Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - November 2014

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

The drug safety section in this issue reminds clinicians that agomelatine (Valdoxan®) may cause liver toxicity in some people and that liver function should be tested before and during treatment. It is recommended that treatment is stopped if serum transaminases exceed three times the upper limit of normal and that patients are advised to stop taking agomelatine and to get medical help immediately if they have any signs or symptoms of liver injury. This section also reports that there have been reports of Colobreathe® (colistimethate sodium) capsules shattering when pierced by their inhaler device. The instructions for inhaler use have been revised and it is recommended that the new inhaler is demonstrated to patients and carers and that the first dose is supervised.

The stop press section reminds readers of the risk of ingestion of desiccants in blister packs. There have been two reports recently of people swallowing the desiccant that came with their nicorandil tablets instead of the tablet itself. It is noted that the foil blister and patient information leaflet clearly advise people not to swallow the desiccant. It is recommended that people receiving blister packs containing a desiccant are reminded the desiccant should not be swallowed.

The other information section advises that the arrangements for email alerts about Drug Safety Update are changing. Current subscribers can check their settings at https://service.govdelivery.com/accounts/UKMHRA/subscriber/new.

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

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SMC Update - November 2014

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

Brinzolamide and brimonidine eye drops (Simbrinza®) have been accepted for use to decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. It is noted that this combination is not significantly more expensive and allows patients to administer fewer drops.

Denosumab (Prolia®) has been rejected for the treatment of osteoporosis in men at increased risk of fractures. The manufacturer failed to make a submission and as a result this treatment cannot be recommended.

Saxagliptin (Onglyza®) has been accepted for use in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Voriconazole (Vfend®) has been rejected for the prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients. The manufacturer failed to make a submission and as a result this treatment cannot be recommended.

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

The Gallstone disease clinical guideline offers evidence-based advice on the diagnosis and management of gallstone disease in adults.

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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