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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

SMC Update - September 2021

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.

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Drug Safety Update - August 2021

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.

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SMC Update - August 2021

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

Patiromer sorbitex calcium (Veltassa®) has been accepted for restricted use in the treatment of hyperkalaemia in adults. The restriction limits use to patients with hyperkalaemia (defined as a serum potassium of >6.0mmol/L) with chronic kidney disease (CKD) stage 3b to 5 and/or heart failure, who would otherwise need to down-titrate or discontinue their renin-angiotensin-aldosterone system inhibitor (RAASi) therapy to maintain a clinically acceptable serum potassium level (normokalaemia).

Inclisiran (Leqvio®) has been accepted for restricted use in the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

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

The restriction limits use to patients at high cardiovascular risk as follows:

  • patients with heterozygous familial hypercholesterolaemia (HeFH) and LDL-C ≥ 5.0mmol/L, for primary prevention of cardiovascular events or,
  • patients with HeFH and LDL-C ≥ 3.5mmol/L, for secondary prevention of cardiovascular events or,
  • patients with high risk due to previous cardiovascular events and LDL-C ≥ 4.0mmol/L or,
  • patients with recurrent/polyvascular disease and LDL-C ≥ 3.5mmol/L.

It should also be noted that this recommendation 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, or a PAS/ list price that is equivalent or lower. It is therefore expected that this medication would be supplied through secondary care.

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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SMC Update - July 2021

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

Delafloxacin (Quofenix®) has been rejected for use in the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections. The manufacturer failed to make a submission for this indication. The SMC advised that consideration should be given to official guidance on the appropriate use of antibacterial agents.

Bempedoic acid (Nilemdo®) 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, or a statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or
  • Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contra-indicated

The restriction limits use, in combination with ezetimibe, in patients who are:

  • statin intolerant or for whom a statin is contra-indicated, and
  • where ezetimibe alone does not appropriately control LDL-C, and
  • where proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors are not appropriate

Furthermore, this advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) similar to existing NICE guidance that applies in England and Wales.

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 - July 2021

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

This month readers are advised that, following a review of the available toxicological data, chloramphenicol eye drops can be safely administered to children aged 0 to 2 years where antibiotic eye drop treatment is indicated. Some licences for chloramphenicol eye drop products containing borax or boric acid buffers were recently updated to restrict use in children younger than 2 years of age to reflect warnings on maximum daily limits for boron exposure. The product information for affected chloramphenicol products is being updated to reflect the revised advice and remove restrictions for use in infants. In the meantime, healthcare professionals should reassure parents and carers that these products can be safely given to children aged 0 to 2 years at the time of prescribing.

Readers are also reminded to be vigilant for suspected adverse reactions to herbal and homeopathic medicines and to report them to the Yellow Card scheme. It is recommended to specifically ask patients who present with adverse reaction symptoms if they are taking a herbal or homeopathic medicines.

This issue also contains an update on COVID-19 vaccines and medicines that includes emerging information on a very small risk of myocarditis and pericarditis associated with the Modern and Pfizer/BioNTech vaccines. It seems to affect younger men after the second vaccine is administered and cases are typically mild with affected individuals tending to recover within a short time following standard treatment and rest. The advice continues to be that the benefits of getting vaccinated outweigh the risks in the majority of people.

Finally in this issue is a summary of letters to healthcare professionals sent in June that were regarding product recalls. There were also letters noting a change in appearance and formulation for the ViePax 150 XL® brand of venlafaxine and release of some Clenil® inhalers with no dose counter.

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

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