Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - February 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2020 (PDF).

This month clinicians are advised that the licence for ingenol mebutate gel (Picato®) has been suspended as precautionary measure due to risk of skin malignancy. The European Medicines Agency (EMA) continues to investigate these concerns.

This issue also advises of the distribution last month of updated educational materials to support the valproate pregnancy prevention programme. Valproate is contraindicated in girls and women of childbearing potential, unless the conditions of the pregnancy prevention programme are met.

The insertion site and method for etonogestrel (Nexplanon®) contraceptive implants has been amended to avoid this risk of deep insertion. This is following concerns regarding reports of neurovascular injury and implants migrating to the vasculature.

Readers are also encouraged to support ADR awareness week between 17–23 February 2020 by sharing material on social media and discussing with colleagues and patients the importance of reporting suspected side effects.

The summary of letters to healthcare professionals includes this month includes links to letters warning of the risks of congenital malformation with modafinil and potentially fatal dosing errors with methotrexate as well as letters regarding some of the items above. The medical device letters highlights a risk of stoma injury, bleeding and leakage under the skin barrier with specific batches of convex two-piece skin barriers that have been incorrectly manufactured with off-centre starter/stoma hole. Identification and return of affected devices is recommended.

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

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SMC Update - February 2020

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

Sodium zirconium cyclosilicate (Lokelma®) has been rejected for use in the treatment of hyperkalaemia in adult patients. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

Update: Thanks to an observant reader (see comments below), I must clarify that NICE guidance exists that applies to England and Wales for this medicine which should be followed in those member countries.

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 - January 2020

During January 2020 Clinical Knowledge Summaries were published or updated in the following areas.

All of the topics have been reviewed and undergone minor restructuring. The Cows' milk protein allergy in children topic has been renamed within the topic area and the recommendations on the assessment and management of suspected cow's milk allergy have been amended in line with current evidence. A new prescribing information section has been added to provide information on prescribing oral antihistamines, in line with the CKS topic on Food allergy. The Tamoxifen - managing adverse effects topic now includes primary prevention of breast cancer in women at moderate or high risk as a licensed indication for tamoxifen in keeping with the product license.

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 - January 2020

The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of January 2020. This month there are two guidelines that impact upon primary care.

The Supporting adult carers guideline has been published. It covers support for adults (aged 18 and over) who provide unpaid care for anyone aged 16 or over with health or social care needs. It aims to improve the lives of carers by helping health and social care practitioners identify people who are caring for someone and give them the right information and support. It covers carers' assessments, practical, emotional and social support and training, and support for carers providing end of life care.

The Colorectal cancer guideline has been published. It covers managing colorectal cancer in people aged 18 and over. It aims to improve quality of life and survival for adults with colorectal cancer through management of local disease and management of secondary tumours (metastatic disease).

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 - January 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2020 (PDF).

This month clinicians are invited to report suspected adverse reactions associated with use of e-cigarettes or vaping (including lung injury) to the MHRA via the Yellow Card Scheme. More than 2,600 cases of lung injury have been reported to the US Centers for Disease Control and Prevention (CDC) with 60 fatal cases. Clinicians should have a high index of suspicion in patients presenting with respiratory symptoms where there is a history of e-cigarette use or vaping in the past 30 days.

Clinicians are also notified of a small increased risk of oral clefts following use of ondansetron in the first 12 weeks of pregnancy. This information comes from epidemiological studies in the USA which have some limitations but are sufficiently robust to indicate an increased risk. Ondansetron is not usually used as a first line treatment in hyperemesis gravidarum. Where it is offered, women must be counselled on the potential benefits and risks of use, both to her and to her unborn baby and the final decision should be made jointly.

The summary of letters to healthcare professionals this month includes a further group of letters recalling ranitidine, a letter advising that three presentations of Insuman® are being discontinued and an update on the valproate Pregnancy Prevention Programme.

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

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