MHRA alert: Valproate updated contra-indications

26th April 2018

Valproate must no longer be used in women or girls of child-bearing potential unless conditions of the pregnancy prevention programme are met, and only if other treatments are ineffective or not tolerated, as judged by a specialist. All women and girls of child-bearing potential currently taking valproate must be reviewed, provided with a patient guide and effective contraception as per the pregnancy prevention programme.

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Conditions for which over the counter items should not routinely be prescribed in primary care

26th April 2018

Following consultation, NHS England has produced guidance for CCGs on conditions for which over the counter items should not routinely be prescribed in primary care. The list includes 35 conditions, e.g. treatment for haemorrhoids, mouth ulcers, oral thrush where the severity is minor and self-care is considered appropriate. It applies to all patients including those who would be exempt from paying prescription charges, unless they fall under the general or condition specific exceptions outlined.

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Review of the Controlled Drugs Regulations 2013

26th April 2018

The Controlled Drugs (Supervision of Management and Use) Regulations 2013, which underpin the arrangements in England and Scotland for the safe management and use of controlled drugs in hospitals and the community, are being reviewed. A questionnaire has been designed to help inform the review and all interested stakeholders have been asked to respond. The questionnaire closes on the 21 May 2018.

The current Controlled Drugs Regulations (2013) can be accessed here

The survey can be accessed from here.

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T34 syringe pumps MHRA alert

17th April 2018

CME Limited has identified that there can be a +/- 2mm overall size difference between battery brands used with their T34 ambulatory syringe pumps. This could result in battery movement within the battery housing leading to a possible loss of connection and the pump shutting down. MHRA have stated that before use and after each battery change health professionals should check the batteries have adequate connection and that technical staff responsible for servicing the pumps should ensure battery checks are included as part of the regular maintenance programme.

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Denosumab indication extended

17th April 2018

The UK SPC for Denosumab (Xgeva) has been extended to cover the prevention of skeletal related events in adults with multiple myeloma. The indication section now states:

“Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.

Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.”

Editor's note. A new PCF Denosumab monograph will be available very shortly and will reflect this change.

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