pharmacies has a bright future, according to Paul Le
Brun (Hospital pharmacist – clinical pharmacologist,
Leiden University Medical Centre, The Netherlands).
This is being driven by the increasing focus on
patient safety, the demand for personalised
medicine, the advent of complex medicines such as
advanced therapy medicine products (ATMPs) and
the emergence of new technologies such as robotics
and 3D printing.
Ready-to-use (RTU) and ready-to-administer
(RTA) medicines are needed to avoid errors
in reconstitution. These can arise because of
calculation errors, procedural errors such as
incomplete dissolution or use of the wrong
diluent, incompatible administration devices or
microbiological contamination. Dr Le Brun said
that a risk-based approach should be used to
determine where injections should be prepared
and by whom. The European Resolution on good
reconstitution practice (Resolution CM/Res (2016)2)
sets out the requirements for safe reconstitution
of injectable medicines. Among other provisions,
healthcare establishments are expected to nominate
a designated person, preferably a pharmacist,
who is responsible for the management of good
reconstitution throughout the organisation. Risk
assessment of each product determines which
products should be reconstituted where (that is,
pharmacy or clinical area). In practice, more than
90% of reconstitutions are simple and can be carried
out on wards (with suitable training and support);
the remainder are complex and need to be carried
out in the pharmacy. Ongoing risk management
with regular reviews of risks is essential to improve
safety on wards, explained Dr Le Brun.
Personalised medicines for patients with shared
disease markers would increasingly be used in
future. At present everyone receives the same
treatment; some patients benefit from it, some do
not, and some experience adverse effects. In future,
biomarker diagnostics would enable clinicians to
select the right (that is, effective) treatment for each
individual, he predicted. One of the challenges will
be dealing with increasingly complex medicinal
Further development of robotic
technology for parenteral products will
be important not only for efficiency,
productivity and product quality but
also for the safety and health of the
staff involved
products. For example whereas a paracetamol
molecule has a diameter of about one nanometre
(nm), monoclonal antibodies are about 10-times
bigger and cells could be as big as 50 micrometres
in diameter (50,000nm).
In future, pharmacies will be expected to handle
ATMPs. These may be gene therapy (GTMP), cell
therapy (CTMP), tissue engineered products (TEP) or
combined products. For gene and cell therapy, cells
(for example, haematopoietic cells) are harvested
from the patients, loaded with therapeutic genetic
material in vitro and then infused back into the
patient. A number of ATMPs have now received
marketing authorisations, including Holoclar, a
tissue-engineered product for limbal cell deficiency
and Imlygic (talimogene laherparepvec) a GTMP for
unresectable melanoma, noted Dr Le Brun. Special
46 | Issue 90 | 2018 | hospitalpharmacyeurope.com
Ready-to-use
(RTU) and ready-
to-administer
(RTA) medicines
are needed to
avoid errors in
reconstitution
facilities and expertise will be required to handle
ATMPs. The raw materials could themselves be
a source of risk and contaminant control will be
challenging given that sterilisation by filtration is
not an option and there can be no sterilisation of
the final product. Furthermore there is unlikely to
be any product-specific reference material (for final
product testing) and the shelf-life may be hours
or days if the product is not cryopreserved. Good
Manufacturing Practice for ATMPs came into force
in the European Union in May 2018.
Further development of robotic technology
for parenteral products is likely and this will be
important not only for efficiency, productivity and
product quality but also for the safety and health
of the staff involved. Repetitive strain injuries and
exposure to hazardous substances can be avoided by
these means.
Lastly, 3D printing of medicines is likely to
become a reality. In fact, the first 3D-printed
medicine – Spritam (levetiracetam) – has been
approved by the FDA. In future, bioprinting
(organs on chips, diagnostic tissue) and small-scale
preparation of biologicals could follow, said Dr Le
Brun.
All of this means that the need for
pharmaceutical expertise in the preparation of
medicines will not diminish. Proper handling
of the pharmaceutical product is part of clinical
treatment, he emphasised. “Education is paramount.
Now is the time to invest in skills and technology”,
he concluded.
Discharge management
The implementation of a comprehensive discharge
medication management system called for
multidisciplinary input and cooperation, said Irene
Kramer (Director of Pharmacy, University Hospital,
Mainz, Germany). Hospitals in Germany were
required by law to introduce a structured discharge
management scheme by October 2017. The scheme
makes use of the German national electronic
medication record (see HPE 83), a measure that was
developed to improve medication safety and reduce
the number of medication-related problems that
led to hospital admissions. The electronic record
can be printed for patients but also contains all
the information in a 2D-barcode that allows rapid
transfer (by scanning) of accurate information
when a patient is admitted to and discharged
from hospital. Studies have shown that use of
the medication record improves patient knowledge
and reliable use of medicines, noted Professor
Kramer.
The present scheme requires active
pharmaceutical management at the interface, she
explained. At the time of admission, pharmacists
scan the medication record to obtain a list of
medicines and add to the record any medicines that
are being used for self-treatment and any necessary
changes are made to conform to the in-house
formulary. A ‘medication analysis’ is also performed
to check for interactions, dosing inconsistencies, etc.
The electronic record is updated when changes are
made and, at the time of discharge, the medication
is explained and a printed copy of the up-to-date
record is given to the patient.
The 43rd scientific congress of the Bundesverband
Deutscher Krankenhausapotheker (ADKA) took place
in Stuttgart, Germany on 3–5 May 2018.