Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

NICE Guidance - March 2016

The National Institute of Health and Care Excellence (NICE) have published new or updated guidance for the month of March 2016. This month there is one clinical guideline and one guideline that impact upon primary care.

The Antenatal care for uncomplicated pregnancies clinical guideline has been updated to remove two recommendations regarding gestational diabetes because this is now contained in the NICE guideline on Diabetes in pregnancy.

The Community engagement: improving health and wellbeing and reducing health inequalities guideline covers community engagement approaches to reduce health inequalities, ensure health and wellbeing initiatives are effective and help local authorities and health bodies meet their statutory obligations.

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

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Updated advice on the risk of DKA with SGLT2 inhibitors

The manufacturers of the three SGLT2 inhibitors (canagliflozin, dapagliflozin and empagliflozin) have written to healthcare professionals regarding updated advice on the risk of diabetic ketoacidosis (DKA) linked with these treatments. This advice has been agreed with the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA)

The letter advises that there have been rare but serious, sometime life-threatening and fatal cases of DKA. Clinicians are encouraged to continue reporting suspected adverse reactions through the yellow card system.

The updated advice notes that DKA must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Clinicians should inform patients of the signs and symptoms of metabolic acidosis and advised them to seek immediate medical advice if they develop. In patients who develop DKA, treatment with SGLT2 inhibitors should be stopped immediately and only restarted if another clear precipitating factor is identified and resolved.

Additionally, before starting treatment it is recommended that risk factors that predispose individuals to DKA are considered. These include:

  • a low beta-cell function reserve (e.g. type 2 diabetes with a low C-peptide, latent autoimmune disease in adults or patients with a history of pancreatitis)
  • conditions that lead to restricted food intake or severe dehydration
  • sudden insulin reduction
  • increased insulin requirements due to acute medical illness
  • surgery
  • alcohol abuse

Action: Clinicians should be aware of the updated advice. Patients should be advised of the signs and symptoms of DKA and clinicians need to remain vigilant and react quickly should they arise.

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Drug Safety Update - March 2016

The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2016 (PDF).

This issue advises that trametinib (Mekinist®) has been associated with an increased risk of gastrointestinal perforation and colitis. Clinicians and patients using this medication should be vigilant for signs and symptoms of gastrointestinal perforation. Patients should be advised to seek urgent medical attention if they develop severe abdominal pain.

This issue also contains a reminder of the letter sent last month to raise awareness of the risks of developmental disorders and congenital malformations associated with valproate use in pregnancy.

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

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SMC Update - March 2016

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

Capsaicin (Quetenza®) has been rejected for the treatment of peripheral neuropathic pain in diabetic adults either alone or in combination with other medicinal products for pain. The manufacturer failed to make a submission.

Insulin detemir
(Levemir®) has been accepted for restricted use in the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. The restriction limits use to patients unable to achieve good glycaemic control with established insulins.

Oseltamivir (Tamiflu®) has been accepted for use in the treatment of influenza in children aged <1 year including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms.

Sacubitril / valsartan (Entresto®) has been accepted for use in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction. It was noted that sacubitril / valsartan, compared to an angiotensin-converting enzyme inhibitor (enalapril), significantly reduced rates of the composite outcome of cardiovascular death and hospitalisation for heart failure, rates of the component outcomes and of all-cause mortality.

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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