The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Abiraterone (Zytiga®) has been rejected for use in the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy. The manufacturer failed to make a submission but plan to submit a case in December 2013.
Lisdexamfetamine dimesylate (Elvanse®) has been accepted for as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.
Mirabegron (Betmiga®) has been accepted for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. It is noted that alternative treatments are available at a lower drug acquisition cost.
A combination of rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride (Voractiv®) has been rejected for initial treatment of tuberculosis. The manufacturer failed to make a submission.
Vildagliptin (Galvus®) has been rejected for use in the treatment of diabetes as part of triple oral therapy with metformin and a sulphonylurea or in combination with insulin to achieve adequate glycaemic control. The manufacturer failed to make a submission.
Vildagliptin and metformin (Eucreas®) has been rejected for use in the treatment of diabetes as part of triple oral therapy with a sulphonylurea or in combination with insulin to achieve adequate glycaemic control. The manufacturer failed to make a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
MTRAC issued two new Commissioning Support reviews in February 2013. The reviews cover dapagliflozin and insulin degludec for the treatment of diabetes.
The dapagliflozin (Forxiga®) summary advises that this drug is suitable for prescribing in primary care following initiation by a practitioner with a special interest in diabetes. Although the evidence is relatively strong it is suggested that this treatment should occupy a lower place in therapy as there are no longer-term outcome data.
The insulin degludec (Tresiba®) summary advises that this drug is suitable for prescribing in primary care following initiation and stabilisation of dose in secondary care. The evidence was considered to be relatively weak as the trials to date have been short in duration and only made comparisons with insulin glargine. The product is also more expensive and has demonstrated no clinical advantage over current therapies. It is therefore suggested that this treatment should occupy a lower place in therapy
Action: Clinicians should be aware of these reviews and compare current practice to the recommendations, making changes where appropriate.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for April 2013 (PDF).
This issue contains drug safety advice informing clinicians of the potential risk of error with insulin degludec (Tresiba®) due to it being available in two strengths. Clinicians are urged to ensure that the correct insulin product and strength is prescribed and pharmacists should check again when the product is dispensed. It is also advised that patients are trained on how to use the device in particular they should always visually verify the dialled units on the dose counter.
This section also warns of the risk of cardiovascular and bleeding events associated with use of cilostazol (Pletal®). This drug is licensed for use to improve walking distances in patients with intermittent claudication. A recent safety review has concluded that the benefits of treatment are worthwhile in some, but not all patients. It is recommended that cilostazol is now used as second line treatment to lifestyle interventions and that it should not be use in patients with:
- Unstable angina, recent myocardial infarction or coronary intervention (within 6 months)
- A history of severe tachyarrhythmia
- A prescription for two or more other antiplatelet or anticoagulant treatments
The hot topic section advises that clinicians remain vigilant to the potential for errors to occur as a result of drug name confusion. Recent examples of medicine names that have been confused resulting in medication errors include:
- Mercaptamine and Mercaptopurine
- Sulfadiazine and Sulfasalazine
- Risperidone and Ropinirole
- Zuclopenthixol decanoate and Zuclopenthixol acetate
Finally, the stop press section advises of emerging cardiovascular safety concerns related to strontium ranelate (Protelos®). This drug is already associated with an increased risk of venous thromboembolism but recent analysis of randomised controlled trial data has identified an increased risk of cardiovascular events including myocardial infarctions. A full assessment of the risks and benefits will be carried out. In the meantime it is recommended that use of this drug is restricted to cases of severe osteoporosis, it should be avoided in patients who already have a cardiovascular disease and should only be used after careful consideration in those with risk factors for cardiovascular disease.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Insulin degludec (Tresiba®) has been rejected for use in the treatment of diabetes mellitus in adults. The manufacturer failed to make a sufficiently robust economic case.
Insulin glargine (Lantus®) has been accepted for restricted use in the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. The restriction recommends use in patients with Type 1 diabetes when efforts to achieve better glycaemic control result in unacceptable levels of nocturnal hypoglycaemia or to aid carer administration. In patients with Type 2 diabetes use is recommended for patients who experience recurrent episodes of hypoglycaemia or require assistance with their insulin injections.
Timothy grass pollen allergen (GRAZAX®) has been rejected for use as a disease-modifying treatment of grass pollen induced rhinitis and conjunctivitis in adults and children. The manufacturer failed to make a submission.
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 March 2013 (PDF).
This issue contains drug safety advice informing clinicians that dabigatran (Pradaxa®) is now contraindicated in patients with prosthetic heart valves requiring anticoagulant treatment related to their valve surgery due to an increased risk of thrombosis and bleeding events.
This section also notes that aqueous cream may cause local skin reactions, such as stinging, burning, itching, and redness. This seems to be linked with use as a leave on emollient, particularly in children, when the product contains sodium lauryl sulphate. In cases where irritation occurs it is recommended to use an alternative emollient that is free from sodium lauryl sulphate.
Finally, this section notes that there have been reported cases of toxin spread with botulinum toxin type B (Neurobloc®) that have mostly occurred with off-label use. It is recommended that usage should adhere to the licensed indication and that all patients are warned of the signs and symptoms of toxin spread.
This issue also contains information about a new learning module on benzodiazepines. The module covers adverse events, factors that raise the risk of adverse events and how the risk can be reduced.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
