January 30, 2019
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.