In order to strengthen the pharmacological management of medical institutions, standardize the clinical intravenous drug centralized dispensing, improve the quality of intravenous drugs, promote the rational use of intravenous drugs, to protect the safety of intravenous drugs, according to the "Chinese People's *** and State Drug Administration Law" and "prescription management approach", the development of this specification.
The centralized dispensing of intravenous drugs referred to in this specification means that the pharmacy department of a medical institution, according to the physician's prescription or medication prescription, by the pharmacist for suitability audit, professional and technical personnel of pharmacy in accordance with the requirements of aseptic operation, in a clean environment, the intravenous drug addition and mixing and dispensing, so that it can be used for clinical direct intravenous infusion of finished products infusion process. Intravenous drug centralized mixing is a part of drug dispensing.
This specification is a centralized mixing of intravenous drugs quality management of the basic requirements, applicable to parenteral nutritional solutions, hazardous drugs and other intravenous drug mixing of the whole process. Other departments of medical institutions to carry out centralized or decentralized clinical intravenous drug dispensing, with reference to the implementation of this specification.
I. Medical institutions using centralized deployment and supply of intravenous drugs, should be set up intravenous drug dispensing center (room) (Pharmacy intravenous admixture service, PIVAS). Parenteral nutrition solution and hazardous drugs intravenous medication should be centralized deployment and supply.
Second, medical institutions centralized deployment of intravenous drugs should be strictly in accordance with the "centralized deployment of intravenous drugs operating procedures" (see Annex).
Third, the basic requirements of personnel
(a) intravenous drug dispensing center (room) should have a bachelor's degree or above in pharmacy, the professional qualifications of intermediate or above professional and technical positions in this profession, have rich practical experience, strong sense of responsibility, and a certain degree of management ability.
(2) The personnel responsible for reviewing the appropriateness of intravenous medication orders or prescriptions shall have a bachelor's degree or above in pharmacy, more than five years of experience in clinical medication or dispensing, and qualifications for professional and technical positions above the level of pharmacist.
(3) The person responsible for setting up the medication, adding the medication mixing and blending, and checking the finished infusion should have the qualification of professional and technical position above pharmacist.
(d) engaged in the centralized dispensing of intravenous drugs, pharmacy professionals and technicians, should receive post professional knowledge training and qualified by the examination, and regularly receive continuing education in the pharmacy profession.
(E) and intravenous drug dispensing work related personnel, at least once a year for health checks, the establishment of health records. Suffering from infectious diseases or other diseases that may contaminate medicines, or suffering from mental illness and other inappropriate to engage in drug dispensing work, should be transferred out of work.
Four, housing, facilities and layout of the basic requirements
(a) intravenous drug dispensing center (room) the overall regional design and layout, functional room setup and area should be compatible with the workload, and to ensure that the clean area, auxiliary work area and living area of the division, the flow of people between the different areas and logistics access to a reasonable direction, between different cleanliness levels of the region should be prevented from cross contamination of the corresponding facilities. Corresponding facilities between different clean level areas should have to prevent cross-contamination.
(2) intravenous drug preparation center (room) should be set up in a quiet area with little movement of people, and easy to communicate with medical staff and delivery of finished products. Set up the location should be far away from all kinds of pollution sources, prohibited from setting up in the basement or semi-basement, the surrounding environment, pavement, vegetation, etc. will not cause pollution to the process of intravenous drug dispensing. Clean area air intake should be set in the surrounding 30 meters in a clean environment, pollution-free areas, the height from the ground is not less than 3 meters.
(C) intravenous drug dispensing center (room) of the clean area, auxiliary work area should have the appropriate space to place the appropriate facilities and equipment; clean area should contain a dressing, secondary dressing and dispensing operation room; auxiliary work area should contain the appropriate storage of drugs and materials, review the printing of the prescription, the preparation of drugs, finished product verification, packaging and general dressing and other functional rooms.
(d) intravenous drug preparation center (room) room should have sufficient lighting, wall color should be suitable for human vision; ceiling, walls, floors should be flat, clean, non-slip, easy to clean, there shall be no shedding; clean area of the room ceiling, walls, floors shall not be cracked, can withstand cleaning and disinfection, the junction should be curved, the interface is tight; the building materials used should be Meet the environmental requirements.
(E) intravenous drug preparation center (room) clean area should be equipped with temperature, humidity, air pressure and other monitoring equipment and ventilation facilities, to maintain the temperature of the intravenous drug preparation room 18 ℃ ~ 26 ℃, relative humidity of 40% ~ 65%, to maintain a certain amount of fresh air intake.
(F) intravenous drug dispensing center (room) clean area of the cleanliness standards should be consistent with relevant national regulations, by the statutory testing departments to test qualified before being put into use.
Requirements for the cleanliness level of each functional room:
1. primary locker room, laundry room for 100,000;
2. secondary locker room, drug mixing and blending operation room for 10,000;
3. laminar flow operation platform for 100.
Other functional rooms should be strengthened as a control area management, prohibit the entry and exit of non-room personnel. Clean area should be continuously fed into the fresh air, and maintain a positive pressure differential; antibiotics, hazardous drugs, intravenous drug dispensing clean area and the secondary locker room should be 5 to 10 Pa negative pressure differential between.
(VII) intravenous drug preparation center (room) should be based on the nature of the drug to establish different delivery, exhaust (return) air system. Exhaust should be in the downwind direction of the air outlet, the distance shall not be less than 3 meters or set up on different sides of the building.
(viii) drugs, materials storage and the surrounding environment and facilities should be able to ensure the quality of various types of drugs and safe storage, should be divided into refrigerated, cool and room temperature areas, the relative humidity of the warehouse 40% ~ 65%. The secondary drugstore should be clean and tidy, and the width of the door and passageway should be convenient for handling drugs and meet the fire safety requirements. There is to ensure that the drugs received, acceptance, storage, maintenance, unpacking and other operations appropriate housing space and equipment, facilities.
(ix) intravenous drug dispensing center (room) installed in the pool location should be appropriate, shall not cause contamination of intravenous drug dispensing, without floor drains; indoor should be set up to prevent dust and rodents, insects and other facilities to enter; shower and toilet should be set up separately outside the center (room), shall not be set up in the intravenous drug dispensing center (room).
Fifth, the basic requirements of instruments and equipment
(a) Intravenous drug preparation center (room) should have the appropriate instruments and equipment to ensure the operation of intravenous drug preparation, quality of finished products and supply service management. Instruments and equipment shall be certified by the national statutory departments.
(2) intravenous drug dispensing center (room) instruments and equipment selection and installation, should be consistent with easy to clean, disinfect and easy to operate, repair and maintenance. Measuring instruments are accurate and regularly calibrated. Repair and maintenance should be specialized records and archives.
(C) intravenous drug dispensing center (room) should be configured with a hundred biological safety cabinets for antibiotics and hazardous drugs for intravenous drug dispensing; set up nutritional drug dispensing room, equipped with a hundred horizontal laminar flow clean table for parenteral nutritional solutions and general infusion intravenous drug dispensing.
Six, drugs, supplies and materials basic requirements
(a) intravenous drug dispensing drugs, medical supplies and materials should be in accordance with the provisions of the unified procurement by the health care institutions and the relevant departments of pharmacy, should be in line with the relevant provisions.
(2) The storage of drugs, medical supplies and materials should have a suitable secondary library, according to its nature and storage conditions require classification and positioning of storage, and shall not be stacked in the aisle or clean area.
(C) the storage and maintenance of drugs should be strictly in accordance with the "centralized dispensing of intravenous drugs operating procedures" and other relevant provisions of the implementation. Intravenous drug dispensing injection should be used in accordance with the Chinese Pharmacopoeia intravenous injection quality requirements.
(d) intravenous drug dispensing syringes and other apparatus used, should be used in accordance with national standards of single-use products, should be checked before use of the packaging, such as damage or more than the expiration date shall not be used.
VII, the basic requirements of rules and regulations
(a) intravenous drug dispensing center (room) should establish and improve the management system, job responsibilities and standard operating procedures.
(2) Intravenous drug dispensing center (room) should establish the relevant paperwork storage system: self-inspection, sampling and supervision and inspection of management records; prescribers and intravenous drug dispensing related to pharmacy professional and technical personnel signatures of the record documents; dispensing, quality management of the relevant systems and record documents.
(c) the establishment of drugs, medical supplies and materials, the receipt and acceptance, storage and maintenance, according to the medication doctor's orders for drugs and drugs and drug loss management system, and regularly check the implementation of the situation. Drugs should be a monthly inventory and quality checks to ensure that the account matches the goods, the quality is intact.
VIII, health and disinfection of the basic requirements
(a) intravenous drug dispensing center (room) should develop health management system, cleaning and disinfection procedures. The items stored in each functional room should be consistent with the nature of their work.
(2) clean area should be cleaned and disinfected every day, its cleaning and sanitation tools shall not be mixed with other functional rooms. Cleaning tools for washing methods and storage locations should be clearly defined. Selected disinfectants should be regularly rotated, will not contaminate the equipment, drugs, finished infusion and the environment. Monthly airborne colony counts in the clean area should be tested regularly and recorded. The number of people entering the clean area should be strictly controlled.
(c) clean area should be regularly replaced air filter. May affect the air cleanliness of the maintenance, should be tested and verified to meet the clean level standards before being put back into use.
(d) set up a good water supply and drainage system, the pool should be clean and odorless, and its surrounding environment should be clean and tidy.
(E) pay attention to personal hygiene, clean area operators should not enter the makeup and wear jewelry, should be in accordance with the provisions and procedures for changing clothes. Work clothes material, style and wear, should be with the different nature of the functional rooms, tasks and operational requirements, cleanliness level appropriate, not mixed, and should be cleaned separately.
(F) in accordance with the "Regulations on the Management of Medical Waste" to develop a waste disposal management system, according to the nature of the waste classified collection, unified treatment by the Agency.
Nine, with the hospital information system of medical institutions, intravenous drug dispensing center (room) should be established with the medication doctor's orders electronic information system, electronic information system should be in line with the "basic specification for electronic medical records (for trial implementation)" relevant provisions.
(a) the realization of medication prescription group entry, pharmacist audit, label printing and drug management, etc., each process operators should have identification and identification means, the operator is responsible for the use of their own identification.
(b) the identity of the pharmacy staff to log on to the electronic prescribing system to complete the records and other operations and confirmation, the system should display the signature of the pharmacy staff.
(C) electronic prescription or medication order information system should be established information security and confidentiality system, the physician's medication order and transfer operation process is completed and confirmed that is archived, archived may not be modified.
Intravenous medication dispensing center (room) should gradually establish and improve the pharmacy professional and technical electronic information support system.
Ten, intravenous drug dispensing center (room) by the unified management of the pharmacy department of the medical institutions. Pharmaceutical management organizations and quality control organizations are responsible for guiding, supervising and checking the implementation of the norms, operating procedures and related management system.
Eleven, medical institutions should develop relevant rules and regulations and norms, the whole process of centralized dispensing of intravenous drugs standardized quality management.
(A) physicians should be in accordance with the "prescription management approach" relevant provisions of the intravenous drug prescription or prescription; pharmacists should be in accordance with the "prescription management approach" relevant provisions of the "centralized dispensing of intravenous medication operating procedures", review of the medication listed in the doctor's orders of intravenous drug mixing and compounding of the reasonableness, compatibility and stability of irrational use of medication should be communicated with the physician to make adjustments to the proposal. The pharmacist has the right to refuse to dispense any prescription or medication order that is incorrectly administered or that does not ensure the quality of the finished infusion, and to make a record of it and sign it.
(b) the drug, mixing and blending and finished infusion should be implemented two-person checking system; centralized blending should strictly comply with the norms and standard operating procedures, no cross-blending; blending process should be stopped in the event of an abnormality in the blending, and immediately report and identify the cause.
(C) intravenous drug mixing each process is completed, the pharmacy staff should be in accordance with the provisions of the operating procedures, fill out the records, the content is true, complete data, clear handwriting. Each process and records should have a complete backup infusion labeling, and should ensure that the original infusion labeling information is consistent with the backup file should be kept for 1 year for inspection.
(d) physician's medication orders by the pharmacist appropriateness audit to generate infusion labels, labels should be in line with the "prescription management measures" stipulated in the basic content, and there are various positions in the corresponding position of the staff signature. Written or printed labels should be clear handwriting, correct and complete data.
(E) after verification of the finished infusion should have an outer packaging, hazardous drugs should be clearly marked.
(F) finished infusion should be placed in each ward of the special sealed cart, locked or sealed by the workers to deliver. The delivery should have a written handover procedure with the pharmacotherapy nurse.
Twelve, the pharmacist in the intravenous drug dispensing work, should follow the principle of safe, effective, economic, participate in clinical intravenous drug therapy, publicize the rational use of medication for health care workers and patients to provide relevant drug information and consulting services. If there are special precautions in clinical use, the pharmacist should make a written statement to the nurse.
Thirteen, medical institutions, intravenous drug dispensing center (room) construction should be consistent with the relevant provisions of this specification. Issued by the county and municipal health administrative departments, "medical practice permit" of medical institutions, set up an intravenous drug dispensing center (room) should be through the municipal health administrative departments review, acceptance, approval, reported to the provincial health administrative departments for the record; issued by the provincial health administrative departments, "medical practice permit" of medical institutions, set up an intravenous drug dispensing center (room) should be through the provincial health administrative departments review, acceptance, approval, and submit to the provincial health administrative departments for the record; by the provincial health administrative departments, "medical practice permit" of medical institutions, set up an intravenous drug dispensing center (room) should be through the provincial Health administrative department review, acceptance, approval.
Fourteen, this specification of the meaning of the following terms.
(A) hazardous drugs: refers to drugs that can produce occupational exposure risks or hazards, namely, genotoxicity, carcinogenicity, teratogenicity, or reproductive impairment and in low doses can produce serious organ or other toxicity of drugs, including tumor chemotherapy drugs and cytotoxic drugs.
(2) Finished infusion: in accordance with the physician's prescription or medication doctor's orders, by the pharmacist's suitability audit, through the aseptic operation technology will be one or several kinds of intravenous drugs for mixing and blending, can be clinically used for intravenous infusion of the patient's direct solution.
(C) infusion label: based on the physician's prescription or medication doctor's orders by the pharmacist suitability audit generated by the label, its content should be in line with the "prescription management approach" relevant provisions: there should be the patient and the basic information of the hospital district, the physician's orders for medication information, other special precautions, and intravenous medication dispensing of information on the operators of various positions.
(d) cross-dispensing: refers to the same operating table for two groups (bags, bottles) or more than two groups of intravenous drug mixing and dispensing process.
Attachment: Centralized Dispensing of Intravenous Medications
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