NHS England has now published the first set of
product specifications to support the production
and supply of ready-made chemotherapy. 4 The
addition of the dose-banded chemotherapy
standardised product specifications means that
hospitals should be purchasing exactly the same
products from licensed suppliers, with no
variation. Previously, each pharmacy department
or regional purchasing team negotiated their own
product specifications with the suppliers and
there were variations across different areas in
terms of the final product. Examples of variation
include syringe sizes selected as final product
storage, that is, should volumes between 25ml
and 30ml be stored in 30ml or 50ml syringes,
whether to remove the same volume of a fluid
bag to match the amount of active drug being
added, and what volume to state on the final
product label. These variations and others have
led to a large product catalogue being present
across suppliers to NHS hospitals. With a known
capacity issue for specials manufacturing in both
commercial and NHS facilities, removing
variation helps to free up capacity by limiting the
number of different items or presentations that
need to be manufactured.Decreasing the variation
and having set product specifications for dose-
banded products helps to increase the need for
those specific products and doses. This is needed
if we are to take the next logical step of trying
to get some of these products licensed. For
there to be a financially viable product for
pharmaceutical companies to consider investing
in licensing, there first needs to be a market
and sufficient need or usage to make it
a worthwhile investment. National dose banding
implementation and the production of product
specifications information by NHS England are
all initiatives that are hoped will encourage
the development of licensed ready-made
standardised chemotherapy doses. Table 1
outlines some of the advantages of dose banding
for chemotherapy.
Benefits of licensed standardised doses
The benefits of having licensed standardised
chemotherapy doses (LSCDs) are wide ranging.
Unlicensed medicinal products are, by their
nature, high risk. All injectable medicines must
undergo a risk assessment to determine the level
of risk (high–low) associated with the preparation
of the injectable medicines. This allows for
targeting of high-risk injectable medicines to be
manufactured within pharmacy aseptic units. 5
Cytotoxic injectable medicines are high risk in
nature. NHS hospital aseptic units that are not
licensed for manufacturing are operating under
section 10 exemption of the Medicines Act 1968;
this requires them to manufacture chemotherapy
under the supervision of a pharmacist for all
medications prepared. Only patient-specific
doses of chemotherapy in response to a signed
prescription must be prepared and there is
a maximum expiry of seven days for any product.
The injectable cytotoxic and monoclonal
antibodies prepared in hospital aseptic units
therefore tend to be bespoke, have a fast
turnaround, a short expiry, and fewer doses.
This leads to a relatively high cost per dose
manufactured, whereas in contrast standard dose
and formulation, batch manufacture with a long
The benefits of
having licensed
standardised
chemotherapy
doses are
wide ranging.
Licensed
standardised
chemotherapy
doses reduces
a vast proportion
of the risk of
using unlicensed
medicines
table 1
Advantages
of dose
banding of
chemotherapy
• Reduction in variation
of doses
• Reduction in variation
of presentation of doses
of chemotherapy
• Uniform requirements
in presentation and
doses equates to better
price negotiations with
commercial and NHS
licensed units
• Increased capacity for
manufacturing of
complex compounds
and participation in
clinical trials (both
commercial and
non-commercial)
25
HHE 2018 | hospitalhealthcare.com
expiry and high volume either by a ‘specials’
manufacturer or as a LSCD would lead to lower
costs per dose manufactured.
By law, before a medicine can be placed on
the market, it must be given a marketing
authorisation (product licence) by a medicines
regulator (the Medicines and Healthcare products
Regulatory Agency in the UK). 6 This process
guarantees that all those involved in bringing
products to market are accountable for their
actions, ensure that processes, supplies and
quality can be thoroughly monitored, and enable
swift corrective action to be taken when needed.
LSCDs would also have to undergo the rigorous
process of obtaining a marketing authorisation.
Where LSCDs doses are used in accordance with
their Summary of Product Characteristics, the
liability would lie with the manufacturer. The
introduction of LSCDs removes the need for
managing the quality of unlicensed medications
on receipt and it ensures that the product can be
used as soon as it has arrived rather than having
to go through local quality assurance process
prior to release for general use.
Increasing the number of agents available as
LSCDs frees up capacity through the supply chain.
At a local individual hospital aseptic unit, this
could free-up capacity to concentrate on the
bespoke and highly specific items that are not
suitable for licensing. It could potentially provide
capacity to either start or expand a centralised
intravenous additive service (CIVAS) within the
hospital to improve quality of care in therapy
areas other than cancer. With an increased
number of new advanced therapy medicinal
products coming to market, this will allow aseptic
units to focus on these newer treatments, which
tend to be high cost, highly complex, and having
a short shelf life. It could also release time to be
put into clinical trials and research, particularly
with the recent national tender for seven
genomic sites; 7 this released capacity for units
would greatly advantageous. The Carter report
states, “Overall, the standardisation of doses
should reduce costs for providers, while releasing
capacity within local units to support other
activities and, in particular, clinical trial and
research.” 2 A greater number of licensed products
would help to achieve this. If many of the
dose-banded items currently supplied within the
commercial ‘specials’ sector were no longer
needed (by the introduction of LSCDs), this would
free up their capacity at a time when there is
a struggle to meet the required demand. Initial
finding from the recent NHS Improvement
pharmacy aseptic service review 7 revealed that
the dose banded items outsourced to them in
England tend to have low profit margins and
are not allowing companies to invest in future
investments and capital projects. Removing these
would allow commercial suppliers to look at
diversifying what they offer and providing
different services to the NHS as required.
With licensed products should come less waste
and longer times for use because they would have
a much longer shelf life then items made in an
unlicensed hospital pharmacy aseptic unit or
a specials unit. In the event of a dose not being
used for a particular patient, the LSCD could be
returned to local stock holding and re-assigned
to another patient.