The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for May 2013 (PDF).
This issue contains drug safety advice informing clinicians that tolvaptan (Samsca®) which is used in the treatment of hyponatraemia secondary to inappropriate antidiuretic hormone secretion (SIADH) has been associated with an increased risk of of liver injury. Liver function tests are advised in anyone who reports symptoms that may indicate liver injury. This section also advises that thalidomide increases the risk of haematological second primary malignancies.
A Yellow Card update advises that Black Triangle drugs, or drugs that are the subject of closer safety monitoring, are now part of an EU wide scheme. Clinicians are reminded to report any suspected adverse reactions in patients taking
Finally, the stop press section advises clinicians of a stock issue affecting liothyronine 20 microgram tablets from Amdipharm Mercury. Alternative products are being sourced but the interchangeability is uncertain and bioequivalence is not assured. As such clinicians are advised to be aware that symptom control and thyroid-stimulating hormone (TSH) status may be affected by this shortage. Dose adjustments and closer monitoring may be required in such cases.
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 May 2013. This month there are two clinical guidelines that impact upon primary care.
The Social anxiety disorder guideline offers evidence-based advice on the recognition, assessment and treatment of social anxiety disorder in children and young people (from school age to 17 years) and adults (aged 18 years and older). Cognitive behavioural therapy is recommended as the first line treatment intervention with pharmacological interventions reserved for adults who decline cognitive behavioural therapy.
The Feverish illness in children guideline is an update to original guidance issued in May 2007. This version contains new and updated recommendations relating to the assessment and initial management in children younger than 5 years with no obvious cause of feverish illness.
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.
Abiraterone (Zytiga®) has been rejected for use in the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy. The manufacturer failed to make a submission but plan to submit a case in December 2013.
Lisdexamfetamine dimesylate (Elvanse®) has been accepted for as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children aged 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.
Mirabegron (Betmiga®) has been accepted for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. It is noted that alternative treatments are available at a lower drug acquisition cost.
A combination of rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride (Voractiv®) has been rejected for initial treatment of tuberculosis. The manufacturer failed to make a submission.
Vildagliptin (Galvus®) has been rejected for use in the treatment of diabetes as part of triple oral therapy with metformin and a sulphonylurea or in combination with insulin to achieve adequate glycaemic control. The manufacturer failed to make a submission.
Vildagliptin and metformin (Eucreas®) has been rejected for use in the treatment of diabetes as part of triple oral therapy with a sulphonylurea or in combination with insulin to achieve adequate glycaemic control. The manufacturer failed to make a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
MTRAC issued two new Commissioning Support reviews in February 2013. The reviews cover dapagliflozin and insulin degludec for the treatment of diabetes.
The dapagliflozin (Forxiga®) summary advises that this drug is suitable for prescribing in primary care following initiation by a practitioner with a special interest in diabetes. Although the evidence is relatively strong it is suggested that this treatment should occupy a lower place in therapy as there are no longer-term outcome data.
The insulin degludec (Tresiba®) summary advises that this drug is suitable for prescribing in primary care following initiation and stabilisation of dose in secondary care. The evidence was considered to be relatively weak as the trials to date have been short in duration and only made comparisons with insulin glargine. The product is also more expensive and has demonstrated no clinical advantage over current therapies. It is therefore suggested that this treatment should occupy a lower place in therapy
Action: Clinicians should be aware of these reviews and compare current practice to the recommendations, making changes where appropriate.
The Department of Health has announced several changes to the national vaccination programme to include protection against flu, shingles and diarrhoea.
The JCVI has previously recommended the addition of rotavirus vaccine to the childhood vaccination schedule. This infection currently causes around 140,000 cases of diarrhoea in the under 5s each year with 10% of these cases being admitted to a hospital. Use of this vaccine is expected to start from July 2013.
The shingles vaccine will be offered to people aged 70 years from September 2013. A catch up campaign will also be operated which will offer vaccination to anyone aged up to 79 years old. Shingles affects 30,000 people aged over 70 each year and it is hoped that this vaccine will prevent 40% of those cases.
A nasal influenza vaccine will be offered to 2 year old children from September 2013. The following year the programme will be rolled out to include all pre-school and primary school children and the year after that the programme will be extended again to include secondary school children.
Additionally, the current meningitis C booster vaccine given at 4 months old will be replaced with a vaccine given to those aged 12 and 13 years old.
Action: Clinicians should be aware of these changes to the national vaccination programme. Anyone involved with the delivery of the vaccination programme should ensure they familiar with the changes and the new vaccines.