Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

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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Drug Safety Update - November 2020

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

This month readers are advised that modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil.

Additionally, pirfenidone (Esbriet®) has been linked with an increased risk of serious liver injury. Updated advice on liver function testing has been issued that recommends monthly checks during the first 6 months of treatment and every 3 months thereafter.

Ferric carboxymaltose (Ferinject®) has been linked with an increased risk of symptomatic hypophosphataemia leading to osteomalacia and fractures. Additional monitoring of phosphate levels is recommended for patients requiring multiple administrations at higher doses, on long-term treatment or with pre-existing risk factors for hypophosphataemia.

Finally in drug safety news, bupropion (Zyban®) has been associated with several cases of serotonin syndrome, especially when used with other serotonergic drugs or in cases of overdose. It is recommended that patients are informed about the milder symptoms of serotonin syndrome at initiation of treatment. If serotonin syndrome is suspected the dose of bupropion should be decreased or treatment withdrawn depending on the severity of the symptoms.

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

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

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SMC Update - November 2020

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

Patiromer (Veltassa®) has been rejected for use in the treatment of hyperkalaemia in adults. The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC. It should be noted the NICE Guidance exists for England and Wales that contains specific recommendations for use.

Romosozumab (Evenity®) has been accepted for restricted use in the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. The restriction limits use to women who have experienced a fragility fracture and are at imminent risk of another fragility fracture (within 24 months).

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 - October 2020

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

This month readers are advised of new guidance that has been published on monitoring of patients on warfarin and other anticoagulants during the COVID-19 pandemic. In particular it is noted that acute illness may exaggerate the effect of warfarin and necessitate a dose reduction. Patients taking anticoagulants should be encouraged to report if they have symptoms of, or confirmed, COVID-19 infection to allow more careful monitoring of INR and bleed risk.

This issue also highlights that it is Medicines Safety Week from the 2nd until the 8th November 2020. The week long event will promote social media activity (#MedSafetyWeek) and discussion with colleagues and patients to highlight the importance of reporting suspected adverse drug reactions. Clinicians are encouraged to remain vigilant for suspected adverse drug reactions and report them.

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

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

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SMC Update - October 2020

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

Budesonide orodispersible (Jorveza®) has been accepted for restricted use in the treatment of eosinophilic oesophagitis (EoE) in adults (older than 18 years of age). The restriction limits use to patients unsuccessfully treated with proton pump inhibitors.

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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