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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

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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Drug Safety Update - February 2022

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

This issue notes that a UK COVID-19 Antivirals Pregnancy Registry has been created. The safety of COVID-19 antivirals in pregnancy has not been established and information is therefore requested for any pregnancies which occur during use of an antiviral, including paternal use. Reports are welcomes from healthcare professionals, pregnant women and partners of pregnant women.

This issue also highlights an observed increased risk of cardiovascular events in patients with rheumatoid arthritis following co-administration of azithromycin with hydroxychloroquine. Based on this data, healthcare professionals are advised to carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. Clinicians are also reminded to be vigilant for psychiatric reactions associated with hydroxychloroquine or chloroquine, especially in the first month of treatment.

This issue contains the latest COVID-19 vaccine and medicine information including the recent approval of the Nuvaxovid® COVID-19 vaccine developed by Novavax. The update also advises that weekly summaries of Yellow Card reporting events associated with coronavirus vaccine continues to be published.

Lastly in this issue is a summary of letters to healthcare professionals in January. These generally related to supply issues and recalls as well as details of the consultation proposal to make estradiol 10 microgram vaginal tablets available from pharmacies.

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 2022

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

Cannabidiol (Epidyolex®) has been accepted for use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older. This advice applies only in the context of an approved NHSScotland Patient Access Scheme and it is therefore expected that this medication will be supplied direct from the specialist. There is existing NICE and SMC advice on the use of this medicine for seizures associated with Dravet syndrome and Lennox–Gastaut syndrome.

Cenobamate (Ontozry®) has been accepted for restricted use as an adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite treatment with at least 2 anti-epileptic medicinal products. The restriction limits use to patients with drug-resistant epilepsy as a second-line adjunctive anti-seizure medicine, after the failure of the first adjunctive anti-seizure medicine.

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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Drug Safety Update - January 2022

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

This issue contains the latest COVID-19 vaccine and medicine information including information on the approval of Paxlovid® for the treatment of COVID-19 in adults who are at risk of developing severe illness. It is noted that this medication may interact with other medications. Before it is prescribed, the MHRA is therefore advising that patients’ current medications should be carefully reviewed. Further information is available in the Summary of Product Characteristics.

Lastly in this issue is a summary of letters to healthcare professionals in December. 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 - January 2022

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

Opicapone (Ongentys®) has been accepted for use as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. It is noted that opicapone provides an additional treatment choice in the therapeutic class of catechol-O-methyl transferase inhibitors.

Budesonide (Cortiment®) has been accepted for use in the induction of remission in patients with active microscopic colitis. It is noted that other oral budesonide formulations are available at lower cost.

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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