Vitamin D prescribing: the issues with unlicensed products

dence is emerging of its beneficial role beyond bone health.1 With the industrialisation of the modern world, studies reveal an increasing incidence of vitamin D deficiency that in turn has been associated with co-morbidities besides fractures and falls.1–4 In consequence, there has been an exponential rise in the prescription of vitamin D3 products in the UK, yet many of these prescriptions are being met by unlicensed products.5 This may, in part, be related to the previous lack of licensed vitamin D3 products, yet with the emergence of licensed formulations, there should no longer be the need to issue unlicensed products against a prescription. Similarly, there are reasons as to why only licensed preparations should be dispensed against prescriptions for vitamin D. In the UK, the licensing of pharmaceutical products is undertaken by the Medicines Healthcare Products Regulatory Authority (MHRA).6 Marketing authorisation is based upon stringent review with a focus on quality, efficacy and safety, in order that the public is protected. Thus, MHRA market authorisation provides a ‘kite mark’ to reassure both public and prescriber that a medicine achieves these standards. In the case of vitamin D this may seem rather trite as the product is often available on the shelf of a local supermarket, so why worry with regard to which product is dispensed? The answer may be found when in the MHRA remit of quality, safety and efficacy together with pricing in relation to unlicensed vitamin D products.5,7