Home' Australian Pharmacist : Australian Pharmacist June 2014 Contents Australian Pharmacist June 2014 I ©Pharmaceutical Society of Australia Ltd.
It is best for a patient or carer to know
that a medicine is being prescribed
and dispensed for off-label use and
the reasoning behind the decision.
Patients or carers may want the level of
supporting evidence to be disclosed and
indeed have a right to receive relevant
information in order to make an informed
decision. It is also important to explain
that information about the indication
will not be covered in the Consumer
Medicines Information (CMI) leaflet as
CMIs only cover the registered indications
and other details from the approved PI.
Off-label use of medicines is widespread
and often is clinically appropriate.
However, it is a grey area with little
guidance for prescribers and dispensers.6
Pharmacists need to be aware of the
risks involved as it challenges claims and
expectations that medicine safety and
efficacy have been fully evaluated. It raises
particular concerns when medicines have
high potential for toxicity.
Pharmacists should use their
independent clinical judgement,
based on the relevant information
and evidence, to determine whether
the off-label medicine will be safe and
appropriate for the patient.
1. Therapeutic Goods Administration. Product Information
(PI). 2011 [cited 2014 7 May]. At: www.tga.gov.au/hp/
2. Todd A. No Need for More Regulation: Payors and Their
Role in Balancing the Cost and Safety Considerations of Off-
Label Prescriptions. American Journal of Law & Medicine.
3. Gazarian M, Kelly M, McPhee JR, Graudins LV, Ward RL,
Campbell TJ. Off-label use of medicines: consensus
recommendations for evaluating appropriateness. MJA.
4. Gillick MR. Controlling Off-Label Medication Use. Annals of
Internal Medicine. 2009;150(5):344–7 .
5. Australian Medicines Handbook. AMH . Adelaide, 2014.
6. Sansom L. Medications used for unapproved indications.
Journal of Pharmacy Practice and Research. 2010;40(2):88–9 .
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Cochrane on zinc
Zinc supplements reduce diarrhoea and
other infections in malnourished children,
and may prevent death, according to a
study published in The Cochrane Library.
The study is the first Cochrane systematic
review to focus on zinc as a means to
prevent childhood death, including deaths
caused by diarrhoea – one of the biggest
killers of under-fives.
Zinc is a micronutrient with important roles
in growth and in the immune, nervous and
reproductive systems. The human body
cannot make it, so it has to come from our
diet. It is estimated that more than one
in six people globally are deficient in zinc
and that around one in every 58 deaths
in children under five is related to zinc
deficiency. Zinc deficiency is common in
Southeast Asia, sub-Saharan Africa and
parts of Latin America.
The authors were interested in whether
zinc supplements could reduce childhood
death and disease, and help support
growth. They reviewed data from 80
trials involving 205,401 children aged six
months to 12 years, mostly in low and
middle income countries. Overall, they
concluded that zinc supplementation could
benefit children as part of wider programs
to address public health and nutrition
challenges in these countries.
Senior researcher Professor Zulfiqar Bhutta
from the Center of Excellence in Women
and Child Health, Aga Khan University,
Karachi, Pakistan, and Sick Kids Center for
Global Child Health, Toronto, Canada said:
‘We should remember that supplements
are not a substitute for a well-balanced diet.
However, in countries where zinc deficiency
is common, supplements may help to
reduce child deaths and related diseases in
Dabigatran in stroke
Details of a 6,000 patient study of
dabigatran etexilate were announced
last month at the European Stroke
Conference, Nice, France.
The RE-SPECT ESUS study will
investigate the blood thinner
dabigatran etexilate for the prevention
of recurrent stroke in patients who
have already suffered an embolic stroke
of undetermined source (ESUS). Such
a stroke occurs when a blood clot
(embolus) forms somewhere in the body
and travels through the bloodstream to
Boehringer Ingelheim will investigate
dabigatran etexilate in the hope that
even more patients at risk of stroke can
benefit from the treatment.
According to the company dabigatran
etexilate has been shown to successfully
prevent strokes in patients with atrial
fibrillation. Effective antithrombotic
therapy with dabigatran etexilate may
also reduce the risk of recurrent stroke in
patients who have suffered an ESUS.
Professor Hans-Christoph Diener,
Chairman of the Department of
Neurology at the University of Duisburg-
Essen in Germany and lead investigator
of the study said: ‘The results obtained
from the RE-SPECT ESUS study will help
to address current gaps in knowledge,
supporting physician choice of
appropriate therapy and improving
The study will examine the efficacy and
safety of dabigatran etexilate 150 mg or
110 mg twice daily versus acetylsalicylic
acid 100mg once daily for secondary
stroke prevention, with patients being
followed for up to three years.
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