Some important new evidence relating to
prescribing and medicines optimisation
Published during October 2014
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NICE technology appraisals, clinical guidance and public health guidance
NICE evidence summaries1
SIGN guidance, Scottish Medicines Consortium (SMC) and All Wales Medicines
Strategy Group (AWMSG) advice
Safety warnings from the MHRA and manufacturers.
Title/reference
Notes
NICE technology appraisals and clinical guidance
Dabrafenib for treating unresectable or
metastatic BRAF V600 mutation-positive
melanoma (NICE technology appraisal
321)
Dabrafenib is recommended, within its marketing
authorisation, as an option for treating unresectable or
metastatic BRAF V600 mutation-positive melanoma only if
the company provides dabrafenib with the discount agreed
in the patient access scheme.
Multiple sclerosis: management of
multiple sclerosis in primary and
secondary care (NICE clinical
guideline 186)
This guideline replaces NICE clinical guideline 8 (published
November 2003). It offers evidence-based advice on the
care and treatment of adults with multiple sclerosis.
Acute heart failure: diagnosing and
managing acute heart failure in adults
(NICE clinical guideline 187)
This clinical guideline offers evidence-based advice on the
care and management of adults with acute heart failure or
possible acute heart failure.
NICE evidence summaries
No NICE evidence summaries: new medicines published in October 2014
Management of vomiting in children and
young people with gastroenteritis:
ondansetron (ESUOM 34)
A Cochrane review of antiemetic treatment for children and
young people with acute gastroenteritis found oral or
intravenous ondansetron increased the proportion of
children and young people who stopped vomiting compared
with placebo. Oral ondansetron also reduced the proportion
of children and young people needing intravenous fluid
therapy and reduced the immediate hospital admission rate
compared with placebo. Ondansetron was associated with
increased episodes of diarrhoea.
Regulatory status: off-label
Immune (idiopathic) thrombocytopenic
purpura: rituximab (ESUOM 35)
Most of the evidence for using rituximab in adults with
immune thrombocytopenic purpura comes from
observational studies, with no comparator arm. The
populations in the included studies varied, as did the
platelet count considered to represent an overall response
or complete response. The randomised controlled trials
(RCTs) discussed in this evidence summary had a number
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Evidence summaries: unlicensed and off label medicines, evidence summaries: new medicines,
Medicines Evidence Commentaries and Eyes on Evidence articles related to medicines optimisation.
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of limitations, including small numbers of participants. All of
these factors make it difficult to draw firm conclusions from
the evidence.
The evidence for efficacy of rituximab in children and young
people is weaker, drawn from case series and 1 cohort
study with no comparator arm.
Regulatory status: off-label
Acute coronary syndromes: duration of
dual antiplatelet therapy after drug-eluting
stent implantation (Medicines Evidence
Commentary)
An RCT trial reported that continuing dual antiplatelet
therapy beyond a year after stent implantation did not
statistically significantly reduce the risk of the combined
outcome of death or cardiovascular events compared with
continuing aspirin monotherapy. However, continuing dual
antiplatelet therapy was associated with a statistically
significant increase in the combined risk of major or minor
bleeding. This is consistent with NICE guidance that
recommends dual antiplatelet therapy as a treatment option
for up to 12 months after stenting.
Antibiotic prescribing: study suggests
there is scope for improvements
(Medicines Evidence Commentary)
A study looking at trends in antibiotic prescribing in UK
primary care found improvement in some aspects of
antibiotic prescribing between 1999 and 2011, but there
remain some areas of concern and significant variation
between GP practices. For uncomplicated urinary tract
infection in women aged 16−74 years, use of 3-day courses
of trimethoprim in line with guidance increased from 8% of
cases in 1995 to 49% of cases in 2011 (with the range for
GP practices 16% to 71%). The proportion of prescriptions
that were for a recommended antibiotic rose from 77% to
85% for otitis media and from 64% to 69% for sore throat.
However, antibiotic prescribing for coughs and colds
increased from 36% in 1999 to 51% in 2011 (range 32% to
65%). Prescribers should ensure they are following
guidelines from NICE and Public Health England.
Falls: Swedish study highlights the risk of
fall injuries in older people with commonly
prescribed medicines (Medicines
Evidence Commentary)
A Swedish population-based, case-controlled study in a
large general population of older people found that around
half of the 20 most commonly prescribed medications were
associated with severe fall injuries requiring
hospitalisations. The associated risk was greatest with
central nervous system drugs such as antidepressants,
hypnotics and analgesics. Opioids doubled the risk of
severe injury due to falling. This reinforces the NICE clinical
guideline on assessment and prevention of falls in older
people, which recommends medication review as part of a
multifactorial falls risk assessment for older people who
have fallen or who are at risk of falls.
Long-acting injectable paliperidone
compared with haloperidol for
maintenance treatment of schizophrenia
(Eyes on evidence)
A US RCT in adults with schizophrenia or schizoaffective
disorder reports that the long-acting injectable
antipsychotics paliperidone palmitate and haloperidol
decanoate have comparable efficacy and tolerability.
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SIGN, SMC and AWMSG advice
British guideline on the management of
asthma (SIGN guidance 141)
This guideline provides recommendations for the diagnosis
and treatment of asthma in adults and children across the
UK, including acute and difficult asthma, asthma in women
and adolescents, occupational asthma, self-management,
and organisation and delivery of care.
SMC advice (October 2014)
See advice for full details
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Brentuximab vedotin (Adcetris)
Capsaicin cutaneous patch (Qutenza)
Dabigatran etexilate (Pradaxa)
Empagliflozin (Jardiance)
Lurasidone (Latuda)
Misoprostol vaginal delivery system
(Mysodelle)
Trastuzumab emtansine (Kadcyla)
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Brentuximab vedotin: accepted for restricted use in
the treatment of adult patients with relapsed or
refractory CD30+ Hodgkin lymphoma in specified
circumstances.
Capsaicin: accepted for the treatment of peripheral
neuropathic pain in non-diabetic adults, either alone or
in combination with other pain medicines, in specified
circumstances.
Dabigatran etexilate: accepted for the treatment of
deep vein thrombosis (DVT) and pulmonary embolism
(PE), and prevention of recurrent DVT and PE in adults.
Empagliflozin: accepted for restricted use in the
treatment of type 2 diabetes to improve glycaemic
control in adults as add-on combination therapy: in
combination with other glucose lowering drugs including
insulin, in specified circumstances.
Lurasidone: accepted for the treatment of
schizophrenia in adults aged 18 years and over. It is
restricted for use as an alternative treatment option in
patients in whom it is important to avoid weight gain
and metabolic adverse effects.
Misoprostol vaginal delivery system: accepted for
induction of labour in women with an unfavourable
cervix, from 36 weeks gestation, in whom induction is
clinically indicated.
Trastuzumab emtansine: not recommended for use as
a single agent, for the treatment of adult patients with
HER2-positive, unresectable locally advanced or
metastatic breast cancer who previously received
trastuzumab and a taxane, separately or in
combination.
AWMSG advice (October 2014)
See advice for full details
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Alogliptin (Vipidia)
Alogliptin/metformin (Vipdomet)
Bortezomib (Velcade)
Certolizumab pegol (Cimzia) – 1
Certolizumab pegol (Cimzia) – 2
Colestilan (BindRen)
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Alogliptin: recommended as an option for restricted
use for dual oral therapy in specified circumstances for
the treatment of adults aged 18 years and older with
type 2 diabetes mellitus to improve glycaemic control in
combination with other glucose lowering drugs including
insulin.
Alogliptin/metformin: recommended as an option for
restricted use for dual oral therapy in specified
circumstances for the treatment of adult patients aged
18 years and older with type 2 diabetes mellitus to
improve glycaemic control.
Bortezomib: recommended as an option for restricted
use for the treatment of adult patients with progressive
multiple myeloma in specified circumstances.
Bortezomib is not recommended for use in combination
with pegylated liposomal doxorubicin.
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Certolizumab: recommended as an option for the
treatment of adult patients with severe active axial
spondyloarthritis in specified circumstances.
Certolizumab: recommended as an option for use in
combination with methotrexate (or as monotherapy in
specified circumstances) for the treatment of active
psoriatic arthritis in adults in specified circumstances.
Colestilan: not recommended for the treatment of
hyperphosphataemia in adult patients with chronic
kidney disease stage 5 receiving haemodialysis or
peritoneal dialysis.
Safety warnings from the MHRA and manufacturers
Drug Safety Update October 2014
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Interferon-beta: risk of thrombotic
microangiopathy and risk of nephrotic
syndrome
Dexamethasone 4 mg/ml injection
(Organon Laboratories Limited):
reformulation with changes in name,
concentration, storage conditions,
and presentation
Basiliximab indicated for renal
transplantation only; efficacy and
safety not shown in heart
transplantation
Drugs and driving: clarification for
Wales, Scotland, and Northern
Ireland
These new MHRA drug safety advice informs the following
BNF entries (and equivalent BNFC entries); see articles for
full details:
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Information sent to healthcare
professionals about the safety of
medicines in October 2014
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Sulphur hexafluoride (SonoVue)
Pipotiazine palmitate (Piportil Depot)
Interferon beta: advice to be vigilant for early signs or
symptoms of thrombotic microangiopathy and nephrotic
syndrome (see also manufacturer’s letter sent in
September 2014).
Dexamethasone injection: from October 2014
Dexamethasone 4 mg/ml injection (Organon
Laboratories Limited) will be replaced with a new
formulation called Dexamethasone 3.8 mg/ml solution
for injection (Aspen Pharma Trading Limited). As a
result, the storage conditions, presentation, and
packaging will change.
Basiliximab: basiliximab is indicated for preventing
acute organ rejection only for de-novo allogeneic renal
transplantation, not non-renal transplantation (see also
manufacturer’s letter sent in September 2014).
Drugs and driving: A new offence will be enforceable
in England, Wales, and Scotland but not Northern
Ireland where the introduction of a similar offence is
under consideration.
See letters for full details
 Sulphur hexafluoride (SonoVue) Advice to administer
SonoVue with extreme caution if a patient has
cardiovascular instability, and not to use it in
combination with dobutamine in such patients as rare
but severe arrhythmias (sometimes fatal) have been
reported.
 Pipotiazine palmitate (Piportil Depot). The
manufacturer advises that this will no longer be
available from the end of March 2015: Advice to not
start new patients on pipotiazine palmitate, and to
switch patients currently prescribed pipotiazine
palmitate to alternative treatments.
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