What quality assurance measures are medicines required to meet?
Medicines are manufactured within tightly-defined product specification requirements – for InVita D3 (cholecalciferol) 25,000 IU/ml oral solution, the colecalciferol content must be between 95-105% of the stated value.1
Vitamin D-containing food supplements have shown large variation in their colecalciferol content (between 8% and 201% of the labelled amount).2
Not only can there be variation between different food supplements, but there may also be variation among different pills from the same bottle.3
Can medication and food supplements make the same medicinal claims and comparisons?
Only medicines with a Marketing Authorisation can claim to treat or prevent disease.4Food law prohibits claims for a food supplement to treat, prevent or cure disease.5
In the UK, any information, claim or comparison made for a medicine must not be misleading and must be factually accurate.4
Medicines can be distinguished from food supplements by their Marketing Authorisation.4 There is no requirement for food supplements to be registered or authorised for sale in the UK.6 Examples of food supplements prescribed in England include Pro D3, Hux D3 and Valupak.7
Royal Osteoporosis Society guidelines8
Choose InVitaD3 to achieve the ROS recommended doses of vitamin D.
The ROS guidelines titled ‘Vitamin D and Bone Health: A Practical Clinical Guideline for Patient Management’ recommend:
Where rapid correction is required, loading regimens for treatment of deficiency up to a total of approximately 300,000 international units (IU) given either as weekly or daily split doses. The exact regimen will depend on the local availability of vitamin D preparations.
Maintenance regimens may be considered 1 month after loading, with doses equivalent to 800-2000 IU daily (occasionally up to 4000 IU daily), given either daily or intermittently at a higher but equivalent dose.
1. Consilient Health Ltd. Data on File D0F001. July 2014.
2. 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): 158-161.
3. LeBlanc ES et al. Over-the-Counter and Compounded Vitamin D: Is Potency What We Expect? JAMA Intern Med. 2013; 173(7): 585-586.
4. Human Medicines Regulations 2012 (SI 2012/1916).
5. MHRA Guidance Note No. 8. A guide to what is a medicinal product. Revised March 2016.
6. Department of Health. Food supplements Guidance notes on legislation implementing Directive 2002/46/EC on food supplements. Updated January 2012.
7. NHS Prescription Cost Analysis (PCA) data May 2019. https://www.nhsbsa.nhs.uk/prescription-data/dispensing-data/ prescription-cost-analysis-pca-data [Last accessed August 2019].
8. Royal Osteoporosis Society. Vitamin D and Bone Health: A Practical Clinical Guideline for Patient Management. 2018. Available at: https://theros.org.uk/media/100231/nos_vitamin_d_and_bone_-health_in_adults_web.pdf [Last accessed July 2019].
Using InVita D3 to follow the ROS treatment recommendations
1. Consilient Health Ltd. InVita D3 50,000 IU soft capsules. Summary of Product Characteristics.
2. Consilient Health Ltd. InVita D3 50,000 IU oral solution. Summary of Product Characteristics.
3. MIMS, June 2019.
4. Consilient Health Ltd. InVita D3 800 IU soft capsules. Summary of Product Characteristics.