The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Empagliflozin (Jardiance®) has been accepted for use in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. It is noted that empagliflozin offers an additional treatment choice in the therapeutic class of sodium glucose co-transporter 2 inhibitors in this indication.
Liraglutide (Saxenda®) has been rejected for use as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:
- ≥30kg/m² (obese), or
- ≥27kg/m² to <30kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea
It is noted that the submitting company's 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 economic analysis to gain acceptance by SMC.
Bempedoic acid / ezetimibe (Nustendi®) has been accepted for restricted use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
- alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone
- in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.
The SMC restriction limits use to patients who are:
- statin intolerant or for whom a statin is contra-indicated
- where ezetimibe alone does not appropriately control LDL-C
- where proprotein convertase subtilisin / kexin type 9 (PCSK9) inhibitors are not appropriate
It is also noted that this advice only applies in the context of an approved NHSScotland Patient Access Scheme (PAS).
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 October 2021 (PDF).
This issue advises clinicians of a new restriction on the paediatric indication for chloral hydrate and cloral betaine. The treatments should only be used for the short-term treatment (maximum 2 weeks) of severe insomnia only when the child or adolescent has a suspected or definite neurodevelopmental disorder and when the insomnia is interfering with normal daily life. It is also recommended that these treatments are only used when other therapies (behavioural and pharmacological) have failed.
This issue also raises awareness of the sixth annual #MedSafetyWeek social media campaign. This year the focus is on he importance of reporting suspected adverse reactions to vaccines. Readers are encouraged to share MHRA materials on social media, as well as discussing with colleagues and patients how report adverse reactions to vaccines.
This issue also advises readers of the latest COVID-19 vaccine safety information including regulatory updates on the COVID-19 booster vaccine programme, updates to the Summary of Product Characteristics and Patient Information Leaflet for Janssen Vaccine and extension of the shelf life of the Pfizer/BioNTech Vaccine to 9 months
Lastly in this issue is a summary of letters to healthcare professionals in September.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for September 2021 (PDF).
This issue advises clinicians of rare but severe adverse effects that can occur on stopping treatment with topical corticosteroids. This is more likely after long-term continuous or inappropriate use of moderate to high potency products. To reduce the risks it is recommended that clinicians prescribe the topical corticosteroid of lowest potency needed and ensure patients know how to use it safely and effectively. It is also recommended to:
- advise patients on the amount of product to be applied; underuse can prolong treatment duration
- inform patients how long they should use a topical corticosteroid, especially on sensitive areas such as the face and genitals
- inform patients to return for medical advice if their skin condition worsens while using topical corticosteroid, and advise them when it would be appropriate to re-treat without a consultation
- for patients currently on long-term topical corticosteroid treatment, consider reducing potency or frequency of application (or both)
Clinicians should also be vigilant for the signs and symptoms of topical steroid withdrawal reactions. The joint statement from the National Eczema Society and British Association of Dermatologists may be useful in guiding practice. And finally, suspected adverse drug reactions should be reported via the Yellow Card scheme, including after discontinuation of topical corticosteroids.
This issue also advises readers of the latest COVID-19 vaccine safety information including data from safety reporting and changes to the Summary of Product Characteristics for some vaccines in regards to storage, precautions and use in 12 to 17 year olds.
Lastly in this issue is a summary of letters to healthcare professionals in August.
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.
Mercaptamine (Procysbi®) has been rejected for the treatment of proven nephropathic cystinosis. The submitting company's 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 economic analysis to gain acceptance by SMC.
Amikacin liposomal nebuliser dispersion (Arikayce®) has been rejected for use in the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. The submitting company’s 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 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.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for August 2021 (PDF).
This issue advises readers of the latest COVID-19 vaccine safety information including data on menstrual disorders and unexpected vaginal bleeding linked with vaccine administration. It is noted that reporting rates are low, the side effect is usually transient and that there is no evidence to suggest that COVID-19 vaccines will affect fertility and the ability to have children. This section also summarises the available data on the safety of COVID-19 vaccines in pregnancy which has identified no side effect patterns to date. The MHRA will, of course, continue to closely monitor safety data.
Lastly in this issue is a summary of letters to healthcare professionals in July. This includes notification that two desogestrel-containing contraceptive pills have been reclassified as Pharmacy medicines as well as links to recall notifications.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
