Chương III: Thông tư 22/2011/TT-BYT Hoạt động chính của khoa dược

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.