New prescription-only Fultium®-D3 Drops (colecalciferol) launched

Internis Pharmaceuticals Ltd, launches a new Medicines and Healthcare Related Products Agency (MHRA)-licenced and approved vitamin D (colecalciferol) formulation; the first commercially available on prescription for the treatment and prevention of vitamin D deficiency in children under five, pregnant women and breastfeeding mothers. Vitamin D deficiency is a serious and increasing UK public health priority, affecting up to 24% of the UK population. (1)

Internis Pharmaceuticals Ltd, launches a new Medicines and Healthcare Related Products Agency (MHRA)-licenced and approved vitamin D (colecalciferol) formulation; the first commercially available on prescription for the treatment and prevention of vitamin D deficiency in children under five, pregnant women and breastfeeding mothers. Vitamin D deficiency is a serious and increasing UK public health priority, affecting up to 24% of the UK population. (1)

The results from a new survey (2) of over 1000 mothers on Mumsnet, conducted by Internis, highlighted a lack of understanding about vitamin D deficiency and the recommended daily intake. 59% of Mumsnet users received no information at all about vitamin D deficiency from any source. Over 85% of mums who were aware of the benefits, gave their child under five a daily vitamin D supplement without getting a prescription from their GP.

The use of non-licenced vitamin D supplements can increase a patient’s chances of consuming quantities of vitamin D outside of the daily recommended quantity, which can have significant consequences. Too much vitamin D can result in a range of effects including kidney failure. (3) Alternatively, vitamin D deficiency in pregnant women and breastfeeding mothers can lead to inadequate development of foetal stores of vitamin D in early infancy but also this deficiency in young children, can lead to an increased risk of developing rickets. (4)

For new-borns and older infants who are breast-fed or partially breast-fed, vitamin D is essential to absorb calcium and build strong bones and teeth. A mother’s milk does not provide enough by itself; therefore, this at-risk group should be prescribed licenced vitamin D drops. (5)

Dr Christine Burren, Consultant Paediatric Endocrinologist at the Bristol Royal Hospital for Children said: “Our lifestyle and climate mean that many of us do not manufacture enough of our own vitamin D and yet dietary sources are limited. Current Public Health Guidance indicates that all infants and children up to five years of age are advised to take a Vitamin D supplement. The availability of an accurately formulated, licenced drops formulation is relevant and very useful for this age group”.

In 2012, the UK Chief Medical Officers took steps to alert healthcare professionals to their concern about the increasing prevalence of vitamin D deficiency; its potential long-term impact on health (3) and they advocated preventative treatment for pregnant women, breastfeeding mothers and young children who are considered to be the at-risk groups. (4)

Dr Brian Curwain, pharmaceutical consultant, commented: “Unlicenced supplements are not subject to strict regulation of their manufacturing; they are known to vary in composition and quality. Where the prescriber has issued a generic prescription for vitamin D, it is then the pharmacist’s responsibility to ensure the safe fulfilment of that prescription. Supplying a non- MHRA-licenced supplement as opposed to a licenced medicine, will mean that the pharmacist is likely to be liable should the patient suffer any adverse reactions, particularly if they have not consulted the prescriber regarding the supply.”

Despite these inconsistencies in composition, the survey data revealed that only one in five mothers would query the stated dose of an unlicenced, off-the-shelf product. This is despite the fact that tests have shown significant inaccuracies in the labelled dose of these non-prescription products, placing patients at risk of under treatment or of toxicity. (6,7) Fultium-D3 Drops, which are now part of the UK’s most comprehensive range of prescription vitamin D3 preparations, meet all the strict prescription licencing criteria, meaning that there can now be a reliable and consistent dose given to people with vitamin D deficiency.

Fultium-D3 Drops (25ml) are available, with a prescription, from 23rd June 2015 and will cost only 6p per day. To find out if Fultium-D3 Drops are appropriate for your patients, visit www.internisvitd3.com.

References:

1. Food Standards Agency, National Diet and Nutrition Survey Headline results from Years 1, 2 and 3 (combined) of the rolling programme (2008/2009 – 2010/11) Available at: https://www.gov.uk/government/publications/national-diet-and-nutrition-survey-results-from-years-1-to-4-combined-of-the-rolling-programme-for-2008-and-2009-to-2011-and- 2012. Last accessed June 2015.
2. Internis survey of 1,036 mothers, conducted by Mumsnet for Internis. June 2015.
3. Durup D. A Reverse J-Shaped Association of All-Cause Mortality with Serum 25- Hydroxyvitamin D in General Practice: The Cop D Study. J Clin Endocrinol Metab 2012 Aug;97(8):2644–52.
4. CMO letter, Vitamin D – advice on supplements for at-risk groups. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213703/dh _132508.pdf. Last accessed June 2015.
5. Thiele DK et al. Maternal vitamin D supplementation to meet the needs of the breastfed infant: a systematic review. J Hum Lact 2013;29(2):163–70.
6. Davies JS et al. The medico-legal aspects of prescribing vitamin D. British Journal of Clinical Pharmacology. DOI: 10.1111/bcp.12472 Available at: http://onlinelibrary.wiley.com/doi/10.1111/bcp.12472/abstract. Last accessed June 2015.
7. Garg S et al. Evaluation of vitamin D medicines and dietary supplements and the physicochemical analysis of selected formulations. J Nutr Health Aging 2013;17(2):158–61.
8. Fultium-D3 Drops. Summary Of Product Characteristics. June 2015.