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Keele’s ‘Important News and Evidence’ Service
KINES
Monthly News Update
February 2016
Welcome to the KINES Monthly News Update for February 2016. During February, we also published KINES Rapid
Updates on:
a new observational study that found proton pump inhibitor use was associated with a higher risk of incident
chronic kidney disease
a systematic review of blood pressure lowering trials, the findings of which support the perspective that the lower
the blood pressure, the better
a randomised study of different prescription strategies for acute uncomplicated respiratory infections, providing
further evidence that delayed antibiotic strategies can reduce antibiotic use
All KINES outputs are available via login at our website (www.centreformedicinesoptimisation.co.uk).
Update from NICE:
The guidelines on bipolar disorder and epilepsies have been updated to promote use of a new toolkit, developed
by the MHRA, to support better understanding by female patients of the risks of taking valproate in pregnancy.
Final guidance on ezetimibe for the treatment of primary hypercholesterolaemia has now been published.
Recommendations are essentially unchanged from the previous guidance.
In a reversal of earlier draft guidance, NICE has issued a revised appraisal consultation document recommending
Amgen's lipid-lowering proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha (evolocumab) for
use in various scenarios, but only at a dose of 140 mg every 2 weeks and where the company provides
evolocumab with the discount agreed in the patient access scheme. Final guidance on evolocumab is expected to
be published in April 2016. Draft guidance has also been published for Sanofi’s PCSK9 inhibitor Praluent
(alirocumab), in which NICE does not recommend use of this treatment. Final guidance for alirocumab is due to
be available in June 2016.
NICE has updated recommendations on dietary advice in the clinical guideline on attention deficit hyperactivity
disorder (ADHD). A new recommendation for 2016 is that families and carers should be advised there is no
evidence about the long-term effectiveness or potential harms of a 'few food' diet (a type of restriction/elimination
diet) for children with ADHD, and only limited evidence of short-term benefits.
Regulatory agency safety update:
An alert has been issued regarding the recall of various nebulisers and nebulisations kits from Unomedical Inc and
Convatec Ltd, which, due to a manufacturing fault, may fail to deliver treatment to the patient. The list of affected
devices can be downloaded from the manufacturer’s safety notice. A deadline of the 22nd March has been given
in the alert for organisations to identify and quarantine affected devices.
A drug safety update from the MHRA reiterates the importance of monitoring blood electrolytes in patients coprescribed spironolactone and an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor
blocker (ARB) for heart failure. Concomitant use of spironolactone with an ACEi or ARB is not routinely
recommended because of the risks of severe hyperkalaemia, particularly in patients with marked renal
impairment. If co-administration is essential, the lowest effective doses should be used, with regular monitoring of
serum potassium and renal function.
The update also notes there have been several fatal cases of abnormal blood potassium in patients where these
treatments have been co-prescribed and that reports of adverse drug reactions (ADRs) to the MHRA have
recently risen. This has coincided with the publication of advice from the European Medicines Agency (EMA) that
dual blockade therapy with an ACEi and an ARB is not recommended. The recent increase in ADR reports could
therefore possibly reflect increased co-administration of spironolactone and ACEi or ARBs, or stimulated reporting
due to increased awareness of the risks.
The EMA has started a review of metformin-containing medicines in renal conditions. This was at the request of
the Dutch medicines agency following identification that advice on use of metformin in patients with reduced
kidney function varies between countries.
Last September Bayer notified the EMA that use of a defective INR device had been identified in the ROCKET
trial – the pivotal study investigating the efficacy and safety of the oral anticoagulant rivaroxaban (Xarelto) in
patients with atrial fibrillation. The EMA’s Committee for Human Medicinal Product (CHMP) has now concluded
that the defective device would have had only a marginal effect on the study results, and the safety of rivaroxaban
remains unchanged.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has made recommendations to minimise the
risk of diabetic ketoacidosis with sodium glucose transporter 2 (SGLT2) inhibitors (canagliflozin, dapagliflozin,
empagliflozin) in type 2 diabetes. Rare cases, some of which were life-threatening, have occurred in patients
taking these medicines, including a number of atypical cases in patients not having blood sugar levels as high as
expected. The PRAC is therefore recommending that healthcare professionals should consider the possibility of
ketoacidosis, even if blood sugar levels are not high. The PRAC has also recommended temporarily stopping
SGLT2-inhibitor treatment in patients in hospital for major surgical procedures or due to serious illness. These
recommendations will now be considered by the CHMP.
(The MHRA has also previously issued a drug safety update on the risk of diabetic ketoacidosis and late last year,
the US FDA revised the labels of SGLT-2 inhibitors to include additional warnings about ketoacidosis, as well as
the risk of urinary tract infections.)
NHS England/Department of Health/Public Health England:
Following a drop in uptake, Public Health England (PHE) is encouraging eligible older people to have their
shingles vaccination. As a reminder, the shingles vaccine is currently being offered to groups aged 70 or 78 years
on the 1st September 2015. Those who were eligible for immunisation during the first two years of the programme
but who have not yet been vaccinated also remain eligible until their 80 th birthday. These are people who were
aged 71, 72 or 79 on the 1st September 2015.
There have been several publications on the Zika virus, including travel advice for pregnant women, guidance for
primary care, and an update for clinicians. The BMJ has also published a feature “Questions your patients may
have about Zika virus”.
There has been a refresh to some of the data included in the Medicines Optimisation dashboard published by
NHS England. More information can be found on the dashboard webpage, where Keele’s evaluation of the
prototype dashboard is also available. An evaluation of the updated dashboard is also in preparation by Keele.
Other news:
London Medicines Information Service has published a briefing on antidotes to the new oral anticoagulants
(NOACs). On a related note, Praxbind (idarucizumab), a reversal agent for dabigatran, is now available in the UK.
NICE is due to publish an evidence summary for this treatment in May 2016.
A new toolkit has been launched by Pfizer to support community pharmacy teams in the delivery of Medicines Use
Reviews (MURs) and the New Medicine Service (NMS) for people who are taking anticoagulants.
Drug update:
Launched:
Benepali (manufactured by Biogen Idec), the first biosimilar version of etanercept, has now been launched in the
UK. An in-use product safety assessment has been published by UK Medicines Information, which provides a
useful summary of the similarities and differences between Benepali and the originator product Enbrel.