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Issue 16 - June 2018
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Welcome to the June edition of Tablets, a prescribing newsletter produced monthly by the Medicines Management team at Midlands and Lancashire CSU.
 

Contents

Formulary Update

Recommendations

BLACK POTASSIUM HYDROXIDE 5% Solution (MolluDab® or Molutrex®)
The Pan-Mersey Area Prescribing Committee does not recommend the prescribing of Potassium Hydroxide 5% (MolluDab® or Molutrex®) on the NHS. Patients are advised to purchase MolluDab® or Molutrex® if they wish. 

RED  BOTULINUM TOXIN Type A injection for chronic anal fissure
The Pan Mersey Area Prescribing Committee recommends prescribing a maximum of TWO COURSES of botulinum toxin type A injection in the treatment of chronic anal fissure which has not healed despite a minimum course of at least 8 weeks of topical management. 

AMBER FOLLOWING SPECIALIST INITIATION FLASH GLUCOSE MONITOR (FreeStyle Libre®)
The Pan Mersey Area Prescribing Committee recommends the prescribing on the NHS of flash glucose monitor sensors (FreeStyle Libre®) only within the criteria outlined. 

GREY  TIOTROPIUM inhalation (Spiriva Respimat®▼) for asthma in children and young people
The Pan Mersey Area Prescribing Committee does not currently recommend the prescribing of TIOTROPIUM inhalation (Spiriva Respimat®) for asthma in children and young people < 18 years of age. 

Safety Update

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

Class 3 Medicines Recall: Latanoprost Timolol Eye Drops
Medicines and Health Products Regulatory Agency | 02 May 2018
FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing.

Public Health England issues guidance for local areas on planning to deal with illicit fentanyl or other potent opioid entering the market
Public Health England | 08 May 2018
This guide should enable local partners to rapidly understand the scale of the threat of illicit drugs entering the market, and assess the risk, communicate the threat, and take actions to mitigate the threat.

Influenza Season 2017/18: Use of Antiviral Medicines
Medicines and Health Products Regulatory Agency | 09 May 2018
GPs and other prescribers working in primary care should no longer prescribe antiviral medicines, for the prophylaxis and treatment of influenza on an FP10 prescription form.

Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension - company led recall Medicines and Health Products
Regulatory Agency | 16 May 2018
Rosemont Pharmaceuticals Limited, MS 427 is issuing a company-led drug alert for an unlicensed medicine Phenytoin 90mg/5ml Oral Suspension (CLDA (18)A/02).

Home use and Point of Care blood glucose monitoring system: Accu-Chek Aviva, Accu-Chek Performa and Accu-Chek Inform II test strips – risk of strip error messages and false high and low blood glucose results
Medicines and Health Products Regulatory Agency | 18 May 2018
Affected test strips, manufactured by Roche Diabetes Care, may give increased strip error messages prior to dosing with blood and in some cases may give false high or low readings, which may be hard to detect.

Pharmacovigilance Risk Assessment Committee (PRAC) recommends new measures to minimise risk of rare but serious liver injury with ulipristal acetate (Esmya) for fibroids in EU
European Medicines Agency | 21 May 2018
The PRAC has concluded that ulipristal acetate (Esmya) may have contributed to the development of some cases of serious liver injury and must not be used in women with liver problems and that regular liver tests will need to be performed in new patients.

Valproate medicines (Epilim▼, Depakote▼): Pregnancy Prevention Programme materials online
Medicines and Health Products Regulatory Agency | 25 May 2018
The Marketing Authorisation Holder for Epilim has produced new materials to support the Pregnancy Prevention Programme – branded as Prevent. These are available online and will be posted to healthcare professionals in the coming weeks. Once received, dispose of any old materials.

Braltus (tiotropium): risk of inhalation of capsule if placed in the mouthpiece of the inhaler
Medicines and Health Products Regulatory Agency | 25 May 2018
Two Yellow Card reports of patients who have inhaled a Braltus capsule from the mouthpiece into the back of the throat have been received. Health professionals advised to train patients in correct inhaler technique, store capsules in original bottle and check mouthpiece is clear.

 

Prescribing News

NICE Guidance May 2018

There have been no guidelines published in May 2018 by the National Institute for Clinical Excellence.


CKS Updates May 2018

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

·       Acne vulgaris
·       Acute kidney injury
·       Conduct disorders in children and young people
·       Ectopic pregnancy
·       Fungal skin infection – scalp
·       Infertility
·       Smoking cessation
 

There have been substantial changes to some of the topics listed above.  Notably, the Fungal skin infection – scalp topic, has had complications and prognosis notes added to the background information and a differential diagnosis note has been added to the diagnosis section. For the Smoking cessation topic, recommendations regarding e-cigarettes have been added. Additionally, there is now advice added on smoking cessation in adults and pregnant women. Clinicians can use this updated information when reviewing their current clinical practice when reviewing patients.

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 June 2018

New issues
 
Diamorphine injection
 
Last month, The Department of Health and Social Care (DHSC) first wrote about a manufacturing issue with one of the suppliers of diamorphine 5mg and 10mg injection.
DHSC and NHSE have since been working with Accord and their supplier in Germany and the manufacture of diamorphine 5mg and 10mg injection will soon resume with an anticipated resupply date of beginning of September 2018. DHSC and NHSE have also been working with the remaining supplier, Wockhardt, to support the supply issue. Wockhardt have been able to increase their production of diamorphine 5mg and 10mg but are unable to support the entire market in July and August.
A management plan has been developed to manage the supply issue during July and August 2018:

Management plan from 1st July 2018:
  • Primary care and drug misuse centres will be able to continue to order diamorphine in line with historical demand.
  • Secondary care will have access to restricted supplies of diamorphine
Recommended Local Action- Primary care and drug misuse centres
  • Although you will be able to access diamorphine as per historical demand, prescribers are encouraged to be aware of the supply issues and reduce prescribing where appropriate.
  • Please order responsibly during this time, in line with historical demand and do not stock pile to avoid lengthening the stock out period.
  • In the case that diamorphine cannot be accessed, please refer to the clinical guidance issued by UKMI which provides more information on suggested alternatives to diamorphine:  The first-choice is morphine which is given in detail in this link. If you require clinical guidance locally – please liaise with secondary care prescribing partners in substance misuse services or pain specialist services.
  • Further information which you may wish to review include the Patient Safety Alert on high dose morphine and diamorphine  
  • Additional information for patients can be accessed here
Distribution Arrangements (From 1st July)
  • Diamorphine 5mg and 10mg will only be available to order from Alliance. No minimum surcharges will be levied
  • Morphine 10mg injection (Martindale) available to order from AAH only.
  • Diamorphine 30mg injection (Wockhardt), diamorphine 100mg (Accord) and diamorphine 500mg (Accord and Wockhardt) – usual wholesalers.
 For further information on ordering processes please contact:
Alliance -  Phone Number: 0330 1000 448 (customerservice@alliance-healthcare.co.uk)
AAH -  Phone Number: 0344 561 8899
 
Diazepam 5mg/ml Emulsion for injection (Diazemuls)
 
Accord, the sole supplier of diazepam emulsion for injection, will be out of stock of this product until mid-August 2018 due to an issue with the raw material. UKMI have prepared the following advice on alternatives, which can be found here

This suggests the following products as possible alternatives and contact has been made with all the suppliers to make them aware of the issue:
o   Ativan (lorazepam 4mg/ml)- Pfizer in stock
o   Buccolam (Midazolam buccal)- Shire are in stock of all strengths
o   Diazepam rectal tubes- see information below
 
Diazepam Rectal tubes
 
Wockhardt, the sole supplier of diazepam 2.5mg rectal tubes is currently out of stock until July. Wockhardt are also out of stock of the 5mg and 10mg. Diazepam 5mg and 10mg rectal tubes continue to be available from Accord and Desitin.
 
Colestyramine (Questran)
 
There are currently manufacturing issues affecting the colestyramine products, Questran Powder for Oral suspension 4g and Questran light. Supplies of both are expected to be depleted from early June. Further supplies of Questran light are currently expected in early July and by the end of July for the other formulation.
 
Advice from UKMi on suitable alternatives can be found here
 
Phenobarbital injection
 
Martindale are the sole supplier of phenobarbital injection and they are currently out of stock of the 30mg and 60mg presentations. This issue is due to regulatory changes with the British Pharmacopoeia monograph for phenobarbital. Work has been undertaken with both Martindale and the MHRA to resolve this issue and a batch of 200mg has been released. Supplies should now be available via AAH.
 
The timescales for further supplies of the remaining strengths are not yet confirmed but work is continuing towards making these available as soon as possible.
 
UKMI have prepared the following shortages memo, which has now been published on the SPS website . This provides advice on possible alternatives and they have also provided information on using the 200mg product in place of the lower strengths if needed.
 
Adalat LA20 

Bayer are out of stock of Adalat LA 20 tablets. Estimated resupply date Mid July 2018. Other brands of Nifedipine in a 20mg modified/prolonged release formation remain available including;
  • Adipine (Chiesi)
  • Coracten (UCB)
  • Nifedipress (Dexcel)
  • Tensipine (Genus)
Ongoing Issues:

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

Copyright © 2018 Midlands & Lancashire Commissioning Support Unit, All rights reserved.

Our mailing address is:
MLCSU.Tablets@nhs.net


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