Sir, Sherborne and Oliver1 asked whether it is acceptable to be using fluoride varnish Profluorid instead of Duraphat to help prevent caries in children, in line with Delivering better oral health: an evidence-based toolkit for prevention?2

In the above toolkit, it states: 'Clinicians should be aware that there are many fluoride varnishes on the market. They may not be licensed for caries control, although they may have similar formulations, and this should be taken into consideration with respect to prescriber's responsibilities.'2

The use of fluoride varnish other than Duraphat is a frequently asked question within the Childsmile programme in Scotland. The answer states: 'Duraphat is the only fluoride varnish licensed for use as a preventive product in the UK so is always the varnish of choice in the Childsmile programme. If you choose to use another fluoride varnish (containing sodium fluoride 22,600 ppm) then you must have a sound clinical reason for doing so as you would be using it “off label” and our advice is that, in those circumstances, you must give an explanation to the parent/guardian as to why you are using an “off label” product and record this in the notes. You would also assume all responsibility for any adverse event associated with an alternative varnish – whether it is applied by a dentist or a suitably trained dental nurse. It is likely that the main reason for considering the use of an alternative to Duraphat would be when a patient has an established allergy to colophony (a constituent of pink sticking plaster) and again, this should be clearly explained to the parent/guardian and recorded in the patient notes.'3

Both fluoride varnishes Duraphat and Profluorid contain colophony. Therefore they are contraindicated in patients with known allergies to colophony. For these patients, other fluoride varnishes (eg Fluor Protector) should be considered.

The responsibility that falls on healthcare professionals when prescribing an unlicensed medicine or a medicine off-label may be greater than when prescribing a licensed medicine within the terms of its licence. Dentists should pay particular attention to the risks associated with using unlicensed medicines or using a licensed medicine off-label. These risks may include: adverse reactions; product quality, or discrepant product information or labelling.4