The National Prescribing Centre has published a MeReC Bulletin (PDF), the second in a series of three, that focuses on the therapeutic areas of the QIPP agenda.
The topics covered in this bulletin are:
- Antipsychotics in dementia
- Statins and ezetimibe
For each of the therapeutic topic areas the evidence base is summarised and current prescribing data are reviewed.
Action: Clinicians who prescribe in any of the areas above and who are striving to deliver value for money while maintaining or improving the quality of care will find this information is useful and informative.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Midazolam oromucosal solution (Buccolam®) has been accepted for use in the treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents.
Prednisone modified release (Lodotra®) has been rejected in the absence of a submission for the treatment of moderate to severe, active rheumatoid arthritis.
Rivaroxaban (Xarelto®) has been accepted for restricted use in the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors. Treatment is restricted to individuals who have poor INR control despite evidence that compliance good or in individuals who are allergic to or unable to tolerate coumarin anticoagulants.
Rivaroxaban (Xarelto®) has been accepted for treatment of deep vein thrombosis (DVT), and prevention of recurrent DVT and pulmonary embolism following an acute DVT in adults.
Saxagliptin (Onglyza®) has been rejected in the absence of a submission in the treatment of type 2 diabetes mellitus to improve glycaemic control in combination with insulin (with or without metformin).
Tapentadol (Palexia®) has been rejected in the absence of a submission for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for February 2012 (PDF).
This update contains strengthened cardiovascular monitoring advice for fingolimod (Gilenya®). This drug is a niche product that is used in the treatment of relapsing-remitting multiple sclerosis that fails to respond to beta-interferon or is severe and getting rapidly worse. It is already known that this drug can cause bradycardia and perhaps atrioventricular block after the first dose and as such specialist initiation is recommended with a 6 hour period of monitoring.
There have been cases reported recently where cardiovascular events have occurred after this 6 hour window of monitoring so new recommendations have been made including:
- Pre-treatment 12 lead ECG
- Continuos ECG monitoring and hourly blood pressure and pulse assessment for 6 hours after the first dose
- A 12 lead ECG at 6 hours after the first dose
- The above monitoring extended until clinically important cardiac effects resolve
- If fingolimod is discontinued for more than 2 weeks, it is restarted under the above conditions
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The manufacturer of Insulin Glulisine (Apidra®) has written to healthcare professionals to advise that this product is now returning to stock.
The letter notes that the supply shortage that was announced in September 2011 was due to a technical incident at the manufacturing site. The current supply status is as follows:
- Apidra cartridges (for ClikStar) - expected to become available week commencing 6th February 2012
- Apidra SoloStar - expected to become available week commencing 6th February 2012
- Apidra vials - remain unaffected by the supply shortage
- Apidra Optiset - discontinued as planned with effect from 31st December 2011
- Aipdra cartridges (for OptiClik) - discontinued as planned with effect from 31st December 2011
Action: Clinicians should be aware that this product is now returning to stock. Supplies may be sporadic in early weeks as back orders are filled.
Prodigy has been updated in February 2012 for the following clinical areas:
Some of these topics have had minor updates applied since last month including new drug safety information. Quetiapine has been rarely associated with diabetic ketoacidosis and domperidone has been associated with an increased risk of serious ventricular arrhythmias.
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.