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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - April 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2022 (PDF).

This issue advises that a recent study has indicated that pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Data from 2,700 pregnancies with pregabalin exposure in the first trimester was compared with exposure to no antiepileptic drugs or lamotrigine or duloxetine. Full details of the study have been published. Patients are advised to continue to use effective contraception during treatment and avoid use in pregnancy unless clearly necessary.

This issue contains the latest COVID-19 vaccine and medicine information including reassuring real-world data for for Spikevax COVID-19 vaccine and Comirnaty COVID-19 vaccine when used during pregnancy and breastfeeding. This section also notifies readers of the approval of Valneva COVID-19 vaccine and Evusheld (tixagevimab/cilgavimab) for COVID-19 prevention.

Lastly in this issue is a summary of letters to healthcare professionals in March. These generally related to supply issues and recalls.

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

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CKS Updates - March 2022

During March 2022 Clinical Knowledge Summaries were published or updated in the following areas.

The Rehabilitation after traumatic injury topic is new. The remaining topics have been reviewed and updated in keeping with current guidance with minor layout changes. The Breastfeeding problems topic contains updates to the section on management of suspected ductal infection to reflect a lack of evidence of the role of bacteria and yeast and to support the judicious use of antimicrobials. The Cervical cancer and HPV topic has been updated in line with current evidence in the literature and a new section on Assessment has been added to the Diagnosis section. The Molluscum contagiosum topic contains a new section on Risk factors in Background information.

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 - March 2022

The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of March 2022. This month there are five guidelines, one and two technology appraisals that impact upon primary care.

The Mental wellbeing at work guideline has been published. It covers how to create the right conditions for mental wellbeing at work. It aims to promote a supportive and inclusive work environment, including training and support for managers and helping people who have or are at risk of poor mental health.

The Disabled children and young people up to 25 with severe complex needs guideline has been published. It covers support for disabled children and young people with severe complex needs, from birth to 25 years. It aims to encourage education, health and social care services to work together and provide more coordinated support to children and young people, and their families and carers.

The Integrated health and social care for people experiencing homelessness guideline has been published. It covers providing integrated health and social care services for people experiencing homelessness. It aims to improve access to and engagement with health and social care, and ensure care is coordinated across different services.

The Hypertension in adults: diagnosis and management guideline has been updated. It covers identifying and treating primary hypertension in people aged 18 and over, including people with type 2 diabetes. The updated includes new recommendations on blood pressure targets and antihypertensive drug treatment for people with cardiovascular disease.

The Otitis media (acute): antimicrobial prescribing guideline has been updated. It sets out an antimicrobial prescribing strategy for acute otitis media. The update adds a new recommendation on ear drops containing an anaesthetic and an analgesic because a licensed preparation is now available in the UK.

The Empagliflozin for treating chronic heart failure with reduced ejection fraction technology appraisal has been published. This treatment is recommended as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adults, only if it is used as an add-on to optimised standard care with:

  • an angiotensin-converting enzyme (ACE) inhibitor or angiotensin 2 receptor blocker (ARB), with a beta blocker and, if tolerated, a mineralocorticoid receptor antagonist (MRA), or
  • sacubitril/valsartan with a beta blocker and, if tolerated, an MRA

The Dapagliflozin for treating chronic kidney disease technology appraisal has been published. This treatment is recommended as an option for treating chronic kidney disease (CKD) in adults. It is recommended only if:

  • it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated, and
  • people have an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 to 75 ml/min/1.73 m2 at the start of treatment and:
    • have type 2 diabetes or
    • have a urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more

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 - March 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2022 (PDF).

This issue reminds clinicians that amiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. It is recommended that patients on long-term amiodarone treatment are supervised and reviewed regularly during treatment. This should include liver and thyroid function tests before treatment, at 6-monthly intervals during treatment, and thyroid function should be monitored for several months after stopping treatment.

This issue also reports that a large study has shown no safety issues of concern relating to the use of metformin during pregnancy. The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase as an addition or an alternative to insulin, if clinically needed.

This issue contains the latest COVID-19 vaccine and medicine information including a reminder about the UK COVID-19 Antivirals Pregnancy Registry and updated summaries of Yellow Card reporting.

Lastly in this issue is a summary of letters to healthcare professionals in February. These generally related to supply issues and recalls.

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

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SMC Update - March 2022

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

Hydrocortisone modified-release (Efmody®) has been rejected for use in the treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. The manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.

Betula verrucosa extract (Itulazax®) has been rejected for use in the treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis induced by pollen from the birch homologous group. The manufacturer did not make a submission for this indication.

Solriamfetol (Sunosi®) has been rejected for use in adult patients with obstructive sleep apnoea (OSA) to improve wakefulness and reduce excessive daytime sleepiness when these symptoms have not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP). The manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.

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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