driven by cost, rather than clinical, parameters. 6,7
The STEPSelect process
There are four stages in the STEPSelect process: 8
STEP 1: Clinical evaluation
Scientific evaluation by panels of clinicians and
pharmacists with updating of evidence relating to
efficacy, safety, tolerability, ease of use, interactions
and experience of selected products in a product class.
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STEP 2: ‘Fit for purpose’ assessment
Assessment of factors that could impact on the
safe use of products by patients and healthcare
professionals, usually carried out on packaging
and instructions for use.
STEP 3: Economic impact analysis
Evaluation of the use of the agents on the healthcare
economy.
STEP 4: Final product selection with guidance for the
service and formulary support
STEPSelect recognises EU procurement legislation
enabling radical redesign of the medicine tariff based
upon safety, efficacy and economy.
In Northern Ireland, STEPSelect has been applied
strategically, over a number of years, to around
25 product groups (including cardiovascular,
oncology, rheumatology, gastrointestinal, neurology,
psychiatry, gynaecology, obstetrics, nephrology, and
wound management) to achieve product selection
based on efficacy and safety. Efficiencies have also
been realised. In early work, efficiencies from statins
and proton pump inhibitors were €8–10 million
per annum and efficiencies of up to 25% have been
achieved for certain medicine categories. Crucially,
efficiencies are not based on selecting the cheapest
product, but rather driven by clinical evaluation and
safety as the prime factors.
The advantages of STEPSelect for Poland include:
• Web-based design supports remote participation in
medicines selection
• Flexibility enables users to adjust their data and
make relevant selection decisions, while exchanging
and comparing data and experiences between users
• Transparency increases the effectiveness of
medicines selection while reducing/eliminating
Table 1
Examples of LMWHs in Europe, Canada and the USA
Name Method of preparation Mean molecular weight
Ardeparin (Normiflo ® ) Peroxidative
depolymerisation 6000
Dalteparin (Fragmin ® ) Nitrous acid
depolymerisation 6000
Enoxaparin (Lovenox ® ,
Clexane ® ) Benzylation and alkaline
depolymerisation 4200
Nadroparin
(Fraxiparine ® ) Nitrous acid
depolymerisation 4500
Reviparin (Clivarine ® ) Nitrous acid
depolymerisation,
chromatographic
purification 4000
Tinzaparin (Innohep ® ) Heparinase digestion 4500
12 | Issue 90 | 2018 | hospitalpharmacyeurope.com
potential anti-competitive behaviour
• Local pharmaceutical usage data can be
incorporated into STEPSelect and thereby users’ own
data is generated; this is important for formulary
management.
Important elements of a successful local STEPSelect
project are:
1 Local engagement of key stakeholders 8
2 Selection of therapeutic classes that most benefit
patients
3 Generation of local data where medicines are
ultimately selected and procured locally.
In a recent evaluation of the merits of the
STEPSelect approach for introduction in low and
middle income countries (LMICs), an EU Horizon 2020
programme concluded:
• The implementation of a web-based tool in
supporting rational decision-making and supply of
drugs is innovative and addresses a major problem
relevant for healthcare systems in LMICs;
• The usage of IT and especially mobile technology
in STEPSelect is ‘state of the art’;
• STEPSelect has the potential to bring these countries
up to speed with the new system of medicines
selection and thereby leverage scarce resources by
allowing professionals to work remotely;
• Additionally, the non-proprietary, transparent,
data-generating features of the web-based platform
are highly advantageous, and the capacity for local
ownership is a progressive step.
The Medicines Optimisation Innovation Centre
(MOIC) in Northern Ireland started a collaboration
with the University Hospital in Gdansk in 2016.
Following introduction of STEPSelect to various local
audiences, a pilot project was conceptualised. The
objective of this project was to introduce STEPSelect
at an operational formulary management level
to a Polish university hospital and to test possible
constraints in introducing the system as well as to see
if credible results could be achieved.
Methods
The collaborating parties decided that the focus of
the project would be low molecular weight heparins
(LMWHs.) 9 Examples of LMWHs in Europe, Canada
and the USA are shown in Table 1.
A hospital-based panel of clinicians and
pharmacists was assigned to make appropriate
product selections for the therapeutic class of LMWHs.
With the exception of risk assessment (STEP 2), it was
decided that all other steps of the STEPSelect method
would be incorporated into the pilot project.
The project commenced in January 2017 when a
delegation from MOIC visited the University Hospital
in Gdansk and provided training for clinicians and
pharmacists, familiarising them with the interactive
first step module of STEPSelect. This module has
a knowledge and an interactive decision-making
component.
STEP 1 – Element 1
Adaptation of the LMWH matrix to Polish
clinical variation
Relevant knowledge in the therapeutic class
(in this case the LMWHs) is presented in a matrix.
A comprehensive literature search is carried out (by
Digitalis MM Ltd) using major databases including
Pubmed, Cochrane, Embase and guidelines such
as those from the National Institute for Health
and Care Excellence. Northern Ireland specialists
participate in an expert panel to review the
literature search, determine selection criteria
and produce and maintain the matrix with all
presentations of products in a therapeutic group