Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update - August 2014

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

Colestilan (BindRen®) has been rejected for the treatment of hyperphosphataemia in adult patients with chronic kidney disease (CKD) stage 5 receiving haemodialysis or peritoneal dialysis. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

Dapagliflozin and Metformin (Xigduo®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

  • in patients inadequately controlled on their maximally tolerated dose of metformin alone
  • in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products
  • in patients already being treated with the combination of dapagliflozin and metformin as separate tablets

The restriction limits use to patients where a combination of dapagliflozin and metformin is an appropriate choice of therapy.

Lubiprostone (Amitiza®) has been rejected for the treatment of chronic idiopathic constipation and associated symptoms in adults, when response to diet and other non-pharmacological measures (e.g. educational measures, physical activity) are inappropriate. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

Olodaterol solution for inhalation (Striverdi Respimat®) has been rejected for use as a maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

Racecadotril (Hidrasec®) has been rejected for complementary symptomatic treatment of acute diarrhoea in infants older than three months and in children, together with oral rehydration and the usual support measures, when these measures alone are insufficient to control the clinical condition. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

Umeclidinium / Vilanterol (Anoro®) has been rejected for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

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 2014

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2014 (PDF).

This drug safety section in this issued advises clinicians of a recent European review of emergency contraceptives. The relationship between increasing body weight or BMI and efficacy of emergency contraceptives was considered. Concerns have been raised that emergency contraceptives may be less effective as body weight or BMI increases but this review found that the available data are inconclusive. The overall conclusion was that emergency contraceptives are suitable for all women regardless of body weight or body mass index. Readers are reminded that emergency contraceptives should be used as soon as possible after unprotected sex or contraceptive failure to prevent unintended pregnancy and should not be used to replace a regular contraceptive method.

This issue also advises that the learning module on anticoagulants has been launched. Responding to feedback on previous learning modules, this one is reported to be much more interactive.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.

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Drug Safety Update - July 2014

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2014 (PDF).

The stop press section warms of the risks of accidental exposure to strong opioids in patches as a consequence of incorrect disposal. There have been three reported cases of accidental exposure or inadvertent patch transfer. It is recommended that patients and caregivers follow the disposal instructions on the patch carton and in the accompanying leaflet.

This issue also advised that the learning module on opioids has been updated to include recent concerns about transdermal patches and the self-assessment questions have been revised.

Action: Clinicians will find this publication to be a useful review of current issues in drug safety.

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MTRAC Reviews - July 2014

MTRAC issued a new Commissioning Support guidance in July 2014. The review covers DPP-4 inhibitors.

This Commissioning Guidance (PDF) reviews the evidence for all of the currently available 'gliptins'. It notes that no significant differences in blood glucose reducing efficacy have were identified in a systematic review or in a direct comparison between sitagliptin and saxagliptin. It is also noted that the current NICE Guidance recommends continued treatment with DDP-4 inhibitors only when there is a beneficial metabolic response (HbA1c reduction of 0.5% or 5-6mmol/mol). This guidance summary recommends that, "if a gliptin is to be used, it is advised that the gliptin is selected based on the appropriate licensed indications, with the lowest acquisition cost".

Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.

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SMC Update - July 2014

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

Beclometasone and formoterol inhaler (Fostair®) has been accepted for the symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. It should be used in patients for whom beclometasone and formoterol are appropriate choices of corticosteroid and long-acting beta2-agonist respectively, and for whom a metered dose inhaler is an appropriate delivery device.

Dapagliflozin (Forxiga®) has been accepted for restricted use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. The restriction limits use to triple therapy in combination with metformin and sulphonylurea, as an alternative to a dipeptidyl peptidase-4 (DPP-4) inhibitor.

Dapoxetine (Priligy®) has been rejected for the treatment of premature ejaculation in adult men aged 18 to 64 years. The manufacturer failed to make a submission and as a result it 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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