MHRA: Transferring patients to the new licensed buccal midazolam preparation
13th October 2011
The UK Medicines and Healthcare Regulatory Agency (MHRA) have highlighted that care is needed on transferring patients from unlicensed buccal midazolam preparations to the new licensed buccal midazolam preparation (Buccolam, ViroPharma).
Buccolam is oral midazolam 5mg/mL provided in age-specific, individual doses of 2.5mg, 5mg, 7.5mg or 10mg, in pre-filled syringes for buccal delivery (see our news item 14-09-2011). The NHS list price of 4 dose units is £82, £85.50, £89 and £91.50 respectively. It is licensed for patients diagnosed with epilepsy from age 3months to <18years.
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.
- Cochrane review: hydromorphone for neuropathic pain
- Glycopyrronium oral solution authorized for severe drooling in the UK
- Management of chronic pain in adult cancer survivors
- RPS guide for pharmacists working in care homes
- FDA authorizes dronabinol oral solution
- CQC annual report: safer management of controlled drugs
- Citalopram suspected drug interaction with cocaine
- Thalidomide new risks
- Nasogastric tube misplacement: continuing risk of death and severe harm
- Improving the quality of care in the last days of life: A practical guide to getting the medications right