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Issue 13 - March 2018
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Welcome to the March edition of Tablets, a prescribing newsletter produced monthly by the Medicines Management team at 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 9IBD) 
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
 

Guidelines

Green Vitamin D guideline (adults) for Vitamin D deficiency
Issued: 01 March 2018  review 
| Feb 2021
http://www.panmerseyapc.nhs.uk/guidelines/documents/G45.pdf
 

Amber initiated Mesalazine statement for Ulcerative colitis and Crohn’s ileocolitis
Version; 1.0  Review date February 2020
http://www.panmerseyapc.nhs.uk/recommendations/documents/PS230.pdf
 

Sevelamer – salt for Hyperphosphataemia in renal dialysis
Review date January 2019
http://formulary.panmerseyapc.nhs.uk/chaptersSub.asp?FormularySectionID=9
 
Black (
Amber Recommended paediatrics) Alimemazine for Allergy
http://formulary.panmerseyapc.nhs.uk/chaptersSub.asp?FormularySectionID=3
 
Black
Simeticone Infantile colic
Review date June 2020
http://formulary.panmerseyapc.nhs.uk/chaptersSub.asp?FormularySectionID=1
 

AMBER Recommended Levetiracetam granules Epilepsy
Review date June 2020
http://formulary.panmerseyapc.nhs.uk/chaptersSub.asp?FormularySectionID=4
 

GREEN  Fobumix® (budesonide + formoterol dry powder inhaler) Asthma (adults) and COPD 
http://formulary.panmerseyapc.nhs.uk/chaptersSub.asp?FormularySectionID=3
 

AMBER Retained Ulipristol tablets (Esmya®) for Uterine fibroids 
Issue date 9th February 2018
https://www.cas.dh.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=102706
 

RED  Anti-TNF agents Planned conception in inflammatory arthritis 
Version: 3.0 Review date: February 2021
http://www.panmerseyapc.nhs.uk/guidelines/documents/G21.pdf
 

GREEN  Isotretinoin gel (Isotrex®) Acne 
Product discontinued. Alternatives available on formulary; no financial implication.
 

AMBER Recommended  Carteolol eye drops Glaucoma 
Product discontinued. Alternatives available on formulary; no financial implication.
 

AMBER Retained Triptorelin statement Prostate cancer 
Version 4.0
http://www.panmerseyapc.nhs.uk/recommendations/documents/PS46.pdf
 

GREEN  Blood glucose testing strip Diabetes 
Version:4.0 Review date February 2020
http://www.panmerseyapc.nhs.uk/recommendations/documents/PS176.pdf
 

GREEN Hypnotic agents for Insomnia 
Review date June 2020
http://formulary.panmerseyapc.nhs.uk/chaptersSub.asp?FormularySectionID=4
 

Safety

DEXAMETHASONE injection  - different injection strengths 
Routine review of existing safety statement.
http://www.panmerseyapc.nhs.uk/safety/documents/S6.pdf

Safety Update

Included in this month’s Newsletter we have included safety updates relating to November 2017, December 2017, January 2018 and February 2018

Drug interactions with senna or salbutamol increasing the risk of torsade de pointes
Specialist Pharmacy Service| 05 Feb 2018
This memo for prescribers and pharmacy staff has been produced in response to questions from primary care prescribers and pharmacists concerned about seemingly innocuous drug combinations flagged up on prescribing systems.

 
Sodium valproate prescribing data
NHS Business Services Authority | Jan 2018
This report aims to identify the number of female patients of child bearing age that have received prescriptions for sodium valproate. This data will be produced every 6 months to contribute to the monitoring of effectiveness of actions to ensure safe and appropriate use of sodium valproate.

 
Changes to Ribena to reduce sugar levels
Royal Pharmaceutical Society | 07 Feb 2018
Lucozade Ribena Suntory are reducing the sugar content of Ribena Blackcurrant (Ready To Drink and squash by approximately 55%). Pharmacists should be aware of this change as Ribena Blackcurrant is sometimes used by people with diabetes to help manage their blood sugar levels.


Esmya (Ulipristal Acetate) For Uterine Fibroids: Monitor Liver Function In Current And Recent Users; Do Not Initiate Treatment In New Users Or Those Between Treatment Courses
Central Alerting System | 09 Feb 2018
This letter is to inform you of temporary safety measures for the medicine Esmya (ulipristal acetate) indicated for pre-operative and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.The emergency contraceptive ellaOne also contains ulipristal acetate (single-dose, 30mg). No cases of serious liver injury have been reported with ellaOne and there are no concerns with this medicine at this time.

 
Fencino (fentanyl) patches
Ethypharm | 01 Feb 2018
This letter highlights the potential presence of crystals on some patches. They are embedded in the matrix, do not break off by themselves and there is no evidence that the crystals cause skin irritation and there are no patient safety concerns.

 
PRAC recommends new measures to avoid valproate exposure in pregnancy
European Medicines Agency | 09 Feb 2018
PRAC recommend a new pregnancy prevention programme. They also recommend inclusion of a visual warning about the risks in pregnancy on the packaging, as well as a patient reminder card for pharmacists to discuss with the patient at the time of dispensing.
 
PRAC recommends updating measures for pregnancy prevention during retinoid use
European Medicines Agency | 09 Feb 2018
PRAC has now updated and harmonised the pregnancy prevention programme for these medicines across the EU.

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 March 2018

Ipinnia XL
Ethypharm UK has issued a recent communication regarding stock shortage of Ipinnia® XL ropinirole prolonged release tablets. The supply issues are currently affecting the 2mg, 6mg and 8mg strength tablets until further notice. The 3mg and 4mg tablets are not currently affected

Xylocaine 10% spray
Aspen who are the sole supplier of this product are currently out of stock due to capacity issues at their manufacturing site, they have advised there are now very limited supplies left at wholesalers. They are expecting further stock to be available towards the end of March, and then a further delivery to arrive in the middle of April.

In the interim period, UKMI have published the attached guidance, which can be found on the following link. This guidance advises that existing stock should be prioritised for use in areas most in need of this product and that usage should be rationalised where possible.

An unlicensed import (Astra Zeneca product) is available from Europe but there is a 7 to 10 day lead time. There is another licensed lidocaine spray, which contains a lower strength (5%) in combination with phenylephrine hydrochloride 0.5% w/v, available from Martindale that may be appropriate for some indications. Martindale are aware of the Xylocaine 10% spray supply issues and can support additional demand.

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.

Adalat Retard 10mg modified release tablets

Due to manufacturing difficulties, Bayer is out of stock until mid-April 2018. A Bayer communication letter has been issued. A number of alternative Nifedipine MR 10mg preparations remain available including Adipine MR 10mg tablets, Tensipine MR 10mg tablets and Caroten MR 10mg capsules.

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


Ongoing issues

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 find the link to the  information sheet which was drawn up about the special product. This product is available to order form 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.

Bactroban nasal ointment

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 API issue. 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:
 

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.

Tranexamic acid 500mg tablets

Supplies are now available but may be limited. UKMI have provided the following shortage memo which advises on alternatives

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

Allergan
 
  • Carmellose 1% eye drops x 30 unit dose. There is a current shortage with the 30 unit dose which is expected to be resolved by mid-March. In the meantime, there is a good supply of the 60-unit dose pack.

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 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.

Discontinuations

Chlordiazepoxide tablets

Dr Reddy’s, the sole supplier of chlordiazepoxide tablets has discontinued this product in both the 5mg and 10mg strengths. Supplies of generic chlordiazepoxide capsules in 5mg and 10mg strengths are available from Crescent, Athlone and Kent. Supplies of the brand Librium are also available from Mylan.

Prescribing News

NICE Guidance February 2018

Three new guidelines and three new technology appraisals have been published by the National Institute for Clinical Excellence. These are:

The guideline covering Diagnosis and Management of Pancreatic cancer in adults over the age of 18. The guideline aims to improve care via faster and more accurate diagnosis determining the most effective treatments for patients depending on the stage of their cancer.

The guideline on Heavy Menstrual Bleeding has also been updated to include signposting to temporary safety measures as part of the current safety appraisal of ulipristal acetate (Esmya) as an agent used in the management of uterine fibroids.

The guideline on Diagnosis and management of Peripheral arterial disease (PAD) has been updated with two new recommendations for the diagnosis of PAD in patients with diabetes.

The Technology Appraisal for Raloxifene for the primary prevention of osteoporotic fragility fractures in post-menopausal women has been updated to reflect the most up to date recommendations. Strontium and Etidronate are no longer marketed in the UK and hence have been removed from the guidance. Some recommendations have been replaced by more current guidance.

The Technology Appraisal for Raloxifene and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women has been updated to reflect the current recommendations as detailed above. Some recommendations have been replaced by more current guidance.

The Technology Appraisal for Bisphosphonates for treating osteoporosis has been updated in line with the appraisals for Raloxifene.


It is vital Clinicians are aware of these changes and implement any required changes in practice.


CKS Updates February 2018

During the month of February 2018, the following Clinical Knowledge Summaries were updated. Significant amendments have been made to the background, management and diagnosis sections of

Balanitis 
Breast Screening

Other amendments have been made to sections of  

Bites (Human and Animal) - the antibiotics choice section has been simplified with doses added.  
Obesity – updated in line with current NICE Guidance  
Alcohol – Problem Drinking
Erectile Dysfunction
Malaria Prophylaxis
Polycythaemia/erythrocytosis
Pubic Lice
Vertigo

Clinicians who see patients with these conditions may find the updated information useful for management in line with current practice.

NHS Prescription Charges to go up from April 2018

The Department of Health announced in March that the price for an NHS prescription in England will increase by 20p to £8.80 for each medicine or appliance dispensed, with effect from the 1st April 2018.

The prices for 3 and 12-month pre-payment certificates are frozen and have remained the same at £29.10 and £104 respectively. For anyone requiring more than 3 items in 3 months or more than 12 in a year these certificates can provide significant savings.
Other NHS charges such as for dental work, wigs and fabric supports are also being increased in line with inflation.

Medicines ordered by GP Practices – changes to suppliers.

It has come to our attention that certain products that GP practices order via wholesalers will only be available from certain suppliers.
Please see below a list of the products for which Alliance Healthcare will be sole distributor from 1st March 2018:

Depo-Provera
Depo-Medrone
Solu-Cortef
Sayana Press
Genotropin

Alliance Healthcare have confirmed, in relation to the low spend surcharge, GP practices would require An Agency & Solos Lines only Account, as there is no low spend surcharge applied to this type of account. They have also confirmed that items manufactured by Pfizer prescription medicines are exempt from the low spend surcharge. The link  shows which manufacturers’ products are exempt from the low spend surcharge.

We will update you with any other changes to suppliers as appropriate.
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
Kieron Donlon: kieron.donlon1@nhs.net - 0151 296 7076

Copyright © 2017 Midlands & Lancashire Commissioning Support Unit, All rights reserved.

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