Application of FMEA model and 6S management method in reducing dispensing errors in PIVAS of children’s hospitals / 中国药房

OBJECTIVE To reduce dispensing errors in pharmacy intravenous admixture service （PIVAS） of children’s hospitals. METHODS The risk of dispensing procedures in our PIVAS was identified by applying failure mode and effect analysis （FMEA） model. Potential failure modes that might lead to dispensing errors in each link were determined， and failure causes were analyzed. The severity， incidence and detection degree of potential failure modes were quantitatively scored， and their risk priority number （RPN） was calculated to screen failure modes that needed to be improved in priority； the corresponding improvement measures were developed by 6S management method from six aspects， namely， finishing （seiri）， rectifying （seiton）， sweeping （seiso）， sanitation （seiketsu）， literacy （shitsuke） and safety. The effect of intervention before and after rectification was evaluated. RESULTS Based on the RPN， 32 potential failure modes were selected， of which a total of 18 critical failure modes that needed to be improved in priority. After implementing corresponding measures according to 6S management method， the RPN of 18 critical failure modes decreased. The total RPN decreased from 497 to 142 with a decrease rate of 71.43%. The error rates of 15 critical failure modes were significantly lower than before implementation （P＜0.05）. CONCLUSIONS Applying FMEA model and 6S management method to the risk control of all aspects of PIVAS workflow can effectively reduce the risk of PIVAS dispensing errors and ensure the safety of children’s intravenous medication.

Practice and effect of construction of rational drug use mode of PIVAS by the activities of quality control circle / 药学实践杂志

Objective To establish a rational drug use model of PIVAS and promote the rational drug use in clinical practices by enhancing the quality of prescription review by pharmacists. Methods The PIVAS physician orders received from 2014 to 2021 were extracted through the hospital information management (HIS) system. The types of irrational physician orders were statistically analyzed, the improvements were made by the method of quality control circle (QCC). Results The model of PIVAS rational drug use formed a standardized process. The proficiency of physician order review was improved. From 2014 to 2021, the number and proportion of unreasonable physician orders in PIVAS decreased year by year. Every type of unreasonable physician orders was improved year by year. Conclusion The professional and technical levels of pharmacist for physician order review at our hospital were improved by the model of PIVAS rational drug use. The quality of pharmaceutical service was significantly improved which ensured the safety of patients' medication.

Study on environmental residues detection and cleaning method of 15 cytotoxic antineoplastic drugs in PIVAS of our hospital / 中国药房

OBJECTIVE To provide a method to reduce environmental residues for pharmacy intravenous admixture service （PIVAS）， and ensure the occupational health of medical staff. METHODS The residues of 15 cytotoxic antineoplastic drugs such as gemcitabine were detected by UPLC-Q-Orbitrap-HRMS. The cleaning process was optimized with the residual quantity as the index. Nitrogen blowing method was used for alcohol volatilization experiment. CCK-8 assay was used to detect the effect of chlorine-containing disinfectant on the toxicity of cytotoxic antitumor drugs. RESULTS The linear range of 15 cytotoxic antineoplastic drugs such as gemcitabine were 0.5-1 000 ng/mL. RSDs of intra-day and intra-day precision were no higher than 20.00%. Six drugs including gemcitabine， isocyclophosphamide and cyclophosphamide were detected in the PIVAS environment of our hospital， and the residue of cyclophosphamide was relatively high. The optimal cleaning procedure was cleaning once with water + cleaning once with 1 000 mg/L chlorine-containing disinfectant + cleaning once with 75% alcohol， wiping with dry gauze method. The results of alcohol volatilization test showed that there was no significant difference in drug residues between control group and 75% alcohol group （P＞0.05）. The results of CCK-8 test showed that compared with control group， the survival rates of the cells treated with 15 cytotoxic antineoplastic drugs were decreased significantly （P＜0.01）； the survival rates of the cells treated with 15 cytotoxic antineoplastic drugs+chlorine-containing disinfectant were significantly higher than those treated with 15 cytotoxic antineoplastic drugs （P＜0.01）. CONCLUSIONS A method for the simultaneous determination for residues of 15 cytotoxic antineoplastic drugs such as gemcitabine in PIVAS is successfully established； the optimal cleaning procedure can significantly reduce the residues of drugs， the use of chlorine- containing disinfectant can significantly reduce the toxicity of drug， and the residual drugs will not cause secondary contamination of the operating area with alcohol volatilization.

Visual analysis of research progress of pharmacy intravenous admixture service in China based on bibliometrics / 中国药房

OBJECTIVE To summarize the research status and development trend of pharmacy intravenous admixture service in China in recent 20 years. METHODS Related literatures of pharmacy intravenous admixture service were retrieved from CNKI ， VIP and Wanfang database. The journal source ，authors and keywords were visualized by NoteExpress and CiteSpace 5.8.R1 software. RESULTS Totally 4 128 literature were included ，and the most literature were published in Strait Pharmaceutical Journal （198 pieces）. The configuration service of intravenous administration and the role of clinical pharmacists was cited the most frequently（104 times）；the author cooperation network analysis of literature showed that the author with the largest number of papers in the research field of pharmacy intravenous admixture service was Zhang Xiaoxia （31 pieces）. The top 20 key words showed that the research contents of pharmacy intravenous admixture service mainly focused on the rational drug use ， pharmaceutical care ，quality control ，management mode and other related fields. CONCLUSIONS In recent 20 years，more and more attention has been paid to the research of pharmacy intravenous admixture service. Establishing standard management mode ， strengthening laboratory quality control and implementing occupational exposure prevention and control programs are important means to improve the quality of finished infusion products and ensure clinical rational drug use ，and lay a foundation for the healthy development of pharmacy intravenous admixture service. Emphasizing the core of pharmaceutical care ，simplifying management mode and establishing standard management mechanism are the research hotspots in this field in the future.

Interpretation of Local Standard Specification for Pharmacy Intravenous Centralized Admixture in Beijing / 中国药房

OBJECTIVE：To interpret the key points in local standard Specification for Pharmacy Intravenous Centralized Admixture（DB11/T 1701-2019）（Beijing Local Standard for short ）in Beijing ，and to provide guidance and reference for managers of medical institutions and staff of PIVAS to deeply understand the standard and further improve the quality of PIVAS in medical institutions. METHODS ：The background and main content of Beijing Local Standard were interpreted in detail ，and then compared with Quality Specification of Pharmacy Intravenous Admixture （National Specification for short ）promulgated by Chinese National Ministry of Public Health and Quality Specification of Pharmacy Intravenous Admixture Services of Guangdong Provincial （Trial）（Specification of Guangdong Province for short ）promulgated by Guangdong Pharmaceutical Association. RESULTS & CONCLUSIONS：Beijing Local Standard had been promulgated and implemented by Beijing Municipal Administration for Market Regulation on April 1st，2020. The text of Beijing Local Standard is divided into 7 parts，mainly including the scope of application，normative references ，terms and definitions ，basic requirement ，environmental requirements （design，location， layout），equipment and facilities （ventilation system and console ，operation and maintenance ），and admixture requirements. Beijing Local Standard further refines the relevant contents on the basis of following the requirements of National Specification . Like Specification of Guangdong Province ，the applicability and operability of the standard are enhanced by combining their local characteristics and practice status. As the first local standard in this domain ，the local standard is expected to promote the improvement of the working quality of PIVAS in Beijing ，enable the PIVAS of proposed construction ，under construction and operation maintenance to meet uniform standards and reduce the failure of acceptance or reconstruction after completion.

Establishment of clinical decision support system for physician order of total nutrient admixture / 中华临床营养杂志

Objective:To establish a design of a clinical decision support (CDS) system ithin the computerized physician order entry (CPOE) system to ensure the correct prescribing of total nutrient admixture (TNA) orders.Methods:An improved new workflow was designed in consideration of both the TNA and doctor's prescription work flow. An exclusive CPOE interface for TNA physician order was established, within which a CDS mode was also created. When individual components of the TNA physician order are inputted, automatic calculation is performed through CDS to determine whether patient's clinical nutritional needs and pharmaceutical process requirements are both met. The generated feedback is presented directly to the prescribing clinician in the interface. Through rationality assessment of physician orders and real-time alarm feedback for inappropriate orders, the system can achieve pre-review of TNA orders as well as the education for clinicians on parenteral nutrition order prescription.Results:The usable drug catalog is created at the back end of CDS, thus precluding unreasonable medical orders of therapeutic drugs in TNA regimens. The background CPOE auxiliary support system for parenteral nutrition can correctly evaluate the reasonability of the carrier solution and provide real-time feedback in the CPOE interface.Conclusion:The establishment of the CPOE auxiliary support system eliminates the possibility of unreasonable component proportions and admixture with other therapeutic drugs in TNA orders to ensure TNA orders with rationale component proportion and good compatibility and stability, ultimately satisfying patient's daily calory need and guaranteeing medication safety of parenteral nutrition.

Establishment and Practice of Management of Weighting Recheck for Finished Intravenous Solution in PIVAS Based on Weight Analysis Method / 中国药房

OBJECTIVE：To management recheck and sorting weight for finished intravenous solutions in PIVAS ，to provide reference for reducing dispensing error and improving the safety and quality of intravenous infusion therapy. METHODS ：The weight analysis method was used to determine the weight of main drug and solvent in the finished intravenous solutions and infusion bottle . The weight maintenance information was added in PIVAS information management system ，and the marked weight of finished intravenous solutions was calculated for the verification of finished intravenous solutions. Average daily check quantity of finished product ，checking time ，average checking time of finished products per bag ，detection rate of dispensing error ，external error and timeliness of finished infusion batch were compared before （Mar.-May，2019，n＝83 006）and after （Jun.-Aug.，2019， n＝83 173）management. The effects of weighting recheck management were evaluated. RESULTS ：Compared with before the implementation of weighting recheck management ，there were no significant differences in the average daily check quantity of finished products ，the detection rate of dispensing errors caused by wrong labeling of liquid ，or the times of delayed drug delivery batches after the implementation of weighting recheck management （P＞0.05）. The checking time of finished products ，average checking time of finished products per bag ，the number of bags added or subtracted error ，detection rate of dose dispensing error ， total error detection rate prolonged or increased significantly （P＜0.05），and the number of external error was decreased significantly（P＜0.05）. CONCLUSIONS ：The weighting recheck management improves the accuracy and safety of PIVAS preparation，effectively improves error detection rate ，reduces the occurrence of external error ，but prolongs the time of checking ， which are urgent to be solved by information and automation means.

Application and effect evaluation of logistics robots in hospital pharmacy intravenous distribution / 中华医院管理杂志

Taking the application of logistics robots in intravenous drug distribution at our hospital as an example, this paper discussed the application effect of hospital logistics robots in actual operation, and discussed how to use data analysis to carry out a comprehensive scientific evaluation of the work effect of hospital logistics robots. The results showed that the hospital logistics robots can take charge of the daily heavy workload by using of unmanned technology. And at the same time, the transportation of medical materials by such means ensures the safety of transportation. It can also realize the whole process monitoring and closed-looping of transportation information. Analysis of operational data proves that the use of hospital logistics robots conforms to the expectation of higher quality requirements in hospital logistics, thus strengthening and improving the level of modern management of hospital logistics.

Optimization and Practice of Prescription Audit Platform of PIVAS in Our Hospital / 中国药房

OBJECTIVE： To optimize prescription audit platform of PIVAS in our hospital， and to provide reference for rational drug use in pediatric department. METHODS： The records of irrational drug use and prescription comment record of physicians were collected and sorted out. Retrieved from drug instruction， China’s National Prescription Collection： Chemicals and Biological Products Volume （Children’s Edition） （2013） and other data， PIVAS prescription audit guideline of our hospital was filed. Based on it， PIVAS prescription audit platform was optimized. The efficiency and accuracy of prescription audit were evaluated using average daily medical order audit time， the number of audit pharmacists， average daily number of telephone communication with clinicians， average daily number of irrational medical orders， the detection rate of irrational medical order as indexes. RESULTS： The revised PIVAS prescription audit guideline is simple and easy to consult. After optimizing and implementing PIVAS prescription  auditor platform， average daily medical order audit time， the number of audit pharmacists， average daily number of telephone communication with clinicians， average daily number of irrational medical orders decreased by 33.33 ％， 50.00 ％， 57.89 ％， and 57.14 ％， respectively； the detection rate of irrational medical orders decreased from 1.38％ to 0.54％， with statistical significance （P＜0.05）， which indicated the efficiency and accuracy of prescription audit were improved significantly. CONCLUSIONS： The optimized PIVAS prescription audit platform can significantly improve the standardization of medical order audit and the level of rational drug use， and contribute to rational drug use in pediatric department.

Practice of linear quality control on manually compounded total nutrient admixtures / 中华临床营养杂志

Objective To establish a quality control model ensuring good stability and compatibility of manually compounded total nutrient admixtures (TNA). Methods A parenteral nutrition medication order entry system was establish for standardizing nutritional medication usage and supporting physician's TNA prescribing. TNA medication orders were reviewed by pharmacists for validating the stability and compatibility. TNAs were compounded by pharmacists in a standard way following "four factors of sterile compounding". The goal of quality control was achieved by establishment of the preliminary standard. Results The quality of manually compounded total nutrient admixtures achieved the goal since pharmacy intravenous admixture service (PIVAS) started on 2003. Conclusions The quality of TNA is well assured while manually compounded by pharmacists in PIVAS.

Practice of linear quality control on manually compounded total nutrient admixtures / 中华临床营养杂志

Objective@#To establish a quality control model ensuring good stability and compatibility of manually compounded total nutrient admixtures (TNA).@*Methods@#A parenteral nutrition medication order entry system was establish for standardizing nutritional medication usage and supporting physician's TNA prescribing. TNA medication orders were reviewed by pharmacists for validating the stability and compatibility. TNAs were compounded by pharmacists in a standard way following "four factors of sterile compounding" . The goal of quality control was achieved by establishment of the preliminary standard.@*Results@#The quality of manually compounded total nutrient admixtures achieved the goal since pharmacy intravenous admixture service (PIVAS) started on 2003.@*Conclusions@#The quality of TNA is well assured while manually compounded by pharmacists in PIVAS.

Application of Full-course Pharmaceutical Care in Day-time Chemotherapy Center of Our Hospital / 中国药房

OBJECTIVE： To provide reference for improving the utilization rate of medical resources， the compliance of patients with chemotherapy and the rational use of drugs. METHODS： The working model of day-time chemtherapy center and the model of full-course pharmaceutical care were introduced in our hospital. The effects of full-course pharmaceutical care were summarized. RESULTS： As one of the core team members of the multidisciplinary collaborative working group on day-time chemotherapy， clinical pharmacists participated in the selection of chemotherapy schemes， the formulation of clinical pathways， the formulation of inclusion criteria for patients undergoing day-time chemotherapy， and the participation in information management of day-time chemotherapy centers. With the intervention of clinical pharmacists， prescription pharmacists and dispensing pharmacists， the patients were provided with full-course pharmaceutical care relying on pharmacy intravenous admixture service （PIVAS）， including the combination of pre-reviewing and real-time reviewing to examine and verify the medical orders for chemotherapeutic drugs， standardizing deployment of PIVAS chemotherapeutic drugs， real-time monitoring of the whole process of drug use in the background with the help of closed-loop management information system， actively providing pharmaceutical care， medication education and so on. The full-course pharmaceutical care model could effectively reduce irrational drug use. The qualified rates of chemotherapy pretreatment， hydration rate， administration sequence， flushing tube， placement time， drip rate for chemotherapy injection increased from 76％， 50％， 94％， 50％， 54％， 54％ before providing full-course pharmaceutical course （May-Jul. 2017） to 100％， 100％， 100％， 100％， 94％ and 96％ after providing full-course pharmaceutical course （Sept.-Nov. 2017）. CONCLUSIONS： The development of full-course pharmaceutical care in day-time chemotherapy center can improve the utilization of medical resources， patient compliance and rational drug use.

Construction and maintenance of the pharmacy intravenous admixture service / 中国医学装备

Objective: The construct a pharmacy intravenous admixture service (PIVAS) for changing configuration of intravenous drugs from decentralized configuration to centralized allocation supply so as to guarantee the safety of clinical drugs of hospital. Methods: Through constructed PIVAS, adopted purified air-condition system and established fluid-layers room of different grade to achieve sterile environment for configuration of intravenous drugs. And the centralized allocation should be implemented as the characteristics of different drugs. Results: The PIVAS could reduce the waste of drugs and decrease their cost. At the same time, it guaranteed the safety of clinical medication of hospital on the bases of enhancing work efficiency of clinical nurse and reasonably resolving allocation of human resources. Conclusion: The PIVAS that changes the configuration of intravenous drugs from decentralized configuration to centralized allocation supply can positively and effectively promote the safety of clinical medication and increase work efficiency of nursing and care.

Application of Whole Process Information Management in PIVAS of Our Hospital / 中国药房

OBJECTIVE:To conduct whole process information management in PIVAS of our hospital,and to promote the work quality and efficiency of pharmacy intravenous admixture service(PIVAS). METHODS:The whole process information management in PIVAS of Tianjin medical university cancer hospital(it is called our hospital for short)was introduced in respects of prescription review,medical order disposal,the deployment of the outboard and so on. Related data were selected from PIVAS of our hospital during Jun. 2015-Feb. 2017. The effects of whole process information management in PIVAS of our hospital in May 2016 were evaluated by retrospective analysis,pre and post control research method. RESULTS:Through the application of whole process information management system,the improvement of relevant management,the functions of primary checking of medical order,drug quantity statistics,record traceability,workload account,responsible person and operation time recording were realized in the links of prescription checking,medical order processing,outboard allocation,inboard allocation,cabin checking,automatic sorting. Compared with before application,6 indexes of work efficiency were improved by 33.3%-86.1% after application(P<0.05);4 indexes of the work quality were improved by 28.6%-66.7%(P<0.05);quality index of finished product infusion was improved by 12.5%(P<0.05). CONCLUSIONS:The application of whole process information management in PIVAS can improve work quality and efficiency,and facilitate the convenience of management assessment.

Development of Cytotoxic Drug Packing Bag and Its Application / 中国药房

OBJECTIVE: To strengthen the occupational protection of pharmacy intravenous admixture service (PIVAS) staff, and to ensure the safe and timely delivery of drugs. METHODS: The cytotoxic drug packing bag was made by oxford cloth, velvet cotton, pearl cotton, silica gel, activated carbon, rope, etc. Taking Paclitaxel liposomes for injection as an example, the application effect of packing bags was observed. A total of 156 medical orders of PIVAS formulated Paclitaxel liposomes for injection were selected and divided into test group and control group aoccording to random number table. The dispensing drugs were packed with cytotoxic drug packing bag in trial group, and packed with previous plastic packing bag in control group. The packing time of each drug, the delivery time, leaking and shattering, the breakage processing time and loss amount were compared between 2 groups. RESULTS: There was no statistical significance in the delivery time between 2 groups (P＞0. 05). The packing time of trial group was significantly longer than control group; there were 16 bottles of leaking in the control group, and 8 bottles of shattering; In trial group, 3 bottles were leaking but not spilled over (infiltrated in the silica gel layer), and there was no shattering bottle; the breakage processing time of trial group was significantly shorter than that of control group; the loss amount was significantly less than that of control group, with statistical significance (P＜0. 05). CONCLUSIONS: The cytotoxic drug packaging bag developed in this study can play a spill-proof, anti-seismic role, reduce the loss of valuable drugs, and also strengthen the occupational safety and health protection of medical staff.

Effect of meticulous management on prevention and control of healthcare-associated infection in pharmacy intravenous admixture service / 中国感染控制杂志

Objective To evaluate the application effect of meticulous management mode on prevention and control of infection related to pharmacy intravenous admixture service(PIVAS). Methods Qualified detection results of hygiene status of object surface,air culture quality,hand hygiene of medical staff in PIVAS in a hospital from Janu-ary 2014 to December 2016 were investigated,meticulous management measures were taken to intervene and analyze the detection results.Results The qualified rates of hand hygiene in 2014-2016 were 68.18%,81.82%,and 100.00% respectively,hand hygiene qualified rates in different years were statistically different(χ2=2.993,P=0.019). Qualified detection rates of surface of small objects,surface of horizontal laminar flow hoods,surface of biosafety cabinets,and air quality of dressing room Ⅰ and Ⅱ in PIVAS all increased to 100% in 2016.Conclusion Strengthening meticulous management of the internal work of PIVAS can effectively improve staff's standardized operation.

Effect of Joint Commission International Accreditation on Pharmaceutical Care in Pharmacy Intravenous Admixture Service / 医药导报

Objective To explore the role of Joint Commission International(JCI) standards on the improvement of pharmaceutical care in pharmacy intravenous admixture service (PIVAS) during the JCI accreditation.Methods The changes of PIVAS in Huangshi Central Hospital were analyzed and compared during JCI accreditation in respect of facilities,software management,service processes,safety awareness of the PIVAS staff and pharmacy management,service evaluation,error rate,etc.Results After JCI accreditation,the process of PIVAS were optimized,the software were updated ,and the safety awareness of PIVAS staff was improved;the management of high alert drugs was implemented more strictly;more importance was attached to the details of pharmaceutical care;the satisfaction degree of the clinic units to PIVAS was increased from 87.0% in 2014 to 98.0% in 2015;error rate was decreased from 0.40‰ in 2014 to 0.15‰ in 2015.The incidence rate of defective product was decreased from 0.32‰ in 2014 to 0.07‰ in March 2015.The correct rate of medical waste classification treatment was increased from about 85.5% in 2014 to 100.0% in 2015.Hand hygiene compliance rate and correct rate were increased up to 100.0%.6S site management activity participation rate was increased up to 100.0%.Conclusion The application of JCI standards and the process of JCI accreditation improve the quality of pharmaceutical care in hospital PIVAS.It can improve the medical safety in hospital.

Management and Practice of Quality Control in the Pharmacy Intravenous Admixture Service in Our Hos-pital / 中国药房

OBJECTIVE:To provide reference for the realization of normalization and standardization of quality control and management of Pharmacy intravenous admixture service(PIVAS). METHODS:The management and effectiveness of PIVAS quali-ty control in our hospital were introduced from aspects of the establishment of internal quality control system,the key indicators and effects of quality control. RESULTS:According to checking items from aspects of examining once in a month,on prescription checking,preparation,infection control,equipments,drugs,consumable materials,sanitation;holding 1 monthly quality control reviews;and analyzing unqualified indexes and existing security risks,the quality control of PIVAS had achieved good results. The qualified percentage of quality control index was increased from 84%(Jan. 2016)to 90%(Jun. 2016),error rate in the same peri-od was decreased from 0.579‰ to 0.099‰. CONCLUSIONS:Developing quality control of the implementation of detailed quality control key indexes for the whole process of intravenous infusion in PIVAS can effectively regulate the position working process,re-duce preparation error and ensure the quality of infusion preparation.

Experience in the Management of the Facilities and Equipment of Pharmacy Intravenous Admixture Ser-vice in Our Hospital / 中国药房

OBJECTIVE:To provide a reference for the management of the facilities and equipment of the pharmacy intrave-nous admixture service(PIVAS). METHODS:The experience in the management of the facilities and equipment of PIVAS in our hospital was introduced in respect of system establishment,archives management and the maintenance of important equipment,and the performance of core purification equipment was tested to evaluate management effect. RESULTS & CONCLUSIONS:The PIV-AS in our hospital established a practical system by developing and improving 7 management systems,9 sets of operational proce-dures and 5 contingency plans,increased the awareness of archives management by perfecting 27 archive files and standardized and conducted the maintenance of key equipment. In 2014 and 2015,after implementing management,the passing rates of all test items of the purification equipment were 100%. It is suggested that facilities management should focus on active preparation of an intelli-gent monitoring system,the improvement of the information system and the training of professional management personnel.

Intervention and prevention against irrational medication orders on antineoplastic drugs and total parenteral nutrition solution / 药学实践杂志

Objective To study the irrational intravenous (IV) medication orders and promote rational medication applications.Methods A retrospective analysis was conducted to analyze the irrational prescriptions from January to December 2016.Results Among 39 948 IV medication orders reviewed, there were 134 irrational prescriptions of cytotoxic drugs (0.33％) and 222 irrational prescriptions of total parenteral nutrition(TPN)(0.56％).Within 356 irrational prescriptions, 19 had improper amount of diluent(5.34％), 95 inappropriate dosage(26.69％), 12 drug incompatibility(3.37％), 8 wrong diluent (2.24％) and 222 inappropriate TPN orders (62.36％).Conclusion The interventions of the clinical pharmacists are needed to reduce medication errors and improve the drug safety and effectiveness.