Prescribing Leads Clinical Update December 2015. Clinical Update New & updated guidelines Significant traffic light updates Significant safety issues

Prescribing Leads Clinical Update

December 2015

Clinical Update

New & updated guidelines Significant traffic light updates Significant safety issues Other issues Feedback from practices

Clinical Guidelines

Management of dyspepsia and GORD - UPDATED

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

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 side-effects.


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


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

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


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.


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

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

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

Treatment algorithms of cost-effective 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

Only minor changes. On-going discussions on including

guidance for patients with sub-therapeutic INRs who may require short-term “bridging” therapy with LMWH

Shared-Care Guidelines

Updated shared care guidelines

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 recommendationPeripherally-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 methylnaltrexonePalliative care teams expect use to be very low.

Significant traffic light updates: BROWNDemeclocycline – BROWN after specialist initiationUsed 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 – BROWNAnother 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 stockfor 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) - BLACKNot bioequivalent to LantusPotential for confusion due to different strength

Evolocumab – BLACKHuman monoclonal antibody, SC injection for hypercholesterolaemia and FH. NICE TA expected April 16

Significant Safety Updates

Drug safety Update – Sep 15Proton Pump Inhibitors – very low risk of subacute cutaneous lupus erythromatosus.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 AppCan 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 15Mirabegron – risk of severe hypertension and associated cerebrovascular and cardiac events.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

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

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®) foremergency contraception (EC).

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 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

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 - £657Annual spend on NOACs based on

October data is £1.2mNote rivaroxaban and dabigatran reducing price to approx.

£600 soon.

Warfarin and NOAC item and spend trend

NOAC resources

Template AF patient leaflet NOAC patient leaflet Treatment algorithm Monitoring required with NOACs

guide

AF toolkit – Keele University 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

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

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

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.


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.


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

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 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:

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

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

Documents

Prescribing Leads Clinical Update December 2015. Clinical Update New & updated guidelines Significant traffic light updates Significant safety issues