The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of July 2014. This month there is one clinical guideline that impacts upon primary care.
The Lipid Modification guideline offers evidence-based advice on the care and treatment of people at risk of cardiovascular disease and people who have had previous cardiovascular disease. It includes new and updated recommendations on risk assessment, lifestyle modifications and the use of lipid-lowering drugs. In particular the following changes are noted:
- The QRISK2 risk assessment tool is recommended to assess CVD risk
- Lipid-lowering drugs are now recommended in people with a QRISK of 10% when the management of all other modifiable CVD risk factors has been optimised
- Atorvstatin 20mg daily is the recommended treatment for primary prevention and 80mg daily is recommended for secondary prevention
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
MTRAC issued a new Commissioning Support guidance in July 2014. The review covers DPP-4 inhibitors.
This Commissioning Guidance (PDF) reviews the evidence for all of the currently available 'gliptins'. It notes that no significant differences in blood glucose reducing efficacy have were identified in a systematic review or in a direct comparison between sitagliptin and saxagliptin. It is also noted that the current NICE Guidance recommends continued treatment with DDP-4 inhibitors only when there is a beneficial metabolic response (HbA1c reduction of 0.5% or 5-6mmol/mol). This guidance summary recommends that, "if a gliptin is to be used, it is advised that the gliptin is selected based on the appropriate licensed indications, with the lowest acquisition cost".
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.
The hard copy of the British National Formulary for Children 2014-2015 has been updated and published. Electronic versions are updated monthly.
Hard copies can be ordered from the publishers however many NHS clinicians should receive a free hard copy through usual channels and can also access the online version.
Significant changes in this revision include:
- Revised dose and monitoring requirements for gentamicin in neonatal sepsis
- Safety restrictions on the use of codeine, domperidone, and metoclopramide
- Significant dose changes to amoxicillin, ampicillin, paracetamol, metronidazole, and naloxone
- New advice on switching between different manufacturers’ products of an antiepileptic drug
- Updated advice on the use of ototoxic ear drops in children with perforated tympanic membrane or patent grommet
- Changes to recommendations on interchangeability of oral mesalazine preparations
- Updated guidance on prevention of pertussis
- Rotavirus vaccine included on immunisation schedule, and changes to schedule for meningococcal group C conjugate vaccine
- New safety information on serious hypersensitivity reactions with intravenous iron
Action: BNFC is the primary source of prescribing information when prescribing to all children up to the age of 18 years.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Beclometasone and formoterol inhaler (Fostair®) has been accepted for the symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators. It should be used in patients for whom beclometasone and formoterol are appropriate choices of corticosteroid and long-acting beta2-agonist respectively, and for whom a metered dose inhaler is an appropriate delivery device.
Dapagliflozin (Forxiga®) has been accepted for restricted use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. The restriction limits use to triple therapy in combination with metformin and sulphonylurea, as an alternative to a dipeptidyl peptidase-4 (DPP-4) inhibitor.
Dapoxetine (Priligy®) has been rejected for the treatment of premature ejaculation in adult men aged 18 to 64 years. The manufacturer failed to make a submission and as a result it cannot be recommended.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2014 (PDF).
This issue contains drug safety advice informing clinicians that a recent review of combination use of renin-angiotensin system blocking agents has identified an increased risk of hyperkalaemia, hypotension and impaired renal function. New product warnings have been agreed. In particular, clinicians are advised that people with diabetic nephropathy should not be given an ACEI with an ARB as they are already prone to developing hyperkalaemia. Combining aliskiren with an ACEI or ARB is contraindicated in people with kidney impairment or diabetes.
The yellow card section sign posts an e-learning resource produced by NHS Education for Scotland. These modules review Adverse Drug Reactions including incidence, identification, classification, risk minimisation strategies and pharmacovigilance.
The stop press section notes that emerging clinical trial evidence has indicated an increase in cardiovascular risk in patients taking ivabradine (Procorolan®). A trial using higher doses than are currently licensed identified a small but statistically significant increase in the combined risk of cardiovascular death and non-fatal myocardial infarction in patients with symptomatic angina (CCS class II or more). This increase in risk may be associated with bradycardia; it is recommended that heart rate is monitored and the ivabradine dose reduced or stopped if persistent bradycardia is detected.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.