HPE Drug stability: What do we need to know? | Page 20

In the aim to
reduce hospital
stays and with
availability of
homecare
services,
additional shelf
life on aseptically
compounded
products means
fewer deliveries
for patients and
hence reduces
costs and
increases
convenience of
this treatment
option
in terms of lower overall doses and fewer
interventions. This option also means less nursing
time is required, but stability data and shelf life
assignment need to consider this extended infusion
period, often in portable elastomeric infusers, as
traditional studies often lack these in-use data. 3
Filling in these gaps in better-designed studies is an
important development in order to maximise the
development of these types of service.
Standardisation
Standardisation of treatment in terms of
dose-banding for chemotherapy alongside
standardising presentations and labelling
requirements for these products 4 enables an
increased potential for batch preparation of these
products, either in-house in hospital aseptic units
or by outsourcing to commercial suppliers. Clearly
a longer shelf life is of paramount importance in
order to facilitate the process of batch preparation,
which has added benefits in terms of workload and
capacity planning and also in the potential to make
savings from campaign vial sharing. Within the
UK, vial sharing is generally restricted to campaigns
as defined in the NHS standards document, 5
although it is less restricted in some other parts
of Europe.
Outsourcing
As referred to above, with the ever-increasing
workload in hospital cancer units and in other
areas of medical treatment, the demand on services
is outstripping capacity and hence there is more
reliance on outsourced products from commercial
licensed aseptic compounding companies, in the UK
these work under manufacturing specials licences.
For these companies, extending the shelf life of
these products is important in order to facilitate
workload flexibilities, increase efficiency of product
throughput and maximise the opportunity for vial
sharing. For these units, the availability of robust
stability data and/or the laboratory facilities to
run their own stability programmes to fill in the
gaps are of paramount importance. Independent
oversight of supporting stability data is an important
consideration when approving such suppliers to
supply into the healthcare sector, particularly for the
more complex products such as biopharmaceuticals
and parenteral nutrition. Within the NHS, there
are a series of documents that can be used to assess
these studies against, and which are freely available
through the Specialist Pharmacy Service website. 6–8
In-house aseptic compounding
When considering aseptic compounding within
hospital aseptic facilities, then it might often be
possible to work with relatively short shelf lives
such as those contained within products’ SPCs;
however, this does mean that the aseptic unit has
to be very responsive in producing treatments
just in time and inevitably there are often delays
to patient treatment because of this. Hence even
in this scenario, there is an advantage in having
robust extended stability data available. This enables
more opportunity to prepare patient treatments in
advance and also reduces the risk of wastage when
a patient’s treatment is deferred at a late stage,
meaning that the treatment may still be suitable
when the patient is ready for it. Alternatively with
the more standardised treatments, this can often be
reassigned to another patient.
In terms of workload planning and capacity
management, preparation in advance of treatment
offers many advantages compared with preparation
20 | 2019 | hospitalpharmacyeurope.com
just in time, and this applies to the aseptic unit and
also the clinic; the patient should have less waiting
time and hence an improved experience too. In
terms of the aseptic unit, preparation in advance
can be used to even out requirements on the service;
those units without this flexibility often have
significant workload peaks and troughs.
Storage and transport considerations
In general, aseptically prepared products, in order to
minimise microbial proliferation risks, are expected
to be stored in a refrigerator unless this adversely
affects them; 9 hence these would be expected to
be transported using a validated cold chain. An
increased understanding of product stability can be
important in understanding the impact of product
handling once preparation is completed until it
reaches refrigerated temperatures; this might be an
extended period if it not possible to cool products
in a refrigerator before packing for transport. It
may take a significant time to complete a batch
and release it and this should be considered in
assessment of stability data and assignment of shelf