clinical safety searches for EMIS Web

MHRA - Valproate in women update

27/4/2018

The MHRA have strengthened and updated their guidance for Valproate in women of childbearing age. There is now an absolute contraindication unless a pregnancy prevention programme is in place. For more details fo what this means, please see:
https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-contraindicated-in-women-and-girls-of-childbearing-potential-unless-conditions-of-pregnancy-prevention-programme-are-met

QMasters' tools to help GP practices implement this guidance

QMasters' safety search for valproate will help identify patients at risk.

Please download our free search to identify pregnant patients who are taking valproate.
You must right-click on this and select "Save As" and import the file into Population Reporting in EMIS Web.

valproate_pregnancy__v8.0_.xml
File Size:	25 kb
File Type:	xml

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Please note our search relies on accurate clinical coding to identify these patients and we are unable to guarantee that all patients will be correctly identified.

GP practices subscribing to our QToolset will receive an updated clinical safety pop-up warning with their next update. This warning will appear whenever valproate is issued for a woman of childbearing age who is not receiving contraception.

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MHRA: Valproate and developmental disorders

30/4/2017

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The MHRA has issued a further warning about the risks of taking valproate during pregnancy in April 2017

Babies born to mothers who take valproate medicines (Epilim▼, Depakote▼) during pregnancy have a 30–40% risk of developmental disability and a 10% risk of birth defects. Despite communications to prescribers in January 2015 and February 2016 on the magnitude of this risk and the actions to take, there is evidence that women are still not aware of the risk.

More information can be found on the MHRA website.

MHRA advice to healthcare professionals

Do not prescribe valproate medicines for epilepsy or bipolar disorder in women and girls unless other treatments are ineffective or not tolerated; migraine is not a licensed indication.
Ensure women and girls taking valproate medicines understand the 30–40% risk of neurodevelopmental disorders and 10% risk of birth defects and are using effective contraception.
Valproate use in women and girls of childbearing potential must be initiated and supervised by specialists in the treatment of epilepsy or bipolar disorder

QMasters' tools to help GP practices implement this guidance

Please download our free search to identify pregnant patients who are taking valproate.
You must right-click on this and select "Save As" and import the file into Population Reporting in EMIS Web.

valproate__v7.3_.xml
File Size:	24 kb
File Type:	xml

Download File

Please note our search relies on accurate clinical coding to identify these patients and we are unable to guarantee that all patients will be correctly identified.

GP practices subscribing to our QToolset will receive an automatic clinical safety pop-up warning with their next update. This warning will appear whenever valproate is issued for a woman of childbearing age who is not receiving contraception, or who are pregnant.

For more information about our QToolset and to learn how it will save GPs time, maximise income, and improve clinical safety please visit www.QMasters.co.uk/qtoolset.

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MHRA: Spironolactone and renin-angiotensin drugs in heart failure

13/12/2016

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The MHRA has clarified their guidance on concomitant use of these medicines in heart failure in December 2016.

Concomitant use of spironolactone with ACEi or ARB increases the risk of severe hyperkalaemia, particularly in patients with marked renal impairment, and should be used with caution
Use the lowest effective doses of spironolactone and ACEi or ARB if coadministration is considered essential
Regularly monitor serum potassium levels and renal function
Interrupt or discontinue treatment in the event of hyperkalaemia
The same advice applies regarding concomitant use of eplerenone with ACEi or ARB in heart failure
Suspected adverse reactions should be reported to MHRA on a Yellow Card

Further information is available on the MHRA website.

QMasters' tools to help GPs implement this guidance

Please download our free searches to identify those patients prescribed both spironolactone and an ACEi or ARB with a raised potassium level, eGFR below 30, or no recent renal function blood tests.
You must right-click on this and select "Save As" and import the file into Population Reporting in EMIS Web.

spironolactone_and_ace_or_arb__v1.1___www.qmasters.co.uk_.xml
File Size:	14 kb
File Type:	xml

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Please note our search relies on accurate clinical coding to identify these patients and we are unable to guarantee that all patients will be correctly identified.

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MHRA: Miconazole and warfarin

30/6/2016

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The MHRA has issued a warning about the risks of patients on warfarin taking miconazole-containing medicines (including topicals) in June 2016

Miconazole, including the topical gel formulation, can enhance the anticoagulant effect of warfarin—if miconazole and warfarin are used concurrently, the anticoagulant effect should be carefully monitored and, if necessary, the dose of warfarin reduced

Further information is available on the MHRA website.

MHRA advice to healthcare professionals

Patients should be advised to tell their doctor or pharmacist if they are receiving warfarin before using products that contain miconazole (including those available without prescription), and to seek medical advice if they notice signs of over-anticoagulation during treatment, such as sudden unexplained bruising, nosebleeds or blood in the urine

QMasters' tools to help GPs implement this guidance

Please download our free search to identify patients who are taking warfarin and miconazole.
You must right-click on this and select "Save As" and import the file into Population Reporting in EMIS Web.

miconazole_and_warfarin_last_month__v1.0___www.qmasters.co.uk_.xml
File Size:	4 kb
File Type:	xml

Download File

Please note our search relies on accurate clinical coding to identify these patients and we are unable to guarantee that all patients will be correctly identified.

GP practices subscribing to our QToolset will receive an automatic clinical safety pop-up warning with their next update. This warning will appear whenever miconazole is prescribed for a patient on warfarin.

For more information about our QToolset and to learn how it will save GPs time, maximise income, and improve clinical safety please visit www.QMasters.co.uk/qtoolset.

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NICE: Metformin prescribing with impaired renal function

1/12/2015

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NICE guideline NG28 (Dec 2015) is about the management of type 2 diabetes in adults. It advises that where patients are taking metformin and renal function is impaired there is a risk of causing lactic acidosis.

In adults with type 2 diabetes, review the dose of metformin if the estimated glomerular filtration rate (eGFR) is below 45 ml/minute/1.73m2:
Stop metformin if the eGFR is below 30 ml/minute/1.73m2.
Prescribe metformin with caution for those at risk of a sudden deterioration in kidney function and those at risk of eGFR falling below 45 ml/minute/1.73m2. [2015]

.More information can be found on the NICE website

QMasters' tools to help GP practices implement this guidance

Please download our free search to identify those patients taking metformin with a eGFR below 30 ml/minute/1.73m2.
You must right-click on this and select "Save As" and import the file into Population Reporting in EMIS Web.

patients_taking_metfomin_with_egfr_below_30__v1.0___www.qmasters.co.uk_.xml
File Size:	3 kb
File Type:	xml

Download File

Please note our search relies on accurate clinical coding to identify these patients and we are unable to guarantee that all patients will be correctly identified.

GP practices subscribing to our QToolset will receive an automatic clinical safety pop-up warning when any member of staff attempts to issue a prescription of metformin when the eGFR is below 30ml/minute/1.73m2.

For more information about our QToolset and to learn how it will save GPs time, maximise income, and improve clinical safety please visit www.QMasters.co.uk/qtoolset.

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These free searches are provided to help GP practices improve clinical safety. This page is updated regularly as new guidance is published.

QToolset subscribers also receive live monitoring of EMIS Web to ensure users are alerted immediately a potential clinical safety issue has been identified. These alerts have been rated as "outstanding" by CQC.

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MHRA - Valproate in women update

MHRA: Valproate and developmental disorders

MHRA: Spironolactone and renin-angiotensin drugs in heart failure

MHRA: Miconazole and warfarin

NICE: Metformin prescribing with impaired renal function

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