The Newsletter of the
Cumbria Area Prescribing
Committee
PRESCRIPTION PAD
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Clinical policy and
Formulary news
Recommendations on new
medicines
Lothian Joint Formulary
amendments
 Antisecretory drugs and
mucosal protectants
 Potassium-sparing
diuretics and aldosterone
antagonists
 Drug treatment of major
depression
Antibiotic guidelines
Converting from opiate patches to
oral opiates
Pregabalin or gabapentin for
neuropathic pain
Infant formula prescribing
Powerbreathe®
Eplerenone tablets– heart failure
Colecalciferol capsules (Fultium®) –
vitamin D deficiency
Colecalciferol capsules (Dekristol®)
– vitamin D deficiency
Fidaxomicin tablets – C.difficile
infection
Fluticasone + formoterol inhaler
(Flutiform®) - asthma
Strontium granules – osteoporosis
in men
Zonisamide capsules –
monotherapy for partial seizures
February 2013
News from the MHRA
Diclofenac
No. 22
NICE Guidance
TA265 – Denosumab – bone
metastases from solid
tumours
TA266 – Mannitol dry powder
for cystic fibrosis
TA267 – Ivabradine for
chronic heart failure
Clinical Policy and Formulary News
Lothian Joint Formulary
amendments
Antisecretory drugs and
mucosal protectants
There are 2 prescribing notes relating to the appropriate prescribing of esomeprazole.
Previously where esomeprazole would be appropriate, prescribers were encouraged to prescribe
esomeprazole capsules rather than tablets, as they were cheaper. The tablets have now been added
to the drug tariff, therefore there is no longer this requirement.
Note that esomeprazole 40mg daily may be required only on the advice of a GI consultant, for
patients with endoscopically proven treatment failure of oesophagitis or those whose next
treatment option is surgery. Omeprazole and lansoprazole remain the first-choice agents.
Potassium-sparing diuretics Following a formulary application for the use of eplerenone in NHYA class II hear failure, the section
and aldosterone
has been amended. Spironolactone remains the aldosterone antagonist of choice for NHYA class
antagonists
III/IV heart failure.
Drug treatment of major
depression
Antibiotic guidelines
The section was updated to reflect the maximum recommended daily dose of 40mg citalopram.
Information on dose dependent QT-interval prolongation has also been included.
The new antibiotic guidelines for Primary Care are available now available here. There are very few changes in the antibiotics
recommended, but there are more recommendations as to whether prescribing is actually necessary, mostly for upper respiratory
tract infections.
The duration of treatment for many infections has been shortened.
Was
Sinusitis
7 days
Otitis externa
7 days
Community acquired pneumonia 5 to 10 days
Limb cellulitis
Surgical infections
7 days
7 days
Now
5 days
5 days
Mostly 5 days, 5 to 7 days in
more severe cases
5 days
5 days
There is a new section on oral infections, including mucosal ulceration and pericoronitis.
Converting from opiate
patches to oral opiates
Guidance is available on the conversion of patients from transdermal fentanyl and buprenorphine patches to equivalent doses of
oral morphine or codeine. It is important to note that the effect of the transdermal opiate will persist for some time after the patch
is removed and that substitution with oral morphine or codeine should be delayed to take this into account.
Pregabalin or gabapentin
for neuropathic pain
The NICE guidance on the treatment of neuropathic pain has caused considerable controversy with its recommendation on the use
of pregabalin. It is recommended as an alternative to amitriptyline.
Gabapentin can be used to treat neuropathic pain at considerably less cost, with no statistical difference in the efficacy or safety
compared with pregabalin. A guide on the use of gabapentin and pregabalin is available on the Medicines Management website,
here.
The recently published neuropathic pain pathway in the Map of Medicine puts gabapentin on an equal footing with amitriptyline
and pregabalin as first-line treatments.
Pregabalin is now the sixth highest costing drug in Cumbria, at over £1.6 million a year.
Infant formula
prescribing
Guidance on the prescribing of infant formula in cow’s milk protein allergy and lactose intolerance has recently been agreed. It
includes recommendations on lactose-free milks and soya products. It can be found here.
Powerbreathe®
Powerbreathe® is a device to which claims to
‘make the breathing muscles work harder to improve their strength and endurance. When training with
Powerbreathe® you will notice that you have to work harder to breathe in. This is the effect of resistance
training acting on the muscles used to inhale - primarily the diaphragm and rib cage muscles. When breathing
out, there is no resistance and you can exhale normally, allowing the chest and breathing muscles to relax,
naturally pushing the air from your lungs’.
There have been a significant number of trials of inspiratory muscle training as part of a management programme in the treatment
of Chronic Obstructive Pulmonary Disease (COPD), which have been summarised in a number of systematic reviews.
The latest, most comprehensive analysis included 32 RCT’s (430 treatment patients, 400 control patients). Significant improvements
were found in a number of markers, such as maximal inspiratory muscle strength (PImax, maximal inspiratory pressure, +13 cm H2O),
endurance time (+261 seconds) and 6- or 12-minute walking distance (+32 and +85 metres respectively).
The validity of the measures that were used has been questioned. The only outcomes currently accepted as valid for COPD by
regulatory agencies in Europe and the USA are FEV 1, exacerbation and death. Improvement in FEV1 was not assessed by the metaanalysis, but examination of the trials showed statistically significant improvement in one trial and no improvement in nine of the
trials. None of the trials assessed benefit on exacerbation or death (most trials were too short anyway). As a device, it does not
have to undergo the same trial rigour as that for drugs.
Quality of life improved by 3.8 points, although the St. George’s Respiratory Questionnaire states that a minimum change in score
of 4 units was established as clinically relevant after patient and clinician testing. Dyspnoea was significantly reduced (Borg score 0.9 point; Transitional Dyspnoea Index +2.8 units). Endurance exercise capacity tended to improve, while no effects on maximal
exercise capacity were found. Respiratory muscle endurance training revealed no significant effect on PI,max, functional exercise
capacity and dyspnoea.
The NICE guidance on the management of COPD published in 2010, made no reference to Inspiratory Muscle Training (IMT). The
GOLD guidelines states ‘inspiratory muscle training appears to provide additional benefits when included in a comprehensive
pulmonary rehabilitation programme’, although it provides no evidence to back up that statement.
The American College of Chest Physicians and the American Association of Cardiovascular and Pulmonary Rehabilitation published
pulmonary rehabilitation guidelines in 2007. Their recommendation on inspiratory muscle training was that ‘the scientific evidence
does not support the routine use of IMT as an essential component of pulmonary rehabilitation’. It does however say that IMT
may be considered in selected patients with COPD who have decreased inspiratory muscle strength and breathlessness despite
receiving optimal medical therapy. They point out that most of the trials were small and single-centred. They recommend that
larger multicentre trials be carried out to give a better idea of the role of IMT.
Likewise, the Australian Lung Foundation recommends that ‘Inspiratory Muscle Training may also result in modest improvements in
6 minute walking distance and health-related quality of life. However, it remains unclear whether IMT combined with a program of
whole-body exercise training confers additional benefits in dyspnoea, exercise capacity or health-related quality of life in patients
with COPD. At present, the evidence does not support the routine use of IMT as an essential component of pulmonary
rehabilitation program’.
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Recommendations on New Medicines
The following drugs have
been recommended as
suitable for use:
Eplerenone
Tablets, 25, 50mg
(Inspra®)
Colecalciferol
Capsules, 800iu
(Fultium-D3®)
The following drugs were
not approved by SMC and
LJF, on the basis that a costeffectiveness case was not
submitted by the
manufacturer:
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Addition to standard optimal therapy, to reduce the risk of
cardiovascular mortality and morbidity in adult patients with
NYHA class II (chronic) heart failure and left ventricular systolic
dysfunction (LVEF ≤30%).
Prevention and treatment of vitamin D deficiency.
Colecalciferol
Capsules, 20, 000
iu (Dekristol®)
Treatment of vitamin D deficiency.
Fidaxomicin
Tablets, 200mg
(Dificlir®)
Treatment of adults with Clostridium difficile infections.
Fluticasone
propionate and
formoterol
fumarate Inhaler
(Flutiform®)
in the regular treatment of asthma where the use of a
combination product [an inhaled corticosteroid (ICS) and a
long-acting β2 agonist (LABA)] is appropriate:
 for patients not adequately controlled on ICS and ‘as
required’ inhaled short-acting β2 agonist or
 for patients already adequately controlled on both an
ICS and a LABA.
Treatment of osteoporosis in men at increased risk of fracture.
Strontium ranelate
granules, 2 grams
(Protelos®)
Zonisamide
Capsules, 25mg
(Zonegran®)
Monotherapy for the treatment of partial seizures (with or
without secondary generalization) in adults with newly
diagnosed epilepsy. (This was previously licensed as ‘add-on’
therapy).
Included on the LJF as a prescribing note
for the treatment of NYHA class II
patients only, subject to clarification of
the patient numbers. AMBER
Included on the formulary for the
prevention of vitamin D deficiency,
after treatment with high dose vitamin
D. GREEN
Included on the formulary for the
treatment of vitamin D deficiency.
GREEN
Note that this is an unlicensed
preparation
Included on the LJF for the indication in
question. AMBER, but recommended
for use only after recommendation by
a microbiologist.
Included on the LJF for the indication in
question, suitable for prescribing where
fluticasone, formoterol and a MDI are
suitable. GREEN
Not recommended for use due to nonsubmission. BLACK
News from the MHRA
Diclofenac
A new review on the cardiovascular safety of NSAIDs has highlighted further evidence that diclofenac is associated with cardiovascular risks
that are higher than the other non-selective NSAIDs, and similar to the selective COX-2 inhibitors. Naproxen and low-dose ibuprofen are still
considered to have the most favourable cardiovascular safety profiles of all non-selective NSAIDs.
This review, by the European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP), evaluated all available data on
this issue since the last review conducted in 2006.
The findings highlighted in this review are not new; an increase in risk of heart attack and stroke with some non-selective NSAIDs, such as
diclofenac, particularly with long-term use of high doses and in patients who are already at high risk, is well recognised. Warnings have been
included in the product information for healthcare professionals and patients, and in the BNF, for some years.
The need for any update to the existing treatment advice for diclofenac will now be assessed by the European Medicines Agency’s
Pharmacovigilance and Risk Assessment Committee (PRAC).
Healthcare professionals are reminded that, when prescribing NSAIDs, patients should use the lowest effective dose for the shortest time
necessary to control symptoms. The patient’s individual risk factors, including any history of cardiovascular and gastrointestinal illness, should
also be taken into account.
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NICE guidance
These are brief summaries. The complete guidance should be consulted (www.nice.org.uk )
TA265
Drug
Denosumab
Condition
Bone
metastases
from solid
tumours
Resume
Recommended as an option for preventing skeletal related events (pathological fracture, radiation to bone, spinal
cord compression or surgery to bone) in adults with bone metastases from breast cancer and from solid tumours
other than prostate if:
 bisphosphonates would otherwise be prescribed and
 the manufacturer provides denosumab with the discount agreed in the patient access scheme. RED
Denosumab is not recommended for preventing skeletal-related events in adults with bone metastases from
prostate cancer. BLACK
NICE costing template anticipates that this will be given solely in secondary care.
TA266
Mannitol dry
powder
Cystic fibrosis
Recommended as an option for treating cystic fibrosis in adults:
 who cannot use dornase- because of ineligibility, intolerance or inadequate response to dornase- and
 whose lung function is rapidly declining (FEV1 decline greater than 2% annually) and
 for whom other osmotic agents are not considered appropriate. RED
TA267
Ivabradine
Chronic heart
failure
Ivabradine is recommended as an option for treating chronic heart failure for people:
 with New York Heart Association (NYHA) class II to IV stable chronic heart failure with systolic dysfunction
and
 who are in sinus rhythm with a heart rate of 75 bpm or more and
 who are given ivabradine in combination with standard therapy including ß-blocker therapy, ACE
inhibitors and aldosterone antagonists, or when ß-blocker therapy is contra-indicated or not tolerated and
 with a left ventricular ejection fraction of 35% or less.
Ivabradine should only be initiated after a stabilisation period of 4 weeks on optimised standard therapy with ACE
inhibitors, ß-blockers and aldosterone antagonists. Ivabradine should be initiated by a heart failure specialist
with access to a multidisciplinary heart failure team. Dose titration and monitoring should be carried out by a
heart failure specialist, or in primary care by either a GP with a special interest in heart failure or a heart failure
specialist nurse. AMBER
This is available at the PCT Medicines Management website at:
http://www.cumbria.nhs.uk/ProfessionalZone/MedicinesManagement/PrescriptionPad/Home.aspx
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