The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for June 2014 (PDF).
This issue contains drug safety advice advising 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.
The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of June 2014. This month there is one clinical guideline and one technology appraisal that impacts upon primary care.
The Atrial fibrillation clinical guideline is an updated to guidance issued in June 2006 and it offers evidence-based advice on the care and treatment of people with atrial fibrillation. New recommendations have been added for a personalised package of care and information, referral for specialised management, stroke prevention, rate and rhythm control and the management of acute atrial fibrillation.
Additionally, this guideline recommends using CHA2DS2-VASc score to assess stroke risk and the HAS-BLED score to assess bleeding risk. Stroke prevention therapy is not recommended at low levels of stroke risk (CHA2DS2-VASc 0 for men and 1 for women).
Anticoagulation should be considered in men with a CHA2DS2-VASc risk score of 1 and offered to everyone with a risk score of 2 and above. Anticoagulation may be with apixaban, dabigatran and rivaroxaban or a vitamin K antagonist. Recommendations for the newer agents are adopted from existing technology appraisals. If a vitamin K antagonist is used, time in therapeutic range (TTR) should be calculated regularly and used with INR results to assess anticoagulation control. If control is poor and remains poor despite addressing factors that may contribute to poor control (cognitive function, adherence, illness, drug interactions, lifestyle) the risks and benefits of alternative stroke prevention strategies should be evaluated and discussed with the patient.
The Type 2 diabetes - Canagliflozin technology appraisal recommends this treatment as an option in dual therapy with metformin in patients who cannot take a sulphonylurea or is at risk of hypoglycaemia. It can also be used in triple therapy with metformin with a sulphonylurea or a glitazone. Finally, it can be used in combination with insulin, with or without antidiabetic drugs.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Avanafil (Spedra®) has been rejected for use in the treatment of erectile dysfunction in adult men. The manufacturer failed to make a submission but plans to make a submission in November 2014.
Budesonide granules (Budenofalk®) have been accepted for the induction of remission in patients with mild to moderate active Crohn’s disease affecting the ileum and/or ascending colon.
Canagliflozin (Invokana®) 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 therapy 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 the following situations:
- dual therapy in combination with metformin
- triple therapy in combination with metformin plus standard of care
- add-on to insulin therapy in combination with insulin plus standard of care
Fluticasone / vilanterol (Relvar Ellipta®) has been accepted for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (ICS/LABA) is appropriate. The review notes that some alternative ICS/LABA combination inhalers are available at a lower daily cost.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
Several legislative changes to controlled drug laws come into force with effect from tomorrow. These changes affect tramadol, lisdexamphetamine, zopiclone and zaleplon.
Tramadol will become a Schedule 3 CD and lisdexamphetamine will become a Schedule 2 CD. Scripts can only be issued by a prescriber with a UK address, are only valid for 28 days, prescription must meet Controlled Drug Prescription requirements and they cannot be repeated.
Zopiclone and zaleplon are both being added to Schedule 4. This limits prescription validity to 28 days. All four drugs must also now be denatured during disposal.
Action: Clinicians should be aware of these changes and of the impact these changes may have upon current prescribing practices.
MTRAC issued a new Commissioning Support review in June 2014. The review covers avanafil.
The avanafil (Spedra®) summary advises that this drug is suitable for restricted prescribing in primary care within the existing regulations imposed by the Department of Health for prescribing treatments for erectile dysfunction. The review notes that this medicine has relatively weak evidence because the currently published trials compared this agent to placebo rather and against an active PDE-5 inhibitor comparator such as sildenafil.
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.