Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - September 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for September 2019 (PDF).

This month clinicians are advised that fingolimod (Gilenya®) has been associated with an increased risk of congenital malformations. It is recommended that women of childbearing potential must use effective contraception during fingolimod treatment and for 2 months after discontinuation.

Also this month pentosan polysulfate (Elmiron®) has been rarely linked with pigmentary maculopathy leading to visual impairment. Patients taking this drug are advised to have regular ophthalmic examinations and to promptly seek medical advice in case of visual changes.

Clinicians are also reminded of the risk of neuropsychiatric reactions associated with montelukast (Singulair®). Clinicians are reminded to be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur.

The summary of letters to healthcare professionals this month includes a notification letter from Santen warning of the risk of medication error during a transition to a new bottle design. Affected products include Cosopt®, Trusopt® and Timoptol®.

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

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SMC Update - September 2019

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

Melatonin prolonged-release (Slenyto®) has been rejected for use in the treatment of insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient. The justification of the treatment's cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.

Dapagliflozin (Forxiga®) has been accepted for use in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥27kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.

Ospemifene (Senshio®) has been accepted for use in the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy.

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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New HRT Risk Data

Last week the Medicines and Healthcare products Regulatory Agency issued an update after new data on breast cancer risk linked with HRT use were published.

This new analysis, published in The Lancet was a prospective, observational study of over 100,000 women. The study extended our understanding as follows:

  • All forms of systemic HRT are associated with a significant excess incidence of breast cancer, irrespective of the type of oestrogen or progestogen or route of delivery
  • Risk of breast cancer increases further with longer duration of HRT use
  • Risk of breast cancer is lower after stopping HRT than it is during current use, but remains increased in ex-HRT users for more than 10 years compared with women who have never used HRT

More reassuringly, the study also found that use of systemic HRT for less than a year is associated with little or no increase in risk and there is also no increase in risk with low doses of oestrogen applied directly via the vagina to treat local symptoms.

New risk tables have been produced to aid communication about risks and benefits. Table 1 summarises risk compared to duration of use while Table 2 summarises risk by HRT type.

The MHRA are advising that this new information is shared with women who use or are considering starting HRT at their next routine appointment. It is also recommended that HRT is used for the shortest time and at the lowest dose to relieve post-menopausal symptoms that are adversely affecting quality of life and that users are advised to be vigilant for signs of breast cancer and attend for breast screening.

Action: Clinicians who prescribe HRT should be aware of this new data and include this new information when discussing the risks and benefits of treatment.

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CKS Updates - August 2019

During August 2019 Clinical Knowledge Summaries were published or updated in the following areas.

The Sepsis topic is new. The Neutropenic sepsis has been updated in line with current evidence and new sections have been added on Specialist assessment and Follow-up. The other topics have undergone reviews and minor restructures.

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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NICE Guidance - August 2019

The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of August 2019. This month there are two guidelines and one technology appraisal that impact upon primary care.

The Hypertension in adults: diagnosis and management guideline has been published. It covers identifying and treating primary hypertension (high blood pressure) in people aged 18 and over, including people with type 2 diabetes. It aims to reduce the risk of cardiovascular problems such as heart attacks and strokes by helping healthcare professionals to diagnose hypertension accurately and treat it effectively. This guideline updates and replaces NICE guideline CG127. It also updates and replaces the section on blood pressure management in the NICE guideline on type 2 diabetes in adults (NG28).

The Type 2 diabetes in adults: management guideline has been updated. It covers the care and management of type 2 diabetes in adults (aged 18 and over). It focuses on patient education, dietary advice, managing cardiovascular risk, managing blood glucose levels, and identifying and managing long-term complications. The update removed the recommendations on blood pressure management which were updated and replaced by recommendations in the NICE guideline on hypertension in adults mentioned above.

The Dapagliflozin with insulin for treating type 1 diabetes technology appraisal has been published. Dapagliflozin with insulin is recommended as an option for treating type 1 diabetes in adults with a body mass index (BMI) of at least 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, only if:

  • they are on insulin doses of more than 0.5 units/kg of body weight/day and
  • they have completed a structured education programme that is evidence based, quality assured, delivered by trained educators and includes information about diabetic ketoacidosis, such as:
    • how to recognise its risk factors, signs and symptoms
    • how and when to monitor blood ketone levels
    • what actions to take for elevated blood ketones
  • treatment is started and supervised by a consultant physician specialising in endocrinology and diabetes.

It is also recommended that haemoglobin A1c (HbA1c) levels are assessed after 6 months and regularly after this. Stop dapagliflozin if there has not been a sustained improvement in glycaemic control (that is, a fall in HbA1c level of at least 0.3%).

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

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