009 MHRA, NPSA and CAS alerts

009 MHRA, NPSA and CAS alerts

Do you have a reliable process for managing MHRA, NPSA, CAS or other alerts?

At Primary Care IT we scope these for you and build searches for you, so you don't have to do this yourself.

You can see the current searches on the left.


MHRA001-a) On Desmopressin for possible Diabetes Insipidus, MHRA001-b) Diabetes Insipidus Codes, MHRA001-c) Hypothalamic Disorder Codes

These searches support your practice to identify if the omission of desmopressin for the treatment of cranial diabetes insipidus has or could occur in your organisation.  This alert was prompted as four incidents in the past seven years where omission of desmopressin has resulted in severe dehydration and death. A further 76 incidents to the NRLS described omission or delay that had been detected and acted on before the patient became critically ill.  You should contact any patients identified and make sure they are aware of the importance of not missing or delaying doses.  These incidents occurred in in-patient settings, so alerts or cards could be considered to mitigate this risk as well as ensuring relatives and NOK are aware of these risks.

MHRA002-a) Adrenaline Pens Recent Issues (5y) - Not on Repeat,  MHRA002-b) Adrenaline Pens Active Course - Quant <2, MHRA002-c) Adrenaline Pens Active - Out of Date (12m) 

Healthcare Professionals should contact all patients, and their carers, who have been supplied with an Emerade auto-injector device to inform them of potential device defects and reinforce the advice to always carry two in-date adrenaline autoinjectors with them at all times AND to request a new prescription to replace each Emerade microgram auto-injector with one new adrenaline pen in an alternative brand.
  1. Use a to consider adding a device to the repeat prescription
  2. Use b to adjust the repeat prescription to read "2 devices"
  3. Use c to review the ongoing need to carry an adrenaline pen and issue up to date devices.

MHRA003-a) Ranitidine Active Course, issued within 6m

Alert
Multiple Alerts dated:

This alert highlights possible NDMA contamination reported for multiple suppliers.  Use this search to review ongoing treatment.

MHRA004-a) Picato Gel Active Course

Possible skin malignancy reported with product and withdrawn pending review.
Use this search to identify patients prescribed Picato Gel due to concerns on the possible risk of skin malignancy.

MHRA005-a) Finasteride Current & Issued 210218-311021 + signs of depression 

Use these searches to identify patients prescribed Finsteride 5mg between the dates noted as they may not be aware of mood alterations and depression: Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 5 mg. Patients should be monitored for psychiatric symptoms and if these occur, the patient should be advised to seek medical advice.

MHRA006-a) Esmya Current, MHRA006-b) Esmya Current and Issued past 12m

Use these searches to identify patients who could order repeat prescriptions for Esmya and ask them to stop taking their medication as soon as possible and return any unused medicine to their pharmacy. All patients currently being treated with Esmya/ulipristal acetate for uterine fibroids should contact their doctor for advice about other possible treatments for uterine fibroids. 

MHRA007-a) NPSA - Consider a Steroid emergency card and MHRA007-b) NPSA - Consider a steroid emergency card No SEC in 18 months

To encourage the issuing of a Steroid Emergency Card to support early recognition and treatment of adrenal crisis in adults
Use these searches to identify patients who may need advising to carry a STC. 
Clinical judgment is advised, especially where a patient is identified becasue of inhaled or topical corticosteroids. 
We would suggest utilisiing the NICE guidance on beclomethasone dose equivalents (BDEs) when looking at the report outputs as thhe dosage instructions on inhhalers may add the patient to the risk group

MHRA008-a) Hydrocortisone 1% Ointment 200820-310823

Safety concern over Pseudomonas Infection
Use this search to identify patients who have been supplied 1% w/w Hydrocortisone Ointment. First distributed 20/08/2020 exp. 31/8/2023.  The Boots Company PLC has informed MHRA that retained samples of the affected batch showed presence of Pseudomonas aeruginosa.  This search CANNOT specify if BOOTS HC 1% was issued. 

Advice for healthcare professionals
• Advise patients who have been supplied this product to stop using the ointment immediately and return this to Boots Stores.
• GP practices should be aware of potential medical concerns reported by patients
• Any suspected side effects should be reported via the Yellow Card Scheme

MHRA009-a) Betahistine 210420-011022

Safety concern over Theophylline Contamination
Use this search to identify patients who have been supplied Betahistine Tablets. First distributed 21/04/2020 exp. 01/10/2022.  Kent Pharmaceuticals Ltd has informed that several affected batches are contaminated with theophylline due to a cross-contamination.

Advice for healthcare professionals
  1. The risk of adverse reactions is low with respect to the level of contamination. However, if patients experience any side effects related to hypersensitivity or those not normally experienced with betahistine, please ensure appropriate clinical advice is sought. 
  2. Any suspected side effects should also be reported via the Yellow Card Scheme


MHRA010-a) DOAC and ANY Valve Replacement, MHRA010-b) DOAC and MECHANICAL Valve Replacement coded

NatPSA/2021/006/NHSPS -Inappropriate anticoagulation of patients with a mechanical heart valve
These searches identify patients coded as having a ANY or a MECHANICAL heart valve replacement coded & currently is on a DOAC.

Use this search to identify any heart valve patients on a DOAC and switching to VKA or consider askling Cardiologist if the valve type requires VKA.

All patients with prosthetic mechanical heart valves require life-long oral anticoagulation with a vitamin K antagonist (VKA), usually warfarin, as these valves predispose the patient to systemic embolism. Thrombosis of a prosthetic valve is potentially lifethreatening as it can result in haemodynamically severe stenosis or regurgitation and acute heart failure. The risk depends on the type of valve, its position, and other factors. Since 1 March 2020, 14 incidents have been reported of patients with a mechanical heart valve being switched to a LMWH or a DOAC.

Inappropriate anticoagulation of patients with a mechanical heart valve; Additional patient identification search. 

Following the National Patient Safety Alert, highlighting the need to review those patients who have received a mechanical heart valve and who may now be inappropriately anticoagulated, system suppliers have produced searches looking for mechanical heart valve codes in patients on DOACs.  We have noted that the searches will require precise coding of the valve type in order to identify patients who may be at risk of inappropriate anticoagulation.  We are aware that specific valve type coding may not be universal practice and that some patients may remain vulnerable due to inappropriate anticoagulation.  

Primary Care IT have produced a further search to identify DOAC use with any heart valve replacement.  We have produced a standard enquiry letter for your local cardiology department, asking them to review the valve type and give you an urgent opinion on the appropriateness of a DOAC for your patient.  We have also produced a carefully worded standard letter for your patient, explaining the situation and reminding them not to stop taking their medication until you have received a response.   

We would advise running the additional search and, if it is not clear from correspondence whether the coded cardiac valve replacement is a metallic or mechanical valve, sending both letters and planning a follow up with the patient.  
Info
All of these resources can be downloaded from the PCIT Hub.

MHRA011-a) - Simvastatin: dose limitations with concomitant amlodipine or diltiazem

Key messages and actions:  The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.

MHRA013) Men on Valproate

A report to identify all males over the age of 10 who are on sodium valproate.

The code "Contraceptive advice for patients on valproate for epilepsy (2014871000006103)" is appropriate to record that the advice has been given.


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