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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update - July 2024

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

Empagliflozin (Jardiance®) has been accepted for restricted use in adults for the treatment of chronic kidney disease. The restriction limits use to patients on individually optimised standard care (with ACEi or ARB) and, at the start of treatment, either:

  • an estimated glomerular filtration rate (eGFR) of 20 mL/min/1.73m2 up to 45 mL/min/1.73m2, or
  • an eGFR of 45 mL/min/1.73m2 up to 90 mL/min/1.73m2 and either:
    • A urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more, or
    • Type 2 Diabetes Mellitus

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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SMC Update - June 2024

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

Tirzepatide (Mounjaro®) has been accepted for restricted use for weight management, including weight loss and weight maintenance, as an adjunct to a reduced-calorie diet and increased physical activity in adults. The restriction limits use to adults with BMI ≥30 kg/m2 and at least one weight-related comorbidity. It is noted that a lower BMI may be more appropriate for members of minority ethnic groups known to be at equivalent risk of the consequences of obesity at a lower BMI than the white population. NICE guidance is expected to be published on October, and it is expected that specialist weight management services would be responsible for providing this medication for this indication.

Last month, budesonide/formoterol (Symbicort®) was accepted for restricted use as a reliever therapy for adults and adolescents (12 years and older) with mild asthma. The restriction limits use to for use in patients who would otherwise receive low dose inhaled corticosteroid (ICS) maintenance therapy plus short-acting beta-2 adrenoceptor agonist (SABA) as needed.

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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SMC Update - April 2024

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

Daridorexant (Quviviq®) has been accepted for restricted use in the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning. The restriction limits use to people who have failed cognitive behavioural therapy for insomnia (CBT-I) or for whom CBT-I is unsuitable or unavailable. It is noted that the prescribing information recommends using this treatment for the shortest period possible.

Tirzepatide (Mounjaro®) has been accepted for restricted use in the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
  • in addition to other medicinal products for the treatment of diabetes

The restriction limits use to combination treatment with other oral anti-diabetic medicines as an option when glucagon-like peptide-1 (GLP-1) receptor agonists would be considered. Monotherapy treatment is not recommended as the company's submission related only to its use in addition to other medicinal products.

Glycopyrronium / formoterol fumarate (Bevespi Aerosphere®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

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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SMC Update - March 2024

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

Pitolisant (Wakix®) has been rejected for use to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA) whose EDS has not been satisfactorily treated by, or who have not tolerated, OSA primary therapy, such as continuous positive airway pressure (CPAP). The manufacturer failed to make a submission for this indication.

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 2024

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2024 (PDF).

This issue notifies clinicians that codeine linctus has now been reclassified as a prescription-only medicine (POM), following a public consultation. A recent review identified greater levels of recreational use than the intended use as a cough suppressant. As a risk minimisation measure to protect the health of patients this product will no longer be supplied without a prescription.

This issue also advises clinicians that pseudoephedrine has been very rarely associated with posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These conditions present with a sudden severe headache or thunderclap headache, sudden onset of nausea and vomiting, confusion, seizures and/or visual disturbances. Urgent medical attention should be sought if these symptoms occur and patients presenting with these symptoms should be asked about their medication history.

Lastly in this issue is a summary of letters to healthcare professionals in January. These generally related to supply issues and recalls but also include letters sent to appropriate healthcare professionals about revised educational materials for valproate-containing medicines, the dose-dependent increased risk of atrial fibrillation in patients using omega-3-acid ethyl ester medicines as reported in the drug safety update last month and a change to the pump priming advice prior to first use of Tostran® (Testosterone, 2% gel) following a manufacturing change.

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

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