innovation, and needs to be changed in their
reimbursement system. There were no reports of
similar incentives from other countries.
• Unless the RTA product is supplied in
concentrations that are within the acceptable range
of a hospital’s dose banding, the commercial
product will not be used.
• Pharmacists are required to buy and store several
RTA bags rather than, say, a single vial: storage is
a real problem
Is existing guidance fit for purpose?
Status, standards and advocacy
Throughout the day, mention was made of the two
guidelines that internationally inform the choice
between licensed RTA/RTU products and unlicensed
equivalents made within the hospital: the European
Statements of Hospital Pharmacy (European
Association of Hospital Pharmacy) and the Standards
of Practice. Safe Handling of Cytotoxics
(International Society of Oncology Pharmacy
Practitioners). Both advocate that, before pharmacy
manufacture or preparation of a medicine, the
hospital pharmacist should ascertain whether there
is a suitably commercially available pharmaceutical
equivalent. And it is a sound principle that, if there
is a licensed/authorised product that fulfils your
needs and that comes at a reasonable price, then you
shouldn’t be making it yourself, for all the safety
and capacity reasons above.
National and local guidance may have greater
influence. In the Netherlands, for example, it is
illegal to make a medicine if there is an RTA/RTU
equivalent on the market, whereas in Germany, you
are allowed to manufacture for your own hospitals.
But the situation is not at all clear cut for the
sorts of product we are dealing with here. In the UK,
for example, the Medicines and Healthcare products
Regulatory Agency Guidance Note 14, which is their
interpretation of the Medicines Act (1968), says that
you should not be using something for which there
is a licensed equivalent, but these products are
specifically excluded from the scope of that
document. Add to this grey area the fact that
hospitals that do not make/source their own
products are increasingly finding themselves in very
difficult situations in the event of drug shortages.
Let us look at midazolam syringes. They are
marketed/soon to be marketed across Europe.
Hospital pharmacies are already preparing them
– the identical product. If the only reason to
continue to prepare is to save money, then
something is clearly wrong with the guideline.
The problem is to
define what kind
of drug must be
or should be
prepared in an
RTA form
Alain Astier, France
And what if your hospital’s pumps are programmed
for syringes other than that being marketed? That’s
always a big problem for companies coming to
market with a special syringe.
Existing guidance is insufficient. What is needed
is a published consensus, led by pharmacists and
founded on a critical analysis of the literature, that
aligns with the special situations surrounding these
sorts of product (e.g. what concentration, what
formulation), defining drugs that should be
furnished by the hospital and those that should be
manufactured by the company, for example, in an
RTA syringe.
Conclusion
There are clearly many situations in which
commercially available RTA products are preferred
to those manufactured internally. Industry must
continue to listen to the needs and opinions of their
market, and promote and develop their products
accordingly.
For their part, and in co-operation with Industry,
pharmacists should lead the way in developing
fit-for-purpose guidance.
There is always more that can be done to improve
patient safety, regardless of cost, and one tool is
clearly the continued development of RTA drugs.
Recommendations
In Germany there is the aim to standardise concentrations of products for use in
ICU, with the involvement of the Society of Anaesthesiology and The German Society
of Intensive Care Medicine. But this is not enough: what is needed is standardised
concentrations all over Europe – otherwise, Industry will have a problem choosing
which products to prepare. What we need is a consensus between all countries as
to which products they need, in which concentrations, to make it more efficient for
Industry to produce – then perhaps they will become more affordable.
Meticulous barcoding and labelling on syringes, bags and primary packaging of
all RTA products is a significant driver of their use as they minimise the likelihood
of administration error. There is a call for standardised barcoding across the EU.
RTA gemcitabine bags would be very useful in outpatient clinics, where patients
and staff are currently often kept waiting for hours for Pharmacy to provide in house.
Existing guidance is insufficient. What is needed is a published consensus, led by
pharmacists and founded on a critical analysis of the literature, that aligns with the
special situations surrounding these sorts of product (e.g. what concentration, what
formulation), defining drugs that should be furnished by the hospital and those that
should be manufactured by the company, for example, in an RTA syringe.
There was also 100% consensus that spike ports (spikes, not needles) or Luer
Loks would be equally acceptable for bag access, and industry was encouraged to
manufacture both types, so as to service all markets.
There is preference in some quarters to have RTA 10mg/ml gemcitabine bags
available in fewer volumes – 140ml and 160ml seem to be preferred – because
having currently six from which to choose is too complicated and takes up too much
storage space. This means less of a storage issue, and you use vials for those
patients that use other doses.
Products to be considered for ICU RTA syringes include those that are:
• High risk in terms of either complex preparation, complex calculation or
microbiological risk (risk calculation in the UK defined by National Patient Safety
Agency, NPSA 20)
• High volume (e.g. 50ml KCl)
• Anything used in ICU (in standardised concentrations)
Products recommended for RTA availability include:
• 1 unit per ml insulin in 50ml syringe
• Cisplatin
• Oxaliplatin
• Epinephrine and norepinethrine (syringe)
• Amphotericin (stability issues nonwithstanding)
• Piperacillin and tazobactam (if made in house, nurses will draw up before fully
dissolved)
6 | 2020 | hospitalpharmacyeurope.com