired;

b) Control mixing, packaging, labeling process by assigning one control person for every person mixing drugs.

Article 9. Drug quality testing

1. If drugs mixed in accordance with Clause 2 Article 2 hereof are mixed in batches, test 100% of the batches based on quality standards approved by heads of medical establishments.

2. Medical establishments shall test or send samples to facilities capable of testing drugs as per the law.

Article 10. Mixing and separating doses of permissible radioactive drugs in medical establishments

1. The mixing and dose separation of radioactive drugs must satisfy provisions under Articles 3, 4, 5, 6, 7, 8, and 9 hereof.

2. Persons in charge, persons mixing drugs, persons carrying out quality control for radioactive drugs, radioactive isotopes must receive radiation safety training, professional training, and fully comply with regulations and law in nuclear energy.

3. The mixing and dose separation of radioactive drugs shall be carried out at medical establishments possessing the license to carry out radiation-related activities and complying with Circular No. 19/2012/TT-BKHCN dated November 8, 2012 of the Minister of Science and Technology.

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5. Do not mix simultaneously with other drugs to prevent exposure, confusion, and losses.

6. Radioactive drugs after being mixed must be labeled and contain the following information: name of medical establishment, address of medical establishment, date of manufacture, name of drug, radioactive isotopes, chemical forms, total activity, date of measuring radioactivity, name of carrier, persons mixing drugs, mixing batches, volume of radioactive medicinal products in solution form, expiry date, and other information required by pharmaceutical laws.

7. Radioactive drugs after being mixed, separated by dose, inspected, and satisfying requirements, must be packaged and kept in specialized lead containers, in separate areas and placed under specific measures and equipment for ensuring radiation safety and radiation security sources as per the law.

8. Medical establishments mixing radioactive drugs must produce and keep records of disposal of mixed unused radioactive drugs together with disposal measures in accordance with Circular No. 22/2014/TT-BKHCN dated August 22, 2014 of the Minister of Science and Technology.

Article 11. Entry into force

1. This Circular comes into force from March 01, 2022.

2. Annul Clause 3 Article 4, Article 12, and Article 18 of Circular No. 22/2011/TT-BYT dated June 10, 2011 of the Minister of Health from the effective date hereof.

Article 12. Transition clauses

1. Medical establishments mixing drugs in accordance with Clause 3 Article 2 hereof shall continue while meeting provisions hereof before January 1, 2023.

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3. For ingredients of drugs under Clause 2 Article 2 hereof that have entered storage of medical establishments before the effective date hereof, medical establishments shall use these ingredients to mix drugs within 12 months from the effective date hereof.

Article 13. Terms of reference

In case documents referred to in this Circular are replaced or amended, the new versions shall prevail.

Article 14. Responsibilities for implementation

1. Department of Medical Service Administration - Ministry of Health is responsible for guiding, organizing, inspecting, and assessing implementation of this Circular.

2. Departments of Health of provinces and central-affiliated cities, health authorities of ministries and departments are responsible for organizing, inspecting, and assessing implementation of this Circular in their provinces.

3. Medical establishments that mix drugs are responsible for:

a) Promulgate the list of mixed drugs for on-site treatment;

b) Promulgate procedures for mixing drugs in the list of drugs mixed on-site;

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d) Produce annual reports on drug mixing in medical establishments which contain: list of drugs mixed, quantity of drugs produced to superior health authorities (Ministry of Health, Departments of Health, Heath Department of Ministry of Public Security, Department of Military Medicine of Ministry of National Defense) before January 15 of the following year.

4. Chief of the Ministry Office, Ministry Inspectorates, General Director, Directors of Departments, General Departments affiliated to the Ministry of Health, Directors of Health Departments of provinces and central-affiliated cities and other relevant agencies, organizations, units and persons shall have the responsibilities for the implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Vietnam Administration of Medical Services)./.

PP. MINISTERDEPUTY MINISTERNguyen Truong Son