Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

NICE Guidance - October 2014

The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of October 2014. This month there are two clinical guidelines that impact upon primary care.

The Multiple sclerosis guideline offers evidence-based advice on the diagnosis, care and treatment of adults with multiple sclerosis.

The Acute heart failure guideline offers evidence-based advice on the care and management of adults with acute heart failure or possible acute heart failure.

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

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BNF 68

The 68th Edition of the British National Formulary has been published and it is currently being distributed in the NHS. As previously noted, the BNF will now only be distributed annually in the NHS.

New or revised content in this version includes updated advice in the following areas:

  • Updated guidance on the incidence of venous thromboembolism associated with combined hormonal contraceptives
  • Updated oral doses of amoxicillin and ampicillin for children
  • New MHRA restrictions on the use of domperidone following a review of the risks and benefits of its use
  • Changes made to the recommendations on interchangeability of oral mesalazine preparations
  • New MHRA advice on self-administration of adrenaline for anaphylaxis
  • The dose of naloxone for acute opioid overdosage in adults and children has been revised
  • Updates to recommendations on doses and indications of paracetamol in children
  • Updates to guidance on the treatment of epilepsy

The web version has already been updated but requires registration or an Athens account for continued access. The printed version is available for purchase.

Action: All clinicians should start using BNF 68 as soon as the print version arrives. The web version can be used to access the latest information if necessary.

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Drug Safety Update - October 2014

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

The drug safety section in this issue advises clinicians that there have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment. Clinicians should be vigilant for early signs or symptoms of these conditions and treat these conditions promptly if they occur.

This section also advises that with effect from October 2014 dexamethasone 4mg/ml injection is being replaced by a 3.8mg/ml product. It has a different manufacturer and as such the storage conditions, presentation, and packaging will change.

Other information also clarifies that new laws that set blood concentration limits to be set for certain controlled drugs are only applicable in England, Scotland and Wales. In Northern Ireland a similar offence is under consideration. This new law applies to the following medicines:

  • Cannabis (tetrahydrocannabinol, THC)
  • Cocaine
  • Morphine
  • Diamorphine
  • Methadone
  • Ketamine
  • Amphetamine
  • Flunitrazepam
  • Clonazepam
  • Diazepam
  • Lorazepam
  • Oxazepam
  • Temazepam

Patients should be advised that it is against the law to drive if your driving ability is impaired by a medicine and not to drive while taking a medicine until you know how it affects you (especially just after starting or changing the dose of the medicine) or if feeling sleepy, dizzy, unable to concentrate or make decisions, or if there is blurred or double vision.

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

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SMC Update - October 2014

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

Alogliptin (Vipidia®) has been accepted for restricted use in the treatment of adults aged 18 years and older 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 dual therapy with metformin or a sulphonylurea. This treatment is not recommended as monotherapy or in triple therapy.

Alogliptin plus metformin (Vipdomet®) has been accepted for restricted use in the treatment of adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control. It can be used alone or in combination with pioglitazone or insulin. The restriction limits use to patients for whom this fixed dose combination of alogliptin and metformin is an appropriate choice of therapy.

Azelastine + Fluticasone (Dymista®) has been accepted for the relief of symptoms of moderate to severe seasonal and perennial allergic rhinitis if monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme.

Capsaicin (Qutenza®) has been accepted for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. The restriction limits use to patients who have not achieved adequate pain relief from, or have not tolerated, conventional first and second line treatments.

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

Empagliflozin (Jardiance®) has been accepted for restricted use in the treatment of type 2 diabetes to improve glycaemic control in adults 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 the following situations:

  • dual therapy in combination with metformin, when a sulphonylurea is inappropriate
  • triple therapy in combination with metformin plus standard of care
  • add-on to insulin therapy in combination with insulin plus standard of care

Lurasidone (Latuda®) has been accepted for restricted use in the treatment of schizophrenia in adults aged 18 years and over. The restriction limits use to those patients in whom it is important to avoid weight gain and metabolic adverse effects.

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 - September 2014

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

The drug safety section in this issue advises clinicians about updated recommendations to reduce the risk of osteonecrosis of the jaw (ONJ) associated with use of denosumab (Prolia® and Xgeva®). Dental examination and appropriate preventive dentistry are now recommended prior to initiating treatment to reduce the risk for both indications (osteoporosis and cancer).

This section also advises that nitrofurantoin now contraindicated in most patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min. However, it can be used in patients with an eGFR of 30 to 44 ml/min to treat lower urinary tract infection with suspected or proven multidrug resistant pathogens when the benefits of nitrofurantoin are considered to outweigh the risks of side effects. This contraindication allows nitrofurantoin to be used in patients for whom it was previously not recommended. A renal function check should also be considered when choosing to treat with nitrofurantoin, especially in the elderly.

The yellow card scheme update advises clinicians that new guidelines for reporting suspected adverse drug reactions (ADRs) in children and adolescents aged under 18 years have been published. Previously, reporting was requested for all ADRs however it is now advised that yellow cards should be completed for:

  • all suspected ADRs that are serious or result in harm. Serious reactions are those that are fatal, life-threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason.
  • all suspected ADRs associated with new drugs and vaccines (identified by the black triangle symbol: ▼)

The stop press section reminds clinicians that domperidone is no longer available to purchase in pharmacies.

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

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