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Issue 14 - April, 2018
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Welcome to the 14th edition of Tablets, a prescribing newsletter produced monthly by the Medicines Management team of Midlands and Lancashire CSU.

Contents

Formulary Update

Recommendations
 
BLACK FULVESTRANT solution for injection (Faslodex®) 
NICE does not recommend the prescribing of FULVESTRANT solution for injection (Faslodex®) for untreated locally advanced or metastatic oestrogen-receptor positive breast cancer as  per NICE TA503, which recognised the uncertainty over cost-effectiveness.
https://www.nice.org.uk/guidance/ta503
http://www.panmerseyapc.nhs.uk/recommendations/documents/PS228.pdf

BLACK 
LESINURAD 200mg TABLETS (Zurampic®▼) 
NICE does not recommend the prescribing of LESINURAD 200mg TABLETS (Zurampic®▼) for Chronic hyperuricaemia in people with gout as per NICE TA506 which recognises that the cost effectiveness estimate is substantially above the range normally considered to be cost-effective use of NHS resource.
https://www.nice.org.uk/guidance/ta506
http://www.panmerseyapc.nhs.uk/recommendations/documents/PS229.pdf
 

AMBER INITIATED  FERRIC MALTOL 30mg hard capsules (Feraccru®) for Iron deficiency anaemia (IDA) in people with inflammatory bowel disease (IBD)  
Only recommended for use in patients with stable IBD where an adequate trial of at least two oral iron preparations containing ferrous salts (e.g. ferrous fumarate, ferrous sulfate) has been tried and the patient has suffered intolerable adverse effects, haemoglobin is ≥95g/L and the patient is being considered for IV iron therapy.
http://www.panmerseyapc.nhs.uk/recommendations/documents/PS185.pdf


AMBER INITIATED Insulin DEGLUDEC 100units/mL and 200 units/mL solution for subcutaneous injection (Tresiba®▼)
Degludec is recommended as an alternative long-acting and/or high-strength insulin analogue to glargine, in circumstances where degludec may be considered more clinically appropriate.
http://www.panmerseyapc.nhs.uk/recommendations/documents/PS172.pdf
 

GREEN VORTIOXETINE tablets (Brintellix®▼) for Major depressive episodes
http://www.panmerseyapc.nhs.uk/recommendations/documents/PS157.pdf
 

GREY IXEKIZUMAB solution for injection (Taltz®▼) for Psoriatic Arthritis
http://www.panmerseyapc.nhs.uk/recommendations/documents/PS227.pdf
 
BLACK  
(Amber Recommended paediatrics)  Alimemazine for Allergy 
Not recommended in adults.

BLACK
Simeticone Infantile colic 
Not recommended
 

RED  Anti-TNF agents Planned conception in inflammatory arthritis
http://www.panmerseyapc.nhs.uk/guidelines/documents/G21.pdf

AMBER INITIATED  Sevelamer salt – Hyperphosphataemia in renal dialysis 
Sevelamer listed in formulary without specifying salt (hydrochloride or carbonate). Local expert opinion is that different salts are clinically equivalent, and prescribing without specifying salt allows reimbursement at generic price. Cost saving (generic price £26.05, branded price £167.04 per 180 tablets).

AMBER Recommended Levetiracetam granules Epilepsy 
Restricted to use in patients with feeding tubes (oral liquid use is off-label for feeding tube administration).
 

AMBER Retained Ulipristol tablets (Esmya®) for Uterine fibroids 
Restricted use and additional liver function testing following MHRA alert
https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102706


GREEN Fobumix® (budesonide + formoterol dry powder inhaler) Asthma (adults) and COPD  
 

GREEN Isotretinoin gel (Isotrex®) Acne
Product discontinued. Alternatives available on formulary.
 

AMBER Recommended  Carteolol eye drops Glaucoma  
Product discontinued. Alternatives available on formulary.
 

Guidelines
 
AMBER INITIATED Mesalazine statement for Ulcerative colitis and Crohn’s ileocolitis 
http://www.panmerseyapc.nhs.uk/recommendations/documents/PS230.pdf
 

Unlicensed and off-label medicines guideline.
http://www.panmerseyapc.nhs.uk/guidelines/documents/G7.pdf
 

Safety

DEXAMETHASONE injection - different injection strengths
http://www.panmerseyapc.nhs.uk/safety/documents/S6.pdf
 
Please note that all links are accessible via the Wirral RAG list or the Guidelines section of the Wirral Medicines Management website.

Prescribing News

NICE Guidance March 2018

The following guidelines have been published by the National Institute for Clinical Excellence in March 2018:

The Attention deficit hyperactivity disorder guideline has been published and replaces the 2008 guidance. The guideline aims to improve the recognition, diagnosis, support and management of attention deficit hyperactivity disorder (ADHD) in children, young people and adults.


The Heavy menstrual bleeding guideline has been published and replaces the 2007 guidance. The guideline covers the assessment and management of heavy menstrual bleeds (menorrhagia). The guidelines aim to help healthcare professionals investigate the cause of heavy periods that can affect a woman’s quality of life and to offer the right treatments.
It is vital clinicians are aware of these changes and implement any required changes to their practice.


CKS Updates March 2018

During the month of March 2018, the following Clinical Knowledge Summaries were updated:
 
The most significant change is to the topic on Gout which has been updated in line with national guidance. The alopecia areata and leg cramps topic have both been expanded.

Local news

Homely Remedies

The CSU in conjunction with the Wirral CCG have published the Homely Remedies Guide which Care Homes may wish to use from the 1st April 2018.

A homely remedy is a medicinal preparation used to treat minor ailments e.g. indigestion, coughs, mild-moderate pain, constipation etc. It is purchased from supermarkets and other stores (GSL) or obtained from the Pharmacy (P) and does not require a prescription. The Care Quality Commission agrees that a small range of products may be kept as stock in a care home for residents for the treatment of minor ailments.

Homely remedy products are kept in the home to allow access to products that would commonly be available in any household and allow treatment of minor conditions in a safe and timely manner. Use must however be discussed with the resident and/or family member and their GP and only the named preparations listed in the guidance may be obtained and administered without a prescription. Information on medications that can be used are included in the guide but Pharmacists can also provide advice on the best treatment and give guidance on their use as well.

A training event which will include a session on Homely remedies is yet to be finalised. Date and venue to be confirmed.


Wirral Community Trust Clostridium difficile update for February 2018

There were four reported cases of community attributed clostridium difficile infection (CDI) in February 2018.
The key learning points from these reviews were:

* Always document rationale for choice of antibiotics
* Prescribe treatment for CDI in line with antimicrobial guidelines

Areas of good practice identified from these reviews were as follows:

* Prompt stool sample collection and prescribing of treatment for CDI
* Recognition of CDI as a cause for diarrhoea


Wirral CCG Datix Newsletter

The Wirral CCG DATIX Newsletter will be distributed to GP Practices on a quarterly basis. It is a way of communicating and updating practices on the following:

* Any changes that are being made to the Datix System
* Any trends that are appearing from incident reporting.
* Lessons Learnt that may be useful in GP Practices.


Guidance about Methotrexate 10mg Tablets – for all practice managers and prescribers

As you are all aware it is Wirral Policy not to prescribe 10mg Methotrexate Tablets, this has been the case since 2006 when the first MHRA Alert was actioned. Since this time we have always had a handful of patients still prescribed 10mg tablets, usually at the request of a consultant, for severe compliance issues.

The Pan Mersey APC Formulary does not make exception for any patients, this incudes children at Alder Hey.

An updated safety statement from Pan Mersey is expected soon and this will be circulated via this bulletin.


This issue was discussed at the Wirral CCG Medicines Management Committee and it was decided that we should be moving towards Pan Mersey APC guidance as soon as possible. The committee asked that the Medicines Management team identify any patients currently prescribed 10mg tablets and take the following action :-

 
  • Discuss with GP to see if patient is now able to be switched to an equivalent dose using 2.5mg tablets. The patient and pharmacy must always be contacted before the change is made to ensure that both are aware and understand the change.
  • EMIS Web restricts prescribing of Methotrexate to GPs therefore any changes must be made by the GP and not the medicines management team.

The team are currently highlighting any 10mg prescribing but going forward the practice need to review this and follow ScriptSwitch prompts.

For any particular requests from consultants or any queries both WUTH and Alder Hey have agreed to liaise with consultants directly.

Community pharmacies will also be asked not to stock methotrexate 10mg tablets as per the Wirral policy.
Any queries please email abigailcowan@nhs.net in the MLCSU Medicines Management Team.

Safety Update

Please click here for more information on all of the below safety updates.
 
Esmya(ulpristal acetate) for uterine fibroids: do not initiate or re-start treatment; monitor liver function in current and recent users
MHRA | 09 Mar 2018
The March edition of the Drug Safety Update newsletter discusses temporary safety measures introduced to protect women’s health whilst a safety review of this product is ongoing. The EU-wide review was initiated in December 2017 following reports of serious liver injury.

Head lice eradication products: risk of serious burns if treated hair is exposed to open flames or other sources of ignition, e.g. cigarettes
MHRA | 09 Mar 2018
The March edition of Drug Safety Update highlights the risk of fires with these products. Despite the addition of warnings to the pack and patient information for Hedrin 4% cutaneous solution, there have since been two further cases of serious burns associated with other products.

Updated Measures for pregnancy prevention during retinoid use
European Medicines Agency | 23 Mar 2018
The EMA has completed a review of available data on teratogenicity and neuropsychiatric disorders with retinoid medicines and concluded that there is the need to strengthen the recommendations for pregnancy prevention and to raise awareness about possible neuropsychiatric risks.


Colour change for Fiasp(Insulin aspart) to avoid mix ups with Tresiba (insulin degludec)
European Medicines Agency | 23 Mar 2018
The colour of Fiasp cartridges, pre-filled pens and vials is changing from yellow to red and yellow, following cases where patients have mistakenly injected it instead of Tresiba (available in the EU as light green cartridges and pens) or the other way around.

New measures to avoid valproate exposure in pregnancy
European Medicines Agency | 26 Mar 2018
Valproate is now contraindicated for migraine or bipolar disorder during pregnancy, for treating epilepsy during pregnancy unless there are no alternatives and, in any woman or girl able to have children unless conditions of a new pregnancy prevention programme are met.

SPC updates here

Drug Availability

Products in short supply and product discontinuations

The following links provide prescribers with up to date information on commonly prescribed products which are currently in short supply from the manufacturers.
 
The information held on these lists is not exhaustive. Availability can vary geographically and also between wholesalers. Up-to-date information should be sought from manufacturers, local community pharmacies and suppliers.


Supply issues update for primary care April 2018

Ongoing issues

Epipen 0.3mg (Senior) Auto-injectors
 
Due to manufacturing delays Mylan are reporting intermittent supply constraints of EpiPen® 0.3mg (Senior) Adrenaline Auto-Injector in the UK. To assist in the stock management of EpiPen® 0.3mg (Senior), Mylan are allocating stock on a prescription-only basis and pharmacies will be able to place orders for up to a maximum of two EpiPen® 0.3mg (Senior) Auto-Injectors per prescription.
 
Lacri-lube eye ointment
 
Allergan are out of stock with no resupply date due to a manufacturing issue. The Royal College of Ophthalmology is aware of the issue and is recommending Xailin Night Ointment. 
 
Menadiol tablets
 
Alliance, the sole supplier, is out of stock from mid-January until approximately October 2018. They are now supplying an unlicensed special which is the same formulation as the licensed product. Please see the information sheet which was drawn up about the special product. This product is available to order from Alcura.
 
Other specialist importers are also able to source unlicensed supplies.
 
UKMI have drafted a shortages memo, which will provide advice on alternatives, this is available on the SPS website.
 
Octenisan nasal gel
 
GSK have a manufacturing issue and are out of stock. GSK are expecting new stock to be available during the w/c 19th March, but supplies may be limited until a further delivery is made available at the end of May.
 
UKMI have published a shortages memo, which provides advice on clinical alternatives. This is available at the following link.
 
Discussions have been held with the suppliers of the alternatives, who are aware of GSK’s issues and are working with their supply chains to bring in additional stock:
 
  • Naseptin Nasal Cream - Alliance Pharmaceuticals available via the wholesalers: AAH, Alliance Healthcare and Well Pharmacy.
  • Prontoderm - B.Braun have advised that supplies currently available, with further deliveries expected.
  • Octensian Nasal gel - Schülke & Mayr UK Ltd - currently have stock and are expecting another delivery in March and a further one in April. 
Hydrocortisone sodium phosphate 100mg injection
 
Concordia are out of stock of hydrocortisone sodium phosphate injection 100mg/ml (formerly marketed as Efcortesol) due to an  issue with the active pharmaceutical ingredient.
 They are expecting further supplies in spring 2018. Solu-Cortef (hydrocortisone sodium succinate) 100mg, manufactured by Pfizer, is considered an acceptable alternative during this time. Solu-Cortef is currently available and we have made Pfizer aware of the supply issues with Concordia’s hydrocortisone injection.
 
  • There are differences in the formulation and administration between these two products, the following guidance provides further information about the administration of Solu-Cortef.
  • Additional information on the use of Solu-Cortef injection can also be found on these sites:
    • Injection video demonstrating the preparation technique for Solu-Cortef with a standard syringe.
    • Solu-Cortef with a safety syringe.
    • The ADSHG photo instructions for preparing Solu-Cortef with a safety needle
 
Acetazolamide MR
 
Diamox MR – Concordia have advised resupply not due until April - June 2018. Immediate release acetazolamide 250mg tables are available from both Teva and Concordia.
  
Trimovate cream
 
This product has recently been divested from GSK to Ennogen, but Ennogen will not be in stock until late in 2018. Ennogen have now imported in Trimovate cream as an unlicensed product and are now distributing this product.
 
Trifluoperazine tablets
 
There have been ongoing supply issues affecting trifluoperazine 1mg and 5mg tablets and supplies will not improve until some point in 2019 due to manufacturing issues with the active ingredient. Concordia and Rosemont have trifluoperazine available in liquid formulations and they have good supplies available.
 
Unlicensed supplies of both the 1mg and 5mg tablet are available from both Ennogen and a number of specialist importer companies. Under the medicines legislation, doctors can prescribe unlicensed products for their patients if they think it appropriate, but do so entirely on their own responsibility.  Pharmacies can obtain unlicensed supplies via these specialist companies or Ennogen. 
 
Eye drops/ treatments
 
Novartis
  • Iopidine (apraclonidine) 5mg/ml eye drops x 5ml. – new supplies released recently.
  • Maxidex (dexamethasone) 0.1% eye drops x 5ml.  There is limited stock available but the company is chasing for a new delivery.
  • Icaps (lutein & zeaxanthin) tablets x 30. There is limited stock available, the company is chasing for delivery.
  • Azarga (brinzolamide & timolol) eye drops x 5ml.  There have been recent shortages due to a significant increase demand; the company is responding to the increase and is waiting for the next batch to be released from QA.
  • Simbrinza (brinzolamide & brimonidine) eye drops x 5ml. There is limited stock available but the company is chasing for a new delivery.
  • Duotrav (timolol & travoprost) eye drops x 2.5ml.  There is limited stock available but the company is chasing for a new delivery.
 
RPH Pharmaceuticals AB - Betnesol Eye Ointment 0.1% w/w x 3g
  • RPH Pharmaceuticals AB (marketing authorisation holder) who distribute the product through Focus Pharmaceuticals have advised about the discontinuation of Betnesol Eye Ointment 0.1% w/w x 3g towards the end of March.
  • RPH Pharmaceuticals will be launching Betamethasone Eye Ointment 0.1% w/w x 3g and are currently expecting stock in mid-May.
 
Vaccines
 
Pneumococcal Polysaccharide Vaccine (PPV23):
  • MSD are the sole UK supplier of this vaccine and limited supplies are currently available.
  • Further supplies are expected in late March.
  • Supply may be intermittent throughout 2018.
  • PHE have previously issued guidance to GP’s  on how to manage patients if unable to obtain PPV vaccine.
  • Updates on recommendations are now  available in February edition of PHE’s Vaccine Update Bulletin (Page 7).
 
Menveo (meningitis A, C, W, Y):
  • GSK are out of stock of Menveo until at least summer 2018 (date has not yet been confirmed).
  • Pfizer have confirmed they are in stock of Nimenrix and currently able to support increased demand.
 
Hepatitis B Vaccines
  • PHE previously developed temporary recommendations on hepatitis B vaccine including risk-based prioritisation of vaccine, dose-sparing and deferral of boosters.
  • Supply of Hepatitis B vaccines has improved, however will remain constrained and controlled stock management  and ordering restrictions will continue to allow for  the backlog of patients/staff who had vaccination deferred last year and because manufacturers have not got their usual full UK allocation.
  • However, a recovery plan for 2018 was published by PHE on 26th February 2018 and vaccine ordering will be opened out in a phased approach over 2018 to lower priority group (4) patients, from March. Priority group 1-3 patients/staff will continue to have access to vaccine.
  • Information on the temporary recommendations and recovery plan can be found at the following link.
  • PHE have issued a letter to GPs  outlining the implication for GPs.
  • PHE have also issued a letter to NHS and non-NHS  occupational health service providers (see attached document) outlining the implication for OH.
  • A mechanism remains in place for both suppliers to allow for exceptional orders if there is an urgent and immediate need.
Drug tariff price Changes

This summary document shows the top 10 price changes this month, the top 25 changes this quarter, and the top 100 this year. 
Tell me more about drug tariff price changes.
Please note that the information in this newsletter is correct at the time of publication.
Clinicians should always refer to the most up to date information.


Contacts