Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update - November 2016

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

Dequalinium (Fluomizin®) has been accepted for restricted use in the treatment of bacterial vaginosis where the initial treatment is ineffective or not well tolerated.

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 - 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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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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Drug Safety Update - September 2016

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

This issue contains updated advice on emergency hormonal contraception in patients taking hepatic enzyme inducers. It is now advised that women taking hepatic enzyme inducers, or who have taken them in the previous 4 weeks, are recommended to preferably use a non-hormonal emergency contraceptive - i.e. a copper intrauterine device. Where this is not possible a double dose of levonorgestrel must be used. It is also advised that a pregnancy test is performed to exclude pregnancy after use of levonorgestrel-containing emergency contraception and advice sought if they do become pregnant.

Hepatic enzyme inducers include medicines used to treat:

  • epilepsy (e.g. barbiturates, primidone, phenytoin, carbamazepine)
  • tuberculosis (e.g. rifampicin, rifabutin)
  • HIV (e.g. ritonavir, efavirenz)
  • fungal infections (e.g. griseofulvin)
  • and Herbal remedies that contain St John’s wort (Hypericum perforatum)

This issue also contains additional information that posaconazole suspension and tablets are not dose equivalent as noted in the summary of letters to healthcare professionals in last month's update.

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

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