Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update - April 2014

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

Macitentan (Opsumit®) has been accepted for restricted use in the treatment of pulmonary arterial hypertension in adult patients. The restriction limits initiation and prescribing to a specialist.

Rilpivirine/emtricitabine/tenofovir (Eviplera®) has been accepted for use in the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1). This treatment is already approved for treatment-naive patients; this advice extends use to treatment-experienced patients.

Fluticasone/vilanterol (Relvar®) has been accepted for restricted use in the treatment of adults with chronic obstructive pulmonary disease (COPD). The restriction limits use to patients with an FEV1 less than 50% their predicted normal.

Adapalene and benzoyl peroxide gel has been accepted for restricted use in the treatment of cutaneous treatment of acne vulgaris when comedones, papules and pustules are present. The restriction limits use to patients with mild to moderate facial acne when monotherapy with benzoyl peroxide or adapalene is not considered appropriate.

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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ACWY Vax to be discontinued

The manufacturer of ACWY Vax (meningococcal polysaccharide groups ACW135Y vaccine) has written to healthcare professionals advising that this product is being discontinued in the UK. It is expected that stocks will be exhausted by June 2014.

The letter notes that two alternative conjugate vaccines that contain the same A, C, W135 and Y strains are available but also notes that the licensed indications may differ. The brand names for these products are Menveo® and Nimenrix®.

Action: Clinicians who currently use ACWY Vax should be aware of this product being discontinued and make themselves familiar with the alternatives.

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MTRAC Additional Review - March 2014

MTRAC issued an additional Commissioning Support review in March 2014. This review covers fluticasoe/vilanterol dry powder inhaler.

The fluticasoe/vilanterol (Relvar®) summary advises that this inhaler cannot be recommended for prescribing for the treatment of chronic obstructive pulmonary disease (COPD). It is noted that the evidence for efficacy was considered relatively weak although strong enough to gain regulatory approval. The main reason for this recommendation is a potential safety concern regarding the similarity of this inhaler to reliever inhalers in terms of colour that could result in accidental overuse of the inhaled steroid. The SPC describes the inhaler as having a "light grey body, a pale blue mouthpiece cover and a dose counter". Until now, blue coloured inhalers have generally contained short-acting beta-adrenoceptor agonists (SABA), not inhaled corticosteroids and long-acting beta-adrenoceptor agonists.

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 - March 2014

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

Alogliptin (Vipidia®) has been rejected for use in adults with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. The manufacturer did not present sufficiently robust clinical and economic analysis to gain acceptance.

Dapagliflozin (Forxiga®) has been accepted for restricted use in adults with type 2 diabetes mellitus to improve glycaemic control 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 combination with insulin, when insulin with diet and exercise, does not provide adequate glycaemic control.

Insulin degludec (Tresiba®) has been rejected for the treatment of diabetes mellitus in adults. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance

Saxagliptin (Onglyza®) has been rejected for use as monotherapy in adult patients with type 2 diabetes mellitus to improve glycaemic control inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. The manufacturer failed to make a submission.

Solifenacin and tamsulosin (Vesomni®) has been accepted for the treatment of moderate to severe storage symptoms (urgency, increased micturition frequency) and voiding symptoms associated with benign prostatic hyperplasia in men who are not adequately responding to treatment with monotherapy.

Zonisamide (Zonegran®) has been accepted for restricted use as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescents and children aged 6 years and above. The restriction limits use only when advised by specialists (paediatric neurologists or paediatricians with an expertise in epilepsy).

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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New advice on strontium ranelate

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a press release noting that updated advice will be distributed to healthcare professionals regarding strontium ranelate (Protelos®) which is used to treat severe osteoporosis in post-menopausal women and men with a high risk of fracture.

A review was conducted by the European Medicines Agency recently because of study data which suggested an increased risk of heart problems. The review concluded there is no increased risk in individuals who have no history of heart or circulatory problems. However, in individuals who do have a history of heart or circulatory problems strontium is now only recommended if they are unable to take alternative medicines.

This advice will be disseminated to healthcare professionals via letter and will also be included in the March edition of the Drug Safety Update.

Action: Clinicians should be aware of this new advice. This change in advice would make a good topic for an audit.

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