MHRA (Medicines and healthcare products regulatory agency)


03.05.2019

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

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

Class 4 MHRA Drug Alert – Prednisolone 5mg Tablets (Genethics Europe Ltd (Distributed by Genesis Pharmaceuticals Ltd)) Caution in use
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for certain batches of Prednisolone 5mg Tablets Genethics Europe Ltd (Distributed by Genesis Pharmaceuticals Ltd) Prednisolone 5mg Tablets Genethics Europe Ltd (Distributed by Genesis Pharmaceuticals Ltd).

Full information and the full alert is available on PSNC website.

Epanutin 50mg Infatabs (Pfizer) Supply Issue
Pfizer will be out of stock of Epanutin 50mg Infatabs (phenytoin) until November 2019 and have issued a letter detailing the issue and a management plan.

For further information please contact the Pfizer Customer Contact Centre on 0845 608 8866

Mylan EpiPen ® and EpiPen Jr Auto-injectors
Due to a local report we would like to remind pharmacies that there is still a potential shortage of the above items but it is possible to obtain two per patient. If a pharmacy has difficulties in obtaining stocks of the above medicines from Alliance they should contact their Alliance account manager, as stock can be redistributed amongst the Alliance depots.

If necessary, you can contact Mylan’s customer service team on 01707 853 100 or mguk_customer.services@mylan.co.uk, from 8.00am to 5.00pm Mon to Friday.
 

26.04.2019

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

Class 4 MHRA Drug Alert – Ativan 4mg/1ml Solution for injection (Lorazepam) (Pfizer Limited) Caution in use
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for Ativan 4mg/1ml Solution for injection (Lorazepam) (Pfizer Limited). Full information and the full alert is available on the PSNC website.

MHRA Drug Safety Update April 2019
A new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (Vol 12 Issue 9 March 2019:1) has been published and includes articles on:

  • Yellow fever vaccine (Stamaril) and fatal adverse reactions: extreme caution needed in people who may be immunosuppressed and those 60 years and older.
  • Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme.
  • Belimumab (Benlysta ▼) : Increased risk of serious psychiatric events seen in clinical trials.
  • Pregabalin (Lyrica), gabapentin (Neurontin) and risk of abuse and dependence: new scheduling requirements from 1 April 2019.
  • Elvitegravir boosted with cobicistat: avoid use in pregnancy due to risk of treatment failure and maternal-to-child transmission of HIV-1
  • Letters and drug alerts sent to healthcare professionals in March 2019
  • Medical Device Alerts issued in March 2019

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

12.04.2019

Class 4 MHRA Drug Alert – Chloramphenicol 0.5% W/V Antibiotic Eye Drops (Martindale Pharmaceuticals Limited)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for Chloramphenicol 0.5% W/V Antibiotic Eye Drops (Martindale Pharmaceuticals Limited)
To view the alert please visit the GOV.UK website

URGENT Levomepromazine 25mg/ml injection supply issue – information for Primary Care

Overview of Supply

  • Sanofi informed NHS England and DHSC on 05 April 2019 that they are going out of stock this week of levomepromazine 25mg/ml injection and new stock is expected to be available from the end of April.
  • The supply issue is due to a quality deviation experienced at their Italian factory and is not linked to EU exit.
  • The only other UK supplier, Wockhardt, have informed that due to the unexpected increase in demand, they will also go out of stock of levomepromazine injection and their next delivery has been delayed with further stock expected at the end of April.
  • Wockhardt have confirmed the remaining levomepromazine 25mg/mL injection stock which is held at Alliance will be ring-fenced for primary care use only. Stock at Alliance is limited and will not last until the end of April.
  • Existing stocks are likely to be exhausted by end of this week and no new supplies are expected until end of April.
  • GPs, palliative care networks and community pharmacies should consider the following advice and work together during this period to ensure patients can be managed appropriately.

Alternative agents

  • UK Medicines Information with support of national clinical specialists have developed the following clinical information to help support the management of patients  who may be affected by this issue.
  • Please follow the link to view this guidance: https://www.sps.nhs.uk/articles/shortage-of-levomepromazine-hydrochloride-25mg-ml-solution-for-injection/
  • All the suppliers of the following medicines have  been made aware of this supply issue and have confirmed they can support an increase in demand should this be required.
  • Haloperidol 5mg/1ml solution for injection ampoules (DrugsRUs)
  • Midazolam 10mg/2ml solution for injection ampoules (Hameln, Accord, Roche)
  • Cyclizine 50mg/ml solution for injection ampoules (Advanz)
  • Metoclopramide 10mg/2ml solution for injection ampoules (Hameln, Ennogen)

Management Plan – GPs, Palliative Care Networks and Community Pharmacies to review and action immediately

  1. During the period of shortage, new patients should only be started on levomepromazine if other treatment options have been exhausted. This is to try to avoid disrupting existing treatment regimens where possible whilst acknowledging that for some new patients levomepromazine may be the only option available.
  2. Community pharmacies who require stock for existing patients should order Wockhardt stock from Alliance.
  3. Community pharmacies having difficulty obtaining stock should contact their local secondary care trusts as they have been asked to support primary care and hospices where possible, to understand if they have stock that can be made available to allow the continuation of treatment in existing patients.
  4. Some specialist importers have identified stock they can bring into the UK. Lead times vary between 7-21 days. If community pharmacies are considering ordering unlicensed imports, the community pharmacist will need to inform the prescribing doctor the product being supplied to the patients is an unlicensed product. Please consider placing orders now for 1-2 weeks of stock based on forecasted demand. We are currently aware that Clinigen, Waymade, Alium and Mawdsleys have sourced unlicensed supplies from abroad.
  5. Community pharmacies unable to obtain levomepromazine injection should liaise with the prescriber to discuss using an alternative product as outlined in the guidance above.

29.03.2019

MHRA Drug Safety Update March 2019
A new Medicines and Healthcare products Regulatory Agency (MHRA) Drug Safety Update (Vol 12 Issue 8 March 2019:1) has been published and includes articles on:

  • Fluoroquinolone antibiotics: new restrictions and precautions for use due to very rare reports of disabling and potentially long-lasting or irreversible side effects
  • Onivyde (irinotecan, liposomal formulations): reports of serious and fatal thromboembolic events
  • Medicines with teratogenic potential: what is effective contraception and how often is pregnancy testing needed?
  • Letters and drug alerts sent to healthcare professionals on February 2019
  • Medical Device Alerts Issued in February 2019

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

Reclassification of gabapentin and pregabalin as CDs
Community pharmacy teams are reminded that from 1 April 2019 gabapentin and pregabalin will be reclassified as Schedule 3 Controlled Drugs (CDs).

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.