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Nice vitamin D guidance puts pharmacists in legal grey area – experts

In a letter to the medicines body, a group of health experts said Nice must emphasise that its consultation guidance does not refer to unlicensed vitamin D products

Nice must clarify its proposed guidance on vitamin D products to avoid putting pharmacists in a difficult position legally, academics have said.


Nice should emphasise that only licensed vitamin D medicines are supplied on the NHS or it will risk causing adverse reactions, a group of health experts organised by manufacturer Internis Pharmaceuticals said in a letter to the medicines body last week (June 10).


Pharmacists were put in a "difficult position" if they were asked to dispense a prescription for an unlicensed vitamin product, said independent NHS consultant Brian Curwain, who co-wrote the letter.


Nice must emphasise that its consultation guidance does not refer to unlicensed vitamin D products, says the group of health experts

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Prescribers were liable if a patient experienced an adverse drug reaction because they received an unlicensed vitamin dosage or product, said Mr Curwain. NPA guidance advises pharmacists to contact the prescriber if they had recommended an unlicensed product, but pharmacists were under "extreme" pressure and did not have the time to do this, he told C+D this week (June 16).


The Nice guidance does not differentiate between licensed medicines and unlicensed products.


In its letter, the group said it was concerned that, unless the guidance made it clear that only licensed products should be prescribed, the "large and vulnerable" group of patients who were intended to benefit from vitamin D products could be at risk of receiving a "sub-therapeutic or excessive" dose.


"We note that the MHRA, the General Medical Council and the Royal Pharmaceutical Society all state that, where there is an available licensed medicine, it should be prescribed in preference to unlicensed products, such as food supplements. Not doing so raises potential medico-legal issues for the prescriber and the dispensing pharmacist," the group said in its letter, which was sent to four national newspapers.


Prescription cost analysis data showed that the "exponential" increase in prescriptions of vitamin D products on the NHS had been "driven by the dispensing of unlicensed products purporting to be medicines", the group added.


In its draft guidance, which is open for consultation until June 24, Nice proposed providing free vitamin supplements to at-risk patient groups and increasing access to supplements at a local level.


The news came the same week that clinicians raised concerns that draft Nice guidance on statins would put five million healthy people onto unjustified treatment.


Nice's decision to halve the threshold for treatment by recommending it for anyone with a 10 per cent or greater chance of developing cardiovascular disease within 10 years was not justified by the health benefits, doctors and researchers said in a letter to the medicines body.


The authors of the letter, including former Royal College of GPs chair Claire Gerada, also raised concerns that they could not access the research used to influence the guidelines. They asked Nice to delay its final guidance, which is due to be published next month, until it had addressed their concerns.


Have you faced any problems with prescriptions of vitamin D products?
 
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2 Comments

Halal Butcher, Academic pharmacist

*This comment and an ensuing exchange have been removed in response to a reader complaint and a breach of the community principles (http://www.chemistanddruggist.co.uk/community-principles) - Editor, C+D

UKMi maintains a list of available vitamin D products which community pharmacists may find helpful, including licensing status:

http://bit.ly/1phk5ib

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