Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update - February 2018

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

Fluticasone furoate / umeclidinium / vilanterol (Trelegy Ellipta®) 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 beta-agonist. The restriction limits use to patients with severe COPD (forced expiratory volume in one second [FEV1] < 50% predicted normal).

Lacosamide (Vimpat®) has been accepted for restricted use as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adolescents and children from 4 years of age with epilepsy. The restriction limits use to patients with refractory epilepsy and should be initiated by physicians who have appropriate experience in the treatment of epilepsy.

Levonorgestrel (Kyleena®) has been accepted for use as a contraceptive for up to 5 years.

Sevelamer carbonate (Renvela®) has been accepted for restricted use to control of hyperphosphataemia in paediatric patients (>6 years of age and a Body Surface Area of >0.75m2) with chronic kidney disease. The restriction limits use to second-line management of hyperphosphataemia in patients receiving haemodialysis and treatment would normally be initiated by a 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 - February 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2018 (PDF).

This issue advises clinicians that mycophenolate mofetil or mycophenolic acid have teratogenic and genotoxic effects and while the current evidence does not indicate an increased risk of malformations or miscarriage in pregnancies while fathers were taking these medicines but is insufficient to rule out a risk. As a precaution it is recommended that men taking these drugs, or their female partner, should use effective contraception.

This issue also contains a summary of recent drug and device alerts, including a potential defect with midazolam (Buccolam®) oral syringed as reported last month, notification that a shortage of UK zanamivir (Relenza®) will be filled by stock from abroad and a warning that all Philips HeartStart MRx monitors/defibrillators will be affected by a significant delay in the fulfilment of orders for new batteries.

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

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SMC Update - January 2018

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

Eluxadoline (Truberzi®) has been rejected for use in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS-D). The submitting company did not present a sufficiently robust economic analysis to gain acceptance

Metformin hydrochloride (Glucophage SR®) has been rejected for use to reduce the risk or delay of the onset of type 2 diabetes mellitus in adult, overweight patients with impaired glucose tolerance and/or impaired fasting glucose and/or increased HbA1C who are:

  • at high risk for developing overt type 2 diabetes mellitus and
  • still progressing towards type 2 diabetes mellitus despite implementation of intensive lifestyle change for 3 to 6 months

The manufacturer failed to make a submission.

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 - January 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2018 (PDF).

This issue advised clinicians that Daclizumab (Zinbryta®) has new restrictions on use and strengthened liver monitoring recommendations due to the risk of severe liver injury. Awareness is also raised on the very rare risk of severe cutaneous adverse reactions associated with recombinant human erythropoietins; patients on these medicines should stop treatment and seek immediate medical attention if they develop widespread rash and blistering.

Clinicians are also reminded to take extra care when prescribing or dispensing drugs when there are other names that look or sound similar. For example: risperidone and ropinirole. Following recent cases, six new examples have been added.

This issue also advised that co-dydramol has recently been licensed in two new strengths. Previously it was available as 10mg/500mg of dihydrocodeine and paracetamol. It is now available as 20mg/500mg and 30/mg/500mg, although these have existed previously as paracetamol and dihydrocodeine (Remedeine®). It is therefore now recommended that when prescribing co-dydramol that the tablet strength and dose are clearly indicated.

Finally this month, readers are encouraged to report suspected adverse reactions to the Yellow Card Scheme for any patients taking herbal medicines. When an adverse reaction is suspected, clinicians are encouraged to ask patients whether they are taking any herbal medicines and report the reaction accordingly.

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

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Notice of Testim Discontinuation

The manufacturer of Testim® has advised that it intends to cease production and supply of this product in 2018.

The product is currently out of stock but supplies are expected to be delivered in early 2018, currently estimated as February. However, once this delivery of stock has been made it seems the product will be discontinued with no further supplies being made. The manufacturer stresses that the decisions to discontinue this product is not due to issues regarding safety, quality or efficacy of the product.

Testim® contains 50 mg of testosterone in a 5g unit dose container. Testogel® would appear to be a reasonable replacement; it contains the same strength of testosterone in the same unit dose presentation.

Action: Clinicians should be aware of this product being discontinued. It would be prudent to run clinical system searches to identify any patients who are currently prescribed this product to allow suitable alternatives to be arranged.

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