Circular No. 22/2011/TT-BYT stipulates the organization and operation of the Pharmacy Department.

CIRCULAR

Regulations on the organization and operation of hospital pharmacy departments

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Pursuant to the Law on Diagnosis and Treatment No. 40/2009/QH12 dated November 23, 2009;

Pursuant to the Medicine Law No. 34/2005/QH11 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;

The Ministry of Health hereby stipulates the organization and operation of hospital pharmacy departments as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

These Circulars stipulate the organization and operation of hospital pharmacy departments, the responsibilities and duties of positions within hospital pharmacy departments.

Article 2. Functions of the Pharmacy Department

The Pharmacy Department is a specialized department directly led by the Hospital Director. The Pharmacy Department has the function of managing and advising the Hospital Director on all pharmaceutical work in the hospital to ensure the timely provision of sufficient quality drugs and to monitor and advise on the safe and rational use of drugs.

Article 3. Tasks of the Pharmacy Department

1. To develop plans and supply drugs to meet the quantity and quality requirements for treatment and clinical trials to satisfy diagnostic, treatment, and other health care needs (disease prevention, disaster response).

2. To manage and monitor drug procurement and distribution for treatment needs and other urgent demands when required.

3. To be responsible for organizing and implementing the activities of the Drug and Treatment Council.

4. To store drugs according to the principles of "Good Storage Practices."

5. To organize the preparation of drugs, disinfectants, traditional medicine formulations, and the production of drugs from medicinal herbs for use in the hospital.

6. To implement clinical pharmacy work, provide information and advice on drug use, participate in pharmacovigilance activities, and report adverse drug reactions.

7. To manage and monitor compliance with professional pharmaceutical regulations in hospital departments.

8. To conduct scientific research and training; serve as a practical base for universities, colleges, and secondary schools of pharmacy.

9. To coordinate with clinical and paraclinical departments to monitor, evaluate, and supervise the safe and rational use of drugs, particularly antibiotics, and to track antibiotic resistance trends in the hospital.

10. To participate in directing lower-level facilities.

11. To participate in consultations when requested.

12. To participate in monitoring and managing drug expenditure.

13. To manage the hospital pharmacy's operations in accordance with regulations.

14. To perform supply, monitoring, supervision, inspection, and reporting tasks related to medical consumables (cotton, bandages, alcohol, dressings) and medical gases for healthcare facilities without a Medical Supplies and Equipment Department, upon assignment by the heads of those facilities.

Chapter II

PHYSICAL CONDITIONS; RESPONSIBILITIES AND TASKS OF POSITIONS IN THE PHARMACY DEPARTMENT

TITLES IN PHARMACY

Article 4. Location and Physical Conditions of the Pharmacy Department

1. The Pharmacy Department should be located in a convenient place with adequate working conditions for pharmacy staff (computer systems; printers; telephones; internet; fax; software for drug and chemical preparation management; relevant drug and pharmacy practice materials) and should provide full support for information, advisory, and drug usage management work.

2. The warehouse, preparation rooms, production areas for traditional medicine and herbal drug formulations, and dispensing rooms should be located in positions that facilitate transportation and distribution according to the principles of "Good Distribution Practices." Warehouse conditions must ensure lighting; temperature; humidity; ventilation; protection against insects and pests; fire and explosion prevention; and infection control according to the principles of "Good Storage Practices."

4. Chemical and alcohol storage areas must be separate from drug storage areas.

5. Depending on the specific conditions of the hospital, the Hospital Leadership decides whether the preparation room for traditional medicine formulations and the traditional medicine warehouse should be located in the Traditional Medicine Department or the Pharmacy Department. The planning, procurement, distribution, inventory, and reporting of drugs must comply with the regulations of the Pharmacy Department.

Article 5. Staffing of the Pharmacy Department

Implement according to the guidelines for staffing standards in state-owned healthcare facilities.

Article 6. Organizational Structure of the Pharmacy Department

Depending on the hospital level: general hospitals, specialized hospitals; number of staff; equipment; infrastructure, human resources for the Pharmacy Department should be arranged appropriately. The Pharmacy Department includes the following main units:

1. Pharmaceutical operations;

2. Warehousing and distribution;

3. Pharmaceutical statistics;

4. Clinical pharmacy, drug information;

5. Drug compounding, testing, quality control;

6. Management of professional activities of the Hospital's Pharmacy.

Article 7. Requirements, Duties, and Responsibilities of the Head of the Pharmacy Department

1. Educational requirements: at least a bachelor's degree in pharmacy. For hospitals classified as Level 3 and unclassified without a bachelor's degree in pharmacy, the hospital director shall authorize a high school graduate pharmacist to manage the department in writing.

2. Duties and responsibilities:

a) Fulfill the common duties and powers of the Head of Department in the hospital.

b) Organize the operation of the department in accordance with this Circular.

c) Be responsible to the hospital director for all activities of the department and pharmaceutical professional work in clinical departments and hospital pharmacies.

d) Serve as the permanent Vice Chairman of the Drug and Treatment Council, advise the hospital director and the Chairman of the Drug and Treatment Council on selecting drugs for use in the hospital; act as the focal point in drug tendering work; monitor and supervise prescription and drug usage to enhance drug efficacy and improve treatment quality.

đ) Based on the hospital's overall plan, develop and organize the implementation of drug supply, storage, and usage plans (compounding, sterilization).

e) Implement drug importation, exportation, statistical reporting, inventory taking, and coordination with the Finance and Accounting Department for settlement; monitor and manage drug expenditure accurately in accordance with current regulations.

g) Monitor and inspect drug storage; drug and chemical importation, exportation (compounding, sterilization) to ensure quality in compliance with current regulations.

h) Provide drug information, advice, and guidance on drug usage to medical staff.

i) Be responsible for participating in consultations or assigning pharmacists in the department to participate in consultations when requested by hospital leadership.

k) Manage the professional activities of the Hospital's Pharmacy.

l) Participate in scientific research, teaching, and specialized training in pharmacy for colleagues and lower-level staff.

m) Perform other tasks assigned by the hospital director.

Article 8. Requirements, Duties, and Responsibilities of Pharmacists Engaged in Pharmaceutical Operations

1. Educational requirements: at least a bachelor's degree in pharmacy for special-class, Class 1, and Class 2 hospitals. For Class 3 and unclassified hospitals, the minimum requirement is a high school diploma in pharmacy.

2. Duties and responsibilities:

a) Carry out professional inspections of pharmaceutical practices in the Pharmacy Department, clinical departments, and hospital pharmacies.

b) Regularly update regulatory documents on professional management, advise the Head of the Pharmacy Department to submit to the hospital director plans for disseminating and implementing these regulations in hospital departments.

c) Take responsibility for drug supply.

d) Periodically inspect drug storage, management, and distribution in the Pharmacy Department.

đ) Inspect drug usage and storage in clinical departments' emergency cabinets.

e) Take responsibility for drug testing and quality control (if the hospital does not have a testing unit, samples must be sent to competent agencies for testing after compounding).

g) Perform other tasks assigned by the Head of the Pharmacy Department.

h) Be accountable to the Head of the Pharmacy Department for assigned tasks.

Article 9. Requirements, Duties, and Responsibilities of the Pharmacist in Charge of the Drug Storage Warehouse

1. Qualification requirements: The custodian of narcotic drugs must be a university-level pharmacist or a college-level pharmacist with authorization as prescribed; the custodian of other drugs must have at least a college-level pharmacist qualification.

2. Duties and responsibilities:

a) Shall be responsible for fully implementing the principles of "Good Pharmacy Practice," ensuring the safety of the warehouse.

b) Shall guide and assign tasks to staff working in the warehouse to comply strictly with the internal regulations of the pharmacy warehouse and the Department of Pharmacy.

c) Shall closely monitor and supervise drug entry and exit according to the regulations of the Department of Pharmacy and regularly or urgently report to the Head of the Department on warehouse operations and drug distribution.

d) Shall participate in scientific research, provide guidance, and enhance professional skills for members within the department and other trainees as assigned.

đ) Shall perform other tasks when assigned by the Head of the Department of Pharmacy.

e) Shall be accountable to the Head of the Department of Pharmacy for the assigned tasks.

Article 10. Requirements, Duties, and Responsibilities of Pharmaceutical Statistics Staff

1. Qualification requirements include pharmaceutical statistics and pharmacy expertise.

2. Duties and responsibilities:

a) Shall accurately track and record data on drugs entering the pharmacy warehouse, data on drugs distributed to inpatients, outpatients, and other urgent needs.

b) Shall report statistical data upon request from the Hospital Director or the Head of the Department of Pharmacy. Shall be accountable to the Head of the Department of Pharmacy for the assigned tasks.

c) Shall implement periodic annual reports on the work of the Department of Pharmacy, drug usage, chemicals (compounding, disinfection), medical supplies consumption (if applicable) in the hospital (according to Appendices 3, 4, 5, 6) sent to the Health Department, Ministry of Health (Department of Medical Examination and Treatment; Traditional Medicine Department for traditional medicine hospitals) before October 15th each year (data for one year is calculated from October 1st to September 30th of the following year) and submit urgent reports when required.

d) Shall perform other tasks when assigned by the Head of the Department of Pharmacy.

Article 11. Requirements, Duties, and Responsibilities of Clinical Pharmacists

1. Minimum qualification requirement is a university-level pharmacist.

2. Duties and responsibilities:

a) Shall be responsible for drug information in the hospital, implementing a network for monitoring, reporting adverse drug reactions, and pharmacovigilance activities.

b) Shall advise on safe and rational drug use for the Drug and Treatment Council, healthcare personnel, and patients.

c) Shall participate in monitoring and supervising inpatient and outpatient prescription practices to promote safe, rational, and effective drug use.

d) Shall guide and inspect drug use in the hospital; shall be responsible for calculating dose adjustments for patients requiring dosage changes; has the authority to consider substituting drugs (if interactions are detected in prescriptions, prescriptions with the same active ingredient, or if pharmacy department stock is depleted) with equivalent drugs while informing the clinical department and reaching consensus on the substitution.

đ) Shall participate in scientific research and enhance professional skills for members within the department and other trainees as assigned.

e) Shall perform other tasks when requested by the Head of the Department of Pharmacy.

g) Shall be accountable to the Head of the Department of Pharmacy for the assigned tasks.

1. Qualification requirements: at least a bachelor's degree pharmacist for hospitals compounding medications for pediatric specialties, oncology departments, and addictive substances; compounding medications for other specialties requires at least a diploma-level pharmacist; pharmacists involved in compounding medications containing radioactive elements must have a certificate on safe radiation practice in healthcare.

2. Duties and responsibilities:

a) Implement regulations on pharmaceutical work and infection control.

b) Compound medications strictly according to approved technical procedures and the list of medications compounded at the hospital.

c) Timely compound and ensure the quality of emergency and special medications, particularly when compounding medications for children (dose division, intravenous medication preparation), and cancer treatments.

d) Monitor and coordinate with staff assigned in nuclear medicine units, oncology departments regarding the compounding and use of radioactive drugs and chemotherapy agents to ensure patient, healthcare worker, and environmental safety.

đ) Participate in scientific research, provide guidance, and enhance professional skills for department members and other trainees as assigned.

e) Perform other tasks as assigned by the Head of the Pharmacy Department.

g) Shall be accountable to the Head of the Department of Pharmacy for the assigned tasks.

Article 13. Duties and Tasks of Other Staff Members

Carry out assignments and be accountable to the Head of the Pharmacy Department.

Chapter III

MAIN ACTIVITIES OF THE PHARMACY DEPARTMENT

Article 14. Planning and Organizing Medication Supply

1. Planning

a) Develop the annual list of medications used at the hospital based on the reasonable treatment needs of clinical departments. When developing this list, it should be based on:

- The local disease model, the structure of diseases statistically compiled annually by the hospital;

- The qualifications of staff and the Technical List that the hospital implements;

- Specific conditions of the hospital: scale and diagnostic and treatment equipment currently available;

- Financial capacity: state budget, health insurance budget, local economic capability;

- The main list of medications used in healthcare facilities issued by the Ministry of Health.

- The list of medications used at the hospital must be reviewed, supplemented, and adjusted annually to suit actual treatment conditions.

b) Participate in developing the list of medications and the stock of emergency medications in clinical departments. This list is proposed by the Chief of the Department based on the treatment requirements and tasks of the department and submitted for approval by the Director.

c) Plan medication supply to present to the competent authority for approval to ensure adequate and quality supply of medications for inpatient and outpatient diagnosis and treatment, health insurance, and align with the hospital's financial capacity. Prepare additional forecasts (according to Appendix 2 form) when medication demand exceeds the plan, there is no contractor participating, and the medication is not included in the list but has urgent need.

d) Depending on specific unit conditions, the Pharmacy Department or other departments plan medical equipment supply (as specified by the Hospital Director).

2. Organizing Medication Supply

a) Ensure sufficient supply of medications for treatment needs and other urgent needs.

b) Serve as the organizing body for tendering (or compile the unit's medication usage needs to submit to the competent authority) to purchase medications in accordance with the Bidding Law and relevant current regulations.

c) Supply controlled medications (addictive substances, psychotropic drugs and precursors used as medications, radioactive drugs) in compliance with current regulations.

Article 15. Monitoring and managing drug imports and exports

1. Drug imports:

a) All types of drugs and chemicals (compounding, disinfectants) must be inspected before being admitted to the warehouse.

b) The Inspection Committee shall be decided by the Hospital Director. The members of the Inspection Committee include: Head of the Pharmacy Department, Head of the Finance and Accounting Department, warehouse manager, pharmacy statistician, supply staff.

c) Content of inspection: check the type, quantity, quality of drugs and chemicals from all sources (purchase, aid, projects, programs) within the hospital according to the following requirements:

- When inspecting, it is necessary to compare the invoice with the actual situation and the tender results for each item's details such as: drug name, chemical name, concentration (content), unit of measurement, packaging specifications, quantity, batch number, unit price, expiration date, manufacturer, country of manufacture;

- Whole-case drugs are inspected first, all drugs are inspected within a maximum period of one week from when they are received at the warehouse;

- Record a report when goods are damaged, excess, or short, and notify the supplier to make up for or resolve the issue;

- Upon receiving goods, check the storage conditions for drugs that require special storage or as indicated on the product label;

- Drugs requiring special control (narcotics, psychotropic drugs, and precursor substances used as drugs, radioactive drugs) shall have separate inspection reports;

d) The inspection report must have signatures of all committee members.

đ) Enter the drug inspection log (according to Form Appendix 14).

2. Quality control of drugs used at the facility:

a) Conduct 100% sensory quality control of drugs entering the Pharmacy Department.

b) Conduct periodic and random sensory quality control of drugs in the warehouse, compounding area, and dispensing area of the Pharmacy Department.

c) Conduct periodic and random sensory quality control of drugs in clinical departments.

3. Dispensing drugs and chemicals (compounding, disinfectants):

a) The Pharmacy Department reviews drugs before dispensing.

b) Dispensing drugs to clinical departments:

- The Head of the Pharmacy Department or authorized pharmacist approves the Drug Withdrawal Order during regular working hours;

- The Pharmacy Department ensures timely and full provision of drugs and chemicals (compounding, disinfectants) based on the Drug Withdrawal Orders of clinical and paraclinical departments;

- Depending on the human resources conditions of the unit, the Pharmacy Department delivers drugs to clinical departments or clinical departments collect drugs at the Pharmacy Department as stipulated by the Hospital Director.

c) Dispensing drugs to outpatients with health insurance cards.

d) Refuse to dispense drugs if errors are found in the prescription or Drug Withdrawal Order, inform the prescribing doctor and the approving doctor; cooperate with clinical doctors in adjusting prescriptions or substituting drugs.

đ) Check and verify when dispensing drugs:

- Format of the Drug Withdrawal Order or prescription;

- Verify the drug name, concentration (content), dosage form, dose, route of administration, interval between doses on the prescription with the drugs to be dispensed;

- Drug labels;

- Drug quality;

- Quantity and batches of drugs in the prescription or Drug Withdrawal Order with the drugs to be dispensed.

e) After dispensing, update the daily inventory card.

g) Dispense drugs based on the principle of first-in-first-out and prioritize drugs with shorter expiration dates. Only dispense drugs that are still within their shelf life and meet quality standards.

h) Enter the import/export tracking log or inventory card (according to Form Appendix 1).

4. Storage of export and import documents, outpatient prescriptions shall be carried out in accordance with regulations on medical record storage.

5. Handover (when the warehouse manager changes duties):

a) Before handing over, the warehouse manager must fully enter the log and record the handover figures; reconcile actual figures with export and import documents; clearly state the reasons for excess, shortage, or damage;

b) The handover content includes books, papers, documents, reconciliation with actual quantities and quality, matters to follow up and complete (clearly stating specific responsibilities and tasks);

c) The handover report must be clear, witnessed and signed off by the immediate superior leader of the person handing over, the person receiving, and stored according to regulations.

Article 16. Monitoring and managing the use of medicines, chemicals (compounding, disinfectants), consumable medical supplies (if any)

1. Statistics, reporting, payment for medicines, chemicals (compounding, disinfectants)

a) Statistics, reporting:

- Establish a system of ledgers to track the issuance and receipt of medicines, chemicals (compounding, disinfectants) and store supporting documents and prescriptions according to regulations or have a software system for tracking and statistics on medicines. If the facility has a monitoring and management software system for issuance and receipt, print out the inventory card monthly, sign off, and store it according to regulations;

- Drug statistics: update the quantity of issued and received medicines, chemicals (compounding, disinfectants) and periodically or randomly reconcile with the warehouse manager;

- Statistics and report data on errors, excesses, shortages, and deterioration periodically and randomly.

- Coordinate with the Finance and Accounting Department to implement reporting as stipulated at point c of Article 10 of this Circular.

b) Payment: The Pharmacy Department will compile and aggregate the quantities issued, compare them with the supporting documents for issuance and receipt, and transfer them to the Finance and Accounting Department for settlement.

c) Handling surplus, shortage, deterioration, and expired medicines.

d) Expired medicines must be disposed of according to regulations on drug quality management.

đ) Medicines returned by clinical departments shall be inspected and re-entered according to the accounting procedures for issuance and receipt.

e) Donated medicines, epidemic prevention medicines, disaster relief medicines shall be implemented according to the guidelines of the Ministry of Health.

2. Inventory of medicines, chemicals (compounding, disinfectants)

a) Time of inventory:

- Conduct inventory of medicines, chemicals (compounding, disinfectants) in the Pharmacy Department once a month. Inventories of self-defense medicine stocks, flood and storm prevention stocks, and other stocks shall be conducted quarterly and have provisions for rotating these stockpiles;

- Conduct inventory of emergency medicine cabinets in clinical departments every three months;

b) Provisions for the Inventory Committee:

- The Inventory Committee in the Pharmacy Department's warehouse shall consist of the Head of the Pharmacy Department, the pharmacy accountant (statistician), the pharmacy warehouse manager, and a staff member from the Finance and Accounting Department monthly;

- The Inventory Committee in clinical departments: establish an inventory team with at least three members, headed by a representative from the Pharmacy Department, the head nurse of the department, and a nurse as members;

- The Hospital's end-of-year Inventory Committee shall include: the hospital leadership as the Chairman of the Committee; the Head of the Pharmacy Department as the Secretary of the Committee; the Heads of the Planning and Coordination Department, the Finance and Accounting Department, the Nursing Department; the pharmacy accountant, and the pharmacy warehouse manager as members.

c) Content of inventory:

- Reconcile ledgers with supporting documents;

- Reconcile records with actual quantities and quality;

- Recalculate the quantity and quality of medicines, chemicals (compounding, disinfectants), identify causes of excesses, shortages, and deterioration;

- Prepare an inventory record for medicines, chemicals (compounding, disinfectants), and consumable medical supplies (according to Model Appendices 8, 9, 10);

- If the quality does not meet requirements, the Inventory Committee shall prepare a confirmation record and propose handling measures (according to Model Appendices 11, 12).

Article 17. Regulations on storing medicines

1. Requirements for the medicine warehouse must ensure good storage practices principles

a) Requirements for location and design:

- The medicine warehouse should be located in a dry, safe place convenient for issuance, receipt, transportation, and protection;

- Ensure hygiene to prevent contamination;

- The warehouse area must be sufficiently spacious to ensure proper storage of medicines according to the requirements of each type of medicine;

- The chemical warehouse (compounding, disinfectants) should be located in a separate area;

b) Equipment requirements:

- Equip refrigerators to store medicines requiring low temperatures;

- The warehouse should have exhaust fans, air conditioners, thermometers, hygrometers, dehumidifiers;

- Equipment used to monitor storage conditions must be calibrated regularly;

- There should be enough shelves, racks, and cabinets to store medicines; the distance between shelves and racks should be wide enough for cleaning and handling;

- Adequate fire-fighting equipment (fire extinguishers, sand boxes, water hoses) should be available.

2. Storage regulations:

a) Maintain ledgers for storage work, control, temperature, and humidity monitoring (at least twice daily, morning and evening), and track issuance and receipt of products.

b) Avoid direct sunlight and other external influences.

c) Store medicines, chemicals, vaccines, biological products according to the storage conditions specified by the manufacturer on the label or according to the requirements of the active ingredient (for manufacturers that do not specify on the label) to ensure product quality.

d) Special control medicines (narcotics, psychotropic drugs, precursor substances used as drugs, radioactive drugs) and medicines stored under special temperature conditions must be stored according to current regulations and the manufacturer's requirements.

đ) Regularly monitor the expiration date of medicines. When medicines nearing their expiration date or showing signs of cracking, breaking, discoloration, or cloudiness are found, they should be placed in a separate area awaiting disposal.

e) Flammable and explosive medicines, chemicals, vaccines, biological products should be stored in a separate warehouse.

g) Conduct health checks for warehouse managers of medicines and chemicals every six months.

1. Requirements for equipment, rooms, areas for compounding modern medicines, radioactive medicines, traditional medicine preparation rooms, and medicine preparation from herbal materials:

a) Modern medicine compounding rooms, radioactive medicine compounding rooms, and traditional medicine preparation rooms must follow a unidirectional process flow to ensure safety, hygiene, and prevent contamination, meeting technical standards and necessary conditions to meet compounding requirements; each room must be designed according to the specific product requirements (external use medicines, injectable medicines, eye drops, cancer medicines, radioactive medicines, traditional medicines).

b) All necessary equipment for compounding and preparation must be available.

2. Requirements for personnel working in compounding and preparation rooms: Must meet professional and health standards as prescribed (radiation safety practice certificate if compounding radioactive medicines).

3. Requirements for raw materials (modern medicines, traditional medicines, medicines from herbal materials, radioactive medicines):

a) Raw materials and chemicals used for compounding must meet quality standards based on foundation standards or pharmacopoeia standards, within their expiration date, and accompanied by test certificates.

b) Herbal materials must meet quality standards.

4. Scope of compounding modern medicines, radioactive medicines, traditional medicines, and medicines from herbal materials:

a) Scope of compounding modern medicines:

- Compounding medicines according to prescriptions for patients, compounding specialized therapeutic medicines.

- Preparing cancer treatment drugs: The Pharmacy Department is responsible for compounding cancer treatment drugs into infusion solutions or injection solutions for clinical departments. Where conditions are not met, the Pharmacy Department must establish compounding procedures, guide, and monitor the compounding of cancer drugs for patients in clinical departments. The drug preparation room must ensure safety for preparers and environmental safety.

- Dividing doses for pediatric patients: The Pharmacy Department is responsible for dividing doses for pediatric specialties or guiding nurses to perform compounding procedures according to the manufacturer's requirements.

b) Scope of compounding radioactive medicines:

- Collaborating with the Nuclear Medicine Department to develop compounding procedures for radioactive medicines;

- Compounding and dividing doses of radioactive medicines listed for use at the hospital in isolated areas, ensuring radiation safety;

- All packaging, tools, waste, and rinse water during the compounding of radioactive medicines must be collected and processed according to radiation quality management regulations;

- The quantity compounded, volume compounded, quantity dispensed, and dispensing location must be detailedly monitored and updated after each compounding and dispensing.

c) Scope of preparing traditional medicines and medicines from herbal materials:

- Preparing and roasting traditional medicines used in hospitals;

- Decocting traditional medicine prescriptions for patients;

- Producing certain forms of medicines from herbal materials used in hospitals;

- Depending on the conditions of each general hospital, the Hospital Director decides whether to prepare traditional medicines and medicines from herbal materials under the Traditional Medicine Department or the Pharmacy Department.

5. Compounding procedures:

a) Establish compounding procedures for each medicine, seek approval from the Hospital Scientific Council, and submit for the Director's approval. The compounding procedure includes:

- Professional standards (foundation standards, Vietnamese standards);

- Compounding formula;

- Compounding process;

- Standards and requirements for raw materials and excipients;

- Finished product standards.

b) Control semi-finished products or finished products according to the requirements of each type of compounded or prepared traditional medicine and medicine from herbal materials.

c) After compounding, record in the compounding monitoring log (according to Appendix 15), cross-check the prescription, verify the chemical name and dosage used for compounding, and immediately affix the finished product label.

d) Inspect finished products before dispensing them to patients (self-inspection or send finished products for inspection at other legitimate facilities).

đ) Emergency prescriptions must be compounded immediately, the compounding time recorded on the prescription, and the medicine handed over promptly.

6. Strictly control and test compounded medicines and retain samples as required.

7. Health check-ups for compounding pharmacists: Every six months.

Article 19. Drug information and drug usage advice

1. Drug information work and advice on drug usage

a) Establish a drug information unit to disseminate, monitor, and promote safe, rational, and effective drug use.

b) Provide drug information including: drug name, active ingredient, dosage, toxic dose, overdose; dosage adjustment for special patient groups; indications, contraindications, adverse effects of drugs, drug interactions, compatibility, and incompatibility; drug selection for treatment; drug use for pregnant women/breastfeeding mothers; precautions when using drugs.

c) Timely notify new drug information: drug name, components; pharmacological effects, adverse effects, indications, contraindications, dosage to clinical departments.

d) Advise the Drug and Treatment Council on selecting drugs for inclusion in the hospital drug list and in establishing criteria for drug selection in bidding.

đ) Advise doctors on drug selection for treatment.

e) Guide nurses and patients on drug use to enhance safe and rational drug use; instruct on drug administration route, interval, timing, and monitoring treatment.

g) Participate in disseminating and updating specialized knowledge related to drugs and their use for healthcare staff.

h) Participate in pharmacovigilance activities; monitor and collect reports on drug adverse effects within the unit and report to the National Center for Drug Information and Adverse Reaction Monitoring. Propose measures to address and advise on rational and safe drug use.

i) Participate in scientific research on drug use, clinical drug trials, and economic evaluation of medical care in hospitals.

k) Participate in directing the line.

2. Drug Usage

a) Develop guidelines for hospital drug list usage.

b) Develop criteria for drug and chemical selection (compounding, disinfection) to be provided to the Drug and Treatment Council and Bidding Committee for selection of drugs and chemicals (compounding, disinfection) for use in hospitals.

c) Monitor and supervise rational and safe drug use in hospitals.

d) Evaluate drug usage regarding indications (alignment with treatment guidelines, hospital drug list), contraindications, dosages, and drug interactions through drug approval for clinical departments and participation in drug usage analysis in clinical cases and drug usage process evaluation.

đ) Control chemical use in departments and wards.

Article 20. Management and monitoring of implementation of specialized regulations on pharmacy in hospital departments and pharmacies

1. Monitor and manage drug use in emergency cabinets in hospital clinical departments.

2. Monitor and advise the Hospital Director on the implementation of specialized pharmacy regulations for clinical, paraclinical departments, and hospital pharmacies.

Chapter IV

IMPLEMENTING PROVISIONS

Article 21. Effective Date

This Circular takes effect from July 25, 2011, and replaces the provisions on "Pharmacy Department Regulations," "Pharmacy Supervisor for Ward and Distribution," "Compounding Pharmacist," and "Head of Pharmacy Department" in Decision No. 1895/1997/BYT-QĐ dated September 19, 1997, issued by the Minister of Health on the issuance of Hospital Regulations.

Article 22. Responsibility for enforcement

Gentlemen, Ladies: Director of the Ministry's Office, Director of the Department of Medical Examination and Treatment, Inspector General of the Ministry, Director-General, Directors of Departments, Heads of Divisions under the Ministry of Health, Directors of Hospitals directly under the Ministry of Health, Directors of Provincial Health Services, and Heads of Health Departments of Ministries and sectors are responsible for implementing this Circular.

During implementation, if there are difficulties or obstacles, units and localities need to promptly reflect them to the Ministry of Health (Department of Medical Examination and Treatment) for guidance, consideration, and resolution./.