Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update - January 2020

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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Drug Safety Update - January 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2021 (PDF).

This month readers are advised of a review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs conducted by the Commission on Human Medicines. It has confirmed that lamotrigine and levetiracetam are the safer of the medicines reviewed during pregnancy. It is recommended that clinicians use this information when discussing treatment options with women with epilepsy at routine recommended annual reviews and with women who are planning to become pregnant.

Readers are also signposted to the information available about the COVID-19 vaccines authorised for use in the UK, including advice for people with allergies and for women during pregnancy and breastfeeding.

This issue also highlights data from observational studies suggesting that the use of SSRI/SNRI antidepressants during the month before delivery may result in a small increased risk of postpartum haemorrhage. Prescribers should consider this risk in the context of an individual patient's bleeding and thrombotic risk assessment during the peripartum period and the benefits of antidepressants for the patient's mental health during this time.

Finally this month, aminoglycosides have been linked with an increased risk of deafness in patients with mitochondrial mutations with some reports of this happening at serum levels within the recommended ranges. Micochondrial mutations are rare but genetic testing may need to be considered especially in patients requiring recurrent or long-term treatment with aminoglycosides. Urgent treatment should not be delayed while awaiting genetic testing results.

The summary of letters to healthcare professionals were generally regarding product recalls.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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NICE Guidance - December 2020

The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of December 2020. This month there are eight clinical guidelines, two COVID-19 Rapid Guidelines and one technology appraisal that impact upon primary care.

The seven clinical guidelines of relevance to primary care this month have all been updated.

The Osteoarthritis: care and management guideline, Low back pain and sciatica in over 16s: assessment and management guideline and the Peripheral arterial disease: diagnosis and management guideline have both been updated in line with guidance on the use of opioids for non-cancer pain in response to a Public Health England evidence review on dependence on, and withdrawal from, prescribed medicines.

The Pancreatitis guideline and the Eating disorders: recognition and treatment guideline have both been updated in line with MHRA advice highlighting the importance of rotating insulin injection sites within the same body region.

The Type 1 diabetes in adults: diagnosis and management guideline and the Type 2 diabetes in adults: management guideline have both seen minor changes to the recommendations on diabetic retinopathy to align them with the NHS diabetic eye screening programme.

The Diabetes in pregnancy: management from preconception to the postnatal period guideline has seen changed recommendations on intermittently scanned CGM (isCGM, also commonly referred to as flash) and continuous glucose monitoring during pregnancy for women with type 1 diabetes.

The COVID-19 rapid guideline: managing the long-term effects of COVID-19 guideline has been published. It covers identifying, assessing and managing the long-term effects of COVID-19, often described as 'long COVID'. It makes recommendations about care in all healthcare settings for adults, children and young people who have new or ongoing symptoms 4 weeks or more after the start of acute COVID-19. It also includes advice on organising services for long COVID.

The COVID-19 rapid guideline: vitamin D guideline has been published. It covers vitamin D use in the context of COVID‑19. It is for adults, young people and children in hospitals and community settings. Vitamin D is important for bone and muscle health. It may also have a role in the body's immune response to respiratory viruses.

The Liraglutide for managing overweight and obesity technology appraisal has been published. Liraglutide is recommended as an option for managing overweight and obesity alongside a reduced-calorie diet and increased physical activity in adults but it is restricted to prescribing in secondary care by a specialist multidisciplinary tier 3 weight management service with a commercial agreement in place.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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Drug Safety Update - December 2020

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2020 (PDF).

This month readers are advised that systemic and inhaled fluoroquinolones are associated with a small increased risk of heart valve regurgitation. Fluoroquinolones are only recommended for use in serious, life-threatening bacterial infections. It is recommended that other options are considered first in patients at risk of heart valve regurgitation.

Readers are also advised that erythromycin has been associated with events secondary to QT interval prolongation including cardiac arrest and ventricular fibrillation. Clinicians are reminded to be aware of reports of cardiotoxicity with macrolide antibiotics, in particular with erythromycin and clarithromycin. These drugs should be avoided in patients with a history of QT interval prolongation or ventricular cardiac arrhythmia and those with current electrolyte disturbances. It is also noted that erythromycin may interact with rivaroxaban and increase the risk of bleeding. This interaction should be considered when prescribing antibiotics and precautions in the product information followed if concomitant use is necessary.

The summary of letters to healthcare professionals were generally regarding product recalls. Of note, Solu-Medrone® (methylprednisolone as sodium succinate) has been reformulated to be lactose free and as such there is a risk of serious allergic reactions if formulations are confused.

Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.

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SMC Update - December 2020

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Mexiletine (Namuscla®) has been accepted for restricted use in the symptomatic treatment of myotonia in adult patients with non-dystrophic myotonic disorders. It is noted that this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based. As such it would be expected that prescribing would occur in secondary care.

Bempedoic acid (Nilemdo®) has been rejected for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • In combination with a statin, or a statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin
  • Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contra-indicated.

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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