Home' Australian Pharmacist : Australian Pharmacist April 2016 Contents Australian Pharmacist April 2016 I ©Pharmaceutical Society of Australia Ltd.
CONTINUING PROFESSIONAL DEVELOPMENT
services in pharmacy
BY HANNAH GIBBONS MPS, JOEL FOSSOUO-TAGNE & ASSOCIATE PROFESSOR LIZ MILWARD
Shifts in global approaches to personalised health care and patient-
centred medicine are placing new emphasis on the need to take into
account a person’s individual genetic factors, along with their lifestyle
and environmental exposures, in order to optimise health care.
For example, President Obama’s
Precision Medicine Initiative, now being
implemented by the United States
National Institutes of Health, has a strong
focus on pharmacogenomics, the study
of how genetic factors influence how
different patients respond to drugs.
Genetic testing for clinically actionable
pharmacogenomic gene variants has
routinely informed medicine regimens
for some years in various leading
hospitals overseas, including the Mayo
Clinic, St Jude’s Children’s Research
Hospital and Mount Sinai Medical
Center.2 With new technologies driving
large-scale direct-to-consumer gene
testing and rapid expansion of the
genomics field into the public arena,
gene-testing services are now entering
pharmacy practice here and overseas.
At present, gene tests being marketed
through pharmacies are usually
performed off-site. Such genetic tests
are typically restricted to a small number
of well-characterised gene variants
with pharmacogenomic relevance
(see Australian Pharmacist May 2015).
There are some exceptions such as
paternity tests and 23andMe,
a high-throughput microarray test that
simultaneously examines thousands
of gene variants. The 23andMe gene-
testing kit is now being marketed
through over 600 UK pharmacies.
Off-site testing of a small number of
gene variants minimises legal and ethical
considerations and greatly simplifies
service requirements. It is a natural point
of entry for pharmacies interested in
exploring the possibility of expanding
into the new areas now beginning to
revolutionise medicine. Pharmacies
acquiring experience in the provision of
simple gene-testing services will be better
positioned to make the transition into
the more extensive customer-centred
health information services now starting
to emerge with the advent of personalised
health care and precision medicine.
This article considers the key
components of genetic-testing services,
starting from the initial steps of selecting
a genetic test and explaining the service
to customers, through the subsequent
steps of customer DNA collection and
the gene test itself, to the final steps of
informing the customer of the results
and subsequent follow-up. The process
will be illustrated by examples relating to
two Australian gene tests. These are the
myDNA gene test (previously DNAdose),
available through medical practitioners
or Chemmart pharmacies, and Sonic
Genetics’ Pharmacogenetic Screen
gene test, also known as Pharmaco
Profile, again available through medical
practitioners.5 The third example we
consider is the 23andMe gene test,
through pharmacies in the UK as noted
above and available direct-to-consumers
in Australia, the US and other countries
over the internet.
Choosing an adequately
supported and accredited
We will not provide a detailed review of
factors that may need to be taken into
account when a pharmacy is deciding
whether to implement a gene-testing
Hannah Gibbons (BBiomed Sci, MPharm). MPS.
Liverpool Hospital, Sydney.
Joel Fossouo-Tagne (BBiomed Sci). The University of
Liz Milward (BSc Hons, PhD). Associate Professor of
Medical Genetics. The University of Newcastle.
The authors have no financial interests or other
conflicts of interest to disclose.
After reading this article, pharmacists should be
Describe the core components of a gene-
Explain what is meant by ‘informed consent’
Discuss how counselling on gene-test results
may be used to inform treatment options
in patients with suboptimal responses to
Identify factors likely to influence the success of
a gene-testing service.
Competencies addressed: 1.3, 1.4, 1.5, 3.4, 4.2, 7.1,
7.2, 7.3 .
Accreditation number: CAP160404B
service and which gene tests to offer.
Many of the considerations will be similar
to those for any service or will be specific
to individual pharmacies or pharmacy
banner groups. However we will touch
briefly on two particularly important
factors relevant to gene testing: the level
of support the company supplying the
test provides to participating pharmacies
and whether a gene test is formally
accredited by an appropriate body.
The level of support a gene-testing
company provides to pharmacies may vary
considerably. As exemplified by myDNA,
most of the steps involved in delivering
an entry-level gene-testing service are
presently performed by the gene-testing
company itself. The role of the community
pharmacist is restricted to explaining the
test to customers at the beginning of the
process and sometimes discussing test
results with customers or prescribers. The
level of support provided by a company
may not be a concern if staff already has
strong pharmacogenomics knowledge.
However, at present this is unlikely to be
making support and staff training
and education a critical factor for most
pharmacies, as further discussed below.
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