Currently for the majority of dose-banded
items outsourced to specials manufacturers,
a minimum quantity (five of one particular drug
and strength) has to be ordered. With licensed
products, it is likely that minimum orders would
not be needed. LSCDs could become part of
a normal delivery from a wholesaler. Often orders
placed to wholesalers are available the next day
rather than the usual five-day turnaround from
specials; this would allow a smaller stock holding
as fewer items could be ordered (but more
frequently) to meet the local need.
LSCDs would have product branding and
design incorporated into their marketing
authorisation applications. This process ensures
that product licence holders ensure a risk
reduction in their labelling and identification
of different product strengths, and which would
reduce the chance of picking errors within the
pharmacy as the majority of products from
a single specials supplier would usually look the
same and might only be differentiated by reading
the label for drug and dose. At present, there is
an individual licensed ready-made chemotherapy
agent – Sun Pharmaceuticals’ gemcitabine
– available on the market. 8 The product was
table 2
Key implications for the
introduction of licensed
standardised chemotherapy
doses
• Extended product shelf life – helping with
reduction of ‘wasted’ doses
• Removal of unlicensed product quality assurance
processes
• Increased capacity for NHS aseptic units to
participate in/expand CIVAS service, complex IMP
manufacture in clinical trials
• Quicker turnaround times, for ordering licensed
standardised chemotherapy doses in contrast to
outsourced chemotherapy batch ordering
• Reduction in picking errors – as licensed products
must undergo branding and design
• Release of aseptic unit staff to participate in other
activities and service development, for example,
Research and Development, staff training and
development
introduced to the market in line with national
dose bands. Doses currently range from 1200mg
to 2200mg and each individual dose of
gemcitabine (1200mg/120ml; 1600mg/160ml;
1800mg/180ml; 2000mg/200ml; 2200mg/220ml;
a 1400mg dose will be available in Summer 2018)
is presented in a different coloured outer box.
Our experience and implementation
At Milton Keynes University Hospital NHS
Foundation Trust, we implemented the use of the
licensed ready to administer gemcitabine bags
and this has been beneficial in a number of ways.
No longer having to manufacture on average 50
doses of gemcitabine per month has freed time
to be spent on other activities. For example,
our organisation was one of the initial UK NHS
Trusts to be involved in the OCEAN clinical trial:
a randomised, controlled, open-label study where
one of the investigational medicinal products
(IMPs), melflufen, required manufacturing under
strict conditions owing to its high sensitivity to
light and short expiry time.
The difference in time taken per one dose in
our unit equates to 24 minutes of time saved (this
is primarily on production tasks such as label and
worksheet generation, spray and wipe
sanitisation and manufacturing). This one product
in a medium-sized district general has therefore
saved 20 hours per month of staff time to be
focused on other tasks. We have found the
ordering, supply and use of the product very easy
and straightforward. We are able to keep just
a few of each strength in stock to limit the
space required as we are confident of receiving
deliveries at our stated times and there is no need
to assess them against a product specification
when they are received. Therefore, there is no
delay in being able to use the doses. As previously
mentioned, the five available strengths come in
colour coded boxes to aid in picking the correct
strength and in the last 12 months since using the
product, there have been no reported picking or
dispensing errors.
Conclusions
Table 2 lists the key positive implications for
the introduction of LSCDs and their potential
impact to NHS Trusts. At our facility, we have
implemented the use of the licensed ready to
administer gemcitabine bags and the benefits
are evident.
110
HHE 2018 | hospitalhealthcare.com
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Health by Lord Carter of Coles.
February 2016.
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