Jext Adrenaline Pen Update 2

East Berkshire Clinical Commissioning Groups Groups Commission Groups Clinical Commissioning Groups

VOLUME 2 ISSUE 11 FEBRUARY 2014

CONTENTS JEXT ADRENALINE PEN UPDATE The advice following the recall was for patients to receive a new prescription for an alternative adrenaline auto-injector, EpiPen being the only alternative. The manufacturer has agreed with the DoH to fully reimburse the NHS for every Jext returned through the recall procedure. They are collecting data on returns at postcode level which will allow them to map returns to CCG and we will deliver this report to DoH. The DoH is currently looking at how to reimburse CCGs for the additional prescribing of EpiPen to replace the recalled Jext. THE EUROPEAN MEDICINES AGENCY’S PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE (PRAC) RECOMMENDS SUSPENDING USE OF PROTELOS (STRONTIUM RANELATE)

PRAC has recommended that Protelos (strontium ranelate) should no longer be used to treat osteoporosis. The recommendation is to be considered by CHMP for final opinion. In April 2013 the Agency had recommended restricting its use to reduce the risk of heart problems. The PRAC has now conducted an in-depth review and noted that for every 1,000 patients being treated for 1 year there were 4 more cases of serious heart problems (including heart attacks) and 4 more cases of blood clots or blockages of blood vessels than with placebo. In addition, it is associated with a number of other risks, such as serious skin reactions, disturbances in consciousness, seizures, liver inflammation and reduced number of blood cells.

With regard to its benefits, strontium has been shown to have a modest effect in osteoporosis, preventing about 5 non-spinal fractures, 15 new spinal fractures and 0.4 hip fractures for every 1,000 patient-years.

The PRAC weighed the benefits against the known risks and concluded that the balance was no longer favourable and recommended Protelos (strontium ranelate) be suspended until there are new data showing a favourable balance in a defined patient group.

The PRAC recommendation will now be sent to the Agency’s Committee for Medicinal Products for Human Use (CHMP), which is expected to issue the Agency’s final opinion at its meeting of 20 to 23 January 2014.

Patients on Strontium need to be reviewed and their prescription stopped. A bisphosphonate should be considered as an alternative.

NOVEL ORAL ANTICOAGULANTS (NOACS) VS WARFARIN: THE TRUTH IS RELATIVE Extracts from an article by John Mandrola December 2013. http://www.medscape.com/viewarticle/818013_print Compared with warfarin, novel anticoagulants have been sold as both superior and more convenient, but are these drugs worth the added expense? The answer depends on how you define value and superiority. The drugs are priced and promoted as if they are special and more valuable. Do two recently published meta-analyses of novel anticoagulant trials demonstrate the drugs' superior safety and efficacy compared with warfarin? In the measures that matter for patients with atrial fibrillation, hard outcomes like stroke, bleeding, and mortality, the author calculates that the NOACs perform almost identically to warfarin.

The key word is relative. It is widely accepted that this is not a useful way for doctors to interpret clinical evidence or to explain differences to a patient. We should always look at the absolute risks and benefits of each drug.

Intracranial haemorrhage (ICH): The absolute difference between the two groups was 0.65%. Therefore for 151 of 152 patients treated, there was no difference between NOAC drugs and warfarin. That means we can tell an AF patient similar to the 60 000+ enrolled in the three randomized clinical trials that s/he has a 99.4% chance of not having an ICH on a NOAC drug and a 98.8% chance of not having one on warfarin.

Stroke or systemic-embolism events: The reduction in absolute risk between the two groups was 0.7%. Therefore 141 of 142 patients treated with a NOAC drug received no benefit over warfarin. That means an AF patient has a 96.9% chance of not having an embolic event on a NOAC drug and a 96.2% chance of not having one on warfarin.

Trying to quantify both clinical and cost effectiveness in paying such a large premium for a drug promoted to prevent devastating brain bleeding when there is a greater than 99% chance of no incremental benefit is central to decision making.

There are advantages and disadvantages of NOAC drugs (details available in the patient counselling sheet – to be reissued shortly). They have some practical advantages, like convenience, lack of dietary interactions, and fewer drug-drug interactions and not all patients do well with warfarin. Guidance for where NOAC drugs may be an alternative to warfarin is currently in draft form and will shortly be issued as a priority document.

THERABITE An application for Therabite was taken to Heatherwood & Wexham Park DTC by Speech & Language Therapy but was rejected, remaining low priority & non formulary. Please reject any of these requests.

For compassionate reasons, Therabite has been accepted for use post cancer/radiotherapy for head & neck cancers under direction and care of a specialist head & neck cancer therapist. These requests will come only from specialist centres and they should provide the device and first prescription.

CLINICAL ADVICE ABOUT MEDICINES The Medicines Information Centre at Southampton has a new phone number: 023 8120 6908 or 09. The old one will shortly no longer work. They can answer your clinical questions about medicines such as the management of side effects, information about unfamiliar medicines, the safety of herbal products, and the appropriate use of medicines in pregnancy.

INCIDENT/ NEAR MISS REPORTING

NHS information states organisations reporting near misses/ incidents on a regular basis suggest a stronger organisational culture of safety. A key priority of the NHS Medication Safety Team (replaced NPSA) is to increase reporting from primary care Of over 500,000 incidents reported to NPSA over a 5 year period, 822 involved severe harm or death. But only 8.5% of these reports were from primary care. Key facts are: - Prescribing errors: 1 in 20 items with an error; 1 in 550 with a serious error - Dispensing errors: 1.7% dispensing 7 1.6% labelling errors; 33% ‘serious errors’ - Preventable medicines-related admissions: 4.68% of emergency admissions [250,000]

The Medicines Optimisation Team wish to encourage the reporting of medicines- related near misses/errors to the Team so that any recurring themes can be identified and awareness raised throughout the 3 CCGs to promote safety. Recent examples include: - Codeine prescribed and dispensed regularly for several years for a child - High-dose simvastatin with amlodipine/ diltiazem - Bendroflumethiazide 5mg as starting dose.

A simple excel template has been designed [attached]. Please complete and send to the Medicines Optimisation Team at WAMCCG.medicines-optimisation- [email protected] where this will be reviewed and data collated aiming to improve safety.

SIMILAC ALIMENTUM ADDED TO FORMULARY AS 1ST CHOICE EXTENSIVELY HYDROLYSED INFANT FORMULA

A new infant formula called SimilacAlimentum has been added to the East Berkshire Joint Formulary as 1st choice extensively hydolysed infant formula for mild to moderate cow’s milk protein allergy (CMPA). This change has been agreed with HWPH and BHFT Dieticians.

This product is equivalent to Aptamil-Pepti and Nutramigen Lipil. EH formulas are for special medical purposes which can be prescribed to infants with a cow’s milk allergy (CMA) or other conditions where an EH formula is indicated.

N.B. Amino acid (AA) formula milks do not contain allergens; are non allergenic and required for CMPA with anaphylaxis i.e. severe. For mild to moderate CMPA, an AA formula is not required in most cases and the use of an EH formula, which is designed to be less allergenic than regular cows milk based feeds is usually sufficient. Amino Acid formulas, such as Neocate LCP, are considerably more expensive and have not been shown to be more clinically superior than EH formulas in mild- moderate cow’s milk protein allergy. Please see below also for the price comparison between these products.

Extensively Hydrolysed Formula Amino Acid Formula Similac Nutramigen Aptamil Althéra Neocate LCP Alimentum Lipil 1 Pepti 1 Cost per tin (£) 9.10 10.38 9.54 10.68 27.40 Cost per day (750ml) (£) 2.16 2.63 2.41 2.35 7.55 Annual prescribing 788.44 959.01 881.41 857.60 2,756.53 cost (£) DAPOXETINE (PRILIGY) IS NON-FORMULARY

Dapoxetine is a new treatment licensed for premature ejaculation. It is a SSRI administered as an on-demand dose 1-3 hours before sexual activity.

RCT have shown Dapoxetine to be effective in 27-37% of participants with an average intravaginal ejaculatory latency time of 3.1 minutes with 30mg dose and 3.6 minutes with 60mg dose compared to 1.9 minutes with placebo and 0.9 minutes pre-treatment.

The treatment cost is £26.48-£34.42 for 6 tablets depending upon the dose.

At present this medication is not on the East Berkshire Joint Formulary.

CHAMPIX- via PGD (NOT FP10)

Recently the Medicines Optimisation Team has received a number of queries related to Solutions4Health smoking cessation advisors requesting GPs to prescribe Champix (varenicline). Our advice is to please decline to prescribe, as Solutions4Health are contracted to supply all forms of NRT to patients.

An exception may be patients seeing advisors outside Berkshire e.g. Surrey or patients excluded from the PGD, please refer to the next article.

Varenicline should be supplied via PGD from Community Pharmacies. Please refer to the list of Community Pharmacies providing the service locally.

For further information go to www.smokefreelifeberkshire.com

Slough

H A McParland Pharmacy, 8 The Harrow Market, Langley Boots Slough 184 High Street, Slough Boots Slough, 30 High Street, Burnham, Slough B&P Pharmacy, 6 Stoneymead, Slough H A McParland Pharmacy, 226 Farnham Road, Slough H A McParland Pharmacy, 306 Trelawney Avenue, Langley Asda Pharmacy , Telford Drive, Slough Alcham Pharmacy, 301 Farnham Rd, Slough

Windsor Ascot & Maidenhead

Cookham Pharmacy, Lower Road, Cookham Rise Park Pharmacy, 4 Cookham Road, Maidenhead Woodlands Park Pharmacy - Waltham Road, Maidenhead Boots Maidenhead, 54 High Street, Maidenhead Boots Windsor, 17-18 Peascod Street, Windsor Boots Windsor, 83 Dedworth Road, Windsor H A McParland, 9 Shifford Crescent, Maidenhead Superdrug, 36-40 Nicholsons Centre, Maidenhead Hetpole Pharmacy, 398 Dedworth Road, CJ Reid Pharmacy, 30 High Street, Eton, Windsor Boots Ascot, 23 High Street, Ascot

Bracknell & Ascot

Boots Ascot, 23 High Street, Ascot, SL5 7HG Boots Bracknell, 13 Princess Square, Bracknell, RG12 1LS Boots Bracknell, 5 The Square, Bracknell, RG12 9LP Bullbrook Pharmacy, 3 Bullbrook Row, Bracknell, RG12 2NL Tesco Bracknell, Jigs Lane, Bracknell, RG40 3JP

CHAMPIX (VARENICLINE) SUPPLY VIA PGD- WHEN THE PHARMACIST CAN’T SUPPLY PATIENTS

It has recently come to our attention that GP’s may be asked to supply Champix via FP10 if patients fall under one of the exclusion criteria listed in the PGD. The most common reasons for this will be patients with epilepsy or depression and the full list of exclusions may be found below.

Solutions4Health have been asked to include an explanation regarding the exclusions when they send patients to the GP . Unless an explanation is given, then patients should be advised to go along to one of the community pharmacies, as per the previous article.

The full list of exclusions (i.e. situations where a pharmacist cannot legally supply varenicline to patients) are:

 Tobacco users not sufficiently motivated to quit or use Varenicline▼.  Patient has had an unsuccessful attempt to quit using Varenicline ▼ on the programme in the last 12 months  Patient under 18 years of age  Hypersensitivity to Varenicline▼ or any of its excipients.  Patients with a history of renal impairment.  End Stage Renal disease.  Pregnant or breastfeeding women  No valid consent.  Patient not registered with a GP  No consent to share information with GP.  Not to be used in conjunction with other smoking cessation therapies.  Patients with current (or a history of) psychiatric illness such as schizophrenia, bipolar disorder and major depressive disorder.  Any psychiatric patients – smoking cessation has been associated with an exacerbation of underlying psychiatric illness. Certain antipsychotic medication can be affected by stopping smoking (notably Clozapine and Olanzapine)  Patients with epilepsy.  Patients taking theophylline or warfarin.  Patients with a history of myocardial infarction or at risk of myocardial infarction.  Patients taking Cimetidine with reduced renal function.

When a clinician receives a request to prescribe varenicline, to patients who are excluded from the PGD, the information below provides some guidance.

Do not prescribe to:  pregnant, breast feeding women, less than 18 years old, people with end- stage renal disease.

Prescribing cautions include:  risk of relapse, irritability, depression, and insomnia on discontinuation (consider dose tapering on completion of 12-week course);  history of psychiatric illness (may exacerbate underlying illness including depression); predisposition to seizures, including conditions that may lower seizure threshold;  history of cardiovascular disease

MHRA/CHM advice on suicidal behaviour and varenicline is:

 Patients should be advised to discontinue treatment and seek prompt medical advice if they develop agitation, depressed mood, or suicidal thoughts. Patients with a history of psychiatric illness should be monitored closely while taking varenicline

For further prescribing information go to CKS http://cks.nice.org.uk/smokingcessation#!prescribinginfosub:16

CONTACT DETAILS FOR THE MEDICINES OPTIMISATION TEAM King Edward VII Hospital, St Leonards Rd, Windsor SL4 3DP Main office number 01753 636845 Fax: 01753 636055

Email: [email protected]

Tim Langran Acting Head of Optimisation Mobile: Email: [email protected] Slough CCG, 07775 010727 CCG Lead Support Pharmacist Melody Bracknell & Ascot CCG Mobile: Email Chapman CCG Lead Support Pharmacist 07826 533736 [email protected]

Dawn Best Maidenhead/Windsor/Ascot Mobile: Email: [email protected] CCG Lead Support Pharmacist 07825 691163 Caroline Pote CCG Prescribing Support Pharmacist Mobile Email: [email protected] 07824 476439 Sundus Bilal Care Home & Practice Support Mobile: Email:[email protected] Pharmacist 07909 505658 Sally Clarke CCG Prescribing Support Pharmacist Mobile: Email:[email protected] 07747007934