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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Drug Safety Update - June 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2021 (PDF).

This month readers are advised of reports of interstitial lung disease and pneumonitis associated with use of CDK4/6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼). Patients taking these medicines should be made aware of the need to seek advice right away if they develop new or worsening respiratory symptoms at clinic reviews. Patients on these medicines who present in primary care with respiratory symptoms should be managed cautiously and should be advised to make contact with their specialist.

Readers are also advised of the risk of severe cutaneous adverse reactions (SCARs) including SJS and TEN associated with use of atezolizumab▼ (Tecentriq®) and other immune-stimulatory anti-cancer drugs. Patients on these drugs should be advised by their specialist to be vigilant for the signs of severe skin reactions and to seek urgent medical advice if they occur. In such cases continued treatment should be withheld, and patients referred to a specialist for diagnosis and treatment.

This issue also contains an update on COVID-19 vaccines and medicines that includes information on a newly licensed vaccine from Janssen and licence extension to younger age groups for the Pfizer/BioNTech vaccine.

Finally in this issue is a summary of letters to healthcare professionals sent in May that were regarding product 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 - June 2021

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

5-aminolevulinic acid (Alacare®) has been accepted for single use treatment of mild actinic keratoses lesions with a maximum diameter of 1.8 cm on the face and scalp (hairless areas). It is noted that another licensed formulation of 5-aminolevulinic acid is available and there may be an associated small net budget impact with the use of this product.

Vigabatrin (Kigabeq®) has been accepted for restricted use in infants and children from 1 month to less than 7 years of age for:

  • treatment in monotherapy of infantile spasms (West's syndrome)
  • treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated

The restriction limits use to patients in whom other formulations of vigabatrin are not suitable.

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 - May 2021

During May 2021 Clinical Knowledge Summaries were published or updated in the following areas.

All topics have been reviewed and updated in keeping with current guidance with minor layout changes. No major changes have been made within these topics

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 - May 2021

The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of May 2021. This month are three guidelines and one technology appraisal that impact upon primary care.

The Heavy menstrual bleeding: assessment and management guideline has been updated. It covers assessing and managing heavy menstrual bleeding (menorrhagia). It aims to help healthcare professionals investigate the cause of heavy periods that are affecting a woman’s quality of life and to offer the right treatments, taking into account the woman's priorities and preferences. The update reinstated recommendations on the use of ulipristal acetate (Esmya®) for uterine fibroids in line with updated MHRA safety advice on the risk of serious liver injury.

The Epilepsies: diagnosis and management guideline has been updated. It covers diagnosing, treating and managing epilepsy and seizures in children, young people and adults in primary and secondary care. It offers best practice advice on managing epilepsy to improve health outcomes so that people with epilepsy can fully participate in daily life. The update reviewed and amended recommendations on carbamazepine, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, pregabalin, topiramate and zonisamide in line with the MHRA updated safety advice on antiepileptic drugs in pregnancy.

The Headaches in over 12s: diagnosis and management guideline has been updated. It covers advice on the diagnosis and management of tension-type headache, migraine, cluster headache and medication overuse headache in young people (aged 12 years and older) and adults. It aims to improve the recognition and management of headaches, with more targeted treatment to improve the quality of life for people with headaches, and to reduce unnecessary investigations. The update amended our recommendation on topiramate for migraine prophylaxis to include discussion of the potential benefits and risks, and the importance of effective contraception for women and girls of childbearing potential when taking topiramate.

The Crisaborole for treating mild to moderate atopic dermatitis in people 2 years and older technology appraisal has been terminated. This treatment is intended for use in the treatment of mild to moderate atopic dermatitis in people 2 years and older. However, the manufacturer withdrew its evidence submission and therefore no recommendation can be made at this time.

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 - May 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2021 (PDF).

This month readers are advised that, while generic prescribing of levothyroxine remains appropriate for the majority of patients, in some patients prescribing a specific product, known to be well tolerated by the patient, should be considered if they report persistent symptoms when switching between different levothyroxine tablet formulations. It is further suggested that if symptoms or poor control of thyroid function persist despite adhering to a specific product, the levothyroxine in an oral solution formulation can be used.

This issue also contains an update on COVID-19 vaccines and medicines that includes a statement from the JCVI on the AstraZeneca COVID-19 Vaccine for people aged under 40.

Finally in this issue is a summary of letters to healthcare professionals sent in April that were regarding product recalls and imported medicine supplies.

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

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