ADVISORY BOARD
A journey towards the ideal
closed system for oncology
FIGURE 1
Safe handling of hazardous drugs in oncology from preparation to adminstration
An advisory board in September 2018 brought together pharmacists and nurses from reputable
institutions across the EU region with the main objective of discussing the role of closed systems
in ensuring the safe handling of hazardous drugs in oncology from preparation in the pharmacy to
administration by nursing staff to patients
The safety risk posed to patients and
healthcare professionals (HCPs) by exposure to
hazardous drugs (HDs) has been debated for decades.
Guidelines and recommendations across the
European region
The US National Institute for Occupational Safety
and Health (NIOSH) defi nes HDs as those drugs that
are carcinogenic, teratogenic, or cause development,
reproductive, and organ toxicity at low doses or
genotoxicity, or have a structure or toxicity profi le
similar to those of known HDs. 1
To minimise the level of exposure risk for HCPs,
patients and the environment at large, there are
currently recommendations like the European Union
policy recommendations 2 as well as guidelines for
the safe handling of HDs including the NIOSH alert, 1
and the US Pharmacopeia guidance. 3 Although most
of the meeting attendees understood the potential
risks associated with the handling of HDs, they were
however not aware that there is no legal framework
at the European level that compels adherence to
these guidelines and recommendations with respect
to the use of closed systems in oncology care.
Interestingly, there is some variation in the existence
of country-level legislation that facilitate adherence
to or even enforcement of these recommendations
in the countries of origin of the attendees. In
Belgium for instance, there is no specifi c legislation
regarding the use of cytotoxic and other similar
drugs, rather it is international recommendations
that are followed. Contrastingly, it was opined that
there is room for improvement in the dissemination
of the international guidelines in the UK, where local
guidelines appear to take precedence, albeit with some
geographical variability (that is, specifi c guidance
from the Health and Safety Executive in England). 4
In Italy the implementation of closed system
transfer devices (CSTDs) in the pharmacy is
supported by institutional recommendations, with
the Italian Society of Hospital Pharmacy, requiring
that CSTDs be used in the transfer, preparation and
administration of HDs. 5
Knowledge of, and adherence to, the current
guidelines also varies among HCPs within the same
country; one advisor reported that a survey conducted
in Italy last year to evaluate HCP awareness of
the safety aspects of HDs use showed that nurses
had a low perception of the risk associated with
these drugs. The advisor further stated that the
environmental contamination was higher with
respect to nurses relative to pharmacists and occurred
more in the day units compared to the pharmacy,
where the drugs are prepared. The European Society
of Oncology Pharmacists, which has a contamination
program in place that focuses on the pharmacy, is
now collaborating with the European Society for
Medical Oncology in order to direct their education
and testing efforts to the wards for nursing staff.
The attendees emphasised that policies at
European and national levels should be aligned
with the reality of the serious health hazard posed
by cytotoxic drugs to medical personnel, and these
policies must take into consideration the wide range
of professionals involved as well as the different
routes of exposure to these drugs.
PARTICIPANTS
Johan De Munter
Oncology Nurse
Consultant, UZ Gent,
Belgium Francesca De Plato
Assistant Pharmacist, ASL
di Teramo, Italy Robert Mark Duncombe
Director of Pharmacy, The
Christie NHS Foundation
Trust, UK Laetitia Cornette Gonan
Oncology Nurse, Clinique
des Ormeaux, France Susana Hinarejos Parga
Oncology Nurse,
Valencian Institute of
Oncology, Spain
Martin Rees-Milton
Principal Pharmacist,
Aseptic Services, Velindre
Cancer Centre, Cardiff, UK María José Tames
Assistant Director of
Pharmacy, Onkologikoa
Foundation, San
Sebastián, Spain Birgit Tans
Responsible pharmacist
for cytotoxic preparations,
UZ Leuven, Belgium Samantha Toland
Senior Lecturer,
Birmingham City School
of Nursing and Midwifery,
UK Anita Zeneli
Lead Research Nurse,
IRCCS IRST, Meldola, Italy
2 | 2019 | hospitalpharmacyeurope.com
Maintaining a closed system from beginning
to end – current practices
Attendees were divided into two working groups,
comprising nurses and pharmacists, to discuss handling
practices for HDs at their institutions, from receipt of
the raw material at the pharmacy, to compounding,
transport of HDs to where they are administered to
the patient, and disposal after use. The need to keep
a closed system between each step from beginning to
end was a unanimous view in the meeting.
Attendees provided insight into the extent to
which closed systems are implemented across the
different countries. Generally, once the raw material is
shipped to the pharmacy, it is stored appropriately in a
dedicated area for hazardous substances. Furthermore,
if there is a prescription (electronic, paper-based, or
a mixture of both) for a specifi c regimen, the raw
material is moved to the pharmacy compounding unit
where it is prepared, either in an isolation room, in
a laminar fl ow cabinet (most European countries) or
a negative pressure isolator (in the UK).
It was agreed that preparation in a laminar
fl ow cabinet may present a risk of spillage, cross-
contamination and exposure to HD. Isolators are
believed to be completely sealed, however, this
belief may provide a false sense of safety as the
preparations will ultimately be taken out of the
isolator which may expose the operator to surface
contamination and aerosols.
To combat this, pharmacists may use different
personal protective equipment, including: gloves
only, gloves and aprons or masks in addition to
gowns and gloves, depending on the dose being
prepared.
In an attempt to maintain a closed system, there
is a regional variability in the use of spikes, needles,
There is no legal
framework at the
European level
that compels
adherence
to these
guidelines and
recommendations
with respect to
the use of closed
systems in
oncology care
*Not all devices mentioned in this
article are currently available for
sale in Europe
CSTDs and robotic systems; for example, in the UK
the infusion bags are generally not spiked in the
pharmacy as part of the preparation process, but
in France, Belgium, Italy, and Spain this is possible.
Needless to say, it is preferable to avoid spiking in
the unit/room where the patient will be receiving
treatment; this is in order to reduce the risk of
exposure and contamination.
According to the meeting participants, once the
drug is out of the pharmacy, most countries try
to maintain a closed system. There are challenges
when it comes to keeping the system closed, such
as the initial set up and connection of the infusion
line to the patient, removing air from the line after
an air-in-line alarm and disconnection and disposal
of the line.
All of these challenges represent risks of opening
the system when the line is disconnected from the
patient, thus potentially exposing HCPs and patients
to HDs – this further highlights the need for a closed
system that supports end to end safety.
The meeting attendees discussed current
practices for nursing staff at the administration
stage as well as the challenges outlined regarding
risks of exposure to HDs.
One of the main challenges during administration
is the removal of air from the line. This is
particularly prominent in oncology as certain
chemotherapeutic agents tend to generate bubbles
leading to air in the infusion line that ultimately
ends up with the infusion pump triggering an air-in-
line alarm. Most infusion pumps currently available
in the market will trigger an alarm after only a small
amount of air, often resulting in a large number of
air-in-line alarms and a signifi cant amount of time
invested by the nurses in resolving these.
hospitalpharmacyeurope.com | 2019 | 3