One of the main
challenges during
administration is
the removal of air
from the line
It eliminates the risk of needlestick injuries and of
accidental disconnections while preventing leaks
and contamination during preparation, transport
and administration in the oncology ward.
The advisors thought that CSTDs like the
ChemoLock and semi-automated compounding
systems like the Diana* decrease the risk of
contamination for patients, contribute to a
reduction in medication errors and reduce risks
of repetitive strain injuries. However, concerns
regarding compatibility with other systems (for
example, labelling and electronic prescribing
systems) and training needs were raised. The
potential reductions in costs resulting from the
ability to reuse the sealed contents of the vials in
minimising drug wastage (which will offset the cost
of the equipment) were also discussed, although this
practice may not be allowed in all countries.
The Plum 360 Infusion system helps to ensure
a closed system is maintained when HDs are being
administered by: 1) providing air management that
doesn’t require disconnecting from the patient
and 2) allowing a direct connection on the cassette
for secondary piggyback and concurrent infusions
independent of head height – this ensures every ML
of medication is delivered as intended.
ICU Medical MedNet closes the medication loop
by providing complete IV-EHR interoperability
with smart pump programming and infusion
documentation. This reduces potential medication
errors with the pharmacy order being sent
directly to the pump and by reducing manual
documentation processes as infusion data are sent
directly to the Hospital EHR.
It was highlighted that there is a need for a
technology, like that offered by the Plum 360,
that is easier and safer than the current methods
used to remove air – this is particularly important
with HDs, and should be possible when you have
two simultaneous infusions running through one
pump. Furthermore, it was suggested that it will
be beneficial to be able to attach a syringe directly
to the pump cassette to administer HD, all while
maintaining a closed system.
There was general frustration around the lack
of adoption of smart pump technology and safety
software like MedNet with one advisor stating “a
lot of places have got a smart pump but they’re
not actually utilising it as a smart pump”. Having
a completely closed loop for the administration
and documentation of the infusion with a fully
integrated system was seen as the “nirvana” that
all the advisors would ultimately like at their
facilities.
Uptake, procurement and transition to
closed systems
The attendees noted that the countries and care
units represented are heterogeneous in terms of
uptake of closed systems. In some regions, closed
systems and automation have not been fully
implemented in the pharmacy, and although smart
pump technology is available it may not be used
to the limits of its capabilities – a rather surprising
fact, given the potential benefits of such devices.
The advisors provided feedback on how the
introduction of closed systems occurred at their
respective institutions. In one case, there was
a gradual increase in the use of the system after an
initial testing phase with a limited number of drugs.
For other institutions represented in the meeting,
it resulted from specific requests from the HCPs,
who recognised the potential to minimise risks
in the workplace or who reported adverse events
6 | 2019 | hospitalpharmacyeurope.com
Summary outputs from interview
of French pharmacists (n=3)
• There are concerns over current handling
with the use of HDs. It was however noted that
the acquisition of closed systems is not always
a ‘final decision’ in the sense that their use has to
be justified periodically in the face of the high costs.
In addition to cost, other barriers to
implementation of closed systems could also derive
from specific evidence requirements, particularly
in the UK. The advisors thought it would be
beneficial if companies marketing such products
could generate data to address these evidence
requirements.
In fact, a Cochrane report 8 which concluded that
there was not enough evidence to support the use of
closed systems was mentioned as being used by an
institution’s management in the UK as grounds for
rejecting proposals for the acquisition of CSTDs. This
report, which included mostly studies evaluating the
systems in the pharmacy, has been challenged due
to the absence of proof of data homogeneity and of
validation of parameters defining safe handling, as
well as its failure to compare devices marketed in
different territories. 9 Besides, lack of awareness of
the risks of handling HDs by HCPs may constitute
a barrier to the adoption of closed systems since
there is no pressure on management from ‘below’.
Other main barriers include cost, interoperability
and compatibility with existing systems, the need
for highly qualified technicians and adjusted process
workflows, resulting in a long process of testing and
validation. An instituted culture of innovation and
the need for a new facility or redesign/rebuild of
a facility are the best drivers for transitioning to
semi-automated and automated systems.
An instituted culture of innovation with
pharmacy and nursing working together was seen as
the best drivers for transitioning to closed systems.
Key themes and take-home messages
• Practices on the proper handling of HDs are mostly
based on recommendations at the moment, rather
than legislation or regulation.
• Awareness programs by the relevant professional
societies are currently shifting their focus to nurses,
after mostly targeting pharmacists in the past.
• Although the importance of maintaining a closed
system from preparation, transport, administration
and disposal was recognised, there is a variation in
the extent to which this is implemented or even
understood across the EU.
• The implementation of closed systems improves
safety and efficiency during the preparation, delivery,
and administration of HDs, with potential cost-saving
implications for institutions and the healthcare system.
• The availability of advanced technology to assist
in the different steps of drug preparation and
administration creates additional needs for specific
training of medical personnel.
• Collaboration between pharmacists and oncology
nurses is fundamental to overcoming barriers to
the wider implementation of closed systems in
oncology.
References
1 NIOSH ALERT. Preventing
Occupational Exposures to
Antineoplastic and Other
Hazardous Drugs in Health Care
Settings. Department of Health
and Human Services. Cincinnati,
OH, USA. September 2004.
Available from: www.cdc.gov/
niosh/docs/2004-165/pdfs/2004-
165.pdf
2 Preventing occupational
exposure to cytotoxic and other
hazardous drugs. European
Policy Recommendations. March
2016. Available from: www.
europeanbiosafetynetwork.eu/
wp-content/uploads/2016/05/
Exposure-to-Cytotoxic-Drugs_
Recommendation_DINA4_10-
03-16.pdf
3 USP General Chapter <800>
Hazardous Drugs – Handling
in Healthcare Settings.
Available from: www.usp.org/
compounding/general-chapter-
hazardous-drugs-handling-
healthcare
4 Safe handling of cytotoxic drugs
in the workplace. Health and
Collaboration
between
pharmacists and
oncology nurses
is fundamental to
implementation of
closed systems
Safety Executive. Available from:
www.hse.gov.uk/healthservices/
safe-use-cytotoxic-drugs.htm
5 Italian Society of Hospital
Pharmacy and Pharmaceutical
Services of Health Companies.
Technical Guidelines: The
protection of the health worker
at risk of exposure to antiblastic
drugs. October 2015 (accessed
January 2019)
6 Diana™ Compounding
Workflow System. ICU Medical.
Available from: http://www.
icumed.com/products/oncology/
practices of hazardous drugs (HDs), such as
cytotoxic immunosuppressants, particularly during
administration.
• Despite the existence of guidelines outlining the
requirement for centralised preparation of HDs
(especially anti-cancer drugs), there is no legal
framework either to facilitate adherence to the
relevant national recommendations or compel the
use of CSTDs specifically.
• In some hospitals, there is a distinction or hierarchy
in the way the different classes of drugs considered
to be hazardous are handled – a major reason for
this being that cytotoxic drugs are considered more
harmful than other HDs. Similarly, a specific HD
could be handled differently depending on whether
or not it is being used in cancer care. An example is
the case of monoclonal antibodies, which are handled
differently (in terms of preparation) depending on
whether they are being used in a cancer and non-
cancer care setting.
• A completely closed system is currently
maintained in only one of the institutions to which
the respondents are affiliated. Other respondents
however report a partially closed system, through the
use of specially sealed bags, for some of the steps
from preparation, to delivery, administration and
disposal.
• Infusion pumps are not connected to pharmacy
systems or the electronic health records in the cancer
units of the represented institutions.
• The number of preparations carried out by
pharmacy technicians ranges from 30 to 150 daily.
Although protocols to deal with the occurrence of
hand strain injuries are not widely established, there
is an appetite for a semi-automated preparation
process according to a majority of the respondents.
• Currently, there is not a widespread adoption of
CSTDs in France. Barriers to their implementation
includes a lack of awareness of the scale of the risk
of contamination and cost of implementation
of CSTDs.
• In most institutions, the departmental pharmacy
budget is utilised for the procurement of such devices
as CSTDs and, as such, pharmacists play a major role
in the decision of whether or not to adopt the devices
in their respective institutions.
• Some of the factors that impact on procurement
decisions for closed systems include: the level
of training required for new devices, clinical and
economic data to prove that one device is better
than the other, practical implementation and ease
of use, and time required to integrate with existing
systems, etc.
pharmacy-compounding-
automation/diana-workflow-
system.aspx
7 ChemoLock™ Needlefree
Closed System Transfer Device.
ICU Medical. Available from:
www.icumed.com/products/
oncology/hazardous-drug-
closed-systems-and-cstds/
chemolock.aspx
8 Gurusamy K et al. Closed-
system drug-transfer devices
for reducing exposure to
infusional hazardous medicines
in healthcare staff. Cochrane
Database of Systematic Reviews
2018, Issue 3. Art. No.: CD012860.
DOI: 10.1002/14651858.
CD012860.pub2
9 Power LA et al. Cochrane
Review on CSTDs Misses the
Mark. Pharmacy Practice
News. September 11, 2018.
Available from: www.pharmacy
practicenews.com/Clinical/
Article/09-18/Cochrane-Review
-on-CSTDs-Misses-the-Mark/
52639
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