table 2
Benefits of adopting RTA gemcitabine
Before After
National standard
doses • Local dose banding tables
• 47 different doses dispensed • National standard doses
• 13 different doses dispensed*
Adoption of licensed
RTA infusions • Unlicensed gemcitabine infusions purchased for high • Licensed infusions (10mg/ml) used where available –
demand doses – shelf life of 84 days
• In-house aseptic dispensing of less commonly used
doses
• 38mg/ml injection concentration used throughout
• All infusions standard fill volume (250ml)
shelf life of two years
• In-house aseptic dispensing of less commonly used
doses (100mg/ml injection)
• Variable fill volumes depending whether licensed
(10mg/ml) or in-house aseptic dispensing (250ml)
• 60% of all doses dispensed as licensed infusions in
last 12 months
• Estimate will rise to 75% with arrival of 1400mg
infusion
• Released 2% of total aseptic items
* Attributable to national standard doses rather than availability of RTA infusions
Dose-dependent volumes were built into the
drug catalogue and tested as shown in Figure 1.
Benefits of adopting RTA gemcitabine infusions
Table 2 summarises the local benefits of adopting
RTA gemcitabine infusions. At present, there are
licensed gemcitabine infusions on the market at the
following doses: 1200mg; 1400mg (anticipated in
2018); 1600mg; 1800mg; 2000mg; and 2200mg.
Conclusions
Following initial efforts to manage the change in
formulation(s) for gemcitabine infusions, the Trust
is now able to offer licensed RTA infusions for the
majority of patients receiving gemcitabine.
Similar change management is applicable to
other switches (for example, adoption of biosimilar
antibody therapies).
Use of a licensed infusion, where available, is
in line with MHRA guidance and offers benefits
to patients and health services through the use
of a high-quality product with a long shelf life.
Additionally, moving from specials releases aseptic
capacity (both in-house and at commercial providers)
to help meet the demand for other drugs/doses.
Review of the volume of drugs/doses used
following the adoption of national standard dosing
might identify other products that are amenable to
production as a licensed product.
Key points
• Where possible
licensed medicines
should be used. 6
• The use of licensed
infusions releases
aseptic capacity for other
treatments.
• e-Prescribing
functionality enables
dose-banding and
dose-dependent
infusion volumes to be
automated, resulting in
long-term benefits and
no additional workload
within busy clinics.
• Longer shelf life
reduces the likelihood of
waste from last minute
deferrals/dose changes.
• With short-term work
to manage transition,
benefits can be realised
in the long-term.
Figure 1 (left)
Dose-dependent volume
table in drug catalogue
References
1 National Institute for
Health and Care Excelllence.
Chemotherapy dose
standardisation. Key therapeutic
topic [KTT22]. February 2018.
www.nice.org.uk/advice/ktt22
(accessed September 2018).
2 Polwart C, Williamson S. North
of England Cancer Network
Guidelines for the dose banding
of cancer chemotherapy. www.
necn.nhs.uk/wp-content/
uploads/2012/11/NECN-dose-
banding-guidelines-version-1_5.
pdf (accessed September 2018).
3 NHS England. How to use
the NHS England dose banding
tables. Version number: 1 First
published: April 2016. www.
england.nhs.uk/commissioning/
wp-content/uploads/
18 | Issue 90 | 2018 | hospitalpharmacyeurope.com
sites/12/2017/01/dose-banding-
tables-how-to.pdf (accessed
September 2018).
4 Summary of Product
Characteristics. Gemcitabine
10mg/ml, solution for infusion.
Ranbaxy (UK) Ltd (a Sun
Pharmaceutical Company).
www.medicines.org.uk/emc/
product/7298/smpc (accessed
September 2018).
5 Ward C. Dose-banded and
outsourced IV chemotherapy — a
strategy to balance demand and
capacity. Clinical Pharmacist 4
Feb 2013. www.pharmaceutical-
journal.com/news-and-analysis/
dose-banded-and-outsourced-
iv-chemotherapy-a-strategy-
to-balance-demand-
and-capacity/11116304.
article?firstPass=false (accessed
September 2018).
6 Medicines and Healthcare
products Regulatory Agency.
Off-label or unlicensed use
of medicines: prescribers’
responsibilities. www.gov.uk/
drug-safety-update/off-label-or-
unlicensed-use-of-medicines-
prescribers-responsibilities
(accessed September 2018).