Medicines Updates

Medicines Updates

January 30, 2019

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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