Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update - September 2017

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Magnesium glycerophosphate (Neomag®) has been accepted for use as an oral magnesium supplement for the treatment of patients with chronic magnesium loss or hypomagnesaemia as diagnosed by a doctor. Magnesium glycerophosphate is also indicated for adult patients with hypomagnesaemia due to the concomitant administration of loop and thiazide diuretics or other drugs which cause hypomagnesaemia. It is noted that unlicensed tablet formulations of magnesium glycerophosphate are available but this product provides a licensed preparation at a similar cost.

Roflumilast (Daxas®) has been rejected for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in one second [FEV1]) post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. The addition of roflumilast did not reduce the annual rate of moderate or severe COPD exacerbations in two double-blind, randomised studies of COPD patients with severe airflow limitation and history of at least two moderate or severe exacerbations in the previous year. The manufacturer did not present a sufficiently robust clinical or economic analysis to gain acceptance.

Stiripentol (Diacomit®) has been accepted for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI; Dravet’s syndrome) whose seizures are not adequately controlled with clobazam and valproate. It would be expected that children with this condition would be under the care of a tertiary paediatric epilepsy specialist.

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.

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Drug Safety Update - August 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2017 (PDF).

This issue contains information on reports of ventricular tachyarrhythmia and an increased risk of hepatitis B reactivation and opportunistic infections in patients treated with ibrutinib (Imbruvica®). Treatment should be suspended in patients who develop ventricular tachyarrhythmia and consultant advice sought.

This issue also notes the rare risk of central serous chorioretinopathy is now associated with topical steroid use, as well as systemic use. Patients on steroid treatment should be encouraged to report any blurred vision or other visual disturbances and referred to an ophthalmologist for evaluation should they report problems with vision.

This issue also advised that, following a European review, it is recommended that two adrenaline auto-injectors are prescribed, which patients should carry at all times, for use in treating anaphylaxis. This recommendation is based upon uncertainties about the site of drug delivery and the speed of adrenaline action within the body. The manufacturers have been asked to carry out studies in humans to more fully understand when and how much adrenaline reaches the blood stream, and how quickly and effectively it acts on body tissues when given through an auto-injector.

In the summary of letters sent to healthcare professionals in July it is noted that further information has been sent to doctors and pharmacists about the use of valproate medicines in girls, women of childbearing potential and women who are pregnant or planning pregnancy. This information supports the advice issued in the Drug Safety Update in April 2017.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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SMC Update - August 2017

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Desmopressin (Noqdirna®) has been accepted for restricted in the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults. The restriction limits use to adults aged 65 years and over.

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.

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Drug Safety Update - July 2017

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2017 (PDF).

This issue contains information on the risk of severe liver injury in patients using Daclizumab (Zinbryta®). This drug is used to treat multiple sclerosis and during use monthly liver checks are recommended. These checks also need to continue for four months after stopping treatment. Liver injury should be monitored for and considered in patients on this treatment pending review by their consultant.

In the summary of letters sent to healthcare professionals in June it is noted that there have been several changes to prescribing information for enoxaparin (Clexane®). The strength will now be noted in milligrams and units, with 1mg equivalent to 100iu. The dosage in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) has been clarified and use in end stage renal disease is not recommended unless to prevent thrombus formation in haemodialysis patients.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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Updated Pregabalin Prescribing Guidance

NHS England has written to CCGs, pharmacies and GP practices with updated advice regarding prescribing of pregabalin.

In 2015, NHS England were required by the courts to issue advice that pregabalin must be prescribed a specific way when used for neuropathic pain due to the existence of a patent that applied to that licensed indication.

This update withdraws and replaces the previous advice and contains the following recommendation for prescribing clinicians:

"In our guidance of 2 March 2015 we asked you to consider amending the operation of any electronic prescription system that is within your power or control to ensure that practitioners were readily able to follow that guidance. If you made such an amendment, we now ask you to reverse it to reflect the revised guidance above as from 17 July 2017."

Action: Clinicians can now return to normal practice when prescribing pregabalin and no longer need to specify a brand name when prescribing for neuropathic pain.

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