Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - November 2016

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

Brimonidine gel (Mirvaso®) has been associated with exacerbations or rebound symptoms of rosacea. This has occurred in up to 16% of patients treated with brimonidine gel in clinical studies and in most cases erythema and flushing resolve after stopping treatment. It is recommended that a small amount of gel is used for the first week and the dose should be increased gradually. Patients should also be advised not to exceed the maximum dose and should stop treatment and consult a doctor if their symptoms worsen during treatment.

This issue also advised of a social media campaign to promote the reporting of suspected adverse drug reactions to the Yellow Card Scheme.

There is also a summary of letters sent to healthcare professionals in October including the reintroduction to market of levothyroxine and introduction of new tablet strengths by Teva.

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

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CKS Updates - October 2016

During October 2016 Clinical Knowledge Summaries were updated for the following topics:

In the Immunizations - Seasonal influenza topic the recommendations on the clinical risk groups eligible for annual influenza immunisation have been updated to include people with morbid obesity and the information on the extension of the national childhood influenza immunisation programme has been updated to include children of appropriate age for school years 1, 2, and 3. Information on the available vaccines and the management of children and adults with egg allergy has been updated in line with the chapter on Influenza in the Public Health England (PHE) document Immunisation against infectious disease (The Green Book).

In the Morton's neuroma topic non-steroidal anti-inflammatory drugs are now included as a management option and there have been minor changes to the recommendations on referral.

Additionally this month there is a new topic area covering Non-alcoholic fatty liver disease (NAFLD).

Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.

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BNF for Children 2016-2017

The hard copy of the British National Formulary for Children 2016-2017 has been updated and published. Electronic versions are updated monthly.

Hard copies can be ordered from the publishers however many NHS clinicians should receive a free hard copy through usual channels and can also access the online version.

Significant changes in this revision include:

  • New safety information about the risk of abnormal pregnancy outcomes with sodium valproate and valproic acid
  • Updated guidance for conditions including asthma and obesity
  • Updated pregnancy-prevention advice for patients taking mycophenolate mofetil
  • New drug monographs including cholic acid
  • New indications for adalimumab including chronic plaque psoriasis
  • New safety information about the risk of osteonecrosis of the external auditory canal with bisphosphonates
  • Guidance on suspected or confirmed drug allergies
  • Evidence grading of BNF recommendations

Action: BNFC is the primary source of prescribing information when prescribing to all children up to the age of 18 years.

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Drug Safety Update - October 2016

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

This issue contains updated advice introducing a lower recommended dose of etoricoxib (Arcoxia®) at 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis. A European review in 2008 requested further clinical trials to compare the safety and efficacy for a 60mg daily dose with the previously recommended daily dose of 90mg. These trials have established that 60mg is an effective dose although some patients may still require the 90mg dose. As such the following recommendations are now made:

  • the lowest effective daily dose should be used, and the need for treatment should be regularly reassessed to reduce cardiovascular and other risks
  • the recommended dose is 60 mg once daily
  • in patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may improve efficacy
  • once the patient is clinically stabilised, down-titration to 60 mg once daily may be appropriate
  • in the absence of therapeutic benefit, other treatment options should be considered

There is also a summary of letters sent to healthcare professionals in September including the planned withdrawal of retigabine (Trobalt®) and the interaction between levonorgestrel-containing emergency hormonal contraception and hepatic enzyme inducers reported in Drug Safety Update last month.

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

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SMC Update - October 2016

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

Budesonide (Cortiment®) is accepted for restricted use in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where aminosalicylate (5-ASA) treatment is not sufficient. The restriction limits use to patients with active left-sided disease and/or proctosigmoiditis who are not suitable for oral prednisolone, as an alternative to budesonide rectal formulations or off-label oral budesonide.

Budesonide / formoterol dry powder and pressurised aerosol inhalers (Symbicort Turbohaler® and pMDI) have been rejected for the treatment of patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) 50% to 70% predicted normal (post bronchodilator) and an exacerbation history despite regular bronchodilator therapy. The manufacturer failed to make a submission. This intervention has previously been accepted for those with an FEV1% predicted of less than 50% and an exacerbation history despite regular bronchodilator therapy. As such this treatment can be used in severe and very severe COPD but is not recommended for moderate COPD.

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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