The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2013 (PDF).
This issue contains drug safety advice reminding clinicians that codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone. These new recommendations are due to an increased risk of morphine toxicity when susceptible children receive codeine for pain, particularly after surgery.
This section also advises that retigabine (Trobalt®) should now only be used as an adjunctive treatment for drug-resistant partial onset seizures in adults with epilepsy, where other appropriate drug combinations have proved inadequate or have not been tolerated. Treatment has been associated with pigment changes of ocular tissue including the retina. A comprehensive ophthalmic examination should be done at the start of treatment and at least every 6 months thereafter during treatment. When pigment changes are detected the benefits and risks of continued treatment should be reassessed.
This issue also contains information about the Pharmacovigilance Risk Assessment Committee which is a scientific committee at the European Medicines Agency that is responsible for the assessment and monitoring of the safety of medicines across Europe. The MHRA has already included recommendations made by PRAC in previous issues of the Drug Safety Update and will continue to do so.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The European Medicines Agency has recommended changes to the use of metoclopramide to reduce the risk of neurological side effects.
The review of metoclopramide, carried out at the request of the French medicines regulatory agency, confirmed the well-known risks of neurological effects including:
- extrapyramidal disorders
- involuntary movement disorders that may include muscle spasms
- tardive dyskinesia
It was noted that the risk of side effects is increased at high doses or with long-term treatment.
The review has recommended that treatment duration is restricted to short-term use (up to 5 days) and that the maximum dose is limited (in adults to 10mg three times daily). It is also recommended that metoclopramide is not used in children under 1 year old.
Metoclopramide is only recommended for:
- prevention of post-operative nausea and vomiting (PONV) in adults
- radiotherapy-induced nausea and vomiting in adults
- delayed (but not acute) chemotherapy-induced nausea and vomiting in adults
- symptomatic treatment of nausea and vomiting including that associated with acute migraine in adults
- second-line option for prevention of delayed chemotherapy-induced nausea and vomiting in children
- treatment of established PONV in children
Action: Clinicians should be aware of these new restrictions and implement any necessary changes to current practice.
Thanks to Kevin Ashworth for spotting this article
The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of July 2013. This month there are two clinical guidelines and one technology appraisal that impact upon primary care.
The Myocardial infarction with ST-segment elevation guideline provides evidence-based advice on the care and treatment of adults with spontaneous onset of myocardial infarction with ST-segment elevation. Although primarily aimed at secondary care this guideline does contain drug recommendation advice and links to other pertinent NICE guidance.
The Varicose veins in the legs guideline offers evidence-based advice on the diagnosis and management of varicose veins in adults aged 18 years and over. The recommendations discuss management options including advice and reassurance, interventional treatments (such as endothermal ablation, foam sclerotherapy and surgery) and compression hosiery.
The Bipolar disorder (children) - aripiprazole technology appraisal recommends this drug as a possible treatment (for up to 12 weeks) for moderate to severe manic episodes in young people aged 13 and older with bipolar I disorder.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The British National Formulary for Children 2013-2014 has been updated, published and made available online.
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:
- Changes to the criteria that define paracetamol overdose included in Emergency Treatment of Poisoning
- Advice on prescribing adrenaline auto-injectors for anaphylaxis by brand name only to ensure patients and carers receive the device they have been trained to use
- Revised drug treatment of septicaemia in neonates to take account of the NICE guideline Antibiotics for Early-onset Neonatal Infection (August 2012)
- NICE guidance on when to prescribe tobramycin by dry powder inhalation for pseudomonal lung infection in cystic fibrosis
- Updated doses of rifampicin and ethambutol in the standard regimen for the treatment of tuberculosis
- MHRA/CHM advice on prescribing oral tacrolimus products by brand name only to minimise the risk of inadvertent switching between products
- Changes to the childhood immunisation schedule
- Prevention of pertussis - contacts requiring antibacterial prophylaxis
- Driving guidance for patients with diabetes
Action: BNFC is the primary source of prescribing information when prescribing to all children up to the age of 18 years.
MTRAC issued three new Commissioning Support reviews in June 2013. The reviews cover linaclotide, ingenol mebutate and imiquimod.
The Linaclotide (Constella®) summary advises that this drug is suitable for prescribing in primary care but only when all other treatment alternatives have proved ineffective or are contraindicated. The committee considered the drug to have a lower place in therapy and relatively weak evidence as there are no comparative studies with existing treatments.
The Ingenol mebutate (Picato®) summary advises that this drug is suitable for prescribing in primary care where there is a confident diagnosis of actinic ketatosis. The committee considered the evidence to be relatively strong but suggest a lower place in therapy based on limited clinical experience and the availability of other, more established treatments.
The Imiquimod (Zyclara®) summary advises that this drug is suitable for prescribing in primary care where there is a confident diagnosis of actinic ketatosis. The committee considered the evidence to be relatively strong but suggest a lower place in therapy based on a higher acquisition cost in comparison to other treatments including imiquimod
5% cream. As such this 3.75% cream offers little advantage over the existing 5% cream.
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.