PanMersey CCG May 18 Newsletter

Issue 15 - May 2018

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Please click here for a summary of safety updates and SPC updates

Which medicines require extra care when switching between liquid and tablet/capsule formulations?
Specialist Pharmacy Services | 16 Apr 2018
This Q&A considers which medicines may require dose adjustment when switching between oral formulations and presents information on dose adjustment in a summary table.

Gabapentin and pregabalin - are they safe whilst breastfeeding?
Specialist Pharmacy Services | 17 Apr 2018
This UKMi Medicines Q & A reviews the evidence available, and makes recommendations, for the use of gabapentin and pregabalin during breastfeeding.

Risk of mix-ups between insulin Fiasp® (fast-acting insulin aspart) and Tresiba® (basal insulin degludec)
Electronic Medicines Compendium | 20 Apr 2018
From 1 June 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 or vice versa. Patients using both should be alerted to this risk.

Valproate contraindicated in women of childbearing potential unless there is a Pregnancy Prevention Programme
Central Alerting System | 24 Apr 2018
Following a review of the situation across the EU, valproate is now contraindicated in women of childbearing potential unless they meet the conditions of a Pregnancy Prevention Programme, which will include a risk acknowledgement form to be completed and signed by the specialist prescriber and the patient in a review at least once a year.

Obeticholic acid (Ocaliva▼): risk of serious liver injury in patients with pre-existing moderate or severe hepatic impairment; reminder to adjust dosing according to liver function monitoring
Medicines and Healthcare products Regulatory Agency | 24 Apr 2018
We are aware of reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted.

Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction
US Food and Drug Administration | 26 Apr 2018
FDA is warning that lamotrigine can cause hemophagocytic lymphohistiocytosis, which typically presents as a persistent fever, usually >101°F, and causes severe inflammation throughout the body and lead to hospitalisation and death, especially if not diagnosed and treated quickly.

Oral antiplatelet agents – are they safe in breastfeeding?
Specialist Pharmacy Service | 27 Apr 2018
This updated medicines Q&A provides advice on the safety of oral antiplatelet agents (aspirin, dipyridamole, clopidogrel, prasugrel, and ticagrelor) in breastfeeding mothers.

NICE Guidance April 2018

Seven new guidelines that impact on primary care have been published in April 2018 by the National Institute for Clinical Excellence.

The following five guidelines have been updated to include warnings that valproate must not be used in pregnancy, and only used in girls and women where there is no alternative and a pregnancy prevention plan is in place:

The recently published Lyme Disease guideline covers the diagnosis, raising awareness of and management of Lyme disease.

The Care and support of people growing older with learning disabilities guideline covers care and support for adults with learning disabilities as they grow older.

Clinicians should be aware of these guidelines and implement any necessary changes to their practice.

CKS Updates April 2018

During the month of April 2018, the following Clinical Knowledge Summaries were updated:

The most significant changes are to the Balanitis and Fungal nail infection topics which have had their management recommendations updated. The Parkinson's disease topic has also been updated in line with NICE guidance.

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 May 2018

New issues

Diamorphine 5mg and 10mg Injection supply issue (Accord)

The following update has been provided by the Commercial Medicines Unit and the Department of Health and Social Care (CMU/DHSC)

There are currently two suppliers of diamorphine injection in the UK; Accord and Wockhardt. Recently Accord’s supplier in Germany have experienced quality issues and the CMU/DHSC are working closely with Accord and the regulators in the resolution of these issues. Having reviewed current stock levels and manufacturing schedules from Wockhardt, even with the additional volumes they are able to provide, the United Kingdom will experience a complete out of stock situation in June 2018.

Based on historical usage and stock available at wholesalers/awaiting release we are expecting to go out of stock of diamorphine 5mg injection week commencing 4th June 2018 and diamorphine 10mg injection week commencing 11th June with a resupply date of week commencing 28th June 2018.
Nb: Accord regions will go out of stock in the next 7 days and so should switch to ordering from Wockhardt until that stock is exhausted.

These are approximate dates and are dependent on the NHS continuing to purchase in line with historical demand over the coming 2 weeks. Any stock piling by trusts/health boards will lead to an earlier out of stock period and reduce the time that the NHS has to brief clinical colleagues and review prescribing guidance.

National Action

CMU/DHSC are working closely with Accord to resolve the manufacturing issues they are currently experiencing as soon as possible.
CMU/DHSC are working with Wockhardt as sole supplier of diamorphine (low strength) to secure increased volumes of diamorphine for the UK market from July.
We have been working with the manufacturers of morphine injection as an alternative to diamorphine. There are currently 3 licence holders of morphine in the UK; Wockhardt, Hameln and Martindale. Wockhardt are currently not manufacturing morphine. Hameln have stock sufficient to cover forecasted demand in May and June but very little surplus for increased use. Martindale have increased morphine 10mg injection production and based on the manufacturing schedules and volumes to be released they have sufficient to cover the diamorphine 5mg and 10mg gap in June.
CMU/DHSC have been working with national clinical leads, pharmacy procurement specialists and UKMI and have produced some clinical guidance to help support this supply issue. The UKMI memo can be found by following this link
Further briefings you may wish to review before engaging with clinical staff include the Patient Safety Alert on high dose morphine and diamorphine
NHS comms to be shared across clinical networks and into primary care.
We will continue to work with all stakeholders and provide a further update in June.

Recommended Local Action

Continue to order all strengths of diamorphine in line with historical demand. Any over ordering will lead to the out of stock period shifting into May or new issues with other strengths.
Do not use diamorphine 30mg injection to cover shortfall as there are insufficient stocks and a risk of miss-selection of medicine.
Morphine 10mg injection will be available to cover the diamorphine supply issue in June from Martindale. There is not sufficient stock of morphine 15mg injection to support the diamorphine supply issue. Please only order extra stock of morphine as diamorphine injection becomes unavailable locally and do not stock pile.
Because Hameln’s morphine 10mg injection is preservative free, this can be used for clinical areas which require a preservative free preparation such as Obstetric regional anaesthesia. Outside of contracted regions please only order Hameln stock for obstetric use and ring fence this stock within your trust. There is insufficient Hameln stock to support all clinical areas in June.
Review and share UKMI guidance with clinical colleagues. You have a two week lead time to engage with clinical colleagues and review/amend clinical guidelines.
Please cascade onto any relevant networks, who may find this information useful.
Please let your regional procurement specialist know of any local issues or if you are considering using an alternative other than morphine.

CMU/DHSC will continue to work with all stakeholders and we will provide further updates when available.

Lofexidine tablets:

Britannia Pharmaceutical Ltd has advised that they will be temporarily withdrawing this product from the market whilst sourcing a new manufacturer.

Currently Britannia has good supplies available, but this stock is short dated (expires at the end of May) and is now only available to order directly from Britannia (telephone number: 01189209500).

Rifampicin 150mg tablets:

Sanofi are currently out of stock of Rifadin 150mg capsules. Estimated resupply in late June 2018.
Sanofi continue to have good stock available of Rifadin 300mg capsules and Mylan have stock of generic Rifampicin 150mg capsule.

Ongoing issues

Epipen 0.3mg:

Mylan has advised that due to manufacturing delays from their contract manufacturer, Meridian Medical Technologies, a Pfizer company, there are intermittent supply constraints of EpiPen® 0.3mg Adrenaline Auto-Injector in the UK.

Alliance Healthcare, has recently received additional stock of EpiPen® 0.3mg Adrenaline Auto-Injector from Pfizer and they will be working with pharmacies to fulfil prescriptions. To further assist in the stock management of EpiPen® 0.3mg, pharmacies are allocated stock on a prescription-only basis and can place orders for up to a maximum of two EpiPen® 0.3mg Auto-Injectors per prescription. At this time, there are no supply constraints of EpiPen® Jr 0.15mg Adrenaline Auto-Injectors.

Mylan have shared the statement, which is also available on their website www.epipen.co.uk and is working closely with Pfizer to manage supply to avoid long-term supply shortages. Pfizer anticipates that production rates will increase over the coming months; however, at this time, cannot commit to a specific time for when the supply constraint will be fully resolved.

There are two alternative adrenaline auto-injector devices, Jext and Emerade. Supplies are available of both of these products in various strengths although they may be limited. Further deliveries are expected in the coming weeks for both products.

Menadiol tablets:

Alliance, the sole supplier of menadiol tablets, 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 and which 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.

Hydrocortisone sodium phosphate 100mg injection:

Concordia are out of stock of hydrocortisone sodium phosphate injection 100mg/ml (formerly marketed as Efcortesol) and do not currently have an estimate for resupply. 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:

Concordia have advised they are unable to supply Diamox MR until Q3 (July-Sep 2018) and Teva have advised that they are unable to supply Eytazox Cap 250mg M/R until late July 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.

Please see a copy of the communication letter .

Tranexamic acid 500mg tablets:

There are ongoing supply issues due to difficulty in obtaining raw material. Currently Teva and Tillomed have supplies available of generic tranexamic acid and Mylan have supplies of the brand Cyklokapron.

Supplies are therefore 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. 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. There are also unlicensed supplies of both the 1mg and 5mg tablet 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.

Zaditen 300ml (1.38mg in 5 ml oral solution):

CD Pharma are currently out of stock of Zaditen oral solution 300ml (no date available for resupply).
In the interim, they can provide alternative 100 ml packs for Zaditen Syrup (Origin Polish market), which is now available from Alloga. The MHRA has approved a variation for CD Pharma to supply this product, so it is considered licensed. Zaditen 1mg tablets are not affected by this issue and remain readily available

Please find the information letter for further info.

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 in 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.

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:
* We are in discussion with the manufacturer of Xailin, Nicox, about their supply position.

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 early June.

Vaccines:

For updates on vaccine supply positions, please refer to PHE’s Vaccine Update Bulletin:

Pneumococcal Polysaccharide Vaccine (PPV23):
* MSD are the sole UK supplier of this vaccine
* Stocks have been recently been made available with further supplies are expected in late July
* Supply may be intermittent throughout 2018
* PHE have previously issued guidance to GP’s (see attached document) 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 (see attached document) 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.

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.

Modecate
* As per previous notifications from the company, Sanofi are discontinuing Modecate in the second half of 2018.
* Sanofi have further advised that UK supplies will no longer be available from the end of Q3
* No new patients should be commenced on this treatment
* We are in discussion with the importers about the availability of unlicensed fluphenazine depot injection and will share further info when it is available.

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

Kieron Donlon: kieron.donlon1@nhs.net - 0151 296 7076

Contents

Formulary Update

Safety Update

Prescribing News

Drug Availability

Drug tariff price Changes