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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

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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CKS Updates - June 2021

During May 2021 Clinical Knowledge Summaries were updated in the following areas.

All topics have been reviewed and updated in keeping with current guidance with minor layout changes. The Vitamin D deficiency in adults topic has updated the recommendation on who should take year-round vitamin D supplementation for the prevention of vitamin D deficiency, in line with PHE guidance. And the Vitamin D deficiency in children topic has changed the recommended dose for vitamin D supplementation for prevention of vitamin D deficiency in line with ROS guidance.

Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.

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NICE Guidance - June 2021

The National Institute for Health and Care Excellence (NICE) have published new or updated guidance for the month of June 2021. This month are seven guidelines and one technology appraisal that impact upon primary care.

The COVID-19 rapid guideline: managing COVID-19 guideline has been updated. It covers the management of COVID-19 for children, young people and adults in all care settings. The update references publication via a global evidence platform.

The Atrial fibrillation: diagnosis and management guideline has been updated. It covers diagnosing and managing atrial fibrillation in adults. It includes guidance on providing the best care and treatment for people with atrial fibrillation, including assessing and managing risks of stroke and bleeding. The update recommends using the ORBIT score to assess bleeding risk.

The Autism spectrum disorder in under 19s: support and management guideline has been updated. It covers the different ways that health and social care professionals can provide support, treatment and help for children and young people with autism, and their families and carers, from the early years through to their transition into young adult life. This updates adds new recommendations on interventions for feeding problems, including restricted diets.

The Autism spectrum disorder in adults: diagnosis and management guideline has been updated. It covers diagnosing and managing suspected or confirmed autism spectrum disorder in people aged 18 and over. It aims to improve access and engagement with interventions and services, and the experience of care, for people with autism. The update clarifies that a person who scores 6 or above on the AQ-10 should be offered a comprehensive assessment.

The Shared decision making guideline has been published. It covers how to make shared decision making part of everyday care in all healthcare settings. It promotes ways for healthcare professionals and people using services to work together to make decisions about treatment and care. It includes recommendations on training, communicating risks, benefits and consequences, using decision aids, and how to embed shared decision making in organisational culture and practices.

The Patient experience in adult NHS services guideline has been updated. It covers the components of a good patient experience. It aims to make sure that all adults using NHS services have the best possible experience of care. The update replaces several recommendations on share decision making and refers to the newly published guideline mentioned above.

The Acne vulgaris: management guideline has been published. It covers the management of acne vulgaris in primary and specialist care. It includes advice on topical and oral treatments (including antibiotics and retinoids), treatment using physical modalities, and the impact of acne vulgaris on mental health and wellbeing.

The Budesonide orodispersible tablet for inducing remission of eosinophilic oesophagitis technology appraisal has been published. This treatment is recommended as an option for inducing remission of eosinophilic oesophagitis in adults. It is noted that since the appraisal process began the product license has been extended to include maintenance treatment but as no evidence was submitted for this newly licensed indication no recommendation is made at this time for maintenance.

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 - June 2021

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

This month readers are advised of reports of interstitial lung disease and pneumonitis associated with use of CDK4/6 inhibitors (abemaciclib▼, palbociclib▼, ribociclib▼). Patients taking these medicines should be made aware of the need to seek advice right away if they develop new or worsening respiratory symptoms at clinic reviews. Patients on these medicines who present in primary care with respiratory symptoms should be managed cautiously and should be advised to make contact with their specialist.

Readers are also advised of the risk of severe cutaneous adverse reactions (SCARs) including SJS and TEN associated with use of atezolizumab▼ (Tecentriq®) and other immune-stimulatory anti-cancer drugs. Patients on these drugs should be advised by their specialist to be vigilant for the signs of severe skin reactions and to seek urgent medical advice if they occur. In such cases continued treatment should be withheld, and patients referred to a specialist for diagnosis and treatment.

This issue also contains an update on COVID-19 vaccines and medicines that includes information on a newly licensed vaccine from Janssen and licence extension to younger age groups for the Pfizer/BioNTech vaccine.

Finally in this issue is a summary of letters to healthcare professionals sent in May that were 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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