The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Dapagliflozin (Forxiga®) has been accepted for use in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Beclometasone / formoterol / glycopyrronium (Trimbow®) has been accepted for use as a maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The MHRA Central Alerting System has issued two alerts warning that aminophylline tablets and morphine sulphate prolonged release granules for oral suspension are both being discontinued.
Aminophylline (Phyllocontin®) modified release tablets are being discontinued in both the 225mg and 350mg strengths. Remaining supplies in the distribution chain are expected to be exhausted by early April 2021. Theophylline (Uniphyllin®) tablets remain available and may provide a suitable alternative or inhaled therapies could be reviewed and optimised.
Morphine sulphate (MST Continus®) prolonged release granules for oral suspension are currently available in 20mg, 30mg, 60mg, 100mg and 200mg strengths. All strengths are being permanently discontinued during 2021 due to difficulty sourcing a key excipient. The alerts notes that alternative morphine presentations, both prolonged release and immediate release, remain available and will be able to support increased demand. The full document contains specific advice on which products can be opened and taken with food in the case of swallowing difficulties or via gastric or gastrostomy tubes.
Action: Clinicians should be aware of these products being discontinued. It would be prudent to run clinical system searches to identify any patients who are currently prescribed these products to allow a review and arrangements made to identify suitable alternatives.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Formoterol / glycopyrronium / budesonide aerosol inhaler (Trixeo Aerosphere®) has been accepted for restricted use as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. The restriction limits use to patients with severe COPD (FEV1 less than 50% predicted normal).
Leuprorelin acetate (Prostap®) has been accepted for use as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in pre- and perimenopausal women at higher risk of disease recurrence. It is expected treatment would continue in primary care at the recommendation of a specialist.
Leuprorelin acetate (Prostap®) has been accepted for use as treatment in pre- and perimenopausal women with advanced breast cancer suitable for hormonal manipulation.. It is expected treatment would continue in primary care at the recommendation of a specialist.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Melatonin prolonged-release (Slenyto®) has been rejected following a resubmission for use in the treatment of insomnia in children and adolescents aged 2 to 18 years with autism spectrum disorder and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient. The submitting company did not present a sufficiently robust clinical or 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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