Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

NICE Guidance - June 2016

The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of June 2016. This month there are two technology appraisals that impact upon primary care.

The Alirocumab technology appraisal recommends this treatment as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia only if low‑density lipoprotein concentrations are persistently above the thresholds specified in the appraisal and the manufacturer provides alirocumab with the discount agreed in the patient access scheme.

The Evolocumab technology appraisal recommends this treatment as an option for treating primary hypercholesterolaemia or mixed dyslipidaemia provided the dosage is 140 mg every 2 weeks and only if low‑density lipoprotein concentrations are persistently above the thresholds specified in the appraisal and the manufacturer provides evolocumab with the discount agreed in the patient access scheme.

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

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Drug Safety Update - June 2016

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2016 (PDF).

This issue highlights the recently identified signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients taking canagliflozin (Invokana® or Vokanamet®). The following recommendations are made:

  • as a precaution, consider stopping canagliflozin if a patient develops a significant lower limb complication (e.g. skin ulcer, osteomyelitis, or gangrene), at least until the condition has resolved, and continue to monitor the patient closely
  • carefully monitor patients receiving canagliflozin who have risk factors for amputation (e.g. previous amputations, existing peripheral vascular disease, or neuropathy)
  • monitor all patients for signs and symptoms of water or salt loss; ensure patients stay sufficiently hydrated to prevent volume depletion in line with recommendations in the product information; note that diuretics can exacerbate dehydration
  • advise patients to stay well hydrated, carry out routine preventive foot care and seek medical advice promptly if they develop skin ulceration, discolouration, or new pain or tenderness
  • start treatment for foot problems (e.g. ulceration, infection, or new pain or tenderness) as early as possible

This issue informs clinicians that there have been rare reports of etonogestrel implants (Nexplanon®) having reached the lung via the pulmonary artery. It is recommended that an implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at the earliest opportunity. If an implant cannot be located within the arm, perform chest imaging. A letter has been sent direct to healthcare professionals about this safety concern.

This issue also reminds clinicians of the potential for miconazole containing medications to have serious interactions with warfarin. There have been reports of serious bleeding events in patients taking the combination and the risk extends to miconazole oral gel. The available data for this interaction are being reviewed to determine whether further measures are required to minimise the risks to patients.

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

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SMC Update - June 2016

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

Co-careldopa intestinal gel (Duodopa®) has been accepted for restricted use in the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results. The restriction limits use to patients who are not eligible for deep brain stimulation.

Evolocumab (Repatha®) has been rejected for use:

  • in adults with primary hypercholesterolaemia
  • in combination with a statin or statin with other lipid lowering therapies in patients unable to reach low density lipoprotein-cholesterol (LDL-C) goals
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated
  • in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies

The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.

Febuxoxtat (Adenuric®) has been accepted for restricted use in the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumour Lysis Syndrome (TLS). The restriction limits use to patients in whom allopurinol is either unsuitable or contraindicated.

Naproxen effervescent tablets (Stirlescent®) have been accepted for restricted use in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, dysmenorrhoea and acute gout in adults. The restriction limits use to patients who are unable to swallow naproxen tablets.

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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NICE Guidance - May 2016

The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of May 2016. This month there are three clinical guidelines and two technology appraisals that impact upon primary care.

The Dementia clinical guideline covers preventing, diagnosing, assessing and managing dementia in health and social care. The recommendation on prescribing medicines for Alzheimer’s disease was reviewed and partially updated.

The Crohn's Disease clinical guideline covers the management of Crohn’s disease in children, young people and adults. In this update a new recommendation on inducing remission was added.

The Psychosis and schizophrenia in children and young people clinical guideline covers recognising and managing psychosis and schizophrenia in children and young people. In this update a new recommendation was added on providing information about olanzapine when choosing antipsychotic medication for children and young people with a first episode of psychosis.

The Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease technology appraisal has been updated to include references to the Dementia clinical guideline.

The Canagliflozin, dapagliflozin and empagliflozin technology appraisal recommends these drugs as monotherapy treatment as an option for treating type 2 diabetes in adults for whom metformin is contraindicated or not tolerated and when diet and exercise alone do not provide adequate glycaemic control, only if:

  • a dipeptidyl peptidase‑4 (DPP‑4) inhibitor would otherwise be prescribed and
  • a sulfonylurea or pioglitazone is not appropriate

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

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Bydureon device change

The manufacturer of exenatide once weekly (Bydureon®) has written to healthcare providers advising that the original 'vial and syringe' kit is being replaced by a pre-filled pen.

The pen has been available for several months and is designed to make administration easier for patients. According to the letter, the older formulation will be phased out later this year. Any patient who is starting this treatment should be supplied with the pen device. This is indicated as 'pre-filled pen' or 'pre-filled disposable device' in the item description on clinical systems. Patients who are currently prescribed the vials should be moved to the new device.

Patient information about the switch is available at talkingtype2.co.uk [acceptance of legal, privacy and cookie terms required] and the Patient Information Leaflet describes how to use the new device.

Action: Clinicians should be aware that the vial and syringe kit is being replaced. It would be prudent to run clinical system searches to identify any patients who are currently prescribed the vials so prescriptions can be updated.

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