Download (used for hepatitis C): risk of severe bradycardia and heart block

Clinical Update
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New & updated guidelines
Significant traffic light updates
Significant safety issues
Other issues
Feedback from practices
Clinical Guidelines
COPD Guideline - UPDATED
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Format changed to make more
primary care focused and concise.
Information included on recently
licensed LAMAs and LABA/LAMA
combination inhalers.
COPD Guideline - UPDATED
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For patients with FEV1<50%, LABA + LAMA may be
considered if ICS contra-indicated, declined or not
tolerated, and LAMA alone not effective.
Limited evidence to suggest lung function and
symptoms may be improved, but not mortality or
exacerbations.
In the small number of patients where combination is
to be used, cheaper to prescribe as a combination
inhaler and may improve compliance e.g.
Aclidinium & formoterol (Duaklir Genuair)
Glycopyrronium & indacaterol (Ultibro)
COPD Guideline - UPDATED
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Tiotropium (Handihaler or Respimat) remains the
preferred LAMA based on its greater body of
evidence in moderate to severe COPD and in
patients with a history of exacerbations.
If tiotropium is not tolerated, contra-indicated, or
the patient is unable to use the device then an
alternative LAMA may be used.
The decision should be based on clinical
effectiveness, safety, patient factors and cost.
Please note that there have been no head-to-head
trials between the different LAMA’s
Management of infective exacerbation
of bronchiectasis in adults - NEW
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When antibacterial therapy may be
indicated:
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Which antibacterial:
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should be a deterioration in symptoms - the
presence of purulent sputum alone, or the
isolation of a pathogen alone is not necessarily
an indication for antibiotic treatment, particularly
in adults.
if required immediately check previous sputum
results to guide choice (table in guideline),
otherwise amoxicillin, clarithromycin or
doxycycline. When sputum results available
check response to empirical treatment before
changing treatment.
Referral criteria for hospital admission.
Management of recurrent UTIs in
adult females - UPDATED
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Includes information on patient
groups that require a longer 5 to 10
day antibiotic course:
Continence Appliance formulary UPDATED
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Updated with cost-effective product
choices by continence working
group.
Pilot on-going with Continence
specialist nurses reviewing specific
patients across north Derbyshire
and Hardwick.
Algorithm for the treatment of refractory
chronic constipation - NEW
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Shows the place in therapy of lubiprostone
and prucalopride in line with relevant NICE
TAs.
All patients – exclude other causes, diet and
lifestyle, 6 month trial of two laxatives at full
dose.
Women: prucalopride – BROWN after gastro
consultant/specialist initiation. GPs may
continue to prescribe as per algorithm.
Secondary care review 12 monthly.
Men: Lubiprostone – RED i.e. hospital
initiation and ongoing prescribing
Management of dyspepsia and
GORD - UPDATED
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Based on NICE GORD guideline and
suspected cancer guideline
Expected on website soon
Primary care management of
Irritable Bowel Syndrome - NEW
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Summary of NICE Clinical guideline:
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Initial assessment and diagnosis
Dietary & lifestyle advice
Pharmacological treatment:
Significant Traffic Light
Changes
Significant traffic light updates: RED
Grazax (oral grass pollen extract) for children with
hay fever due to grass or tree pollen - reclassified from
BLACK to RED.
 Prescribing will be undertaken by paediatric specialist
allergy clinic. Patients should be on maximal medical
treatment for at least one season prior to referral for
assessment for Grazax.
 Referral guideline for use with DTHFT which includes
off-label doses of antihistamines and montelukast, as
well as nasal steroids and eye-drops if necessary.
 Plan to develop county wide referral guidelines for use
with Sheffield.
Significant traffic light updates:
RED
Sildenafil for digital ulcers in
systemic sclerosis – RED. Off-label.
Budesonide multimatrix
(Cortiment) - RED. Oral treatment
for UC with a topical action in the
colon.
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Relatively weak evidence, place in
therapy currently unclear.
Acute course for 8 weeks.
Significant traffic light updates:
RED
Lofexidine – reclassified from
amber. No prescribing outside Derby
City.
Significant traffic light updates: GREEN
Brinzolamide 1% & brimonidine 0.2%
eye-drops (Simbrinza) – Green after
specialist initiation
 Brinzolamide (carbonic anhydrase inhibitor)
and brimonidine (alpha 2 agonist) used
third or fourth line (prostaglandins and
beta-blockers first and second line).
 Combination product reduces exposure to
preservatives and improves compliance.
 Glaucoma and ocular hypertension with
suspected glaucoma treatment algorithms
to be developed.
Significant traffic light updates:
GREEN
Apixaban – Green after specialist
initiation for the treatment and
secondary prevention of DVT and/or PE.
Cabergoline and quinagolide Green after consultant initiation for
hyperprolactinaemia. Reclassified from
amber. Prescribing guidance developed.
Monitoring to be undertaken by
secondary care (periodic monitoring of
prolactin levels and repeat ECHO).
Significant traffic light updates: BLACK
Levosert
 levonorgestrol IUS licensed for heavy
menstrual bleeding and contraception.
 Only licensed for 3 years (Mirena 5
years)
 No clinical benefit over Mirena.
 Levonorgestrel IUS should be
prescribed as the brand Mirena to
ensure most cost-effective product
dispensed and to avoid confusion.
Miscellaneous
IMPROVE-IT study
 Ezetimibe 10 + simva 40 following
ACS vs simva 40 alone.
 Limited patient orientated outcomes
– NNT of 50 over 5 years to prevent
death or CV event.
 Effect due to lipid lowering.
 Current guidance now for atorva 80
which will provide greater lipid
lowering at reduced cost.
Miscellaneous
BMA duty of care – guidance issued and shared
with JAPC
 Responsibility for ensuring results are acted upon rests
with person requesting the test (not acceptable for
hospital doctors to ask GPs to find out results that
hospital had ordered).
 Doctor recommending a prescription should provide
counselling on side-effects and precautions and ensure
any necessary monitoring is agreed between primary
and secondary care clinicians. However, all prescribers
must also be aware that the ultimate responsibility for
the prescription lies with the prescribing doctor and
cannot be delegated.
Miscellaneous
BreathMOR study
 Heart failure study to assess the
benefit of MR morphine on
breathlessness in severely
symptomatic patients.
 CRH is a recruitment site.
 GPs may be asked to continue MR
morphine 10mg twice daily.
Miscellaneous
Meningitis B vaccination
 From Sep 15 meningitis B vaccination
(Bexsero) will be offered as part of the
national program at two, four and 12
months.
 Fever is more common when the MenB
vaccine is given with the other routine
vaccines at two and four months.
 Three doses of paracetamol are
recommended following the vaccination at
2 and 4 months to reduce fever.
Miscellaneous
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Currently paracetamol licences cover the
treatment of pain and fever, not prophylaxis,
and state that no more than two 60mg doses of
paracetamol should be given to infants aged 2
to 3 months, without seeking the advice of a
doctor or pharmacist. Note: very prem
babies born before 32 weeks will require
individual dose prescribed by GP in line
with cBNF
The CHM support the off-label use of
paracetamol in this specific circumstance.
PHE have published resources recommending
that paracetamol should be purchased OTC.
Miscellanous
Gliptins and joint pain
 US FDA have advised that gliptins
may cause joint pain that can be
severe and disabling.
 Symptoms may occur one day to
years after starting treatment but
are usually relieved within a month
of discontinuing treatment.
Miscellaneous
Medicines management website now
has a section for care homes and
social care.
Other issues
Oxycodone high strength incident
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Care needs to be taken when
prescribing liquid preparations with
normal and concentrated strengths
e.g. oxycodone / morphine /
methadone
A protocol can be put on the clinical
system to alert prescribers when
prescribing the concentrated
product to check it is intended. Ask
your medicines management
technician for details.
Pregabalin – spend is increasing
significantly
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Recommended only for use when
gabapentin has been tried, has
been beneficial for the patient but
they have been unable to tolerate
it.
NDCCG spend on pregabalin is 20%
higher this year than last year.
Is it being used in line with
guidance?
Pregabalin cost per denominator
NOACs
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Jon can offer practice training
session on NOACs and AF resources
Significant increase in use of NOACs
Desmopressin for nocturnal
enuresis
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Primary nocturnal enuresis - only tablets are licensed. For
prescribing advice see NICE CG 111 on the management
of bedwetting in children and young people.
See BNF for CSM warning regarding hyponatraemic
convulsions: Patients being treated for primary nocturnal
enuresis should be warned to avoid fluid overload (limit
fluid intake from 1 hour before until 8 hours after
administration and avoid ingesting during swimming) and
to stop taking desmopressin during an episode of vomiting
and diarrhoea (until fluid balance normal). The risk of
hyponatraemic convulsions can also be minimised by
keeping the recommended starting doses and by avoiding
concomitant use of drugs which increase secretion of
vasopressin (e.g. tricyclics)
Molloscum contagiosum posters
and leaflets in GP waiting rooms
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Leaflets recommend treatment with
Molludab, however…
JAPC advice is that this is a
common, self-limiting condition
which usually doesn’t require
treatment.
Lesions clear up within 12 to 18
months and generally affects preschool children.
Molloscum contagiosum posters
and leaflets in GP waiting rooms
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Molludab is RED in Derbyshire for very
specific circumstances (HIV positive
patients with extensive lesions, eye lidmargin or ocular lesions and adults with
anogenital lesions indications) by
consultants or specialists (including GPSIs
and dermatology champions).
Practices may wish to remove the
information, or ensure that routine
prescribing is not recommended except in
very specific circumstances by specialists.
Available OTC but £23.49
Significant Safety Updates
Drug safety Update – June 15
SGLT2 inhibitors (canagliflozin,
dapagliflozin, empagliflozin): risk of
diabetic ketoacidosis.
 Licensed for adults with Type 2 diabetes.
 Serious cases of DKA reported, often with
only moderately raised blood glucose (< 14
mmol/L) i.e. atypical presentation.
 Half of cases occurred during first 2 months;
some shortly after stopping.
 One third of cases involved off-label use in
type 1 diabetes.
Drug safety Update – June 15
MHRA advice is to
 Test for ketones in patients with acidosis
symptoms even if plasma glucose levels are
near-normal.
 Stop SGLT2 inhibitor treatment if DKA is
suspected.
 Inform patients of signs of DKA and to seek
immediate medical help (nausea, vomiting,
anorexia, abdo pain, thirst, difficulty
breathing, unusual fatigue/sleepiness)
Drug safety Update – June 15
High dose ibuprofen (≥2400mg/day): small
increase in cardiovascular risk (heart-attack
and stroke).
 Risk similar to COX-2 inhibitors and diclofenac.
 No increased risk with doses up to
1200mg/day; limited data with doses between
1200mg and 2400mg/day.
Possible interaction between ibuprofen and
low-dose aspirin?
 Ibuprofen competitively inhibits the effect of
low dose aspirin on platelet aggregation, data
does not support a clinically meaningful
interaction, however possibility cannot be ruled
out with long-term use.
Drug safety Update – June 15
Intrauterine contraception : risk factors
for uterine perforation.
 Perforation occurs rarely (less than 1 in 1000
women).
 Applies to both levonorgestrel-releasing IUSs
(Mirena, Levosert, Jaydess) and copper IUDs.
 Most important risk factors are insertion
during lactation and insertion in the 36 weeks
after giving birth (but benefits still strongly
outweigh risks).
 Most often occurs during insertion but might
not be detected until some time later.
Drug safety Update – June 15
Inform women that symptoms include:
 Severe pelvic pain after insertion
 Pain or heavy bleeding after insertion that
continues for more than a few weeks.
 Sudden changes in periods.
 Pain during sex
 Not being able to feel the threads (N.B.
partial perforation may have occurred if the
threads can still be seen – consider if
severe pain following insertion).
Drug safety Update – July 15
Denosumab 60mg and 120mg or
intravenous bisphosphonates:
osteonecrosis of the jaw – further
measures to minimise risk.
 Patient reminder cards are being introduced
which should be provided before
prescribing.
 Denosumab 120mg (RED – cancer
indication) contraindicated in patients with
unhealed lesions from dental or oral
surgery.
Drug safety Update – July 15
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For all patients, explain risk and advise on
precautions to take:
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Tell doctor of any problems with mouth, teeth or
dentures.
Maintain good oral hygiene.
Inform doctor or dentist that receiving
denosumab or IV bisphosphonate if dental
treatment or surgery needed.
Inform doctor or dentist if any problems during
treatment e.g. loose teeth, pain, swelling, nonhealing sores or discharge.
Drug safety Update – July 15
Xalatan (latanaprost): increased
reporting of eye-irritation since
reformulation.
 pH reduced in 2013 to allow long-term
storage at room temperature.
 Increased reports of eye-irritation.
 Not an issue with the generic.
New Yellow card app for reporting
suspected side-effects
 Free, download via iTunes or PlayStore.
Drug safety Update – August 15
Simeprevir with sofosbuvir (used for
hepatitis C): risk of severe bradycardia and
heart block when taken with amiodarone
 concomitant use should be avoided unless
other antiarrhythmics cannot be given due to
a risk of severe bradycardia and heart block if
taken together.
 Extension on previous advice on some
combination therapies for hepatitis C.