Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update - October 2017

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

Beclometasone / formoterol / glycopyrronium inhaler (Trimbow®) has been accepted for restricted use as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. The restriction limits use to patients with a forced expiratory volume in one second less than 50% predicted normal.

Opicapone (Ongentys®) has been rejected for use as an adjunctive therapy to preparations of levodopa / DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. The manufacturer did not make a submission to the SMC and therefore the product cannot be recommended.

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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CKS Updates - September 2017

During September 2017 Clinical Knowledge Summaries were updated in the following areas.

The following topics were all reviewed:

The majority of topics have undergone reviews and minor restructures.

The most significant changes are in the Diverticular disease topic where sections on risk factors and prognosis have been added and the recommendations on assessment and management of suspected acute diverticulitis have been amended in line with current evidence

Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.

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Drug Safety Update - September 2017

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

This issue highlights that over-the-counter miconazole oral gel is contraindicated in patients taking warfarin and prescription use requires very close monitoring. Miconazole can prolong the effects of warfarin and therefore increase the risk of bleeding, in some cases this has resulted in a fatal outcome. Use of alternative oral antifungals where appropriate may be prudent.

It is also noted that loperamide has been associated with reports of serious cardiac adverse reactions with high doses associated with abuse or misuse. Reported infects include QT prolongation, torsades de pointes and cardiac arrest in patients who have taken high or very high doses of loperamide as a drug of abuse or for self-treatment of opioid withdrawal. Overdose can be treated with naloxone if needed. Patients should be reminded not to exceed the recommended dose on the label or in the leaflet.

In the summary of letters sent to healthcare professionals in August it is noted that the salt of triptorelin (Decapeptyl®) is changing from acetate to pamoate. This change has no impact on the dose, method of administration or contraindications, special warnings and precautions regarding use.

It is also noted that a medical device alert was sent earlier this year warning of a risk of hyperglycaemia due to cartridge holder weakening when exposed to certain household chemicals with NovoPen Echo® and NovoPen 5®.

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

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NICE Guidance - September 2017

The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of September 2017. This month there are six guidelines that impact upon primary care.

The Type 2 diabetes: prevention in people at high risk public health guideline has been updated following a review of the evidence for lifestyle-change programmes. Recommendations about lifestyle-change programmes were added and advice on when to offer metformin was changed.

The Depression in children and young people clinical guideline has been updated. Several footnotes have been clarified and recommendations for therapist training added.

The Sepsis guideline has been updated to clarify or correct several recommendations and also to revise the risk level of several symptoms associated with sepsis.

The Fertility problems clinical guideline has been updated. Section 1.7 has been replaced by recommendations in the guideline for endometriosis.

The Endometriosis guideline has been updated to include recommendations on fertility tests and treatments such as assisted reproduction.

The Psoriasis clinical guideline has been updated throughout to include links to other NICE guidance and other relevant resources.

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

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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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