Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

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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Drug Safety Update - June 2014

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

This issue contains drug safety advice advising that a recent review of combination use of renin-angiotensin system blocking agents has identified an increased risk of hyperkalaemia, hypotension and impaired renal function. New product warnings have been agreed. In particular, clinicians are advised that people with diabetic nephropathy should not be given an ACEI with an ARB as they are already prone to developing hyperkalaemia. Combining aliskiren with an ACEI or ARB is contraindicated in people with kidney impairment or diabetes.

The yellow card section sign posts an e-learning resource produced by NHS Education for Scotland. These modules review Adverse Drug Reactions including incidence, identification, classification, risk minimisation strategies and pharmacovigilance.

The stop press section notes that emerging clinical trial evidence has indicated an increase in cardiovascular risk in patients taking ivabradine (Procorolan®). A trial using higher doses than are currently licensed identified a small but statistically significant increase in the combined risk of cardiovascular death and non-fatal myocardial infarction in patients with symptomatic angina (CCS class II or more). This increase in risk may be associated with bradycardia; it is recommended that heart rate is monitored and the ivabradine dose reduced or stopped if persistent bradycardia is detected.

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

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SMC Update - June 2014

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

Avanafil (Spedra®) has been rejected for use in the treatment of erectile dysfunction in adult men. The manufacturer failed to make a submission but plans to make a submission in November 2014.

Budesonide granules (Budenofalk®) have been accepted for the induction of remission in patients with mild to moderate active Crohn’s disease affecting the ileum and/or ascending colon.

Canagliflozin (Invokana®) 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 therapy 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 the following situations:

  • dual therapy in combination with metformin
  • triple therapy in combination with metformin plus standard of care
  • add-on to insulin therapy in combination with insulin plus standard of care

Fluticasone / vilanterol (Relvar Ellipta®) has been accepted for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (ICS/LABA) is appropriate. The review notes that some alternative ICS/LABA combination inhalers are available at a lower daily cost.

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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