Transcript Clinical updates from Prescribing Leads

Prescribing Leads Clinical
Update
December 2015
Clinical Update
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New & updated guidelines
Significant traffic light updates
Significant safety issues
Other issues
Feedback from practices
Clinical Guidelines
Management of dyspepsia and
GORD - UPDATED
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Based on NICE Dyspepsia & GORD guideline and NICE
suspected cancer guideline
Alarm signals and signs are the major determinant of
the need for endoscopy, not age on its own.
Long-term use of PPIs is associated with hip fractures,
hypomagnesaemia and Clostridium difficile
Patients on a long-term PPI for GORD should be
encouraged to
 step-down to the lowest effective dose to control
symptoms,
 continue treatment on a when needed basis
 stop treatment
Prescribing for oral thrush in babies &
surface and ductal thrush in lactating women
- UPDATED
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Guideline supports the use of miconazole
oral gel for infants - it is the most effective
product for oral thrush but is unlicensed in
children under 4 months due to potential
risk of choking if not carefully applied.
Ensure the gel does not obstruct the throat
in infants (avoid application to the back of
the throat and subdivide doses if
necessary). Use after feeds, carefully
smearing around the mouth.
Nystatin is less effective and oral
fluconazole has the potential for sideeffects.
Prescribing for oral thrush in babies &
surface and ductal thrush in lactating women
- UPDATED
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Fluconazole is the most effective treatment
for ductal thrush in lactating women of
healthy term infants. Loading dose followed
by 10 days treatment twice daily.
Considered safe in mother’s breastfeeding
full term infants. Off-license.
Miconazole 2% cream is recommended for
surface thrush (with hydrocortisone if very
sore nipples). Wipe off any cream which can
be seen before next feed. Off-license.
Pain relief can be managed by paracetamol
or ibuprofen tablets
Prescribing for oral thrush in babies &
surface and ductal thrush in lactating women
- UPDATED
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To prevent re-infection, both mother
and infant need to be treated
simultaneously even if only one show
symptoms of thrush:
Oral thrush in baby: treat baby for oral thrush + surface thrush in
mother
Surface thrush in mother: treat baby for oral thrush+ surface thrush in
mother
Ductal thrush in mother +/- oral thrush in baby: treat baby for oral
thrush + ductal and surface thrush in mother
Varenicline prescribing advice UPDATED
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Varenicline is a first line option for
smoking cessation, with weekly
behavioural support from a trained
smoking cessation advisor or HCP,
for 12 weeks.
Stop Smoking Advisors may
recommend the prescribing of
varenicline - the clinical
responsibility will lie with the
prescriber with access to complete
medical notes
Varenicline prescribing advice UPDATED
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Concerns have been raised about suicidal
thoughts and behaviour linked with the use
of varenicline.
Clinicians should be aware of the possible
emergence of anxiety, psychosis, mood
swings, aggressive behaviour, depression,
suicidal ideation etc.
Recent studies have not shown that
smokers with pre-existing mental health
problems are more vulnerable to
neuropsychiatric side effects than other
patients.
Varenicline prescribing advice UPDATED
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There have been some reports of serious
CV events in patients taking varenicline.
Reviews looking at risk have been
conflicting but the EMA has concluded that
the benefits as a smoking cessation
medicine outweigh any potential slight
increase in cardiovascular events.
Patients should be advised to report any
new or worsening CV symptoms.
Antidepressants for moderate and
severe depression - UPDATED
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Sertraline recommended as preferred SSRI
at step 1 if “recent” MI – clarified as within
4 weeks
PHQ-9 rating scale now recommended to
assess for therapeutic response.
Advice on gastro-protection with SSRIs
updated in line with JAPC PPI guidance
Link added to Crediblemeds website which
regularly updates info on medicines with
QTc prolongation risk.
Liothyronine and lamotrigine augmentation
now only at step 4 – after specialist
recommendation.
Derbyshire medication and risk of
falls guidance - UPDATED
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Reformatted to list all drugs
alphabetically.
Useful for non-medical staff to help
identify patients who warrant a
medication review due to risk of
falls.
Updated version will be on the
website soon.
Glaucoma guideline - UPDATED
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Treatment algorithms of costeffective choices which
ophthalmologists should follow for
new patients.
First line preparations – GREEN.
Other preparations – BROWN.
Not advocating changing therapy in
stable patients unless
recommended by the
ophthalmologist.
Oral anticoagulation with warfarin
guideline - UPDATED
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Only minor changes.
On-going discussions on including
guidance for patients with subtherapeutic INRs who may require
short-term “bridging” therapy with
LMWH
Shared-Care Guidelines
Updated shared care guidelines
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Liothyronine for treatment
resistant depression – no major
changes.
Lithium – monitoring aligned to
NICE CG (every 3 months for the
first year and then adjusted
according to lithium levels and
other factors), lithium levels for
bipolar disorder clarified.
Significant Traffic Light
Changes
Significant traffic light updates: RED
Cyclosporin eye drops – RED.
 For severe keratitis in adults with dry eyes.
NICE TA expected December 2015.
Significant traffic light updates: GREEN
Edoxaban – GREEN after specialist
initiation as per NICE TA for DVT/PE
and for stroke prevention in adults.
 Included in the AF resources but no
advantage over the other NOACs.
Tizanidine - GREEN after specialist
initiation following 4 month dose
stabilisation, assessment of response
and monthly LFTs.
 Used for spasticity associated with MS or
spinal cord injury
Significant traffic light updates:
GREEN
Insulin Abasaglar (insulin glargine
biosimilar 100 units per ml) GREEN 1st
line insulin glargine in new patients when
indicated.
 Based on Lantus but therapeutic effect is not
identical.
 Around 15% cheaper than Lantus.
 Not recommending routine switches from
Lantus.
 Insulin glargine should be prescribed by
brand to avoid confusion and risk of
unexpected hypoglycaemia if inadvertently
switched.
Significant traffic light updates: BROWN
Naloxegol – BROWN after
specialist recommendation
 Peripherally-acting oral opioid
antagonist
 Recommended by NICE as an option
for opioid induced constipation in
adults with inadequate response to
laxatives.
 Potential alternative to SC
methylnaltrexone
 Palliative care teams expect use to
be very low.
Significant traffic light updates: BROWN
Demeclocycline – BROWN after specialist
initiation
 Used to treat chronic hyponatraemia
associated with SIADH secondary to
malignant disease where water restriction is
ineffective.
 No specific drug monitoring requirements
but patients with SIADH should be under
specialist review.
 Monitoring of serum sodium levels should be
specified by the specialist. N.B. rapidly
decreasing levels can be life threatening.
 Prescribing expected to be very low. Current
supply issue with licensed product.
Significant traffic light updates: BROWN
Dulaglutide – BROWN
 Another once weekly GLP1 agonist,
price has just been reduced in price
to be in line with exenatide MR.
 Same recommendation as exenatide
MR i.e. when a weekly preparation
is required e.g. compliance issues
or patient requires nursing team to
administer.
Significant traffic light updates BLACK
Meningitis B vaccine (Bexsero) – Black
unless
 part of national childhood immunisation
programme, obtained from centrally purchased
stock
 for children and adults with asplenia, splenic
dysfunction or complement disorders
 for the management of clusters or outbreaks of
meningococcal disease on the advice of Public
Health England.
Significant traffic light updates BLACK
Insulin glargine 300 units per ml
(Toujeo) - BLACK
 Not bioequivalent to Lantus
 Potential for confusion due to
different strength
Evolocumab – BLACK
 Human monoclonal antibody, SC
injection for hypercholesterolaemia
and FH. NICE TA expected April 16
Significant Safety Updates
Drug safety Update – Sep 15
Proton Pump Inhibitors – very low risk of
subacute cutaneous lupus erythromatosus.
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SCLE is a non-scarring dermatosis that can develop in
sun-exposed areas accompanied by arthralgia.
Drug induced SCLE can occur weeks, months or years
after exposure to the drug.
Affected patients should be advised to avoid exposure to
sun-light and stop PPI if possible (and avoid future PPI
treatment).
Symptoms usually resolve with PPI withdrawal. Topical or
systemic steroids may be required if symptoms don’t
resolve after a few weeks or months.
Drug safety Update – Sep 15
Yellow Card App
 Can be used to easily report
suspected adverse drug reactions.
 Can also create a watch list of
medicines of interest and receive
regular updates and alerts.
Drug safety Update – Oct 15
Mirabegron – risk of severe hypertension
and associated cerebrovascular and
cardiac events.
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Mirabegron is a beta-3 adrenoceptor agonist used in
over-active bladder syndrome.
Already known that mirabegron can increase blood
pressure, but cases of severe hypertension have been
reported including reports of TIA or stroke.
Mirabegron is now contra-indicated in patients with
uncontrolled hypertension (systolic ≥ 180 or diastolic
≥110 or both).
Use with caution in patients with stage 2 hypertension
(systolic ≥ 160 or diastolic ≥100)
Drug safety Update – Oct 15
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Blood pressure should be measured before
starting treatment and regularly during
treatment, especially in patients with
hypertension.
Reminder that in patients taking strong
inhibitors of cytochrome P450 e.g.
itraconazole, ketoconazole, ritonavir or
clarithromycin, mirabegron is not
recommended if eGFR is below 30ml/min
and dose should be reduced to 25mg daily
of eGFR 30 – 89 ml/min
Drug safety Update – Nov 15
Crizotinib: risk of cardiac failure
Vemurafenib: risk of potentiation of radiation
toxicity.
Other issues
Janssen OCP discontinuations in
2016
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Ovysmen, Trinovum and Binovum oral
contraceptive tablets will be discontinued in
2016. This planned discontinuation is not
related to any safety, quality or efficacy
issues.
Ovysmen is on our formulary, but same
formulation as Brevinor. Minimal
prescribing of Ovysmen.
TriNovum and Binovum = ethinylestradiol
35mcg + norethisterone phasic preps. No
direct alternatives, Synphase in same
category but norethisterone dose slightly
different. Very little prescribed.
Advice on “quickstarting” hormonal contraception
after use of ulipristal acetate 30mg (ellaOne®) for
emergency contraception (EC).
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In 2010, the FSRH introduced guidelines supporting
immediate commencement (“quickstart”) of
hormonal contraception after administration of oral
emergency contraception (levonorgestrol or
ulipristal).
Concerns have been raised that quick starting a
progesterone containing contraceptive after
ulipristal emergency contraceptive may reduce
effectiveness of both preparations.
Advice is now to wait 5 days after ulipristal
emergency contraception before starting long-term
hormonal contraception and advise barrier methods
until effective hormonal contraceptive cover has
been achieved (another 2 to 9 days depending on
which long-term hormonal contraceptive is chosen).
Haloperidol 5mg/ml injection
supply issues
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Supply issues expected for at least 12 months
Position statement circulated – provides info on
using levomepromazine as a possible alternative.
DCHS considering updating the anticipatory
prescription sheet, at which point MMT will update
JIC autoconsultations
In the meantime, if haloperidol not available,
levomepromazine injection may need to be
prescribed separately and added to the anticipatory
prescription sheet by hand.
Levomepromazine and diamorphine are compatible
in a syringe driver – for other combinations advice is
to check with specialist or Pauline Love.
NOACs
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Position statement issued,
summary:
Increasing uptake of anticoagulation for AF patients is a
national and local priority and current guidelines suggest that
either warfarin or a NOAC can be considered based on clinical
features and patient preferences. However, NOACs are
expensive and it is vital that they are prescribed and taken
correctly to make sure that their potential benefits are realised.
A clinician may choose to initiate dabigatran, rivaroxaban,
apixaban or edoxaban for any patient within the NICE TA
criteria if clinically appropriate. Warfarin remains a suitable first
line oral anticoagulant in most patients.
Annual drug costs of NOACs
Warfarin – approx £42 (plus
monitoring)
 Apixaban – £801.70
 Dabigatran – £801.78
 Edoxaban - £766.50
 Rivaroxaban - £657
Annual spend on NOACs based on
October data is £1.2m
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Note rivaroxaban and dabigatran reducing price to
approx. £600 soon.
Warfarin and NOAC item and
spend trend
NOAC resources
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Template
AF patient leaflet
NOAC patient leaflet
Treatment algorithm
Monitoring required with NOACs
guide
AF toolkit – Keele University
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NICE approved online tool for helping to decide which
anticoagulant to choose for stroke prevention in AF
The first part allows GPs to enter health information about a
particular person into the online tool, which then provides
individualised prescribing recommendations based on the
NICE guideline.
The second part incorporates NICE's patient decision aid, to
help healthcare professionals support the person with AF
weigh up the possible benefits, harms, advantages and
disadvantages of different treatment options.
http://www.anticoagulation-dst.co.uk/
Medicines Waste Campaign #dontjusttickthebox
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New waste medicines campaign to help tackle the
forecast £1.6 million prescribing budget overspend.
Tailored messages to address the different issues faced
by patients, GPs, pharmacists, care homes and carers.
The first part of the campaign is targeting patients in
GP practices.
Regular media releases and newsletter articles on the
subject, working with colleagues across the system and
social media.
All practices will be received a letter, some information
for prescribers and prescription clerks to help reduce
waste medicines and some posters to display in your
practice.
JPEG’s will be available for practices to use on their
customer information screens.
Pull up banners which can used in practices.
Waste campaign posters – please
display them in your practice
Prescribing interval guidance &
Compliance Aid position statement
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Guidance on prescribing interval discussed at PSG.
28 days often gives the best balance between
safety, convenience and minimising waste, but is an
individual prescriber decision and times when a
shorter or longer prescription length is appropriate
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Patients who pay prescription charges may warrant longer
prescription lengths (but remember pre-payment certificates)
Patients at risk of overdosing, frequently changing doses or
stability issues may warrant shorter prescription lengths.
Schedule 2, 3 and 4 controlled drugs should be limited to 30
days supply.
Prescribing interval guidance &
Compliance Aid position statement
Regardless of the prescription supply length deemed
suitable, consider the following practical issues:
 Ensure prescription supply lengths are the same
for an individual patient (usually 7, 28 or 56
days) to minimise inadvertent over-ordering. In
particular avoid mixing 28 and 56 day
prescription lengths.
 Items required only occasionally should not
generally be placed on repeat unless there is
ongoing need. Ensure the quantity prescribed is
sufficient to cover the prescription supply length,
but not excessive.
 Ensure the issue duration is entered correctly on
the repeat template and is in line with the
quantity to be issued – to ensure systems to alert
to over and under ordering work properly.
Prescribing interval guidance &
Compliance Aid position statement
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For patients who require a MCA, providing 7 day
scripts is at the discretion of the prescriber and is
not a method of funding MCAs.
7 day scripts would be required if there are
pharmaceutical or clinical issues with a longer
prescription length e.g. stability issues, risk of
overdose, rapidly changing doses.
7 day scripts should be delivered to the patient on a
weekly basis.
Patients assessed by the CP as needing an MCA with
no clinical or pharmaceutical issues should be
provided free of charge on a 28 day prescription.
SystmOne – recording allergies
best practice document
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Key point is also to add specific
comments about the nature of the
reaction.
This will show on the patient home
screen and the SCR and can help
other prescribers assess the level of
risk.
Raising at SystmOne and EMIS web
user groups to separate allergies
and adverse reactions.
Reporting prescribing concerns to
CRHFT – GP portal
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Direct reporting function on their CRHFT website
that practices can use to report any non-urgent
CRHFT issue related to medicines or prescribing
direct to Martin Shepherd, Chief Pharmacist.
The website address is
http://www.chesterfieldroyal.nhs.uk/gp/?_ts=1
This takes you to the GP log in section of the
website. To log in to the website:
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username = gpuser
password = mozart
Then click on “prescribing concern” in the left hand
list and then click on the “email form template”.
This will open up an automatic email which the GP
or practice member can complete and send direct to
Martin Shepherd at CRHFT. If from an nhs.net
account can include patient data.
BNF paper editions – some errors
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Online version is updated regularly
Paper version, now supplied annually.
Significant changes for this version
List of errors published www.bnf.org
Can print off list from website (they will not
be sending printed amendment sheets)
We will circulate the amendment list –
practices to consider how they use these
e.g. print off and stick in all practice BNFs
or use online version