Medicines Updates

Medicines Updates

January 30, 2019

21.06.2019

Shortage Notice: Disopyramide 100mg/150mg capsules
Sanofi and Mylan, the manufacturers of Disopyramide 100mg and 150mg capsules, are currently experiencing temporary disruptions.

Sanofi and Mylan will be out of stock of Disopyramide 100mg capsules from approximately mid-June 2019 to late-July 2019.
Mylan will be out of stock of the Disopyramide 150mg capsules from approximately mid-August 2019 till mid-September 2019. 

More information and details of alternative products can be found here on the Supply Disruption Alert

Enquiries about this notice should be sent to the DHSC Supply Resilience Team, quoting reference number SDA/2019/002 or email: supplyresiliencemd@dhsc.gov.uk 

Supply Status Update: EpiPen® 0.3mg and 0.15mg Adrenaline Auto-Injectors
Mylan’s manufacturing partner Meridian Medical Technologies, a subsidiary of Pfizer that manufactures EpiPen®, recently experienced manufacturing issues resulting in interruptions in the production of EpiPen 0.3mg and EpiPen Jr 0.15mg Adrenaline Auto-Injectors (AAIs).

To help manage stock availability until a steady supply resumes, Mylan has put in place a prescription-only process for EpiPen 0.3mg, meaning patients can obtain up to a maximum of two EpiPen 0.3mg AAIs per prescription.

The prescription-only process does not affect EpiPen Jr 0.15mg.

Pharmacies presented with a prescription for EpiPen 0.3mg Auto-Injectors (up to a maximum of two devices per prescription) are requested to send anonymized prescriptions along with your Alliance Healthcare account number to Alliance Healthcare’s prescription validation service, either by fax 0330 332 8126 or email scriptvalidation@alliance-healthcare.co.uk

Additional advice and information can be found on the Anaphylaxis campaign website here.

For more information please see www.epipen.co.uk

Important message from the Pharmacy and Medicines Optimisation Team – HMMC December 2018 and February 2019 recommendations
These are the latest versions of the Hertfordshire Medicines Management Committee (HMMC) recommendations summary spreadsheets for NHS East and North Hertfordshire CCG and NHS Herts Valleys CCG. These documents have been filtered for December 2018 and February 2019 and to display the decisions that are most relevant to primary care. The recommendations likely to have most impact on primary care are summarised below:

Nutrition support guidance for care homes – New guidelines (recommended for use):
Provides guidance for care homes on their responsibilities with regards to monitoring and treating malnutrition. Algorithms available for:

  • Low, medium and high risk (MUST) resident management
  • Referring a resident to a dietitian for malnutrition.

Cannabis-based medicinal preparations (unlicensed) – New guidance statement (recommended for use)
Prescribing of unlicensed cannabis-based medicinal preparations is restricted to clinicians listed on the Specialist Register of the General Medical Council. Prescribing by GPs is not permitted.

Emollient guidelines – guidelines updated (recommended for use)
Emollients costing less than £5 per 500g or 500ml updated with additional options. Key additions to note:

  • ExCetra® cream similar lipid profile to Cetraben® cream
  • Epimax® ointment similar lipid profile to Cetraben®, Epaderm® and Zeroderm® ointments
  • Epimax® oatmeal cream – not identical to Aveeno® but an oatmeal containing option
  • Aproderm® ointment – similar lipid profile to Diprobase® ointment
  • Epimax® paraffin-Free added as an option – consider if fire risk is a significant issue – post risk-assessment

Inhaled corticosteroids step-down guidance and algorithms in groups A and B COPD patients – New resources (recommended for use)

  • Guidance: flowchart on eligibility, process and follow-up of stepping down ICS in groups A and B COPD patients
  • Algorithms: support how to step down patients on specific ICS/LABA products

Insulin degludec for type 1 and type 2 diabetes mellitus AMBER INITIATION (recommended for initiation by specialists with prescribing continued by GPs)
Guidance recommendations extended for restricted use in certain Type 2 diabetics. Initiation, titration and stabilisation undertaken by specialists. Once stabilised for continuation in primary care. Prescribe by brand (Tresiba®) and restricted to 100units/ml strength to minimise risk of error with the higher 200units/ml strength.

Omega-3 fatty acids for reduction of pancreatitis risk in severe hypertriglyceridaemia AMBER INITIATION (recommended for initiation by specialists with prescribing continued by GPs)
Recommended for restricted use as an option for secondary prevention of pancreatitis for the treatment of severe hypertriglyceridaemia if triglyceride levels are ≥10mmol/L despite addressing secondary causes, uptake of lifestyle changes and pharmacological therapy. For all other indications omega-3 fatty acid compounds remain DOUBLE RED.

Semaglutide (Ozempic®) for the treatment of type 2 diabetes mellitus AMBER INITIATION (recommended for initiation by specialists with prescribing continued by GPs)
New once weekly GLP-1 analogue. Recommended as a GLP-1 receptor agonist option when a GLP-1 receptor agonist is indicated as add-on therapy in line with NICE guideline 28 for type 2 diabetes in adults.

Testosterone undecanoate (Nebido®) for male isolated primary hypogonadism (adults) AMBER INITIATION (recommended for initiation by specialists with prescribing continued by GPs)
An option in adults for testosterone replacement therapy in isolated primary male hypogonadism when testosterone deficiency has been confirmed by the specialist through clinical features and biochemical tests. Prescribing support document is available.

Ulipristal acetate (Esmya®) for uterine fibroidsDOUBLE RED (not recommended for primary or secondary prescribing)
Not recommended for treatment of uterine fibroids following link with cases of serious liver injury and the publication of the MHRA Drug Safety Updates. HMMC recommended that Esmya® should remain as ‘double red’ and this is supported by local specialists.

Please can you circulate to all relevant pharmacists & staff within your community pharmacy. Please consider these recommendations during interactions with patients. Also you may wish to review your pharmacy’s stock levels & re-order quantities of the affected medicines and adjust them accordingly.

The summary spreadsheets, recommendation documents and guidelines have been added to http://www.enhertsccg.nhs.uk/local-decisions (for NHS East and North Hertfordshire CCG) and https://hertsvalleysccg.nhs.uk/clinicians/medicines-guidance (for NHS Herts Valleys CCG).

The recommendations have been circulated to primary care prescribers in Hertfordshire and also to local provider Trusts and Herts Urgent Care. Please contact your locality Pharmaceutical Adviser if you have any questions.

MHRA Drug Safety Update June 2019
A new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (Vol 12 Issue 11 June 2019:1) has been published and includes articles on:

  • Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
  • GLP-1 receptor agonists: reports of diabetic ketoacidosis when concomitant insulin was rapidly reduced or discontinued
  • Lartruvo▼ (olaratumab): withdrawal of the EU marketing authorisation due to lack of efficacy
  • Oral retinoid medicines▼: revised and simplified pregnancy prevention educational materials for healthcare professionals and women
  • Letters and drug alerts sent to healthcare professionals in May 2019
  • Medical Device Alerts issued in April 2019

To see the latest MHRA Drug Safety Update in full, visit the GOV.uk website.

Updated emollient guidelines and GP reviews to OTC or lower cost products

As part of the OTC reviews in practices there will be many practices undertaking reviews of patients with OTC emollients – they may direct patients to buy OTC, or where FP10 is felt appropriate there may be a change to a lower cost product in line with the formulary.  Pharmacies may need to alter stocks accordingly.

Updated emollient guidelines are here

Key changes to the emollient guidelines are:

  1. To update the list of emollients costing less than £5 per 500g or 500ml

With the introduction of new products to market, the current list of emollients <£5 per 500g or 500ml has become out of date and hence reviewed and updated..

  1. To include a paraffin-free emollient option for a small cohort of patients who have been risk-assessed as having a fire-risk and concluded to require such a product.

The options have been reviewed and Epimax® paraffin-free ointment has been added https://www.gov.uk/drug-safety-update/paraffin-based-skin-emollients-on-dressings-or-clothing-fire-risk

  1. To replace Cetraben® cream with ExCetra® Cream as 2nd line formulary choice for  moisturising of frail skin including ulcer care

 

Practices reviewing emollients

See page 3 with lists of emollients and the ‘similar’ lipid profile alternatives – this may be useful if OTC is not appropriate, there is need to continue an emollient on FP10, but one which meets the <£5/500g criteria.

Aveeno (>£5/500ml)  is a high spend emollient in the CCG – although Aveeno is not listed in the sheet, the Epimax oatmeal cream is an alternative.  Others exist e.g. Aproderm colloidal oat and Zeroveen.

 

14.06.2019

Class 2 MHRA Medicines recall: Paracetamol 500mg Tablets (M & A Pharmachem Limited)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 pharmacy level medicines recall, to be actioned within 48 hours, for certain batches of  Paracetamol 500mg tablets. M & A Pharmachem is recalling certain batches because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination. The fungi have been identified as Penicillium citrinium and Penicillium brevicompactum.
Community pharmacy teams should stop supplying the products/batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
To view the alert please visit the GOV.UK website.

MHRA Central Alerting System: Epanutin (Phenytoin) 30mg/5ml Oral Suspension – Supply Disruption
The Medicines and Healthcare products Regulatory Agency (MHRA) have given the update, Pfizer Epanutin® (phenytoin) 30mg/5ml oral suspension will be out of stock from the week commencing 10 June 2019 until late July 2019.

This alert gives advice for all healthcare professionals who prescribe, dispense or administer Epanutin oral suspension. The alert also makes reference to unlicensed preparations, the Patient Information Leaflet (PIL) and product monograph is included.

Regulatory changes include provision for Serious Shortage Protocols
PSNC advised, amendments to the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 have been laid before Parliament.
Due to come into force from Monday 01 July 2019, these amendments will introduce the Serious Shortage Protocols (SSPs) into the terms of service for NHS community pharmacies. This means that, where an SSP is in place for a particular product, a retail pharmacy business or a dispensing appliance contractor must consider supplying in accordance with the SSP rather than fulfilling an NHS prescription for that product. It may, instead of fulfilling the NHS prescription, supply a different product, or a different quantity of the ordered product, in the circumstances and subject to the conditions set out in the SSP.
SSP legislation was first introduced in February 2019, as part of (but is not dependent on) no-deal Brexit planning, to enable the Health and Social Care Secretary to put in place alternative arrangements for supply where a drug or appliance is ordered on prescription but there is, or may in the future be, a serious shortage of that drug or appliance.
PSNC has been working with DHSC and with PMR system suppliers to agree the endorsements, fees and paperwork that will be associated with SSPs.
PSNC will provide a briefing next week and further guidance to explain what this will mean for community pharmacy teams in due course.
Further information on SSPs can be found on PSNC website. 

AstraZeneca announce changes to their distribution arrangements
AstraZeneca have announced that from 01 July 2019 AAH Pharmaceuticals Ltd will be the solus distributor for all AstraZeneca products to pharmacies in the UK.
You can read AstraZeneca’s announcement to pharmacy here.
If you have questions regarding the change to AstraZeneca’s changes to distribution please contact AstraZeneca’s Supply Chain team on supply.chain@astrazeneca.com
If you do not already have an AAH account you can contact AAH via their website www.aah.co.uk or call 0344 561 2008.

 

07.06.2019

May 2019 Price Concessions – Final update
The Department of Health and Social Care (DHSC) has set the FINAL price concessions for May 2019 detailed on PSNC website.

Important Message from the Controlled Drugs Accountable Officer
The NHS England Medication Safety Officer for Midlands and East of England would like to bring the following reminder to your attention:

CD Prescriptions
To prevent any CDs getting into the wrong hands, any pharmacists receiving post-dated CD prescriptions should please ensure that they are double checking if they are still needed before dispensing and handing them out.

Sharps Bins
All sharps bins must be secure and out of reach of members of the general public. Sharps bins are being stolen from hospitals and the remains from any syringes being used. Whilst it is unlikely in community pharmacy that any syringes would contain these remains the people stealing these bins are not aware of that so please ensure the bins are out of reach.

Please remember that the Hertfordshire LPC website contains the controlled drug newsletters with important messages and shared learning along with further information including key contact details for the CD team for any concerns and issues.

24.05.2019

May 2019 Price Concessions – 1st and 2nd update
The Department of Health and Social Care (DHSC) has granted the second updated list of price concessions detailed on the PSNC website.

Diamorphine 5mg injections, Microgynon 30 and Ovranette tablets – Supply update
Diamorphine 5mg injections
Accord and Wockhardt have notified the Department of Health and Social Care (DHSC) and NHS England (NHSE) that they are experiencing issues with the manufacture and availability of Diamorphine 5mg injections. There is an anticipated out of stock period between 27th May 2019 and w/c 5th August 2019. It is expected that there will be sufficient supplies of Diamorphine 10mg injections to support the forecasted use of the 5mg via usual wholesalers. Please see the communication from DHSC for further information.

Microgynon 30 tablets
Bayer has notified DHSC that Microgynon 30 tablets will be out of stock from late May until w/c 8th July (wholesalers may have residual stock until early June), this is due to capacity constraints at their manufacturing site in Germany. Please see the communication from Bayer and DHSC for further information.

Ovranette tablets 
Pfizer have notified DHSC they will be out of stock of Ovranette tablets from early June until August 2019 due to capacity constraints.
As both Microgynon 30 and Ovranette contain ethinylestradiol 30microgram/levonorgestrel 150microgram there are several alternative suppliers, DHSC has been advised there are sufficient supplies available from certain suppliers to maintain demand throughout the duration of this supply issue. Further details can be found in the DHSC communication.

MHRA Drug Safety Update May 2019
A new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (Vol 12 Issue 10 May 2019:1) has been published and includes articles on:

  • Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements.
  • Tofacitinib (Xeljanz ▼) : restriction of 10mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing.
  • Magnesium sulfate: risk of skeletal adverse effects in the neonate following prolonged or repeated use in pregnancy.
  • Yellow Card: Please help to reverse the decline in reporting of suspected adverse drug reactions.
  • Letters and drug alerts sent to healthcare professionals in April 2019
  • Medical Device Alerts issued in April 2019

To see the latest MHRA Drug Safety Update in full, visit the GOV.uk website.

Drug Tariff Watch: June 2019 changes
PSNC has published a summary of the changes due to take place in the Drug Tariff from 1 June 2019 available on their website.

17.05.2019

Class 2 MHRA Medicines Recall – Co-amoxiclav 125mg/31.25mg/5ml & 250mg/62.5mg/5ml powder for oral suspension (Sandoz Ltd)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 pharmacy level medicines recall, to be actioned within 48 hours, for certain batches of co-amoxiclav 125mg/31.25mg/5ml powder for oral suspension and 250mg/62.5mg/5ml powder for oral suspension. Sandoz Limited is recalling certain batches from pharmacies as a precautionary measure due to a potential packaging problem relating to poor seal adherence which could cause clumping of the powder within the bottle. A poor bottle seal could lead to degradation of the clavulanic acid within the powder and could potentially render the product ineffective.

To view the alert please visit the GOV.UK website.

Hospitalisation And Deaths Linked To Consumption Of 2,4-Dinitrophenol (Dnp)
This alert provides advice on the latest intelligence regarding hospitalisations and deaths reported across the UK relating to the consumption of 2,4-dinitrophenol (DNP), and to underscore the need for rapid treatment in cases of suspected DNP poisoning. Community Pharmacy could see patients who have consumed 2,4-dinitrophenol (DNP).

Full details of this alert are available via the Central Alerting System.

Hormone Replacement Therapy products (HRT)
We have been advised of recent HRT shortages and would like to bring the following information to your attention.

FemSeven Products

  • Theramex, the supplier of FemSeven Conti and Sequi patches are experiencing long term supply issues affecting both products and expect to be out of stock until late 2019.
  • This supply issue does not affect supplies of FemSeven Mono.
  • Supplies of other HRT patches and products continue to remain available.

Elleste Range

  • Mylan, the sole manufacturer of the Elleste HRT product line has reported that some of the Elleste range (Elleste Solo 1mg, 2mg; Elleste Duet Conti; Elleste Duet 1mg) are currently unavailable due to manufacturing issues.
  • The resupply date for the Elleste range is now expected to be the end of June 2019.
  • As per UKMI advice, please see the table below for equivalent alternatives currently available on the market, if required.

 

Table 1. Equivalent HRT alternatives for the Elleste HRT range Brand Ingredient(s) Current
Availability
Equivalent Ingredient(s) Current Availability
Elleste Solo 1mg estradiol hemihydrate Out of stock Progynova 1mg estradiol hemihydrate In Stock
Zumenon 1mg In Stock
Elleste Solo 2mg estradiol hemihydrate Out of Stock Progynova 2mg estradiol hemihydrate In Stock
Zumenon 2mg In Stock
Elleste Duet Conti estradiol 2mg/ norethisterone 1mg Out of Stock Kliofem estradiol 2mg/ norethisterone 1mg In Stock
Elleste Duet 1mg estradiol 1mg/ norethisterone 1mg Out of Stock NovoFem estradiol 1mg/ norethisterone 1mg In Stock

Pharmacies are reminded that there are useful websites regarding regular updates on out-of-stocks and alternatives as outlined below:

  • Specialist Pharmacy Services (SPS) website that outlines alternative products that pharmacists could suggest to GPs.
  • PSNC website that summarises the contingency arrangements for the manufacturers and products that PSNC is currently most frequently receiving calls about.

Sinemet – Supply update and notice of change of appearance
Supply Update
Merck Sharp & Dohme Limited (MSD) are still experiencing intermittent supply issues which are expected to continue until early June with the following products:

  • Sinemet 25mg/250mg 10×10 tablets.
  • Sinemet 12.5mg/50mg 9×10 tablets.
  • Sinemet CR 50mg/200mg 6×10 tablets.
  • Sinemet plus 10mg/100mg 10×10 tablets.

MSD have confirmed the following Sinemet products should now be available:

  • Sinemet Plus 25mg/100mg 10×10 tablets.
  • Sinemet Half CR 25mg/100mg 6×10 tablets.

Change of appearance
With a view to providing a more consistent supply MSD have moved manufacturing of 3 Sinemet products to another manufacturing site. This move means that the appearance of 3 Sinemet products will change from round to oval.
The 3 products that will change their appearance from early May are:

  • Sinemet 10mg/100mg tablets
  • Sinemet 10mg/100mg tablets
  • Sinemet Plus 25mg/100mg tablets

Full details are available on the PSNC website.

10.05.2019

MHRA Company-led recall – Macopharma intravenous infusion bags (Macopharma)
Macopharma has informed MHRA that it is recalling certain batches of intravenous infusion bags as a precaution. This is due to the detection of metal particles in two infusion bags. No incidents have been reported in the UK.

Pharmacy teams are asked to quarantine any stock from the affected products and batches detailed in the alert and then notify Macopharma Customer Services.

Full information is available on the PSNC website.

End of antiviral medicine prescribing for 2018/19 influenza season
In light of surveillance data indicating that circulation of influenza in the community has returned to baseline levels, the Department of Health and Social Care has published an alert to inform prescribers working in primary care and pharmacy teams that antiviral medicines should no longer be prescribed.

Community pharmacists should no longer supply antiviral medicines for the prophylaxis and treatment of influenza on a FP10 prescription form. Further information is available on the prescribing and supply of antivirals alert.

18.04.2019

Important Reminder Freestule Libre®

Please remember that in the interim, current guidance and funding arrangements remain in place Flash Glucose Monitoring (Freestyle Libre) and are available on the Herts Valleys CCG website and the East and North Hertfordshire CCG website. Primary care prescribing is not recommended. FreeStyle Libre® is to be initiated, managed and supplied by a specialist led diabetes team only.
Whilst there have been national funding arrangements issued by NHS England on 7 March 2019, both local CCGs are currently reviewing and updating their guidance in light of these national arrangements but this has not yet been implemented locally. Please do not advise patients to alter their current regime, even if they are eligible because access to Flash Glucose Monitoring (Freestyle Libre) on the NHS is strictly controlled.

 

05.04.2019 – The national funding arrangements for Flash Glucose Monitoring (Freestyle Libre®) were issued by NHS England on 7 March 2019 and the LPC published information for community pharmacies from PSNC in its e-news on 15 March 2019. The funding arrangements from NHS England outline the reimbursement available to CCGs for relevant diabetes patients that meet NHS England criteria. Both local CCGs are reviewing and updating their current guidance in light of the national arrangements.

In the interim, current guidance and funding arrangements remain in place and are available on the Herts Valleys CCG website and the East and North Hertfordshire CCG website. Primary care prescribing is not recommended. FreeStyle Libre® is to be initiated, managed and supplied by a hospital Trust consultant led specialist diabetes team only. You will be informed if anything changes.

05.04.2019 – Class 4 MHRA Drug Alert: Zoledronic acid 5mg solution for infusion (Sun Pharmaceutical Industries Europe BV)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for Zoledronic acid 5mg solution for infusion (Sun Pharmaceutical Industries Europe BV).
To view the alert please visit the GOV.UK website.

22.03.2019 – Class 2 MHRA Medicines recall: Losartan Potassium 50mg and 100mg Film-coated Tablets (Accord Healthcare Limited)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 pharmacy level medicines recall, to be actioned within 48 hours, for certain batches of  Losartan 50mg and 100mg containing products. Accord Healthcare Limited is recalling identified batches from pharmacies as a precautionary measure due to possible contamination with N-nitroso-N-methylamino butyric acid (NMBA),
Community pharmacy teams should stop supplying the relevant products/batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
To view the alert please visit the GOV.UK website.

 

15.03.2019 – Access to Freestyle Libre is widening for Type 1 diabetes patients
From 1 April 2019, community pharmacy teams may see an increase in prescriptions for Freestyle Libre sensors following a growth in funding which will allow access to flash glucose monitoring throughout the country.

In 2018, NHS England announced that there will be an end to the current variation patients in some parts of the country are facing in accessing Freestyle Libre. NHS England has now published guidance that sets out the eligibility criteria for flash glucose monitoring and the maximum amounts that CCGs will be reimbursed for the ongoing costs of flash glucose sensors.

Freestyle Libre sensors are listed as an Appliance in Part IXA of the Drug Tariff which can be dispensed against NHS prescriptions. The sensors can only be ordered directly from Abbott through their pharmacy ordering portal.

PSNC has a resource relating to dispensing appliances and includes FAQs you may find helpful.

EMIS to join national roll-out of EPS CDs
EMIS plans to implement EPS Controlled Drugs (CDs) for all of their GP practices between Monday 25 March and Monday 8 April 2019. This follows the recent announcement that Vision and TPP have rolled out EPS CDs to their GP practices.

Once the EMIS rollout commences, it will result in a further substantial increase in the number of CD prescriptions that community pharmacies receive via EPS. It therefore continues to be important that all pharmacy staff, including locums, are aware of the roll-out and are prepared to dispense an electronic prescription for a Schedule 2 or 3 CD.

If you receive a prescription for a Schedule 2 or 3 CD via EPS, you should dispense it as you would any other electronic prescription.

Pharmacy teams may find it useful to check when local GP practices are going live by checking the roll-out schedule on the NHS Digital website.

 

15.03.2019 – Reclassification of gabapentin and pregabalin as CDs from 01 April 2019 – update
Community pharmacy teams are reminded that from 01 April 2019, pregabalin and gabapentin will be reclassified as Schedule 3 Controlled Drugs (CDs).

NHS England has published a guidance document providing information on changes to the law relating to the reclassification of the drugs gabapentin and pregabalin and a patient leaflet informing patients of the changes and how it will affect them.

Pharmacy teams are also reminded of the national roll-out of Schedule 2 and 3 CDs in EPS. This means that the number of CD prescriptions that pharmacies receive via EPS will increase significantly as more GP practices have the functionality switched on.

PSNC’s updated briefing provides detailed information for community pharmacy teams with answers to some commonly raised questions.

Supply issues Carbagen (carbamazepine) various preparations information from DHSC
As carbamazepine is considered a Category 1* anti-epileptic medication, patients should normally be maintained on the same brand, however Mylan (the manufacturers of Carbagen) have informed DHSC that the following preparations of Carbagen (carbamazepine) tablet will be unavailable until mid-late 2019.

The affected products are listed below:

  • Carbagen 200mg and 400mg Immediate Release Tablets – unavailable until mid-2019
  • Carbagen 200mg  and 400mg Modified Release Tablets – unavailable until late 2019

Patients currently prescribed Carbagen tablets by brand will therefore need to be switched to an alternative brand of carbamazepine tablets during this time.

Novartis, the manufacturer of Tegretol which is the alternative brand of carbamazepine, tablets have confirmed that they are able to support additional demand during this time for all affected strengths and formulations.

DHSC have worked with NHSE, NHSI and UK Medicines Information  to develop aclinical memo, which has been produced to support clinicians in prioritising and switching patients during this period.

Clinicians and pharmacists should identify potentially affected patients as soon as possible and ensure they are managed appropriately.

*There are clear indications that clinically relevant differences between different manufacturers’ products might occur, even when the pharmaceutical forms are the same and bioequivalence has been shown.
28.02.2019 – Metoprolol 50mg and 100mg tablets

  • DHSC has been made aware of an ongoing supply issue with the following two products:
    • Metoprolol 50mg tablets
    • Metoprolol 100mg tablets.
  • The issue has been caused because of some manufacturers discontinuing the products and others having supply difficulties.
  • Milpharm/Aurobindo, are currently the sole supplier of both presentations to the UK market.
  • Supplies of both presentations are currently available but may be limited, further stock is arriving over the coming weeks however supply is likely to be intermittent for a number of months.
  • If patients are having difficulty obtaining metoprolol, they may need to be switched to an appropriate alternative treatment.
  • Please see a memo which had been developed by UK Medicine Information with input from national experts at NHSE and NHSI, which advises on management options for patients affected by this supply issue, including the use of alternative beta blockers, dosing information for these alternative beta blockers and monitoring requirements.
  • This is available on the SPS website at the following link: https://www.sps.nhs.uk/articles/shoratge-of-metoprolol-50mg-and-100mg-tablets/
  • Suppliers of alternative beta blockers have been contacted to determine if they can meet any additional demand and currently, the manufacturer of carvedilol has indicated it would be unable to meet demand if patients were switched to this product. Manufacturers of bisoprolol, atenolol and propranolol have indicated they have capacity to support any additional demand on their products.
  • DHSC are continuing to work with the manufacturers Milpharm/Aurobindo, to expedite future deliveries will continue to monitor the overall situation.

 

 

MHRA medical device alert – FreeStyle Libre flash glucose sensor (Abbott) – Use of barrier methods to reduce skin reactions to the sensor adhesive
MHRA is aware that some users of the FreeStyle Libre flash glucose monitoring system are applying barrier creams, patches and sprays before attaching the sensor to reduce skin reactions. These barrier methods have not been tested by the manufacturer and may therefore affect the performance of the device.

The severity of the skin reaction can vary from person to person and for certain users this is a skin hypersensitivity reaction rather than an irritation reaction. For this type of reaction, once the person has become sensitised to the adhesive, every time the sensor is reapplied a skin reaction will occur. With each reapplication, the symptoms might appear more quickly and may worsen.

The manufacturer has confirmed that they have revised the formulation of the adhesive, which will be available to UK customers from April 2019. Please note this problem may not be unique to the Abbott FreeStyle Libre sensor adhesive. The same actions should be taken if patients experience similar symptoms with a different brand of continuous glucose monitoring system.

Full details on the MHRA alert and actions that pharmacies should take is available on the PSNC website.

Part VIIIB February 2019 Drug Tariff changes
Please note that some unlicensed (special) products will be deleted from Part VIIIB of the Drug Tariff replaced with licensed alternatives along with one addition effective from 1 February 2019. Any changes to Part VIII of the Drug Tariff impacts reimbursement so it is important to take note when amendments are made to product listings.

Full details regarding the changes are available on the PSNC website.

January 2019 Price Concessions/NCSO – Final update
The Department of Health and Social Care (DHSC) has granted the final list of price concessions for January 2019, detailed on the PSNC website

 

Interruption to supply of Clexane 40mg/0.4ml solution for injection pre-filled syringes
Sanofi have advised NHS England and Department of Health and Social Care (DHSC) that there has been a quality issue with a batch of Clexane 40mg that was due to arrive in January 2019.

It is expected that all wholesalers will currently be out of stock. Further stocks are anticipated mid-February 2019.

To cover the anticipated shortfall in stock available, Sanofi have imported Clexane 40mg from Italy, this will be classed as licensed in the UK. Sanofi are working with Medicines and Healthcare products Regulatory Agency (MHRA) to make this available from 23 January 2019, via usual ordering methods.

Key differences that community pharmacy teams need to be aware of are outlined on the PSNC website along with key actions for community pharmacy teams.

Class 2 MHRA Medicines Recall: Irbesartan 150mg and 300mg tablets (Macleods Pharma UK Limited)
Drug alert number: EL (19) A/02
Date issued: 24th January 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 pharmacy level medicines recall, to be actioned within 48 hours, for certain batches of  Irbesartan containing products. Macleods Pharma UK Limited is recalling the batches identified below from pharmacies as a precautionary measure due to possible contamination with N-nitrosodiethylamine (NDEA).

To view the alert please visit the GOV.UK website.




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