The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Beclometasone, formoterol, glycopyrronium inhaler (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 high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
Somatrogon (Ngenla®) has been accepted for use in the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. It is noted that this is an additional treatment choice in the therapeutic class of recombinant human growth hormones.
Potassium citrate and potassium hydrogen carbonate granules (Sibnayal®) has been accepted for use in the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older. It is noted that this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) and the evidence used for this decision is based on three days of treatment. As such it would be expected that this item would be prescribed in secondary care.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2022 (PDF).
This issue advises clinicians that a new safety review of topiramate has been initiated. This is in response to the results of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy. Topiramate is already associated with an increased risk of congenital malformations and effects on fetal growth if used during pregnancy. Clinicians are advised to counsel patients who can become pregnant on the known and emerging risks of topiramate for an unborn baby and on the need to use effective contraception throughout use. It would be prudent to provide this counselling prior to commencing this medication and also at routine reviews.
This issue contains the latest COVID-19 vaccine and medicine information including product information updates for Vaxzevria®.
Lastly in this issue is a summary of letters to healthcare professionals in June. 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 Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Solriamfetol (Sunosi®) has been accepted for restricted use to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy (with or without cataplexy). The restriction limits use to patients who have failed to respond to modafinil or have a contraindication or intolerance to modafinil.
Delafloxacin (Quofenix®) has been accepted for restricted use for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of this infection. The restrictions limits use to patients with suspected or confirmed polymicrobial infection following treatment failure or when standard antibacterial therapies are not suitable. It is also noted that delafloxacin should be used on the advice of local microbiologists or specialists in infectious disease.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2022 (PDF).
This issue advises clinicians that vitamin B12 deficiency is now considered to be a common side effect in patients on metformin treatment. The risk increases with higher dose or longer treatment duration and in those with existing risk factors. Checking vitamin B12 serum levels is recommended in patients being treated with metformin who have symptoms suggestive of vitamin B12 deficiency, this may include megaloblastic anaemia or new-onset neuropathy. It is also advised that periodic monitoring for patients with risk factors for vitamin B12 deficiency should be considered.
Clinicians are also notified that a National Patient Safety Alert has been issued following serious reports of harm associated with insulin leakage during use of the Accu-Chek Insight Insulin pump with NovoRapid PumpCart prefilled insulin cartridges. It is recommended that patients should be moved onto alternative insulin pumps where possible.
This issue contains the latest COVID-19 vaccine and medicine information including an updated shelf life for Comirnaty® to 12 months and a warning on the risk of flare-ups of capillary leak syndrome in patients who already have this syndrome following Spikevax® use.
Lastly in this issue is a summary of letters to healthcare professionals in May. 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 Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Relugolix / estradiol / norethisterone tablets (Ryeqo®) have been accepted for restricted use in the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The restriction limits use to patients who have not responded to or are unsuitable for conventional therapies (first line treatments), such as tranexamic acid, hormonal contraceptives and intrauterine delivery systems.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
