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Review of economic data on closed system transfer drug for preparation and administration of hazardous drugs
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1. Annaelle Soubieux1,
2. Cynthia Tanguay1,
3. Jean Lachaine2,
4. Jean-François Bussières1,2
1. 1 Pharmacy practice research unit, CHU Sainte-Justine, Montreal, QC, Canada
2. 2 Faculté de pharmacie, Université de Montréal, Montreal, QC, Canada
1. Correspondence to Jean-François Bussières, Unité de Recherche en Pratique Pharmaceutique, Département de pharmacie, Centre Hospitalier Universitaire Sainte-Justine, Montréal, QC H3T 1C5, Canada; jf.bussieres{at}ssss.gouv.qc.ca

## Abstract

Objectives The objectives of this study were to review economic data on the use of closed system drug transfer devices (CSTDs) for preparing and administering hazardous drugs, and to evaluate the quality of data reporting as defined by the Consolidated Health Economic Evaluation Reporting Standards (CHEERS).

Methods All references from a recent Cochrane review about CSTDs were evaluated for inclusion. A literature review was also conducted. Articles containing economic data about the use of CSTDs were retained for analysis. Two researchers independently graded the articles according to the 24-item CHEERS checklist.

Results Of the 138 articles identified initially, 12 were retained for analysis. Nine of these studies did not report acquisition costs or did not detail acquisition costs. Six studies reported economic benefits associated with the used of CSTDs, all related to extending the beyond-use date. The mean number of CHEERS criteria fulfilled by the included articles was 9.2 (SD 2.4).

Conclusions CSTDs are costly to acquire. However, few studies have examined the economic impact of these devices, and the existing studies are incomplete. As a result, hospitals planning to implement these devices will be unable to make a sound economic evaluation. Robust economic evaluation of CSTDs is needed.

• closed system drug transfer device
• hazardous drug
• economic evaluation
• compounding
• preparation

## Introduction

Hazardous drugs are compounds that are carcinogenic or teratogenic, or that present reproductive, organ or genetic toxicity.1 Healthcare workers, especially nurses and pharmacy personnel, experience occupational exposure to these hazardous drugs. Various strategies are used to limit surface contamination and workers’ exposure, such as using biological safety cabinets, priming intravenous tubing in the pharmacy, using personnel protective devices, and providing training.1

Closed system drug transfer devices (CSTDs) can be used for preparing and administering hazardous drugs, in conjunction with other safe handling techniques. These devices create a 'closed' environment that prevents aerosols from escaping.1 Although CSTDs provide additional protection, they must be used inside a safety cabinet for the preparation of hazardous drugs.2

A recent Cochrane review concluded that there is no high-quality evidence to support (or refute) the routine use of these devices in addition to safe handling.3 Even though some studies have shown a reduction in contamination with use of CSTDs,4 5 others have reported lower surface contamination without their use.6 Some of these CSTD studies had observation biases and lacked an adequate control group. Many groups have shown a reduction in surface contamination over time, without using CSTDs.7 8 Certain technical flaws have also been reported (eg, spills, trouble handling the devices).9–11

## Cost savings

There was marked inconsistency in the conclusions: some studies presented high costs, and others reported important cost savings. The savings were based mainly on extending the beyond-use date. The US Pharmacopoeia requires a preparation to be used within 6 hours. Some authors claim that using a CSTD can preserve the sterility and that preparations can be kept for up to 7 days.21 28 Studies supporting this claim have methodological flaws and lack a control group to evaluate the level of contamination when compounding without CSTD. It could be argued that the sterility of most antineoplastic drug preparations would be kept when compounded in a biological safety cabinet by a properly trained technician. For instance, Rowe et al21 found that 1.86% of samples were contaminated, but attributed this to an outside contamination. No tests were conducted without using a CSTD. In addition, cost savings were mostly theoretical and failed to take into account that the entire volume of a phial would not necessarily be used in the 7 days following its preparation.

### Quality of reporting

The majority of the CHEERS criteria were not reported. In the included studies, the reported methods for calculating costs lacked details, and cost data were incomplete. Future studies should detail all costs (and cost savings) to allow generalisation and reproducibility. Sensitivity analyses should also be conducted. Authors of future studies are encouraged to review the CHEERS checklist to improve the quality of the results reported; the criteria should also be reviewed when designing the study. In addition to comparing several CSTDs, authors should make sure to include the costs of the conventional system for preparing and administering hazardous drugs and determine the quantity of devices needed per dose and overall. None of the included studies involved a formal economic evaluation. Such a study should also be free from any conflict of interest. Ideally, economic studies should also include efficacy criteria. Although the US Pharmacopoeia2 recommends use of CSTDs for the administration of hazardous drugs, this organisation also emphasises that there is no guarantee that all CSTDs will perform adequately. A performance protocol for CSTDs is needed, in addition to well conducted studies designed to evaluate if their use can lead to measurable health benefits for workers.

A centre looking to implement CSTDs should critically review the literature to support their choice. It should first include an evaluation of their current working practices to identify other safe handling practices that could be applied. It is recommended that environmental monitoring is performed twice per year to identify the current state of surface contamination; it would be ideal to have at least 1 year of data before implementing a change to avoid confusing the effect of an increase in workers’ awareness with the effect of the change implemented. Centres should make sure that they consider all costs incurred, which in addition to acquisition costs include additional workload, training resources, storage, incineration of material and potential drug loss in the device.

### Strengths and limitations

Two authors independently rated the studies according to the CHEERS checklist. Given the general lack of economic data in the literature, we included all studies that presented costs, even though none of the included studies presented a formal economic evaluation. In the CHEERS analysis, we rated a criterion as 'present' if the study fulfilled any aspect (not necessarily all aspects) of the relevant CHEERS statement (ie, minimal level). Even so, the CHEERS scores were low, and the analysis was conservative.

## Conclusions

This literature review identified a lack of properly conducted economic evaluations of CSTDs, despite their high acquisition costs. As a result, hospitals that are considering implementation of these devices will be unable to make a sound and informed decision.

We advocate for a robust and complete economic evaluation of the use of CSTDs for the preparation and administration of hazardous drugs.

#### What is already known on this subject

• There is no high-quality evidence to support (or refute) the routine use of closed system drug transfer devices (CSTDs) in addition to safe handling regarding the reduction of surface contamination.

• In a context of budgetary constraints, economic evaluation of the use of CSTDs appears to be incomplete.

• CSTDs are an expensive technology.

• This is the first review of the literature on the economic data of CSTDs and evaluation of the quality of data reporting as defined by the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) criteria.

• This literature review identified a lack of properly conducted economic evaluations of CSTDs, despite their high acquisition costs.

## Footnotes

• EAHP Statement 3: Production and Compounding.

• Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

• Competing interests None declared.

• Patient consent for publication Not required.

• Provenance and peer review Not commissioned; externally peer reviewed.

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