MHRA (Medicines and healthcare products regulatory agency)


22.02.2019

MHRA medical device alert – Accu-Chek Insight insulin pumps – some need to be fitted with key frames to reduce the risk of accidentally unlocking keys or pressing the bolus buttons
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for the above product manufactured by Roche Diabetes Care. It includes important instructions on how to fit 2 separate key frames to prevent accidentally activating the pump (MDA/2019/009).

To view the alert and full information please visit the GOV.UK website.

MHRA Drug Safety Update February 2019
A new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (Vol 12 Issue 7 February 2019:1) has been published and is available on the GOV.UK website.

Class 4 MHRA Drug Alert – Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe (Laboratoire Aguettant)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for certain batches of Atropine Sulfate 3mg/10ml Solution for Injection in pre-filled syringe (Laboratoire Aguettant).

To view the alert and full details please visit the Central Alerting System website.

Shortage of Valproate (Epilim and Depakote) Preparations
Sanofi have issued a statement regarding the supply of all their valproate preparations (Epilim and Depakote)
Temporary disruption is expected until mid-March 2019, this is due to temporary disruption at a Sanofi manufacturing site, leading to lower stock levels than usual.
Additionally, following a request from the Medicines and Healthcare Regulatory Agency (MHRA), pack sizes of valproate have been changed from 100 to 30 tablets. Therefore, the packs of 100 may appear as “unavailable” on ordering systems and the packs of 30 should be selected instead.
Community pharmacy teams are recommended to check the pack size of the product being ordered, and if experiencing any difficulty in obtaining stock to contact the Sanofi customer service team on 01483 505515 so they can assist and help resolve the issue. If stock isn’t available, you may need to contact the prescriber for an alternative preparation.

15.02.2019

Class 2 MHRA Medicines Recall: Irbesartan / Hydrochlorothiazide (Actavis Group PTC EHF)
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 / Hydrochlorothiazide containing products. Actavis Group PTC EHF is recalling certain batches from pharmacies as a precautionary measure due to possible contamination with N-nitrosodiethylamine (NDEA).

To view the alert please visit the GOV.UK website
08.02.2019

Class 4 MHRA Drug Alert – Amoxicillin 500mg capsules BP (Accord)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for certain batches of Amoxicillin 500mg capsules (Accord).

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

Shortage of Carbagen (carbamazepine) tablets
Specialist Pharmacy Service (SPS) advises that there is currently a shortage of Carbagen 200mg and 400mg immediate release (IR) tablets and 200mg and 400mg prolonged release (PR) tablets.

The PR 200mg and 400mg tablets are expected back in stock in late 2019, while the 200mg IR are expected at the end of Q2 2019 and the 400mg IR in late 2019.

Further advice can be found on the SPS website.

 

11.01.2019

Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update
A new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (Vol 12 Issue 6 January 2019:1) has been published and includes articles on:

  • Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines
  • Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation
  • Yellow Card App: download the updated App to receive the latest MHRA safety news and report suspected side effects, including in pregnancy
  • Letters and drug alerts sent to healthcare professionals in December 2018
  • Medical Device Alerts issued in December 2018

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

 

Amoxil® capsules discontinued
Amoxil® capsules 250mg and 500mg have been discontinued. This discontinuation is not due to any safety or quality issues with Amoxil® presentations. The ScriptSwitch message has been removed and all prescribers are asked to prescribe generically as amoxicillin. A ScriptSwitch message has been put on Amoxil® to remind prescribers to prescribe as amoxicillin.