Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - July 2019

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

This issue advises that febuxostat should be avoided, unless no other therapy options are appropriate, in patients with pre-existing major cardiovascular disease due to an increased risks observed in a clinical trial. The study (CARES) found a higher risk for cardiovascular-related death and for all-cause mortality in patients assigned to febuxostat than in those assigned to allopurinol.

This issue also advises that tocilizumab (RoActemra®) has been linked with rare risk of serious liver injury including cases requiring transplantation. It is recommended that alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab and monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter. Some areas may arrange monitoring under shared care.

There is also a reminder that rivaroxaban (Xarelto®) 15 mg and 20 mg tablets should be taken with food. There have been reports of reduced efficacy when taken on an empty stomach. The lower strengths can be taken with or without food.

Finally this month, the summary of letters to healthcare professionals includes a letter regarding the risk of teratogenicity and neuropsychiatric disorders with retinoids and the pregnancy prevention programme launched last month. There is also a link to a letter regarding the febuxostat advice mentioned above.

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

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CKS Updates - June 2019

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

The majority of topics have undergone reviews and minor restructures. The Bowel screening topic has been updated regarding the adoption of the faecal immunochemical test (FIT). The Cellulitis - acute topic now recommends doxycycline as the antibiotic of choice in patients taking a stain who cannot take penicillin antibiotics. The Developmental rheumatology in children is a new topic and the Premenstrual syndrome topic has been updated to clarify the definition of and information on the severity of premenstrual syndrome.

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 - June 2019

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

The Urinary incontinence and pelvic organ prolapse in women guideline has been updated. It covers assessing and managing urinary incontinence and pelvic organ prolapse in women aged 18 and over. It also covers complications associated with mesh surgery for these conditions. Two recommendations on the use of synthetic polypropylene or biological mesh insertion for women with recurrent anterior vaginal wall prolapse have been withdrawn.

The Hypertension in pregnancy guideline has been published; it replaces previous guidance. It covers diagnosing and managing hypertension (high blood pressure), including pre-eclampsia, during pregnancy, labour and birth. It also includes advice for women with hypertension who wish to conceive and women who have had a pregnancy complicated by hypertension. It aims to improve care during pregnancy, labour and birth for women and their babies.

The Depression in children and young people guideline has been published; it replaces previous guidance. It covers identifying and managing depression in children and young people aged 5 to 18 years. Based on the stepped-care model, it aims to improve recognition and assessment and promote effective treatments for mild and moderate to severe depression.

The Ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor for treating type 2 diabetes technology appraisal has been published. Ertugliflozin is recommended as an option for treating type 2 diabetes in adults when diet and exercise alone do not provide adequate glycaemic control, only if:

  • the disease is uncontrolled with metformin and a DPP‑4 inhibitor, and
  • a sulfonylurea or pioglitazone is not appropriate.

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

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HPV vaccination extended to include boys

Public Health England has announced that the human papillomavirus (HPV) vaccination programme is to be extended to include boys from 1 September 2019.

The vaccine has been offered to girls as part of the NHS immunisation programme since 2008. Based on the advice of the Joint Committee of Vaccination and Immunisation (JCVI) the programme is being expanded and will now have universal coverage.

Action: This information is aimed at health professionals who will be responsible for implementing the new programme but may be useful for anyone who may see patients presenting following vaccination.

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Drug Safety Update - June 2019

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

This issue advises that direct-acting oral anticoagulants (DOACs) are not recommended in patients with antiphospholipid syndrome due to an increased risk of recurrent thrombotic events. A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin in patients with antiphospholipid syndrome and a history of thrombosis. This particularly affects high-risk patients who test positive for all 3 antiphospholipid tests. It is also recommended to review any patients with antiphospholipid syndrome who are currently prescribed a DOAC and consider switching to a vitamin K antagonist such as warfarin.

This issue also advises of reports of diabetic ketoacidosis seen in patients on GLP-1 receptor agonists when concomitant insulin was rapidly reduced or discontinued. It is recommended that insulin reductions should be done in a step-wise manner with careful glucose self-monitoring if GLP-1 receptor agonist therapy is initiated and the insulin is dose is reduced.

New materials have been launched to support the pregnancy prevention programme including a new prescribed checklist for oral retinoid medicines. In conjunction with this, advice about the risk of neuropsychiatric reactions has been made consistent for all oral retinoid medicines.

Finally this month, the summary of letters to healthcare professionals includes a letter regarding the shortage of Epanutin (phenytoin) oral solution which contains prescribing and dispensing advice. There is also a link to a letter regarding DOAC use in patients with antiphospholipid syndrome.

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

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