The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2022 (PDF).
This issue invites clinicians to respond to a consultation that will influence how the MHRA communicate with healthcare professionals in the future.
This issue contains the latest COVID-19 vaccine and medicine information including information on newly licensed vaccines and updated product information.
Lastly in this issue is a summary of letters to healthcare professionals in October. 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.
The Chief Medical Officer has written to healthcare professionals via the Central Alerting System (PDF) to advise that antiviral medicines may now be prescribed at NHS expense due to rising levels in reporting of influenza-like illness.
Surveillance data indicates an increase in influenza cases in the community and as such GPs and other prescribers working in primary care may now prescribe antiviral medicines for the prophylaxis and treatment of influenza. NICE has issued guidance on the treatment and prevention of influenza with antiviral medication.
Clinicians should remember to endorse the prescription with 'SLS' to ensure that it can be dispensed in community pharmacies without undue delay.
Action: Clinicians should be aware of this letter and familiarise themselves with the current prescribing guidance.
The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of November 2022. This month there is one technology appraisal that impacts upon primary care.
The Slow-release potassium bicarbonate–potassium citrate for treating distal renal tubular acidosis technology appraisal has been terminated. NICE is unable to make a recommendation because the manufacturer withdrew its evidence submission. The decision will be reviewed if the company decides to make a submission.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Esketamine (Spravato®) has been rejected for use in adults with a moderate to severe episode of Major Depressive Disorder, as acute short-term treatment, when co-administered with oral antidepressant therapy, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency. The manufacturer failed to make a submission for this indication.
Buprenorphine / naloxone (Zubsolv®) has been accepted for restricted use in substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The restriction limits use to patients for whom methadone is not suitable. It is expected that clinicians with specialist experience in the field will undertake prescribing.
Sodium zirconium cyclosilicate (Lokelma®) has been accepted for restricted use in the treatment of hyperkalaemia in adult patients. The restriction limits use to emergency care settings for the treatment of acute, life-threatening hyperkalaemia alongside standard care.
Levofloxacin plus dexamethasone (Ducressa®) has been accepted for use in the prevention and treatment of inflammation, and prevention of infection associated with cataract surgery in adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Finerenone (Kerendia®) has been accepted for use in the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
During October 2022 Clinical Knowledge Summaries were published or updated in the following areas.
All of the topics have been reviewed and updated with minor structural and layout changes. The Herpes simplex - genital topic has been updated to include a Prescribing information section that covers oral antiviral drugs that may be used for episodic or suppressive therapy in primary care.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
