Real-world hospital pharmacy and nursing study assessing the time and motion comparison of 3 different marketed formulations of a cephalosporin antibiotic.

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Abstract

Purpose

To assess the comprehensive workflow and time and motion activities associated with hospital pharmacy and nursing staff for a cephalosporin antibiotic in 3 different marketed formulations: (1) a formulation prepared by traditional compounding, (2) a dual-chamber IV bag stored with prefilled diluent in the upper chamber and powdered drug in the lower chamber, and (3) a standard diluent container with an integrated drug vial adaptor that allows for drug admixture after connection to a single-dose powdered drug vial.

Methods

The study was conducted at 3 hospital locations from a single hospital network located in Arkansas. Study procedures were assessed by direct observations of pharmacists, pharmacy technicians, and nurses. Sequences and durations of tasks were observed to identify and document the actual time for each task.

Results

Approximately 402 observational hours of data collection occurred, with more than 100 formulated doses observed per formulation, with 98.6% overall study confidence. Use of the dual-chamber IV bag formulation resulted in a 63% decrease in labor time compared to traditional compounding. When comparing the dual-chamber IV bag formulation to the standard diluent formulation, there was about a 22% decrease in labor time.

Based on the number of process steps, use of the dual-chamber formulation resulted in approximately 54% fewer opportunities for error versus traditional compounding and 35% fewer opportunities for error than use of the standard diluent formulation.

Conclusion

Independent descriptive statistical analysis verified that the dual-chamber IV bag cephalosporin antibiotic formulation is a faster, simpler-to-use drug administration platform and associated with less chance of formulation and dosing errors.

Hospitals in the United States are facing formidable challenges over the next decade. The demands of the past decade on the healthcare system have had lasting impacts that will not easily be remedied, ie, the coronavirus disease 2019 (COVID-19) pandemic, the aging Baby Boomer generation, and a steadily shrinking birth rate are all impacts that will be felt by generations to come.1–3 These challenges combined with changes in how hospitals are required to navigate reimbursement, economic inflation, advancements of artificial intelligence, technologies to provide better patient care, and growing labor force shortages all contribute to the need to reduce unnecessary labor time requirements that face hospital care teams, including nursing and pharmacy professionals.4–10

Nurses and pharmacy staff are an integral part of patient care; they must be ready to provide critical care and deliver lifesaving pharmaceuticals at a moment’s notice. They also represent a fundamental part of hospital functions that carries a significant cost burden. The ability of hospital managers to maximize the efficiency and effectiveness of the frontline staff without sacrificing patient care is paramount.9

Workforce supply and demand remain a challenge for US hospital leadership. According to the Bureau of Labor Statistics’ employment projections, the need for clinicians in nursing and pharmacy is expected to grow from 2024 to 2034.11–13 The registered nurse (RN) workforce is projected to grow by 5% from 3.39 million in 2024 to 3.55 million in 2034.11 Similarly, the pharmacist workforce is projected to expand by 5% from 335,100 in 2024 to 350,500 in 2034.12 Lastly, the pharmacy technician workforce is projected to increase by 6% from 490,400 in 2024 to 521,800 in 2034.13

Despite the increases projected by federal authorities, the expected growth of full-time staff will still be insufficient. The Workforce Projections Dashboard published by the Health Resources and Services Administration (HRSA) predicts a shortage of 307,010 full-time RNs in 2027 and 207,980 full-time RNs in 2037, as well as a shortage of 8,780 full-time pharmacists in 2027 and 17,030 full-time pharmacists in 2037.14 While the HRSA Workforce Projections Dashboard indicates there will be a surplus of pharmacy technicians from 2022 to 2037, operational struggles persist today. A 2021 executive summary report from the American Society of Health-System Pharmacists (ASHP) indicated a 22% pharmacy technician vacancy rate, with administrators filling pharmacy technician shifts through use of overtime 97% of the time and pharmacists performing technician duties 89% of the time.15 Together, these statistics underscore the operational impact shortages have on medication process steps from preparation through administration.

To fully enable hospital leaders to enact real and effective change, evaluations of facilities’ current processes and techniques are helpful to establish a baseline for the current state and new technology needs. A popular tool for benchmarking the current state is making observations, recording time durations and efficiency opportunities for specific processes. This straightforward and effective tool is known as a time and motion study.

Time and motion studies have been used for more than 110 years old and have been utilized specifically in healthcare since the early part of the 20th century.16 Time and motion studies were first utilized in healthcare and the life sciences by Frank and Lillian Gilbreth in 1914 to identify and assess inefficiencies.17 This tool continues to be used to support measurable observations of hospital staff.9

This study was designed to assess the comprehensive workflow and time and motion activities, including labor requirements and subsequent tasks (excluding drug administration), within a real-world hospital pharmacy and nursing setting associated with the preparation of 3 marketed formulations of a cephalosporin antibiotic. Additionally, a cost-minimization analysis was performed to evaluate the time and labor costs across the 3 available formulations.

Methods

Study design and data source

Time and motion studies can measure efficiency and provide data for process improvement. Tasks are broken into small, simple steps, or elements, and then carefully observed and tracked by trained project engineers utilizing time study software to capture specific task times in decimal seconds.

Data collection was performed using electronic data collection equipment utilizing time study software (Workstudy + 6.20.190810; Quetech Ltd., Kitchener, ON, Canada) specifically designed to achieve detailed data collection in the minimal amount of time possible.

WorkStudy + has data collection features that allows flexibility in what is collected and how it is collected. The software capabilities that were utilized during the study include the following: recording an unlimited number of observations, tracking multiple clinicians simultaneously, tracking numeric unit counts and job cycles, tracking value-added and non–value-added time for lean analysis, entering comments for any recorded observation, interrupting and resuming any recorded observation, and viewing and editing any recorded observation at any time. The study was conducted at 3 hospitals (facility number 1 had 120 beds, facility number 2 had 827 beds, and facility number 3 had 225 beds) from a single hospital network in Arkansas.

Due to unique hospital practices across the 3 study facilities, some study elements had to be standardized. These standardized study elements were equally applied across the different formulations to appropriately assess the observed data. Standardized study elements included the following: receive and verify drug order; scan and assign to automated dispensing cabinet (ADC); travel to ADC room; load to ADC; access patient profile and remove via ADC (only dual-chamber IV bag and traditional compounding); perform hand hygiene and don gloves/personal protective equipment as appropriate; obtain tubing and supplies required for IV drug administration; travel to nursing station, emergency room, pharmacy, or patient’s room; and travel for supplies.

Additional items that were assessed included the probability of errors (based on the number of process steps observed) in the hospital pharmacies studied.

Direct observations of pharmacy and nursing personnel were conducted by study monitors. Documentation of labor and process times, workflow, and layout was also performed. Sequences and durations of tasks were observed to identify and document the actual time for each task.

Pharmacists, pharmacy technicians, and nurses were observed while using each formulation. Each of the 3 clinician types were observed while performing the study elements, as follows:

Three different formulations of a cephalosporin antibiotic, each requiring a different preparation process from the time of drug order receipt through the time it is ready to be administered to patients, were assessed in a real-world hospital pharmacy and nursing environment. A high-level summary of procedures for the 3 cephalosporin antibiotic formulations is displayed in Figure 1 for the traditional compounded formulation, Figure 2 for the dual-chamber IV bag with prefilled diluent in the upper chamber and powdered drug in the lower chamber, and Figure 3 for the standard diluent container with an integrated drug vial adaptor that allows for drug admixture after connection to a single-dose powdered drug vial.

The governing body of the hospital system reviewed the study protocol and determined that as the study would not directly involve patient interaction and would not include access to identifiable patient confidential information, it was exempted from institutional review board (IRB) review. An independent poststudy IRB review of the protocol was requested, and the IRB considered the study likely to be exempt from formal IRB review.

Outlier methodology

Per protocol, outliers were identified and removed prior to statistical analysis of the data. For this analysis, outliers were defined as observations exceeding 1.5 standard deviations from the mean in either direction (ie, z > 1.5). This threshold was selected to balance sensitivity to outlying values while preserving the majority of the data under a generally normal distribution.

In a normal distribution, approximately 68% of data falls within ±1 SD and 95% within ±2 SD. A threshold of 1.5 SD is expected to flag roughly 13% to 14% of observations as outliers (consistent with empirical results) and is appropriate for process time standardization where extreme variability may reflect nonstandard conditions. Application of this criterion resulted in the exclusion of 397 outlier elements (14.02%) from the total of 2,831 recorded elements for the purpose of calculating average dose/batch process times.

These data points remain in the raw dataset for transparency and potential future analysis but were not used in mean calculations to avoid skewing results. Table 1 summarizes the frequency distribution of element durations before and after outlier exclusion.

Results

Results were summarized using mean, SD, median, minimum value, maximum value, number of occurrences, and time percentages for each element(s) studied. The desired confidence level for this time and motion study was 90% with 10% standard error. Approximately 402 observational hours of data collection occurred, with more than 100 formulated doses observed per formulation, with an overall study confidence of 98.6% (formulation range, 72.7%-99.6%).

Statistical outliers ranging from 2.3% to 4.0% were identified and excluded from the final analysis. A post hoc analysis was performed using the statistical outliers. Supplemental eTable 1 displays the total per-dose preparation times, and eTable 2 shows the estimated labor cost per dose of cefazolin.

The dual-chamber IV bag was more advantageous in performance than traditional compounding and the standard diluent container regarding labor time. For pharmacy technicians, use of the dual-chamber IV bag was observed to result in:

With regard to nursing labor time, use of the dual-chamber IV bag was observed to result in 23% (or 32 seconds less) labor time than the standard diluent container.

The overall labor time savings associated with the dual-chamber IV bag formulation were:

In addition, use of the dual-chamber IV bag formulation resulted in 53.5% less chances for error versus traditional compounding based on the reduced number of process steps and touchpoints. When compared to the standard diluent container formulation, the dual-chamber IV bag formulation was observed to present 35.0% less opportunities for error based on the reduced number of process steps and touchpoints. The total number of process steps was 13 for the dual-chamber IV bag, 20 for the standard diluent container, and 28 for traditional compounding.

Furthermore, the standard diluent container and traditional compounding require multiple components for preparation of a complete formulation and thus are more susceptible to shortages, while the dual-chamber IV bag is less vulnerable to such shortages.

Results from this study indicate the overall estimated labor cost for cephalosporin antibiotics in the dual-chamber IV bag formulation was lower than both the traditional compounding and the standard diluent container formulations. Based on data from the US Bureau of Labor Statistics on median weekly earnings in 2022,18 the labor time per dose and the labor cost per dose across the 3-hospital staff was found to be lower for the dual-chamber IV bag formulation. Per Table 2, the estimated direct labor cost per dose for a pharmacist, pharmacy technician, and nurse (by average hourly wage) was $2.33 for traditional compounding, $1.73 for the standard diluent container, and $1.36 for the dual-chamber IV bag formulation.

The labor and cost savings noted in this time and motion study were based on 2022 earning averages and thus may vary depending on regional differences. In part, this lower labor cost for the dual-chamber IV bag formulation is related to fewer procedural steps. These results may be adjusted to approximate costs in other regions within the United States.

Discussion

This study provides a comprehensive evaluation of the time, motion, and workflow efficiencies associated with 3 marketed formulations of a cephalosporin antibiotic (traditional compounding, a dual-chamber IV bag, and a standard diluent container) as observed in a real-world hospital pharmacy and nursing setting.

Use of the dual-chamber IV bag formulation resulted in a 62.9% reduction in total labor time when compared to traditional compounding and 22% less labor time than the standard diluent container. These reductions were driven primarily by a 92% decrease in pharmacy technician labor time and a 23% decrease in nurse labor time compared to the standard diluent container. These time savings are attributable to the dual-chamber IV bag’s streamlined design, which integrates prefilled diluent and powdered drug into a single unit, eliminating multiple preparation steps required by the other formulations.

Similarly, the 21.6% labor time savings provided by the dual-chamber IV bag versus the standard diluent container underscores the advantage of minimizing manual reconstitution processes, which often involve additional components and procedural complexity. While labor time savings was a significant finding with use of the dual-chamber IV bag, drug acquisition costs were not included in this analysis, and all cost comparisons reflect only labor costs and savings.

Beyond time efficiency, the dual-chamber IV bag formulation was associated with a 53.5% reduction in the probability of error compared to traditional compounding and a 35.0% reduction compared to the standard diluent container. This is a critical finding in the context of patient safety, as medication errors remain a significant concern in hospital settings. The reduced number of process steps and touch points with use of the dual-chamber IV bag formulation inherently lowers the risk of contamination, misdosing, and procedural mistakes or other issues that are more prevalent in traditional compounding, which requires manual mixing, and with use of the standard diluent container, which involves multiple components.

These results suggest that adopting the dual-chamber IV bag formulation could enhance both operational efficiency and clinical outcomes, addressing key priorities for hospital administrators. While the dual-chamber IV bag may be a premium product with an initial higher cost, it’s worth considering the potential downstream savings in labor time for clinicians as well as the potential for enhanced patient safety.

The economic implications of these findings are equally compelling. Using wage data from the US Bureau of Labor Statistics, the study estimated that the dual-chamber IV bag formulation incurs the lowest labor costs among the 3 options evaluated. Given the projected shortages of 207,980 registered nurses and 17,030 pharmacists by 2037, optimizing staff time is not merely a cost-saving measure, but a strategic necessity.

The ability to reallocate labor time from repetitive preparation tasks to direct patient care could mitigate the impact of workforce constraints. These findings build on the legacy of time and motion studies, a methodology pioneered by Frank and Lillian Gilbreth over a century ago and widely applied in healthcare to identify inefficiencies. The use of advanced tools like WorkStudy + software in this study enabled precise, real-time data collection across 402 observational hours and over 300 formulated doses, achieving 98.6% overall study confidence.

This statistical approach included the exclusion of outliers of 1.5 standard deviations, ensuring robust and reliable results while maintaining consistency with standard practices for analyzing normally distributed data. However, the removal of 14.5% of total elements as outliers warrants consideration, as it may reflect real-world variability (eg, interruptions or procedural deviations) that could influence outcomes in less controlled settings.

Despite its strengths, the study has limitations. Because the study was conducted across 3 hospitals within a single network, these findings may not be fully generalizable to diverse healthcare settings with varying resources, staffing models, or patient populations. Additionally, the study focused solely on preparation tasks up to, but not including, administration, leaving potential differences in administration time or patient outcomes unexplored.

The standardization of certain hospital-specific practices across formulations, while necessary for consistency, may also mask site-specific nuances that could affect real-world applicability. Finally, while labor cost estimates were based on median wages, they did not account for regional wage variations or indirect costs such as training or equipment maintenance, which could influence the economic advantage of the dual-chamber IV bag formulation.

The implications of this study extend beyond the immediate findings. For hospital leaders, the dual-chamber IV bag formulation represents a practical solution to optimize resource allocation amid workforce shortages and rising costs. Its simplicity and reduced error potential also align with broader trends in healthcare technology, whereby innovations aim to enhance efficiency without compromising safety.

However, future research should explore the scalability of these findings across diverse hospital systems, incorporate administration-phase observations, and assess long-term outcomes such as error rates. Cost-benefit analyses that include regional cost of living variations, indirect expenses, and potential savings from error prevention would further strengthen the case for adoption.

In summary, the results demonstrated that the dual-chamber IV bag formulation offers significant advantages in terms of reduced labor time, lower cost of labor, and fewer opportunities for error compared to both traditional compounding and the standard diluent container. These findings are particularly relevant given the mounting pressures on US healthcare systems, including workforce shortages, rising operational costs, and the need for enhanced patient safety.

Conclusion

The dual-chamber IV bag was advantageous when assessing labor time, process steps, and percent chance of error during preparation by formulation. Its use involves fewer preparation steps, resulting in less chances of contamination as well as formulation and dosing errors. Additionally, it is a labor efficient alternative to traditional compounding and the standard diluent container as it offers a faster and simpler-to-use drug administration platform.

In addition, the dual-chamber IV bag may improve patient safety due to fewer procedural steps decreasing the likelihood of errors in preparation and administration. As hospitals navigate an increasingly complex landscape, such innovations could play a pivotal role in sustaining high-quality care while addressing operational and workforce challenges.

Supplementary Material

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