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Letter to the Editor
Letters about Published Papers
Letters of comment about recently published papers should be sent
by email to: bgoldspiel@verizon.net
Re: Cox et al. Development and
evaluation of a novel product to remove
surface contamination of hazardous
drugs. J Oncol Pharm Pract, published
2017, 23(2): 103–115. DOI: 10.1177/
1078155215621151
Cleaning up the facts?
To the Editor,
I read with interest in the recent edition of the Journal
the article on the evaluation of a new de-contamination
product for the removal of surface contamination of
hazardous drugs.1 Of the many claims, one of the
authors’ conclusion is that this product ‘‘is equal to or
more effective than CSTD in controlling surface exposure’’. This statement is misleading and dangerous. The
authors claim this based on their results, yet make no
effort to describe the closed system transfer device
(CSTD) used in the study. The nine citations used to
justify this claim involve three different CSTDs, with
one reference in their conclusion being an in vitro study.
There is no single solution to effectively control, or
eliminate, the risk of exposure to hazardous medicines.
Thus, it is important to consider a systems approach.
The hierarchy of hazard control is a widely accepted
system used in several industries to minimise or eliminate exposure to hazards. The International Society of
Oncology Pharmacy Practitioners has modified this
concept in its standards of practice for the safe handling
of cytotoxic agents.2 The principles involve a step-wise
approach to reduce worker’s exposure to hazardous
substances, starting with the highest level of safety
and ending with a minimal safety standard. The basic
components are (a) elimination of the hazard, (b) isolation of the hazard, (c) engineering and administrative
controls and finally (d) personal protective equipment
(PPE).
This article suggests that the use of a cleaning system
(an administrative control) is equal to a CSTD
J Oncol Pharm Practice
2017, Vol. 23(7) 557–560
! The Author(s) 2017
Reprints and permissions:
sagepub.co.uk/journalsPermissions.nav
DOI: 10.1177/1078155217722407
journals.sagepub.com/home/opp
(an isolation control). For those experienced in cytotoxic drug manipulation it would seem intuitive to isolate the source of contamination to avoid the spread of
cytotoxic residues within workstations. The appropriate use of a CSTD has allowed pharmacy personnel to
isolate the hazard during the preparation of these
agents, thereby containing the hazard at its source. It
is unclear to the reader why the CSTD failed in this
study, and the authors make no attempt to explain
this failure. Was it a failure because the CSTD used
did not meet the true definition of a CSTD?2 Was it
because of the poor technique in using the device? Was
it a failure of the device itself? The authors leave more
questions than answers.
Healthcare workers rely on sound studies to make
realistic and informative decisions in their workplace.
While the information from this article is informative,
the conclusions are not. While HD CleanTM may be a
useful adjunct in the minimisation of hazardous
exposure by the ability to remove contamination, it
does not prevent or isolate the hazard in the same
manner as a CSTD does; therefore, it cannot replace
an acceptable CSTD. Readers of this article may
be misled to believe the authors’ conclusions and
substitute this product for a CSTD. Healthcare workers should carefully review their practice before
making any changes to the use or implementation of
a CSTD.
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.
References
1. Cox J, Speed V, O’Neal S, et al. Development and evaluation of a novel product to remove surface contamination
of hazardous drugs. J Oncol Pharm Pract 2017; 23:
103–115.
2. Connor T, McLauchlan R and Vandenbroucke J. ISOPP
standards of practice. Safe handling of cytotoxics. J
Oncol Pharm Pract 2007; 13(Suppl): 1–81.
Jim Siderov
Cancer Services, Olivia Newton-John Cancer Wellness
& Research Centre, Austin Health, Heidelberg,
Australia
Corresponding author: jim.siderov@austin.org.au
Reply
To the Editor,
Re: Cox et al. Development and
evaluation of a novel product to J
Oncol Pharm Pract, published 2017,
23(2): 103–115.
DOI: 10.1177/1078155215621151
It takes a village to raise awareness of
and to address surface contamination of
hazardous drugs
Antineoplastic agents are known to be harmful to both
healthy and cancerous cells, and thus are considered as
hazardous drugs (HDs). The new USP Chapter 800
outlines the standards to protect healthcare personnel
when handling HDs. Even while following best practices, surface exposures of HDs are high and numerous.
Thus, it is important to develop new products to reduce
the surface contamination of HDs. Hazardous Drug
Clean (HDCleanTM) was developed to decontaminate
and remove HDs from various types of surfaces and
overcome the problems associated with other products. We reported on a series of research and development (R&D) testing and studies in three separate
cancer centers that evaluated the ability of HDClean
to remove surface contamination of a series of HDs
with vastly different chemical characteristics and solubilities. The evaluation of HDClean was performed in
pharmacies and nursing units. Analytical chemistry
methods also were used to accurately measure the concentrations of HDs on surfaces as outlined in
USP800.1 However, a recent letter to the editor
(LTE) has raised concerns over our objectives, methods, and conclusions of our studies presented in
the manuscript. A summary of our responses to
these criticisms is included below.
The LTE states, ‘‘Of the many claims, one of the
authors’ conclusion is that this product ‘‘is equal to or
more effective than close system transfer device (CSTD)
in controlling surface exposure. This statement is misleading and dangerous.’’ As stated in the publication,
the objectives of our study were to evaluate the ability
of HDClean to remove surface contamination of a
series of HDs as part of R&D tests and studies in hospitals. Institutions and pharmacies are evaluating overall worker exposure to HDs based on detectable surface
exposures of HDs, as this is relatively easy to perform
compared with other more complicated or invasive
methods. Thus, the end points of our study were
designed to use this same industry standard measurement of surface exposure of seven HDs for the studies
in three separate hospitals. In addition, the use of surface exposures of HDs as the end point allows for the
results to be extrapolated to other potential environments where HD exposures are important but CSTDs
do not apply (e.g. research labs and manufacturing centers). As referenced in the manuscript, the comparison
of HDClean alone with CSTD alone used multiple
prior studies of various types of CSTD.2–11 The overall
incidence of surface exposures of HDs when using
CSTDs in the published studies was 60%, which is
higher than the results after using HDClean alone to
clean the surfaces at the end of preparing chemotherapy
(detectable exposures in only 1.1% of locations).2–11
Thus, our conclusions as related to HDClean reducing
the surface exposures of HDs are correct. However, we
agree that the issue is more complex and that multiple
levels of interventions are required. Thus, we also evaluated HD exposures after the use of a CSTD in combination with HDClean as discussed below.
The LTE also states, ‘‘The authors claim related to
effectiveness of HDClean compared to CSTD, yet make
no effort to describe the closed system transfer device
(CSTD) used in the study. The 9 citations used to justify
this claim involve 3 different CSTD. . .’’ By design, the
co-investigators responsible for the analytical studies
were blinded to the use or non-use of a CSTD and
the type of CSTD used in each hospital. In addition,
the type of CSTD was not unblinded to avoid any perceived bias towards the goals and results of the study.
As related to the number and type of publications referenced in the manuscript, these were some of the few
published studies on CSTDs at the time of our publication, which demonstrated different products on the
market.2–11 We agree that more systematic and larger
studies on the use and comparison of CSTDs need to be
performed and published.
The LTE also states, ‘‘It is unclear to the reader why
the CSTD failed in this study, and the authors make no
attempt to explain this failing.’’ The reasons for the
surfaces exposures of HDs after the use of CSTDs
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