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Journal of Pharmacy Practice

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Research article

First published online July 8, 2020

Evaluation of Cost, Workflow, and Safety of Implementing a Vial Transfer Device for Ready-to-Mix Drugs at an Academic Medical Center

Lena K. Tran, PharmD https://orcid.org/0000-0002-7047-7512 [email protected], Kevin E. Anger, PharmD, BCPS, […], Heather Dell’Orfano, PharmD, CACP, CPPS, BCPS, Megan A. Rocchio, PharmD, BCPS, and Paul M. Szumita, PharmD, BCPS, BCCCP, FASHP, FCCM https://orcid.org/0000-0002-3679-7037+2View all authors and affiliations

Volume 34, Issue 6

https://doi.org/10.1177/0897190020938195

Abstract
Introduction
Methods
Results
Discussion
Conclusion
Declaration of Conflicting Interests
Funding
ORCID iDs
References

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Objective:

To evaluate the cost, workflow, and safety of implementing a vial transfer device system.

Methods:

In this retrospective analysis, pharmacy systems and electronic health record reports identified high-volume and high-cost medications prepared by a Vial2Bag^® (V2B) system from July 2017 to June 2018. The major outcome was the extrapolated yearly cost avoidance (EYCA) from utilization of a V2B system, calculated by subtracting total costs of the V2B system from total cost of ready-to-use products and locally compounded sterile products. Secondary outcomes included a workflow and safety analysis.

Results:

Implementing a V2B system led to a total EYCA of $2 295 261. A total of 283 209 potential V2B units were available for dispensing from automated dispensing systems and 41 082 yearly sterile product room units were avoided. A 0.02% safety report incidence per V2B administration was calculated at our institution.

Conclusion:

Use of a V2B system resulted in a substantial cost avoidance compared to purchasing commercial products and preparing locally compounded sterile products. The V2B system appears to be a safe addition to further optimize workflow but may require further investigation in prospective analyses.

Introduction

Optimizing drug product utilization can improve workflow and minimize cost. In the 2018 Third Consensus Development Conference on the Safety of Intravenous Drug Delivery Systems, manufactured ready-to-use (RTU) products were deemed the safest intravenous (IV) drug delivery system.¹ However, these RTU products remain largely vulnerable to the overall highest identified threat to drug delivery systems, drug shortages. Conference surveys showed that 97% of respondents have experienced supply chain disruptions from their hospital’s manufacturer or outsourced facilities. Over 80% of respondents also stated their institution has experienced a patient safety event due to this supply disruption. In comparison, only 45% of respondents agreed that outsourcing IV admixtures was cost-effective. Therefore, decisions regarding implementing various drug delivery systems should include safety considerations as well as nondrug and drug costs.² Vial transfer devices (VTDs) such as the Vial2Bag^® (V2B) system and Mini-Bag Plus (MBP) have gained increasing popularity and may help minimize cost, reduce safety events, and improve workflow by providing alternatives to both RTU products and locally compounded sterile products (LCSP).^3,4 The V2B system consists of a needle-free vial adapter that attaches to a fluid bag for reconstitution and dilution of drugs with a 13 mmol or 20 mmol vial top size for administration at the bedside. The MBP consists of a fluid bag attached to an adapter that is compatible for reconstitution and dilution with drugs having a 20 mmol vial top size. Both devices provide point-of-care mixing at the bedside, allowing for potential shortened time to first-dose antimicrobials, decreased risk of contamination,⁵ and extended stability compared to LCSP.⁶ These VTDs may also be beneficial during times of drug shortages when RTU product manufacturers face interruptions in supply chains.⁷

Brigham and Women’s Hospital is a tertiary academic medical center located in Boston, Massachusetts. The Department of Pharmacy Service provides drug products for the institution through a combination of commercial drug products, outsourced compounded products, and in-house sterile product room compounding. In 2018, the pharmacy produced over 150 000 patient-specific sterile compounded products and close to 300 000 units of sterile compounded medications for anticipatory needs. Due to the increased complexity of patient care, these numbers continue to increase annually, leading to consumption of more personnel time and resources.

Our institution implemented the V2B system in November 2017 as an alternative source of drug product supply in response to the unavailability of the MBP transfer device and worsening drug shortages. The objective of this study was to evaluate the costs, workflow, and safety of implementing a V2B system at our institution.

Methods

This single center, retrospective analysis was approved by institutional review board of Partners Health (2018P002013). Electronic health record reports identified drug utilization for V2B products from July 2017 to June 2018. These reports included dispense data for medications in Brigham and Women’s V2B drug portfolio (Table 1). Preparation instructions for drugs in our V2B portfolio were built into the electronic medical record and also included information on the medication preparation label.

Table 1. Brigham and Women’s Vial2bag^® Drug Portfolio.

Aminocaproic acid^a,b 5 g/250 mL	Imipenem–cilastatin 250 mg, 500 mg
Amiodarone^a,b 450 mg/250 mL	Isoproterenol^a,b,c 1 mg/250 mL
Ampicillin 1 g, 2g	Letermovir^b 480 mg
Ampicillin–sulbactam 3 g	Meropenem 500 mg, 1 g
Azithromycin^b 500 mg	Methylprednisolone 500 mg, 1 g
Aztreonam 1 g, 2 g	Micafungin 100 mg
Bivalirudin^a 250 mg/100 mL	Minocycline 100 mg
Calcium gluconate^a,b 5 g/300 mL	Nafcillin 1 g, 2 g
Calcium gluconate 1 g	Nitroprusside^a,b,c 50 mg/250 mL
Cangrelor^a,b 50 mg/250 mL	Norepinephrine^a,b,c 4 mg/250 mL
Cefepime 1 g, 2 g	Octreotide^a,b,c 500 µg/250 mL
Cefotetan 2 g	Oxacillin 1 g, 2 g
Cefoxitin 1 g, 2 g	Penicillin G 5 million units
Ceftaroline 400 mg	Phenylephrine^a,b,c 10 mg/250 mL
Ceftazidime 1 g, 2 g	Piperacillin–tazobactam 2.25 g, 3.375 g, 4.5 g
Ceftazidime–avibactam 2.5 g	Sodium phosphate^b,c 15 mmol
Ceftolozane–tazobactam 1.5 g	Tigecycline 50 mg, 100 mg
Cefuroxime 750 mg, 1.5 g	Tranexamic acid 1 g
Dexmedetomidine^a 200 µg/50 mL	Vasopressin^a,c 20 U/100 mL
Doxycycline 100 mg	Vancomycin 500 mg, 1 g
Furosemide^a,c 100 mg/50 mL

^a Continuous infusion.

^b Non-MBP compatible fluid bag size.

^c Non- MBP compatible vial top size.

Definitions

Product costs, presented in dollar amounts, were based off wholesale acquisition cost (WAC) as a per unit cost of our manufacturer listing price obtained on November 2018, not including institution contracted pricing. Ready-to-use products were defined as those purchased from manufacturers not requiring mixing prior to administration and commercial admixture products. Labor and material expenses comprised of costs from compounding supplies including needles, syringes, fluid bags, staff salaries, personal protective equipment, and laminar flow hood operational costs. Locally compounded sterile product included drugs compounded according to USP-797 standards without extended beyond-use-date (BUD) testing. Total costs and components for each delivery device are listed in Table 2.

Table 2. Breakdown of Delivery Device Components and Cost.^a

Delivery device	Components	Cost
V2B	SVA WAC, FW, DW	SVA WAC + FW + DW
LCSP	Labor/material, DW	Labor/material + DW
RTU	DW or noncontracted price	DW or noncontracted price

Abbreviations: DW, drug WAC; FW, fluid bag WAC; LCSP, locally compounded sterile products; RTU, ready-to-use; SVA, single vial adapter; V2B, Vial2Bag^® system; WAC, wholesale acquisition cost.

Implementation Process

Workflow surrounding implementation of the V2B system at our institution involved the cooperation of a multidisciplinary team consisting of pharmacy, nursing, and central supply distribution services. Medication vials and fluid bags were supplied by central pharmacy or by medication automated dispensing systems (ADS) located on nursing units. V2B adapters were supplied and replenished by central supply services and were available as a floor stock item.

Major Outcome

Our major outcome was the extrapolated yearly cost avoidance (EYCA) of LCSP and RTU compared to V2B at Brigham and Women’s Hospital. Data were analyzed for all V2B portfolio drugs. A cost avoidance analysis included medications meeting at least one of the following criteria: yearly dispenses ≥5000 U and/or extrapolated RTU costs ≥1.25× V2B costs. EYCA was measured by multiplying the number of documented yearly administrations by the difference in respective LCSP or RTU costs from V2B system costs.

Our LCSP labor and equipment costs were based on previous time study data that evaluated the costs of preparing small volume injectables (SVI).^2,8-12 One time study estimated approximately 3 minutes of pharmacy technician labor time to prepare an IV admixture.¹³ Another study measured preparation and auxiliary times, as well as equipment and material costs of compounding sterile products.⁸ Pharmacist time and technician time spent preparing bulk-prepacked SVIs were approximately 1 minute and 3 minutes, respectively. Bulk-prepacked items included drugs prepared in large quantities appropriately stored until dispensed. More labor-intensive compounding involved patient-specific doses or preparations with short stability and required about 1.5 minutes of pharmacist time and 6 minutes of technician time. Based on hourly salary data from the 2017 Bureau of Labor Statistic Occupational Employment Statistics, estimated sterile product room labor costs were between $1.78 and $3.06 per unit dose, which included preparation and auxiliary time for pharmacists and technicians, calculated by multiplying appropriate wages by personnel time.¹⁴ Our LCSP personnel labor costs averaged $2.42 per unit dose, accounting for both simple and more complex sterile product compounding. Material and equipment costs which included fluid bags, syringes, filters, needles, alcohol swabs, and laminar flow hood costs were estimated to be about double the labor costs per unit dose, or $4.84. Our total LCSP cost per unit equaled $7.26 in addition to the cost of the individual drug.

Minor Outcomes

Minor outcomes included a workflow and safety analyses. Our workflow analyses calculated the number of yearly LCSP units avoided. This number represented the number of V2B drugs that were non-MBP compatible which would otherwise require purchasing commercial premixed bags or compounding in the sterile products room. In addition, the number of ADS yearly dispensable V2B units was calculated. This number represented the total number of potential V2B dispenses from the ADS on nursing units rather than delivered from central pharmacy services as patient-specific doses. Medication safety reports were gathered from medication reporting software from January 1, 2018, to June 30, 2018, representing a 6-month time period following implementation of the V2B system, allowing a 1-month washout period for completion of nursing in-servicing. The total number of V2B-related safety reports was recorded and categorized. The percentage of V2B-related safety report incidences per V2B administration was also calculated.

Results

Forty-one medications were added to Brigham and Women’s V2B drug portfolio including 13 continuous infusions and 25 antimicrobials. Over 250 000 doses of V2B medications were dispensed during July 2017 to June 2018.

Cost

There was a total of 174 299 documented yearly administrations of drugs in our cost avoidance analysis, amounting to a total of $2 295 261 in EYCA of a V2B system (Table 3). Results showed substantial EYCA when comparing RTU to V2B and LCSP to V2B delivery systems. Although per unit costs of less expensive drugs were minimal, these drugs were frequently dispensed and still resulted in high EYCA.

Table 3. Cost Avoidance Analysis.

Selected drugs	LCSP	RTU	V2B		LCSP to V2B^a	RTU to V2B^a
	$^b	$^c	$^d	No.	$	$
Amiodarone	15	46	12	3332	9996	113 288
Ampicillin–sulbactam	13	-	10	6409	19 227	-
Calcium gluconate	24	23	21	18 879	56 637	37 758
Cefepime	15	18	12	32 209	96 627	193 254
Ceftazidime	14	15	12	11 940	23 880	35 820
Dexmedetomidine^e	20	46	18	19 879	39 758	556 612
Furosemide	13	-	10	9201	27 603	-
Meropenem	17	33	24	11 674	35 022	221 806
Norepinephrine	35	-	32	1137	3411	17 055
Piperacillin–tazobactam	15	47	12	37 388	112 164	37 388
Vancomycin	23	24	21	19 127	38 254	57 381
Vasopressin^f	426	600	423	3124	9372	552 948
Total					471 951	1 823 310

Abbreviations: LCSP, locally compounded sterile products; RTU, ready-to-use; V2B, Vial2Bag^® system; WAC, wholesale acquisition cost.

^a Extrapolated yearly cost avoidance.

^b Labor/materials + Drug WAC.

^c Drug WAC or noncontracted price.

^d Single vial adapter WAC + Fluid bag WAC + Drug WAC.

^e Dexmedetomidine 400 µg/100 mL = 2 (200 µg/50 mL V2B).

^f Vasopressin 50 U/250 mL = 2.5(20 U/100 mL V2B).

Workflow

There was a total of 64 644 V2B administrations during these 6 months. Our workflow analysis resulted in 41 082 extrapolated LCSP yearly units avoided and 2 83 209 extrapolated yearly ADS dispensable V2B units.

Safety

For our safety analysis, over 900 safety reports were submitted during January 1, 2018, to June 30, 2018. Of these, 12 reports were determined to be related to the V2B system, resulting in a less than 0.02% safety report incidence related to the V2B system. Ten reports involved fluid bag leakage once attached to the VTD. One report was a process error involving incorrect spiking, and 1 report included the wrong fluid bag used. Of these 12 reports, 10 were assigned a severity level of 0, meaning that the error did not reach the patient, and the remaining 2 were given a severity level of 1, meaning the error reached the patient, but did no harm.

Discussion

Despite the increasing use of VTDs, to our knowledge, this is the first published study to evaluate the implementation of a V2B system with respect to cost, workflow, and safety. The V2B system provides compatibility with a larger variety of drugs due to its capability to attach to any fluid bag size and its compatibility with both 13 and 20 mm vial top sizes. This increased compatibility allowed us to successfully and efficiently transition to a V2B system during a time of critical drug shortages. Our V2B drug portfolio combined with our yearly administration data allowed us to see the cost avoidance of a V2B system with outsourced products and with more commonly used drugs.

Many studies have implemented pharmacy process improvements in order to reduce costs associated with sterile products compounding.^15-19 These new processes led to decreases in both personnel and product costs that stemmed from compounding doses that were modified or discontinued by the provider during preparation. With a V2B point-of-care activation system, medications can be prepared closer to the time of administration, decreasing unnecessary compounding labor and materials, and allowing for unused drugs to be returned to the pharmacy or ADS. Cost savings have also been shown with utilization of other drug delivery systems comparable to the V2B system such as the Viaflex^® with vial adapter, also known as the MBP. When compared with preparation in the centralized pharmacy unit, MBP resulted in a 30% reduced cost.²⁰

In comparison to outsourcing commercial RTU products and preparing LCSP, the V2B system provides substantial cost savings due to its improved operational workflow. Our V2B system allowed for an increased number of drugs to be stocked in our ADS. Medications were loaded onto our ADS rather being picked, prepared, second-checked, delivered to the units as individual patient-specific doses, and placed in the appropriate patient bin. Utilization of an ADS has also been shown to reduce medication errors related to preparation and administration timing.²¹

In our study, of over 900 safety reports submitted in a 6-month time period following V2B implementation, 12 were related to the V2B system and likely attributed to user error. Few of the reports reached the patient and none were deemed harmful. In light of ongoing national drug shortages, the V2B system served as a cost-effective and safe addition to our workflow. The most common safety incident report at our institution included fluid bag leakage. To address this safety issue, our nurse director and medication safety officer provided targeted retraining on the V2B system upon end user request. Leakage from bags has also been reported with premixed ADD-Vantage systems and is not exclusive to the V2B system. Continued nursing education and routine follow-up of safety incident reports has proven beneficial in ensuring the proper use of these drug delivery systems.²²

Our study had several limitations. Our major outcome EYCA was based off WAC pricing and may not represent actual purchasing costs. WAC drug pricing may be an overestimation of actual costs depending on institution or health system–specific drug contract pricing. During the time of implementation, drug shortages resulted in utilization of many drug products and manufacturers, limiting our RTU comparators for outsourced products to our institution-specific vendors. Our LCSP labor and overhead costs per unit were estimated based on historical published time study data and can vary depending on medication prepared, personnel, and time period. Since the time of previously published studies, changes in sterile compounding guidelines now require proper gowning and garbing, sterility testing, and aseptic technique that may not have been performed prior. These newer guidelines may have led to an underestimation of our LCSP costs. Our study did not include a waste analysis or waste resulting from failed V2B system. Our V2B costs did not include the potential increased nursing time expenditure. Although our analysis did not include an assessment of nursing costs or pharmacy staffing costs, pharmacy and nursing staffing ratios were not affected during this time period. Due to the voluntary nature of our safety reporting system, the number of submitted V2B safety reports may have been underestimated. In addition, safety reporting was only analyzed postimplementation of the V2B system. Our analysis did not include a comparison of LCSP with an insourced or outsourced extended BUD or drugs administered by IV push. In addition, our study was limited to drug preparation by single vial adapters and did not include analysis of double or triple vial adapters. The V2B system was recalled in February 2019 for reevaluation of product labeling but is likely to reemerge on the market in the near future.

Our study did not show an EYCA for all drugs in our V2B portfolio. While institution contract pricing may result in cost savings with commercial or outsourced products, these manufacturers were not always capable of fulfilling purchase orders on a consistent and reliable basis. Implementing a V2B system provided a stable option during times of manufacturer back order. This availability allowed for a consistent supply chain and prevented sudden workflow changes or increased sterile product room labor, which may outweigh the small cost savings that result from using certain outsourced products. The V2B system may also serve as an option for locations not set up for sterile compounding.

Conclusion

Implementation of a V2B system at our institution resulted in substantial cost avoidance when compared with outsourcing commercial RTU products or manufacturing sterile products, with an overall low safety report incidence rate. The V2B system also led to decreased LCSP units and an increase in number of medications stocked on the pharmacy ADS. Utilization of the V2B system at our institution provided a safe addition to the workflow. Individual institutions may consider implementing the V2B system when evaluating medication admixture workflow. Future studies evaluating the impact of a new VTD system on nursing staff may be beneficial. In addition, studies comparing the V2B system to LCSP with waste considerations could prove beneficial as a cost analysis.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Lena K. Tran, PharmD https://orcid.org/0000-0002-7047-7512

Paul M. Szumita, PharmD, BCPS, BCCCP, FASHP, FCCM https://orcid.org/0000-0002-3679-7037

References

1. Gabay M, Hertig JB, Degnan D. et al. Third consensus development conference on the safety of intravenous drug delivery systems—2018. Am J Health Syst Pharm. 2020;77(3):215–220.

Abstract