Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
Safety updates
MHRA: Avoid use of aqueous calamine cream before X-ray
The UK Medicines and Healthcare Regulatory agency (MHRA) has issued a reminder that aqueous calamine cream should not be applied to the skin before an X-ray examination because it may affect the outcome of the radiograph. This preparation contains zinc oxide 3.0% w/w, and if used on the skin before an X-ray, the zinc oxide may mimic intramammary calcifications, which can be an important indicator of early breast cancer. The product label and leaflet have been updated to reflect this new advice. For more information click here.
MHRA: Transferring patients to the new licensed buccal midazolam preparation
The UK MHRA has highlighted that care is needed on transferring patients from unlicensed buccal midazolam preparations to the new licensed buccal midazolam preparation (Buccolam, ViroPharma).
Buccolam is midazolam oromucosal solution 5mg/mL provided in age-specific, individual doses of 2.5mg, 5mg, 7.5mg or 10mg, in pre-filled syringes for buccal delivery. The NHS list price of 4 dose units is £82, £86, £89 and £92 respectively. It was recently granted the first ever Paediatric Use Marketing Authorisation (PUMA) by the European Commission and is licensed for patients diagnosed with epilepsy from age 3 months to <18 years. A PUMA is a new type of centralised marketing authorisation designed to encourage the development of older medicines, no longer covered by a patent, specifically for use in children.
Buccolam is half the strength of some of the unlicensed preparations that have been used and is also a different salt; it contains the hydrochloride salt, whereas some other preparations contain the maleate salt of midazolam. MHRA state that although there is some suggestion that the maleate salt may be better absorbed in the buccal cavity, there are adequate studies with midazolam hydrochloride to support the dosing schedule authorized for Buccolam in the SPC. It also references a publication of the experience of a hospital paediatric unit transferring its patients to licensed Buccolam. For more information click here.
MHRA update: lenalidomide
The November 2011 issue of Drug Safety Update from the MHRA features an update about the risk of a second primary malignancy associated with the use of lenalidomide. (see our news item). Clinical trials investigating use of lenalidomide in patients with newly diagnosed multiple myeloma have shown a four-fold increased risk of second primary malignancy (including: haematological malignancies such as acute myeloid leukaemia, Hodgkin’s disease, and B-cell lymphocytic leukaemias; myelodysplastic syndrome; solid tumours; and melanomas). There seems to be a smaller increased risk of second primary malignancy in patients treated with lenalidomide for relapsed or refractory myeloma; the authorised indication.
The MHRA advice continues to be:
•Use of lenalidomide in unlicensed indications is not recommended unless it takes place as part of a clinical trial
•Patients should be carefully evaluated before and during treatment with lenalidomide using routine cancer screening for occurrence of second primary malignancy and treatment should be instituted as indicated
•Healthcare professionals should report all suspected adverse reactions, including second primary malignancy promptly via the Yellow Card Scheme.
For more information click here.
NPSA Rapid Response Report on spinal connectors
The UK National Patient Safety Agency (NPSA) has issued a Rapid Response Report on minimising risks of mismatching spinal, epidural and regional devices with incompatible connectors (NPSA/2011/RRR03). NPSA quote a recent patient safety incident, where a spinal needle with a neuraxial connector was supplied and used in error when a device with a Luer connector was required; the labelling and packaging of the two devices were similar in appearance.
Spinal, epidural and regional devices with non-Luer compatible neuraxial connectors, which will not connect with intravenous equipment, are being produced following the Patient Safety Alert issued in 2009 and updated in January 2011 (NPSA/2011/001). These devices will reduce the risk of wrong route errors. However, effective controls need to be in place to avoid mis-selection and supply of devices with incompatible connectors which could cause delay in clinical procedures and harm patients. The RRR provides additional guidance to the original patient safety alert, with a deadline for action complete of 31st March 2012.
EMA to review cardiovascular safety of NSAIDs
The European Medicines Agency (EMA) is to review the latest available data on the cardiovascular safety of non-selective non-steroidal anti-inflammatory drugs (NSAIDs) and update its opinion which was published in 2006. For more information click here.
Prepared by Sarah Charlesworth and Andrew Wilcock.