Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

NICE Guidance - November 2015

The National Institute of Health and Care Excellence (NICE) have published new guidance for the month of November 2015. This month there are two clinical guidelines and one technology appraisal that impact upon primary care.

The Menopause: diagnosis and management guideline covers the diagnosis and management of menopause, including in women who have premature ovarian insufficiency. The guideline aims to improve the consistency of support and information provided to women in menopause.

The Older people with social care needs and multiple long-term conditions guideline covers planning and delivering social care and support for older people who have multiple long-term conditions. It promotes an integrated and person-centred approach to delivering effective health and social care services.

The Vortioxetine technology appraisal recommends this treatment as a possible option for adults having a first or recurrent major depressive episode, if the current episode has not responded to two antidepressants.

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

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Nicorandil now firmly second line

The manufacturer of nicorandil (Ikorel®) has written to healthcare professionals advising of new restrictions to the licensed indication and additional contraindications and warnings.

Nicorandil is now recommended for the treatment of stable angina in patients whose angina is inadequately controlled by first line treatments or who have a contraindication or intolerance to first line treatments. First line treatments include beta blockers and calcium channel blockers.

It is also noted that nicorandil can cause serious skin, mucosal and eye ulceration that persists unless treatment is stopped. Treatment must be stopped if any ulceration develops and cardiologist advice sought if angina symptoms worsen.

Patients with diverticular disease may be at increased risk of fistula formation or bowel perforation. Patients taking aspirin, NSAIDs or corticosteroids are at increased risk of gastrointestinal ulceration.

Nicorandil is now contraindicated in hypovolaemia, acute pulmonary oedema and in combination with guanylate cyclase stimulators. It should be used cautiously in combination with medicines that increase potassium levels, especially in patients with moderate to severe renal impairment.

Action: Clinicians should be aware of these new restrictions and remain vigilant for ulceration in patients taking nicorandil.

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Drug Safety Update - November 2015

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2015 (PDF).

Clinicians are advised that there have been reports of severe, sometimes fatal, cases of cardiac failure in patients treated with crizotinib (Xalkori®). Most cases occurred within a month of starting treatment and affected patients with or without pre-existing heart disorders. It is recommended that all treated patients are monitored for signs and symptoms of heart failure (including dyspnoea, oedema, or rapid weight gain from fluid retention).

Clinicians are also notified of the risk of potentiation of radiation toxicity with vemurafenib (Zelboraf®) when given before, during, or after radiotherapy. This is unlikely to impact upon primary care.

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

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SMC Update - November 2015

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

Atazanavir and cobicistat (Evotaz®) has been accepted for use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir.

Edoxaban (Lixiana®) has been accepted for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Edoxaban (Lixiana®) has been accepted for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

Everolimus (Certican®) has been rejected for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a cardiac transplant or for prophylaxis of organ rejection in patients receiving a hepatic transplant. The manufacturer failed to make a submission. It is noted that NICE are currently producing guidance.

Raltegravir chewable tablets (Isentress®) have been accepted for restricted use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in children from the age of 4 weeks to <2 years. The restriction limits use to patients who are intolerant or resistant to alternatives or where alternatives are limited by interactions. They must also be prescribed under the supervision of specialists in paediatric HIV.

Raltegravir granules for oral suspension (Isentress®) have been accepted for restricted use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in in adults, adolescents, children, toddlers and infants from the age of 4 weeks. The restriction limits use to patients who are intolerant or resistant to alternatives or where alternatives are limited by interactions. They must also be prescribed under the supervision of specialists in paediatric HIV.

Tiotropium / Olodaterol (Spiolto Respimat®) has been accepted for use as maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Triamcinolone hexacetonide has been accepted for use in juvenile idiopathic arthritis (JIA). This is a new licence extension for JIA where previously an unlicensed preparation has been used.

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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