The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Glibenclamide (Amglidia®) has been rejected for use in the treatment of neonatal diabetes mellitus, for use in newborns, infants and children.
Triptorelin acetate (Decapeptyl®) has been accepted for us as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early stage breast cancer in women at high risk of recurrence who are confirmed as premenopausal after completion of chemotherapy. For this indication, treatment initiation would normally be recommended by a specialist. This decision takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of triptorelin. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
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 September 2019 (PDF).
This month clinicians are advised that fingolimod (Gilenya®) has been associated with an increased risk of congenital malformations. It is recommended that women of childbearing potential must use effective contraception during fingolimod treatment and for 2 months after discontinuation.
Also this month pentosan polysulfate (Elmiron®) has been rarely linked with pigmentary maculopathy leading to visual impairment. Patients taking this drug are advised to have regular ophthalmic examinations and to promptly seek medical advice in case of visual changes.
Clinicians are also reminded of the risk of neuropsychiatric reactions associated with montelukast (Singulair®). Clinicians are reminded to be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur.
The summary of letters to healthcare professionals this month includes a notification letter from Santen warning of the risk of medication error during a transition to a new bottle design. Affected products include Cosopt®, Trusopt® and Timoptol®.
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.
Melatonin prolonged-release (Slenyto®) has been rejected 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 justification of the treatment's cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
Dapagliflozin (Forxiga®) has been accepted for use in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥27kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
Ospemifene (Senshio®) has been accepted for use in the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy.
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 August 2019 (PDF).
This month clinicians are advised that naltrexone/bupropion (Mysimba®) has been linked with adverse reactions that could affect ability to drive. This medicine is licensed for the management of weight in obese adults and in overweight adults with one or more weight-related conditions. Usage levels in the UK are low and it is mainly issued on private prescription. Use has been linked with dizziness or somnolence, which can affect ability to drive, operate machinery, or perform dangerous tasks. Advise patients not to drive if they suspect their ability may be impaired.
The summary of letters to healthcare professionals this month includes details of two patient-level medicine recalls for Neupro 4mg/24hr patches and Vimpat 100mg tablets. Any patient that has any of these affected products is advised to continue taking their medicines and contacting their prescriber to arrange a new prescription. Patients should return the affected batches to their pharmacist once they have a new prescription.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The manufacturer of the Evorel® range of HRT patches has written healthcare professionals advising of an imminent supply shortage.
An increase in demand for the products is cited as one of the reasons for the shortage with the entire product range affected - Evorel®, Evorel® Sequi and Evorel® Conti. It is anticipated that supplies will be restored in mid-2020.
Alternative patches are available to switch from Evorel®, but alternatives to the Sequi and Conti products are going to be more complex, perhaps involving supply of oestrogen patches and progestogen tablets or a switch to tablet versions.
Action: Clinicians should be aware of this supply interruption and be prepared to supply appropriate alternatives.
