Development of regional pharmacy intravenous admixture services data reporting and analysis platform for enhanced quality control ability

Background Pharmacy intravenous admixture service (PIVAS) center has emerged as an important department of hospitals as it can improve occupational protection and ensure the safety and effectiveness of intravenous infusions. However, there is little research on the standardized capability and risk evaluation of PIVAS by using modern information technology. In this research, we established Regional Pharmacy Intravenous Admixture Services Data Reporting and Analysis Platform (RPDRAP) to improve quality control ability for PIVAS management. RPDRAP including evaluation matrix for quality control monitoring. The construction of platform is based on guidelines for the Construction and Management of PIVAS and management specifications of PIVAS in China. Methods RPDRAP was established in 2018. This platform comprises a data collection system and a data analysis system. The data collection system consists of 67 data items. Data collection relied on online platforms through data acquisition module. The collected data were analyzed using a model with 20 indicators within the data analysis system. Fifteen hospitals, public comprehensive healthcare facilities with more than 500 beds, participated in the platform’s application evaluation. Results The study revealed significant differences in PIVAS total score, supervisors, and workload between 2020 and 2022. The platform’s application results demonstrated improvements in personnel management, work efficiency, and infection control within these PIVAS. Although statistical significance was observed in only 8 out of the 25 items, most of the scores showed an increase, with a small portion remaining unchanged and no decline in scores. Conclusions This platform can be recommended for PIVAS homogeneous and regional efficient management. The use of this platform not only improves the quality control ability of PIVAS but also enables the management department to quickly grasp the current situation and characteristics of each PIVAS through standardized data collection and analysis.

Development of regional pharmacy intravenous admixture services data reporting and analysis platform for enhanced quality control ability Shaowu Tian 1 , Genyu Xie 1 , Fan Xu 2* and Jun Zhang 3

Background
Intravenous drug therapy is widely used in clinical treatment in China.The percentage of inpatients receiving intravenous infusion exceeds 80% [1].However, intravenous administration is considered the most risky method of drug therapy, as it can lead to severe adverse reactions and pose a threat to human life and health.According to the 2021 National Annual Monitoring Report on adverse reactions, 55.3% of adverse reactions are attributed to injection administration, with 90.5% of these adverse reactions specifically related to intravenous administration [2].
Pharmacy intravenous admixture services (PIVAS) is a department within medical institutions that provides specialized technical services for the centralized compounding of intravenous medications for patients.In PIVAS, trained pharmacists offer pharmaceutical services such as intervention and review of intravenous medication prescriptions, compounding and mixing of medications, and participation in the assessment of intravenous infusion usage [3,4].Studies have indicated that the implementation of PIVAS can significantly improve the level of rational drug use, enhance infusion safety, and reduce occupational exposure among healthcare workers [5,6].Additionally, it has been shown to decrease medication preparation errors and result in cost savings [7].PIVAS has been widely adopted in developed countries such as the United States, Canada, Australia, New Zealand, and the United Kingdom [8][9][10].In China, over 2,000 PIVAS have been implemented.However, it is important to emphasize that PIVAS is a high-risk institution.Inadequate hardware, unreasonable dispensing processes, and chaotic personnel management can lead to large-scale and unforeseen drug accidents.Abdulwahid and Al-Ani.(2020) collected 99 cases from five hospitals.Among these cases, 52 were drug accidents caused by improper use of intravenous injection include drug-drug interaction, drug-disease interaction, and not indicated medication [11].Curran. (2011) found that infusate contamination can cause infusate-related bloodstream infection and even death [12].Moyen. et al. (2008) discovered drug errors rank seventh in terms of causes of death [13].
At present, many studies have shown the importance of information management in pharmacy administration.A study by Mazrouei. et al. (2021) showed that standardized data collection is conducive to reduce over-the-counter drug abuse [14].Meslamani. et al. (2021) showed that pharmacists' remote intervention through telephone and Internet impact on the medication and clinical outcomes of patients with COVID-19 in rural areas [15].Abdel-Qader. et al. (2022) showd that online collaborative consultation between pharmacists and doctors significantly reduce people's resistance to the COVID-19 vaccine [16].Although various intelligent machines and systems have been implemented in PIVAS, including labeling systems, infusion sequence annotation systems, review prescription databases, and so on [17][18][19], the utilization of this equipment only addresses workload challenges and helps mitigate human errors in specific aspects of the workflow.At present, there is little research on the standardized capability and risk evaluation of PIVAS by using modern information technology.In this research, we established the Regional Pharmacy Intravenous Admixture Services Data Reporting and Analysis Platform (RPDRAP), based on guidelines for the Construction and Management of PIVAS and management specifications of PIVAS in China, to improve quality control ability for PIVAS management.

Platform structure
RPDRAP consists of two systems: the data collection system and the data analysis system.The data collection system comprises a data acquisition module and a data audit module.The data collection module is displayed in the form of an online questionnaire for users to fill in the relevant information including basic information, hardware management, personnel management, work efficiency, information management, and infection control management aspects of 67 data collection items of PIVAS (Table 1).When the data reporter of PIVAS submits the form online every quarter, the system will verify the integrity and validity of the information.Once approved by the experts using the data audit module, the data will be stored in the SQL server database.
The data analysis system comprises a directed acyclic graph(DAG)execute editor, data query model, data analysis module, and data display module.DAG execute editor is used to implement system operations through visualization.The data analysis module consists of functions of computational formula,

Platform application
We had carried out the research and application of this platform in Yunnan Province, China.Since its launch in 2020, an increasing number of PIVAS had participated in the platform's application.In 2020, there were 28 participating PIVAS, followed by 55 in 2021 and 71 in 2022.Through this platform, PIVAS regularly reports information related to its operations.Additionally, PIVAS could easily access their own PIVAS scores for the 20 indicators, as well as the average, maximum, and minimum scores of PIVAS in the region.

Study subjects
To evaluate whether the application of the platform promoted the standardized construction and development of PIVAS, the following inclusion criteria for study subjects were formulated: (1) The subjects under investigation were second-level and above public hospitals (hospitals of county-level and above) in Yunnan Province.(2) The medical institutions in Yunnan Province had implemented PIVAS and had reported data in RPDRAP.(3) Complete data for the years 2020, 2021, and 2022 were submitted in RPDRAP.Fifteen PIVAS met the inclusion criteria, and their three-year operational data were selected as the research objects.

Statistical analyses
Due to the non-normal distribution of the data tested by the normality checking tested Shapiro-Wilk test, we analyzed the data of 20 indicators in five aspects of 15 PIVAS in the past three years with the generalized estimation equation and pairwise comparison.SPSS statistical software (SPSS 24) was used to analyze the data.

Result
The analysis results of 20 indicators across five aspects over three years for the 15 PIVAS are presented in Tables 3 and 4. The scores for the total and each aspect of the 15 PIVAS are displayed in Fig. 2.Over three years, significant improvements were observed in 8 indicators of five aspects (see Table 4).
The indicators of "type of infusion", "the number of comprehensive cleaning times", and "the number of prescriptions per person per day" improved significantly, and the final score was close to the highest score.
The indicators of "usage of syringe (P < 0.001)", "daily infusion allocation quantity per person (P < 0.05)", "unreasonable medical order and disposition (P < 0.001)", "work efficiency management (P < 0.01)" and "information management (P < 0.01)" were significantly improved, but further improvements are needed to meet the standard requirements.
Although the scores of "air filtration", "daily bed infusion quantity", "average daily deployment", "personnel management", and "infection control management" showed an upward trend but there was no significant difference in scores.
The indicators of "rating of work area", "average daily deployment", "all air filter cleaning and maintenance" and "disinfection method" haven't changed for three years and the average score rate exceeded 60% of standard requirements.Score: 5 points.Scoring criteria: when number of training sessions per person is greater than 1, 5 points will be given.When the number is between 1 and 0.2, 2 points will be given.When the number is less than 0.2, 0 points will be given.

Director
The person in charge of PIVAS shall be qualified for professional and technical posts above the intermediate level.
Score: 4 points.Scoring criteria: when title and degree of director are above of supervising pharmacist and bachelor's degree, 4 points will be given.
When title and educational level are supervising pharmacist and bachelor's degree below, 2 points will be given.

C09, C05
Work efficiency management 49 Type of infusion PIVAS should provide intravenous drug dispensing services, including parenteral nutrition, anticancer drugs, antibiotics drugs, and general drugs Score: 10 points.Scoring criteria: when 4 types of drugs are dispensed, 4 points will be given.When parenteral nutrition or anticancer drugs are dispensed, 3 points will be given.When antibiotics drugs or general drugs are dispensed, 2 points will be given.

Average daily deployment
According to an average number of prepared infusions daily of PIVAS in Yunnan Province in the past few years.
Score: 5 points.Scoring criteria: when average daily deployment more than the average, 5 points will be get.Average daily deployment is between two-thirds and one of average,4 points will be given.Average daily deployment is between two-thirds and one-thirds of average,3 points will be given.Average daily deployment is less than onethirds of average, 2 points will be given.

D05 + D15 (D05 + D15: average daily deployment) Daily bed infusion quantity
Based on the average number of daily infusions per sickbed of PIVAS in Yunnan Province in the past few years.
Score: 3 points.Scoring criteria: daily bed infusion quantity is less than average,3 points will be given.The quantity is more than average, 1 point will be given.D10/B10 (D10/B10: daily bed infusion quantity) Score: 5 points.Scoring criteria: daily infusion allocation quantity per person is less than 100,5 points will be given.

D13
Temporary order deployment rate The number of temporary medical orders allocated is proportional to the PIVAS service capacity.

points.
Scoring criteria: temporary order deployment rate is higher than 5%, 5 points will be given.The rate is between 5% and 3%, 3 points will be given.The rate is lower than 3%, no point.

Daily number of prescriptions reviewed per person
To ensure the quality and efficiency of the audition, reviewed prescriptions per person per day are less than 500 medical orders in PIVAS.
Score: 6 points.Scoring criteria: daily number of prescriptions reviewed per person is less than 500, 6 points will be given.The number is between 800 and 500, 3 points will be given.The number is greater than 800,0 points will be given.

Unreasonable prescription and disposition
Based on the average rate of unreasonable prescription and disposition of PIVAS in Yunnan Province in the past few years.
Score: 5 points.Scoring criteria: the rate of unreasonable prescription is lower than the average and disposition rate is higher than the average, 5 points will be given.The rate and disposition rate are more than the average, 3 points will be given.The rate is lower than the average and disposition rate is higher than average, 1 point will be given.
D17/D06,D16 (D17/D06: disposition rate of unreasonable prescription) Error control rate The error rate of dispensed infusion of PIVAS in Yunnan Province in the past few years.
Scoring criteria: error control rate is less than the average, 5 points will be given.Error control rate exceeds 30% of the average, 2 points will be given.

D08 + D18 + D19/D01 (D08 + D18 + D19:error qualities of infusion preparation) Infection control management 13 Comprehensive cleaning frequency
We shall clean and disinfect the workbench and floor at least every day.Fully clean PIVAS at least once a week.Score: 5 points.Scoring criteria: comprehensive cleaning frequency is at least once a week, 5 points will be given.The frequency is once between a week and two weeks, 3 points will be given.The frequency is once a month, 1 point will be given.

E01 Air filter cleaning and maintenance
Clean and maintain air filters at least annually.Score: 5 points.Scoring criteria: completing cleaning and maintenance of all air filters within one year, 5 points will be given.Completing the cleaning and maintenance of one to two types of air filters within one year, 3 points will be given.Completing the cleaning and maintenance of no air filters within one year,0 points will be given.

E04, E05, E06
Disinfection method At least two disinfectants are selected for disinfection in PIVAS.
Score: 3 points.Scoring criteria: two or more disinfection methods are used in PIVAS, 3 points will be given.Only one disinfection method is used in PIVAS,0 points will be given.

Information management 13 Degree of informatics
The more intelligent systems and instruments, the higher the degree of informatization.Score: 8 points.Scoring criteria: when PIVAS has configuration of information systems, 3 points will be given.When PIVAS has clinical records management information system, 2 points will be given.PIVAS has two types of automatic equipment, 2 points will be given.

F01, F02, F03
Tracing control Determine based on whether PIVAS has corresponding intelligent instruments, such as drug dispensing scanner, vertical flow clean bench, etc.
Score: 5 points.Scoring criteria: tracing control is higher 2, 5 points will be given.
Tracing control is between 1 and 2, 3 points will be given.Tracing control is between 1 and 0.5, 2 points will be given.Tracing control is between 0.5 and 0.1, 1 point will be given.

Total scores 100
Note: The data source is from Table 1, and only data item number is referenced in this Table

Table 2 (continued)
The indicators of "director", "temporary order deployment rate", and "tracking control" have no change and the average score rate was less than 60% of standard requirements.

Discussion
At present, quality control has attracted much attention by PIVAS managers.There have been many studies on this research area, but majority of studies more focused on improvement of quality control using a particular innovative technology or equipment.Deng. et al. (2022) explored the development of automatic auxiliary dispensing equipment in PIVAS to improve the work efficiency, and reduce the drug risk caused by dispensing errors [20].Gao. et al. (2020) found that implementation of lean had positive results, which improved the efficiency of the operation, reduced the work start time and the amount of staff, and improved clinical satisfaction [21].Yang. et al. (2023) investigated the emotional disorders including depression and anxiety among staff of PIVAS [3].The result show depression and anxiety are common among PIVAS leaders and staff working in hospitals in China.Hospitals should implement measures to improve the mental health of PIVAS leaders and staff.Chen. et al. (2021) analyzed the current situation of personnel training and scientific research regarding PIVAS [22].The findings indicated that the training content for PIVAS personnel in China was relatively comprehensive, but the areas of management tools, career development, and scientific research training were comparatively deficient, resulting in very low scientific research output.However little research focused on how to evaluate the capability of quality control of existing PIVAS and research in this area is considered to be of great importance for the management of PIVAS.
In this research, we established RPDRAP.Through the platform application, PIVAS managers can not only better understand the requirements of each indicator, but also obtain the highest, lowest, average, and own scores of each indicator within the region.In this way, PIVAS managers can more accurately manage and control the problems that exist in PIVAS.The effect of system application was shown in the results.Due to the high cost of hardware management including the work area, biosafety cabinets, and air conditioning equipment, it is difficult and time-consuming to update.This result can be interpreted as the score for hardware management of the 15 PIVAS has remained unchanged over the past three years.Once the hardware management of PIVAS are completed, there is no margin for changes.PIVAS included in the statistical analysis was the first batch to use the platform, the hardware construction standards were not uniform at that time.In terms of the hardware score of PIVAS added to the platform application in the later stage, it has made significant progress.
Furthermore, over the past three years, the item scores for 5 indicators such as directorship, temporary order deployment quantity, and so on have consistently remained relatively low.The average score of director was 2.13 points, only achieving 53% of the score for this item.County-level hospitals generally have lower scores and remaining unchange in this item.This indicates that the professional and technical level of PIVAS professionals at the county level needs to be improved, and this improvement will take a long time.The average score of temporary order deployment quantity was 1.67 points, only achieving 33.4% of the score for this item.The temporary order deployment quantity requires more professional technical personnel for PIVAS, which is also the reason for the limited improvement and remaining unchanged.The average score of usage of syringe was 2.87 points, only achieving 57.4% of the score for this item.The reuse of syringes in the formulation of similar drugs can save costs.

Conclusion
The safety of intravenous infusion is very important to the treatment outcome, and the safety of PIVAS depends on many aspects.Such as clean workbench, high-quality disinfection equipment, and high-quality staff.RPDRAP is the first PIVAS unified data management platform in China.The use of this platform enables different PIVAS in the region to compare their management measures with each other, which not only enhances the quality control ability of PIVAS but also enables the management department to understand the current situation and characteristics of each PIVAS timely and comprehensively through standardized data, which provides strong evidence for evaluating the service capability of PIVAS.

Strengths and limitations
RPDRAP is the first PIVAS unified data management platform in China.Using this platform PIVAS can systematically and quickly find its own shortcomings by comparing the management and capacity building of PIVAS in the region.Now the platform is only used within Yunnan Province.We hope it can be promoted and applied to a wider range of regions.Furthermore, the evaluation matrix of the analysis system should be further expanded and improved based on the progress of research on quality control.

Table 1
Data collection items of data collection system

Table 2
evaluation matrix

Table 3
Mean and standard deviation of 20 indicators of 15 PIVAS in three years