Download KINES Monthly News Update April 16

Keele’s ‘Important News and Evidence’ Service
KINES
Monthly News Update
April 2016
Welcome to the KINES Monthly News Update for April 2016.
We have also recently published KINES Rapid Updates’ on:
a US trial that found behavioural interventions, including peer comparison, lowered rates of inappropriate prescribing for acute
respiratory tract infections by around 5% compared with control groups.
an observational study on the prevalence of unrecognised bipolar disorder in patients prescribed antidepressants in UK
primary care.
All KINES outputs are available via login at our website (www.centreformedicinesoptimisation.co.uk).
Update from NICE:
NICE is consulting on an update to guidance on low back pain and sciatica. A key change in the draft guidance is
that NSAIDs rather than paracetamol are being recommended first-line for pain management. Use of opioids is
also downgraded, in that weak opioids only (there is no mention of strong opioids) may be considered for acute
pain where NSAIDs are inappropriate or ineffective, and that opioids should not be offered for managing chronic
low back pain. Acupuncture is no longer recommended, and manual therapy should only be used as part of a
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multi-modal treatment package and not as a stand-alone treatment. Consultation is open until 5 May.
Consultation is also open on a new guideline on multimorbidity – the first NICE guideline to address the challenge
of treating patients with multiple conditions. Draft guidance is recommending the development of polypharmacy
treatment plans for people prescribed 15 or more regular medicines, with this approach also considered for people
prescribed 10 to 14 medicines, or fewer than 10 medicines where they have a higher risk of adverse events.
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Consultation continues until 12 May, with final publication of the guideline due September 2016.
NICE has updated guidance on routine preoperative tests for elective surgery. Regarding primary care, GPs are
asked to ensure that results of any preoperative tests are provided in referrals for surgical consultations, including
the most recent HbA1c results for people with diabetes.
NICE has published guidance on the safe use and management of controlled drugs. The guideline provides
further clarity and good practice recommendations on the use of controlled drugs across all NHS settings.
An evidence summary has been published on guanfacine prolonged-release (Intuniv), a non-stimulant treatment
for attention deficit hyperactivity disorder (ADHD). The treatment has shown improvements in ADHD symptoms
compared with placebo in relatively short-term trials (up to 13 weeks); improvements in social functioning have not
consistently been shown and guanfacine has not been directly compared with other active treatments.
An evidence summary has also been published on advanced wound and antimicrobial dressings. Given the
paucity of high-quality evidence on which to base national guidance, the role of local formularies is emphasised,
as a means to rationalising choice of dressings.
Regulatory agency safety update:
The MHRA has issued the following updates this month (please see links for full advice):
Healthcare professionals are being reminded that live attenuated vaccines should not be routinely given to people
who are clinically immunosuppressed and contraindications/special precautions of a vaccine should be checked
before immunisation. Specialists with responsibility for immunosuppressed patients who may be eligible for
vaccination should provide an opinion on a patient’s suitability for vaccination in correspondence with primary
care. If primary care professionals are in doubt about a patient’s immunosuppression status, immunisation should
be deferred until specialist advice has been sought. Following the deaths of 4 neonates, the update also gives
specific advice about delaying immunisation (with live attenuated vaccines) for infants who may be been exposed
to immunosuppressive treatments in utero or via breast-feeding. Also, there have been several reports of elderly
patients receiving shingles vaccine when they were possibly immunosuppressed.
Following the European Medicines Agency’s (EMA) review, the MHRA has issued updated advice about the risk
of diabetic ketoacidosis (DKA) with the sodium-glucose co-transporter 2 (SGLT-2) inhibitors canagliflozin,
dapagliflozin and empagliflozin. Patients should be informed about this rare side effect (estimated to affect
between 1 in 1,000 and 1 in 10,000 patients), including symptoms (rapid weight loss, feeling or being sick,
stomach pain, fast, deep breathing, sleepiness, sweet smell to breath, sweet/metallic taste in mouth, different
odour to urine or sweat). Patients with these symptoms should be tested for raised ketones, with treatment
discontinued where DKA is suspected. Treatment should also be interrupted in patients who are hospitalised for
major surgery or acute serious illnesses.
There is updated safety advice for three multiple sclerosis treatments (natalizumab [Tysabri], fingolimod [Gilenya])
and dimethyl fumarate [Tecfidera]), following cases of progressive multifocal leukoencephalopathy (PML).
Additional MRI imaging, monitoring of blood counts and anti-John Cunningham virus (JCV) antibody testing are
being advised as part of increased vigilance for PML (see the individual MHRA drug update for specific
recommendations for each drug). Additional advice has also been issued for fingolimod in relation to the risk of
opportunistic infections and basal-cell carcinoma.
Patients receiving apomorphine (used in Parkinson’s disease) with domperidone (an anti-emetic often given
ahead of apomorphine dosing) should undergo an assessment of cardiac risk factors and ECG monitoring to
reduce the risk of serious arrhythmia related to QT-prolongation.
Following a recent fatal incident, healthcare professionals are being reminded to warn patients about the fire
hazard risks of paraffin-based emollients, advising them not to smoke, use naked flames or come into contact with
anything that may cause a fire when emollients are in contact with their medical dressings or clothing.
Finally, the EMA has announced a review of the SGLT-2 inhibitor canagliflozin, following an increase in amputations
(mainly toe amputations) seen in ongoing studies (CANVAS and CANVAS-R). An increase in amputations has not
been seen in other previous studies. Whilst the review is ongoing, doctors will receive a letter about the importance of
foot care, and as a precautionary measure, doctors may consider stopping this treatment in patients developing
significant foot problems.
NHS England/Department of Health/Public Health England:
The Vaccine Update for March 2016 from Public Health England (PHE) discussed the revised timing of pertussis
immunisation for pregnant women, which can now be given from week 16 of pregnancy (previously Week 28). In
practice, the most appropriate time to offer the vaccine is following the 20-week scan. Also, rubella susceptibility
screening in pregnancy in England will cease from 1 April 2016. This is because the incidence of rubella is now
very low, and susceptibility is better managed through the routine MMR programme. The April Vaccine Update
has focussed on the ongoing supply issues with the BCG vaccine, with advice on how to prioritise use of existing
stocks.
PHE has published an updated information pack on prostate specific antigen (PSA) testing for prostate cancer, to
help counsel asymptomatic men who are asking about PSA testing.
The latest advice for women returning from areas with active Zika virus is summarised in a new patient leaflet.
PHE has issued a further reminder about the continued outbreak of high-level azithromycin resistant gonorrhoea.
Few antimicrobials remain effective in treating gonorrhoea and the loss of sensitivity to azithromycin is of concern
due to the bacterium’s propensity to develop resistance.
A new guide for medical professionals is available on assessing fitness to drive. The publication is intended to
help with the advice given to patients on whether the DVLA requires notification of a condition and what the
outcome from the DVLA’s medical enquiries is likely to be.
The Department of Health (DH) has published new guidance on the administration of medicines by care assistants
working in care homes. Good practice measures are set out, including the legal framework and safety and quality
assurance requirements. The DH is also consulting on a number of amendments to medicines regulations,
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including the printing of medicines’ prices on dispensing labels. Feedback should be submitted by 17 May 2016.
Other news:
The General Pharmaceutical Council is currently consulting on new standards for pharmacy professionals - the
core standards that pharmacist, pharmacy technicians, students and trainee will be expected to meet.
The Centre for Pharmacy Postgraduate Education has launched a new learning programme on ‘consultation skills:
what good practice looks like’. It is an interactive, video-based course, with experts demonstrating key skills to
enhance consultations.
The impact of a pharmacist-led asthma and chronic obstructive pulmonary disease (COPD) respiratory clinic in
general practice is the topic of a new submission to the NICE shared learning database. The initiative, which was
delivered in 13 practices in NHS City and Hackney CCG, resulted in reductions in inhaled corticosteroid doses in
asthma patients, improvements in measures of asthma and COPD control, and cost-savings through reduced
prescribing costs and reductions in outpatient referrals, admissions and A&E attendances.
Drug update:
Another new biosimilar infliximab molecule is nearing approval, following the EMA’s ‘positive opinion’ for Samsung
Bioepis UK’s Flixabi. Last year the infliximab biosimilar CT-P13 was launched, which is marketed under the brand
names Remsima and Inflectra.
A ‘positive opinion’ has also been given for Trevicta, a 3-monthly depot injection of the atypical antipsychotic
paliperidone.
All ‘positive opinions’ are subject to final approval by the European Commission.