The products below have appeared in the SPOT-List, however as there are useful supporting resources and information already available, we have signposted to these rather than produce new resources.
Magnesium glycerophosphate/magnesium oxide
A licenced magnesium Glycerophosphate 4mmol chewable tablet product is now available priced at £22.77 for 50 tablets. See link below for SPC
Midodrine
Midodrine tablets appear in the top 20 SPOT list. In March 2015 a licensed preparation of midodrine tablets became available as Bramox 2.5mg and 5mg tablets.
Sodium bicarbonate
Sodium bicarbonate 1mmol/ml oral solution was granted a UK license in September 2014. It is licensed for the treatment of hyperacidity, dyspepsia and provide symptomatic relief heartburn and peptic ulceration for patients 12 years and above. Specialist Pharmacist Services have produced a document as the licensed product was subject to some labelling safety concerns and use of unlicensed preparations is currently known to continue. The table in the link below summarises details of currently known products.
Sodium Bicarbonate Oral Liquids - October 2016
NICE evidence summaries: Unlicensed off label medicines
NHS has recently started producing evidence reviews for unlicensed or off-label medicines. It has already published two reviews. The first covers the off-label use of tranexamic acid for the treatment of significant haemorrhage following trauma, and the second reviews the use of unlicensed melatonin preparations for the treatment of sleep disorders in children and young adults with attention deficit hyperactivity disorder. There are plans to publish more reviews in the coming months and a list of those proposed can be found on the NICE website along with the published reviews at the following link:
https://www.nice.org.uk/guidance/published?type=esuom&title=u
NICE has produced a statement to describe what the evidence summaries on unlicensed or off-label medicines cover:
“Evidence summaries: unlicensed or off-label medicines' summarise the published evidence for selected unlicensed or off-label medicines that are considered to be of significance to the NHS, where there are no clinically appropriate licensed alternatives. The summaries provide information for clinicians and patients to inform their decision-making and support the construction and updating of local formularies.
The summaries support decision-making on the use of an unlicensed or off-label medicine for an individual patient, where there are good clinical reasons for its use, usually when there is no licensed medicine for the condition requiring treatment, or the licensed medicine is not appropriate for that individual.
The strengths and weaknesses of the relevant evidence are critically reviewed within this summary, but this summary is not NICE guidance.”
Guidance on prescribing unlicensed eye preparations (May 2014)
The Royal College of Ophthalmologists and the UK Ophthalmic Pharmacy Group have published Ophthalmic Specials Guidance. It has been written in response to the high number of prescriptions for unlicensed eye preparations with an aim to promoting more cost-effective prescribing and more efficient use of NHS resources. The guidance will also assist prescribers in determining the appropriateness and suitability of eye preparations to achieve the best clinical outcomes for their patients. Reviewed every six months, the guidance is available to download on the websites of The Royal College of Ophthalmologists here.
