Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - May 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2018 (PDF).

This issue advised that Pregnancy Prevention Programme materials relating to the recent valproate medicines safety update are now available online.

This is also notifies readers of the risk of inhalation of capsules if placed in the mouthpiece of the Braltus® inhaler. It is recommended that patients are shown how to use the inhaler using a placebo device from the manufacturer. Patients should also be advised to store capsules in the screw-cap bottle provided (never in the inhaler) and to always check the mouthpiece is clear before inhaling.

The summary of letters to healthcare professionals includes information about the risk of mix-ups between Fiasp®▼ and Tresiba®. Fiasp are coloured yellow while Tresiba is light green; they are visually quite similar. Any patient concurrently using these two products should be advised to be extra vigilant in ensuring they are using the correct product. To strengthen the differentiation between the products, from June 2018 Fiasp® will be available coloured red and yellow.

Attention is also drawn to a recent field safety notice regarding faulty batches of Accu-Chek Aviva and Performa test strips. These batches have a higher risk of strip error messages and false high and low blood glucose results.

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

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SMC Update - May 2018

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

Naltrexone / bupropion (Mysimba®) has been rejected for use as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of:

  • ≥ 30 kg/m² (obese), or
  • ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension)

The manufacturer failed to make a submission for this indication.

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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CKS Updates - April 2018

During April 2018 Clinical Knowledge Summaries were updated in the following areas.

The following topics were all reviewed:

The majority of topics have undergone reviews and minor restructures.

The most significant changes are to the Balanitis and Fungal nail infection topics which have had the management recommendations updated in line with current literature and also the Parkinson's disease topic which has been updated in line with NICE guidance with several sections updated and expanded.

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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Drug Safety Update - April 2018

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2018 (PDF).

This issue advises clinicians that valproate medicines (Epilim®, Depakote®) are contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met. Materials supporting implementation of the Pregnancy Prevention Programme are being distributed. GPs are being advised that they must identify and recall all women and girls who may be of childbearing potential, provide the Patient Guide and check they have been reviewed by a specialist in the last year and are on highly effective contraception. These new measures have been reported in the general media. Valproate medicines are also now subject to more intense surveillance ("Black Triangle ▼") and therefore any suspected adverse reactions associated with valproate should be reported, including adverse pregnancy outcomes.

This issue also contains a general reminder that any healthcare professional can submit a Yellow Card if an adverse reaction is suspected. If your occupation is not available in our drop-down list, you can now select 'Other healthcare professional'.

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

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NICE Guidance - April 2018

The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of April 2018. This month there are seven guidelines that impact upon primary care.

Five guidelines have all been updated to include warnings that valproate must not be used in pregnancy, and only used in girls and women when there is no alternative and a pregnancy prevention plan is in place. The affected guidelines are:

The Lyme Disease guideline has been published. It covers diagnosing and managing Lyme disease. It aims to raise awareness of when Lyme disease should be suspected and ensure that people have prompt and consistent diagnosis and treatment. It does not cover preventing Lyme disease.

The Care and support of people growing older with learning disabilities guideline has been published. It covers care and support for adults with learning disabilities as they grow older. It covers identifying changing needs, planning for the future, and delivering services including health, social care and housing. It aims to support people to access the services they need as they get older.

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

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