Thông tư 22/2011/TT-BYT ngày 10/06/2011 quy định tổ chức và hoạt động của khoa Dược bệnh viện do Bộ Y tế ban hành

CIRCULAR

ON ORGANIZATION AND OPERATION OF THE DEPARTMENT OF PHARMACY AT THE HOSPITAL

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

Pursuant to the Law on Medicine No, 34/2005/QH11 dated June 14, 2005;

Pursuant to the Government’s Decree No. 188/2007/ND-CP dated December 27, 2007 on defining functions, tasks, powers and organizational structures of the Ministry of Health;

The Ministry of Health provides regulations on the organization and operation of the Department of Pharmacy at the hospital as follows:

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular provides regulations on the organization and operation of the Department of Pharmacy at the hospital, as well as the positions and tasks of the employees working in such Department.

Article 2. Functions of the Department of Pharmacy

Department of Pharmacy is the specialized department under the direct management of the Director of the hospital. The function of such Department is to manage and provide consulting advices for the Director of the hospital about all pharmaceutical activities of the hospital, in order to timely provide sufficient drugs with good quality, as well as providing counseling and supervision of the safe and reasonable use of such drugs.

Article 3. Tasks of the Department of Pharmacy

1. Make plans and provide drugs which are sufficient and qualified for the treatment demands and clinical trials, in order to satisfy the requirements for diagnosis and treatment, as well as other treatment requirements (prevention and control of diseases and natural disasters).

2. Manage and monitor the process of receiving and providing drugs according to the treatment demands and other surprise demands as requested.

3. Be the key agency to organize and carry out the activities of the Drug and Treatment Council.

4. Maintain drugs in accordance with the “Good Storage Practices” principle.

5. Prepare medicines, antiseptic chemicals and traditional medicines, as well as producing medicines from the medicinal materials used in the hospital.

6. Carry out clinical medicine activities, provide information and counseling on the use of drugs, participate in medicine safety activities, and observe and report information related the side effects of drugs.

7. Manage and monitor the process for implementing regulations on pharmacy at all departments in the hospital.

8. Conduct scientific and training research, which is the basis for experiment of the universities, colleges and high schools of Pharmacy.

9. Cooperate with paraclinical departments and clinical departments in observing, inspecting, evaluating and supervising the safe and reasonable use of drugs, especially antibiotics, as well as keeping track of the antibiotic use of the hospital.

10. Participate in directing the selection.

11. Participate in the consultation as required.

12. Participate in monitoring and managing the costs for medicine use.

13. Manage the operation of the Hospital Pharmacy in accordance with the regulations.

14. Carry out the tasks in providing, monitoring, managing, supervising, inspecting and reporting the medical materials which have been used (cotton balls, band aids, spirits, etc.) in the health facilities that do not have a Medical Materials - Equipment Office as assigned by the head of the facilities.

Chapter II

FACILITIES; POSITIONS AND TASKS OF THE EMPLOYEES IN THE DEPARTMENT OF PHARMACY

Article 4. Location and facilities of the Department of Pharmacy

1. The Department of Pharmacy shall be located in a convenient area, provide suitable facilities for the officials and employees of the Department (such as computer system; printer, telephone, internet, fax machine, pharmacy management software, preparation chemicals, documents related to the drugs and pharmacy profession) and support the activities in providing information, counseling and management of the use of drugs.

2. Storage facility, preparation rooms, area of production and preparation of traditional medicines and medicines from medicinal materials, and drug provision room shall be located in an area which is convenient for transportation and provision of drugs according to the "Good Storage Practices”. The pharmacy storage shall have sufficient light, temperature, humidity and ventilation; it shall prevent insects and termites; prevent and control fire and explosion; control bacteria according to the “Good Storage Practices”.

3. The drugs and perfusion preparation room shall be located in an appropriate area according to the "Good Storage Practices". As for the radioactive drugs and cancer chemicals which are prepared in the special preparation room at the departments or units, the Nuclear Medicine and Oncology Center shall comply with the regulations on safety of radiation and special toxic waste, in order to ensure safety for the pharmacists making the preparation, as well as ensuring environmental safety.

4. The storage facility of chemicals and spirits must be separated from the drug storage facility.

5. The Director of the hospital shall decide the locations of the preparation room and the storage facility of traditional medicines at the Department of Traditional Medicine or Department of Pharmacy, based on the conditions of the hospital. The estimation, import and provision of drugs shall be taken stock and reported in accordance with the regulations of the Department of Pharmacy.

Article 5. Personnel of the Department of Pharmacy

The personnel shall be selected in accordance with the personnel guidelines of the state health facilities.

Article 6. Organizational structures of the Department of Pharmacy

The human resources of the Department of Pharmacy shall be selected based on the rank of the hospital: general/specialized hospital, quantity of employees; equipment; and facilities. The Department of Pharmacy shall include the following divisions:

1. Professional pharmacists

2. Pharmacists in charge of the storage facility and provision of drugs.

3. Pharmaceutical statisticians.

4. Clinical pharmacists.

5. Pharmacists who prepare, test and control the quality of drugs.

6. Pharmacists who manage the specialized activities of the Hospital Pharmacy.

Article 7. Requirements, position and tasks of the Dean of Department of Pharmacy

1. Education requirement: must be a pharmacist with at least a bachelor degree. If the level 3 hospital or the hospital which is not ranked does not have a pharmacist with a bachelor degree, the Director of the hospital shall send a written authorization to the pharmacist with a high school degree to be in charge of the department.

2. Position and tasks:

a. Carry out the same tasks and rights as all Deans in the hospital.

b. Carry out the activities of the department according to the regulations hereof.

c. Take responsibility before the Director of the hospital for all activities of the department, as well as the specialized pharmaceutical activities at the clinical departments and the hospital pharmacy.

d. Is the permanent Deputy Chairperson of the Drug and Treatment Council. Provide consulting advices for the Director of the Hospital and the Chairperson of such Council about the selection drugs to be used in the hospital; is the selected key provider of drugs; inspect and supervise the prescription and the use of drugs in order to enhance the effectiveness of drug use and improve the treatment quality.

dd. Make plans and provide, maintain and use drugs and chemicals (preparation, antiseptic) based on the general plan of the hospital.

e. Import and export drugs, as well as making statistical reports; cooperate with the Department of Finance and Accounting in aggregating the expenses; monitor and manage the funds for using drugs. Such supervision and management shall be carried out properly and in accordance with the current regulations.

g. Monitor and inspect the maintenance of drugs; import and export drugs and chemicals (preparation, antiseptic) with good quality according to the current regulations.

h. Provide information, counseling and instruction on drug use for the medical employees.

i. Take the responsibility in participating in consultation or assign pharmacists of the department to participate in such consultation as required by the Director of the hospital.

k. Manage the specialized activities of the Hospital Pharmacy.

l. Participate in conducting scientific research, giving lecture and providing specialized trainings for the colleagues and officials of lower level.

m. Carry out other tasks assigned by the Director of the hospital.

Article 8. Requirements, position and tasks of the professional pharmacist

1. Education requirements: must be a pharmacist with at least a bachelor degree in order to work in a special hospital or level 1 or 2 hospital. The level 3 hospital and the hospital which is not ranked require a professional pharmacist who has at least a high school degree.

2. Position and tasks:

a. Inspect the regulations on pharmacy at the Department of Pharmacy, clinical departments and Hospital Pharmacy.

b. Regularly update the documents which specify the regulations on specialized management, provide consulting advices for the Dean to send the dissemination plan to the Director of the hospital, and implement these regulations at all departments in the hospital.

c. Provide sufficient drugs.

d. Carry out periodical inspection for the maintenance, management and provision of drugs at the Department of Pharmacy.

dd. Inspect the use and maintenance of drugs from the emergency cabinets at all clinical departments.

e. Test and control the quality of drugs (if the hospital does not assign one department to carry out the test, then after preparation, the specimen must be sent to the competent authority for examination).

g. Carry out other tasks assigned by the Dean of the Department of Pharmacy.

h. Take responsibility before the Dean for their assigned tasks.

Article 9. Requirements, position and tasks of the Pharmacist in charge of the drug storage facility

1. Education requirement: The pharmacist storing addictive drugs must have at least a bachelor degree or a high school degree and must be authorized according to the regulations; the pharmacist storing other drugs must have at least a high school degree.

2. Position and tasks:

a. Shall fully implement the “Good Storage Practices” principle in order to ensure safety for the storage facility.

b. Guide and assign the employees working in the storage facility to implement the regulation of such facility and of the Department of Pharmacy.

c. Strictly inspect and monitor the import and export of drugs according to the regulations of the Department of Pharmacy, and regularly or surprisingly report the provision activities of the storage facility to the Dean.

d. Participate in conducting scientific research and provide guidelines and professional trainings for the employees of the department, as well as other employees as assigned.

dd. Carry out other tasks assigned by the Dean of the Department of Pharmacy.

e. Take responsibility before the Dean for the assigned tasks.

Article 10. Requirements, position and tasks of the pharmaceutical statistician

1. A pharmaceutical statistician is required to be educated in both statistics and pharmacy.

2. Position and tasks:

a. Monitor and collecting accurate data of the drugs imported to the Department of Pharmacy and the drugs provided for outpatients and inpatients and for other surprise demands.

b. Report the statistical data as required by the Director of the hospital or the Dean of the Department of Pharmacy. Take responsibility before the Dean for the assigned tasks.

c. Make an annual report on the activities of the Department of Pharmacy, the use of drugs and chemicals (preparation, antiseptic) and medical materials (if any) in the hospital (using form No. 3, 4, 5, 6) and send such report to the Department of Health and Ministry of Health (Agency of Health Examination and Treatment, Department of Traditional Medicine, regarding the Traditional Medicine Hospitals) before October 15 every year (data of one year shall be collected from October 01 to September 30 of the following year), as well as a surprise report if being required.

d. Carry out other tasks as assigned by the Dean of Department of Pharmacy.

Article 11. Requirements, position and tasks of the clinical pharmacist

1. Education requirement: must be a pharmacist with at least a bachelor degree.

2. Position and tasks:

a. Be responsible for the drugs information of the hospital, promote the networking of monitoring, supervising and reporting the side effects of drugs and the medicine safety activities.

b. Provide instruction for the Drug and Treatment Council, medical employees and patients to safely and reasonably use drugs.

c. Participate in monitoring, inspecting and supervising the prescription of drugs for inpatients and outpatients, in order to promote a safe, reasonable and effective use of drugs.

d. Provide guidelines and inspect the use of drugs in the hospital; be responsible for the calculation and adjustment of dosage for patients in need; can consider changing drugs (if the storage facility of Department of Pharmacy runs out of drugs and chemical) with similar drugs and report to the clinical departments about such change to receive an agreement from them.

dd. Participate in scientific research and provide specialized trainings for the employees in the department, as well as other employees as assigned.

e. Carry out other tasks assigned by the Dean of the Department of Pharmacy.

g. Take responsibility before the Dean for the assigned tasks.

Article 12. Requirements, position and tasks of the medicine maker (if any medicinal preparation is carried out)

1. Education requirement: must be a pharmacist with at least a bachelor degree to work in the hospital having activities in preparing medicines and addictive drugs for the pediatric and oncology departments; the medicine maker must be a pharmacist with at least a high school degree to work in other departments; the pharmacist who participates in preparing radioactive drugs must process a Radiation Therapy Practice Certificate.

2. Position and tasks:

a. Implement the regulations on pharmaceutical activities and infection control activities.

b. Prepare medicines in accordance with the approved technical process and the list of drugs permitted to be prepared in the hospital.

c. Timely prepare and provide emergency drugs with good quality. Also, pay high attention while preparing drugs for children (make small doses, prepare injectable drugs) and cancer drugs.

d. Control and cooperate with assigned employees from different units, departments or nuclear medicine centers and oncology centers in preparing and using radioactive medicines and cancer chemicals, with the aim to ensure safety for patients, medical employees and the environment.

dd. Participate in scientific research and provide guidelines and specialized trainings for the employees in the department, as well as other employees as assigned.

e. Carry out other tasks assigned by the Dean of Department of Pharmacy.

g. Take responsibility before the Dean for the assigned tasks.

Article 13. Positions and tasks of other employees

Carry out assigned tasks and take responsibility before the Dean of Department of Pharmacy.

Chapter III

MAIN ACTIVITIES OF THE DEPARTMENT OF PHARMACY 

Article 14. Plan-making and provision of drugs

1. Plan-making:

a. Create a list of drugs used in the hospital every year according the reasonable treatment demands of clinical departments. This list shall be based on:

- Medical model of the locality and epidemiology recorded annually by the hospital.

- Qualifications of the medical employees according to the List of Technical Equipment permitted to be used by the hospital.

- Specific conditions of the hospital: scale and existing equipment used for diagnosis and treatment of the hospital.

- Funding capacity: state budget, health insurance budget and economic potential of the locality.

- List of drugs used essentially in the health facilities. Such list is promulgated by the Ministry of Health.

- The list of drugs used in the hospital must be reviewed, supplemented and modified annually in order to comply with the current treatment conditions.

b. Participate in developing the List of Drugs and Quantities Thereof from the emergency cabinets at clinical departments. This list is requested by the Dean based on the requirements and tasks of the department. It shall be submitted to the Director for approval.

c. Make a plan on provision of drugs and submit it to the competent authority for approval, with the aim to provide sufficient drugs with good quality for the diagnosis and treatment demands of inpatients and outpatients who have health insurance, and to comply with the fund of the hospital. Estimate and provide more drugs (using form No.2) if the demands exceed the plan, as well as estimating and providing drugs which are not provided by a selected provider or are not listed but required for a surprise demand.

d. Make plan for providing medical equipment (according to the regulations of the Director of the hospital) based on the specific conditions of the units, department of Pharmacy or other departments.

2. Provision of drugs

a. Make sure to provide sufficient drugs according to the treatment demands and other surprise demands.

b. Assign a key agency to organize the bidding (or make a summarized report on the drug demands of the unit and submit it to the competent authority) for buying drugs according to the Law on Bidding and other related current regulations.

c. Provide drugs which are under special control (addictive drugs, psychiatric drugs and precursor substances used for preparing drugs and radioactive drugs) according to the current regulations.

Article 15. Supervision and management of imported and exported drugs

1. Imported drugs:

a. All drugs and chemicals (preparation, antiseptic) shall be inspected before importing to the storage facility.

b. The members of the Inspection and Import Council must be selected by the Director of the hospital. They include: the Dean of the Department of Pharmacy, Manager of the department of Finance and accounting, manager of the storage facility, pharmaceutical statisticians, and pharmacists.

c. Contents of the inspection and import: inspect the types, quantity and quality of drugs and chemicals from all drug sources (purchase, support, project, and program) in the hospital according to the following requirements:

- During the inspection and import, compare the details of drugs on invoices with the actual details and the bidding results. Such details include: name of drug and chemical, concentration (content), unit, package procedures, quantity, pack number, unit price, expiry date, production company and production country.

- Drugs with intact labels and intact packages shall be prioritized to be inspected and imported. All drugs must be inspected and imported with a maximum duration of one week, from the moment they are received to the storage facility.

- Make a report on the damaged, extra, missing drugs and send it to the selected provider for supplementation and handling of such cases.

- During the import and inspection, check the preservation condition of the drugs which require special preservation or as required by the information on their labels.

- Drugs which require special control (addictive drugs, psychiatric drugs and precursor substances used to prepare drugs and radioactive drugs) shall be recorded in a separate report.

d. The import and inspection report must have enough signatures of all members of the Inspection and Import Council.

dd. Record the drugs into an inspection and import book (using form No. 14 in Appendix hereto).

2. Inspect the quantity of drugs used at the health facilities:

a. Control 100% of the sensory quality of drugs imported into the Department of Pharmacy.

b. Control the sensory quality of drugs imported periodically or surprisingly to the storage facility, preparation room and provision room of the Department.

c. Control the sensory quality of drugs imported periodically or surprisingly to the clinical departments.

3. Provide drugs and chemicals (preparation, antiseptic):

a. The Department of Pharmacy must approve drugs before providing them.

b. Provide drugs for the clinical departments:

- The Dean of the Department of Pharmacy or the pharmacist is authorized to approve the Drug Receiving Note during official hours.

- The Department of Pharmacy shall timely provide sufficient drugs and chemicals (preparation, antiseptic) according to the Drug Receiving Note from the clinical and paraclinical departments.

- Depend on the human resources of each unit, the Department of Pharmacy shall import drugs to clinical departments or such departments shall receive drugs at the Department of Pharmacy according to the regulations of the Director of the hospital.

c. Provide drugs according to the prescriptions of outpatients who have health insurance.

d. Refuse to provide drugs if any mistake is detected in the prescription or in the Drug Receiving Note. Inform the doctor who writes the prescription and the doctor who approves the note; Cooperate with the clinical doctor in adjusting the prescription or in changing drugs.

dd. When provide a drug, check and prepare:

- The form of Drug Receiving Note or prescription.

- The name and concentration (content) of drug to be provided, its' preparation form, dosage, route and frequency.

- Label of the drug

- Quality of the drug

- The quantity and frequency specified in the prescription and the Drug Receiving Note.

e. After providing such drug, immediately report this provision into the stock card to keep track of drugs regularly.

g. Provide drugs according to this principle: any drug imported first must be exported first, any drug with a sooner expiry date must be imported first. Only provide drugs which do not expire and satisfy the quality requirements.

h. Record the drugs into the Import - Export Recording Book or the stock card (using form No.1 in Appendix hereto).

4. Store the documents on import, export and prescriptions of outpatients according to the regulations on storage of medical records.

5. Hand over (when the storekeeper changes his/her tasks)

a. Before the handover, the storekeeper must fully record the data to be handed over; compare the actual data with the documents on import and export; record clear explanations about the extra, missing and damaged drugs.

b. Records, documents, comparison of the actual quantity and quality, tasks required to be monitor and completed (specify the position and tasks) shall be handed over.

c. The handover record shall be clearly written and signed in the presence of the higher authorities who manage the transferor, receiver and archivist.

Article 16. Supervision and management of the use of drugs, chemicals (preparation, antiseptic) and medical materials (if any)

1. Make statistical report and payment for drugs and chemicals (preparation, antiseptic)

a. Take stock and make statistical report:

- Keep recording books of the export and import of drugs and chemicals (preparation, antiseptic). Also, store the documents and the prescriptions according to the regulations, or develop statistical software to keep track of the drugs. If the hospital has software used to monitor and manage the export and import of drugs, monthly print the stock cards out, sign and store them according to the regulations.

- Pharmaceutical statistics: update the quantity of drugs and chemicals being imported and exported (preparation, antiseptic) and compare them periodically with the storekeeper.

- Perform stocktaking and make a periodical or surprise data report on mistakes and extra, damaged and missing drugs.

- Cooperate with the Department of Finance and Accounting in making reports according to point c, Article 10 hereof.

b. Make payment: The Department of Pharmacy shall perform stocktaking, sum up the quantity of provided drugs and compare such quantity with the documents on import and export, as well as transferring it to the Department of Finance and Accounting for them to payment.

c. Handle extra, missing and damaged drugs which expire.

d. The drugs which expire must be disposed according to the regulations on management of drug quality.

dd. The drugs returned by clinical departments must be checked and re-imported according to the process for accounting export and import.

e. The support drugs and drugs used for prevention and control of diseases and natural disasters must be provided according to the guidelines of the Ministry of Health.

2. Take stock of drugs and chemicals (preparation, antiseptic)

a. Stocktaking time:

- Take stock of drugs and chemicals (preparation, antiseptic) at the Department of Pharmacy once every month. The doses of drugs used for prevention and control of storm and flood and other doses shall be taken stock quarterly. Also, there must be regulations on the transfer of such doses.

- Take stock of the drugs from emergency cabinets at clinical departments once every three months.

b. Regulations on the Stocktaking Council:

- The monthly Stocking Council at the storage facility of the Department of Pharmacy shall include: the Dean of the Department of Pharmacy, pharmaceutical statistician, storekeeper and an official from the Department of Finance and Accounting.

- The Stocktaking Council at the clinical department shall include at least 3 members: the Dean of the department who is the leader, the leading nurse and the nurse.

- The Stocktaking Council of the hospital at the end of the year shall include: Chairperson, Dean of the Department of Pharmacy who is the clerk of the council, manager of the Department of Planning and General, manager of the Department of Finance and Accounting, manager of the Department of Nursing, pharmaceutical statistician, and storekeeper of the Department of Pharmacy.

c. Contents of stocktaking:

- Compare the books which record import and export with the documents.

- Compare the records and books with the actual quantity and quality.

- Re-determine the quantity and quality of drugs and chemicals (preparation, antiseptic), and find the reasons why there are extra, damaged and missing drugs.

- Make a stocktaking report on drugs and chemicals (preparation, antiseptic) and medical materials (using form No. 8, 9, 10 in Appendix hereto).

- If the drugs and chemicals do not satisfy the requirements, the Stocktaking Council shall make a confirmation report and request the handling for such drugs (using form No. 11 and 12 in Appendix hereto).

Article 17. Regulations on preservation of drugs

1. The drug storage facility shall satisfy the “Good Storage Practices” principle.

a. Requirements for the location and design:

- The drug storage facility must be located in a high and safe area, which is convenient for import, export, transport and protection.

- It must ensure hygiene and control infections.

- The area of such facility must be wide enough to ensure that the preservation can satisfy the requirements of each drug.

- The chemical storage facility (preparation, antiseptic) shall be located in a separate area.

b. Requirements for equipment:

- There must be a refrigerator used for preserving products at a low temperature.

- There must be a ventilation fan, an airconditioner, a thermometer, a hygrometer and a dehumidifier.

- The equipment used for monitoring the preservation state must be calibrated periodically.

- There must be sufficient shelves and cabinets used for organizing products; the distance between the shelves and cabinets must be wide enough for cleaning and loading products.

- There must be sufficient equipment for prevention and control of fire (extinguisher, sandbox and sprinkler).

2. Regulations on preservation

a. There must be a book recording the preservation and control activities, a book recording the temperature and humidity at least twice (morning and afternoon) a day, as well as a book recording the import and export of products.

b. Products shall be kept away from direct sunlight and other impacts from outside.

c. Drugs, chemicals, vaccines and bio-products shall be preserved in accordance with the preservation requirements written on the labels by the production company or requirements for ingredients (which are not written on the labels by the production company) in order to preserve the quality of the products.

d. Drugs which require special control (addictive drugs, psychiatric drugs and precursor substances which are used for preparing drugs and radioactive drugs) and drugs which require to be preserved at a special temperature shall be preserved in accordance with the current regulations and requirements of the production company.

dd. Monitor the expiry dates of drugs regularly. If drugs, which expire or are still effective but are broken, changed in color and dirty, are detected, they must be kept in a separate area to wait for handling.

e. Drugs, explosive chemicals, vaccines and bio-products must be preserved in a separate storage facility.

g. Provide health examination for the storekeeper of drugs and chemicals once every six months.

Article 18. Preparation and production of drugs used in the hospital

1. Requirements for equipment, rooms and areas which are used for preparing new drugs and radioactive drugs, as well as rooms used for preparing traditional medicines and medicines from medicinal materials:

a. Rooms used for preparing new medicines and radioactive medicines, and rooms used for preparing traditional medicines according to the one-way process, must maintain safety and hygiene to prevent infection and satisfy the technical standards, as well as other necessary requirements in order to meet the technical preparation requirements. The rooms must be designed in accordance with the requirements of each product (drugs for external application, injectable drugs, eye drops, cancer drugs, radioactive drugs, traditional medicines).

b. There must be sufficient equipment for drug preparation.

2. Require the employees of the preparation rooms to satisfy the specialized standards and health standards according to the regulations (must have a Radiation Therapy Practice Certificate for preparing radioactive drugs)

3. Requirements for ingredients (new drugs, traditional medicines and medicines from medicinal materials, radioactive drugs):

a. Ingredients and chemicals used to prepare drugs must satisfy the quality standards of the hospital or the pharmacopoeia standards. They must not expire and must be attached with a test note.

b. The medicinal materials must satisfy the quality requirements.

4. Scope of preparation for new drugs, radioactive drugs, traditional medicines and medicines prepared from medicinal materials:

a. Scope of preparation for new drugs: 

- Prepare drugs according to the prescriptions of patients and prepare special drugs.

- Prepare drugs for treating cancers: the Department of Pharmacy shall mix cancer drugs with perfusion or injected solution for the clinical departments. It shall develop the preparation process, guide and control the preparation of drugs used for treating cancers for patients of the clinical departments if such departments do not have favorable conditions. The rooms used for preparing cancer drugs must ensure safety for the medicine makers and the environment.

- Divide drugs into small doses for children: the department of Pharmacy shall divide drugs into small doses for the pediatric department or guide the nurses to carry out the preparation process in accordance with the requirements of the production company.

b. Scope of preparation for radioactive drugs:

- Cooperate with the Department of Nuclear Medicine in developing the preparation process for radioactive drugs.

- Prepare and divide radioactive medicines, which are specified in the list of permitted drugs of the hospital, into small doses at a restricted area to ensure radiation safety.

- All packages, supplies, waste and cleaning water which are used during the preparation process of radioactive drugs must be collected and handled in accordance with the regulations on management of radiation quality.

- The quantity and volume of drugs being prepared, quantity of drugs being provided and the provision address must be monitored specifically and updated after each preparation and provision.

c. Scope of preparation for traditional medicines and medicines from medicinal materials:

- Prepare and dehydrate “thuốc phiến” which are used in the hospital:

- Slice medicines for patients.

- Produce certain types of medicines from medicinal materials which are used in the hospital.

- It depends on the conditions of each general hospital, the Director of such hospital shall make a decision on the preparation of traditional medicines or medicines from medicinal materials. Such preparation is done in the Department of Traditional Medicine or the Department of Pharmacy.

5. Preparation process

a. Develop the preparation process for each medicine, get opinions from the Science Council of the hospital and submit such process to the Director for approval. The preparation process includes:

- Specialized standards (standards of the hospital and Vietnamese standards)

- Preparation formula.

- Preparation process

- Standards and requirements for ingredients and auxiliary ingredients.

- Product standards.

b. Control the sale of products according to the requirements of each prepared medicine, traditional medicine and medicine from medicinal materials.

c. After preparation, record the prepared medicine into the recording book (using form No. 15 in Appendix hereto), compare with the prescription by checking the name of the chemical and the dose being used to prepare the medicine. Also, label the product immediately.

d. Test the product before providing it to patients (perform the test themselves or send the product to other legal health facilities for the test).

dd. The prescription for an emergency must be prepared immediately. The preparation duration must be written on such prescription and the drugs must be provided immediately.

6. Strictly control and perform tests for the drugs which have been prepared, as well as storing the specimens according to the regulations.

7. Provide health examinations for the pharmacists preparing the drugs once every six months.

Article 19. Provision of drug information and counseling on the use of drugs

1. Activities in providing drug information and counseling on the use of drugs

a. Organize a unit to provide drug information, with the aim to monitor and disseminate a safe, reasonable and effective use of drugs.

b. The drug information shall include: name of the drug, its ingredients, effective dose, toxic dose and overused dose; adjustment of doses for special patients; indication, contraindication and side effects of the drug, as well as its interaction, compatibility and incompatibility; drug selected for the treatment; drug used for pregnant women/breast-feeding women and other notes regarding the use of drug.

c. Timely provide the information about a new drug to the clinical departments: name of drug, its ingredients, effectiveness; side effects; indication, contraindication and doses.

d. Provide consulting advices for the Drug and Treatment Council about how to select drug and include them in the list of drugs used in the hospital, and how to develop the criteria for selecting drugs for bidding.

dd. Provide counseling on the use of drugs for the doctor who prescribes the medication, in order for him/her to select drugs for treatment.

e. Provide guidelines on the use of drugs for nurses and patients, in order to enhance a safe and reasonable use of drugs; provide instruction on such use, as well as the route and frequency; provide counseling on treatment and monitor such treatment process.

g. Participate in disseminating and updating specialized knowledge, which is related to drugs and the use of such drugs, for medical employees.

h. Participate in drug safety activities; monitor and collect the reports on side effects of drugs of the units and send a summarized report to the National Drug Information Center, as well as monitoring the adverse reactions of such drugs. Suggest methods for solving problems regarding the safe and reasonable use of drugs.

i. Participate in scientific research on the use of drugs, the clinical drug test and the evaluation of the health economic effects in the hospital.

k. Central-level and provincial-level hospitals shall provide directions for inferior hospitals.

2. Using drugs

a. Develop a guideline for using the list of hospital drugs.

b. Develop criterion for selecting drugs and chemicals (preparation, antiseptic). Provide them to the Drug and Treatment Council and the Bidding Council, in order for these Councils to select drugs and chemicals (preparation, antiseptic) to use in the hospital.

c. Inspect and monitor the safe and reasonable use of drugs in the hospital.

d. Evaluate the indication (whether it complies with the treatment instruction and the list of hospital drugs), contraindication, doses and interaction of drugs from the drug approval issued to the clinical departments, and participate in analyzing the use of drugs in clinical cases, as well as evaluating the drug use process.

dd. Control the use of chemicals at all departments.

Article 20. Management and supervision of the implementation of regulations on Pharmacy at all departments and at the Hospital Pharmacy 

1. Monitor and manage the use of drugs from the emergency cabinets at clinical departments in the hospital.

2. Monitor and provide consulting advices for the Director of the hospital about the implementation of the regulations on Pharmacy of clinical departments, paraclinical departments and hospital pharmacy. Chapter IV

IMPLEMENTATION 

Article 21. Entry into effect

This Circular shall come into effect from July 25, 2011 and replace the following regulations: “Regulations of the Department of Pharmacy”, “Pharmacist in charge of the storage facility and the provision of drugs", "Medicine Maker" and "Dean of Department of Pharmacy", which are specified in the Decision No. 1895/1997/BYT-QD dated September 19, 1992 of the Minister of Health.

Article 22. Implementation responsibilities

Chief of the Ministry Office, General Director of the Agency of Health Examination and Treatment, Chief Inspector of the Ministry, General Directors of the Departments, General Directors of the Departments under the Ministry of Health, Directors of the hospitals affiliated to the Ministry of Health, Directors of the Departments of Health of provinces and central-affiliated cities, and chief health officers of Ministries and Sectors shall implement this Circular.

During the implementation process, if there is any problem occurs, the units and localities shall timely provide feedbacks to the Ministry of Health (Agency of Health Examination and Treatment) in order to receive their guidelines and solutions.

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