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January 2008

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Handheld device for treating cold sores now available on NHS

From this month your customers may present with a prescription for a Virulite Cold Sore Machine — the first device for treating cold sores to be available on the NHS.
Hannah Pike (editor of Retail Round-up) finds out how it works


ARTICLE CONTENTS
How it works

The evidence

Cost


How to use the Virulite Cold Sore Machine

The Virulite Cold Sore Machine (Virulite CS) is not a new invention. It has been available to buy via mail order or from a small number of community pharmacies since it was launched in 2001.

It works by emitting light of a wavelength that its developers claim heals cold sores twice as quickly as using an antiviral cream.

Following a number of refinements to the device and two clinical trials, Virulite CS has now been accepted as an addition to part IX of the Drug Tariff for England and Wales, (and part 3 of the Scottish Drug Tariff), prescribable on the NHS from 1 January 2008.

Ben Eshelby, pharmacy manager at Calverton Pharmacy, Luton, has been stocking the device for about four weeks. “I would normally be sceptical about this type of product,” he says, “but the fact that it has been included in the Drug Tariff means that it must have been looked into.”

Mr Eshelby says that he ordered ten devices after receiving an NHS circular announcing the addition to the Drug Tariff, and has sold eight of them so far. He says all of his customer feedback has been positive. “People with cold sores try the creams but they are never 100 per cent happy with them and are always going to be hunting for something else,” he says.

How it works

Virulite Cold Sore Machine

The Virulite Cold Sore Machine emits infra-red light of a wavelength that is thought to increase the immune response to the virus

James Haslam, an ophthalmologist and co-founder of Virulite Ltd, explains that the battery-operated device delivers low energy, non-thermal quantities of naturally occurring infra-red light to the area (wavelength 1072nm) from light-emitting diodes.

He believes that this light enhances the local immune response. “Cold sores often occur when a person is run down, and their immune response is low,” he explains.

“Virulite CS restores the immune response to normal levels, allowing the body to heal itself more quickly.”

The evidence

Results of a trial of 60 patients (published in the Journal of Clinical and Experimental Dermatology in 2001) showed that a single application of Virulite CS healed cold sores in an average of 4.3 days, compared with 8.1 days for topical aciclovir applied five times a day.

A second trial, involving 32 patients (published in the same journal in 2006), showed that Virulite CS had a mean healing time of 6.3 days compared with 9.4 days for no treatment. Mr Haslam explains that anecdotal evidence has shown that the device also reduces the recurrence of cold sores and this is the subject of ongoing research.

The device is ISO 13485 compliant (an international quality standard for medical devices) and has CE approval (showing that the device complies with relevant European health and safety legislation). No side effects have been reported.

Cost

Community pharmacists can purchase the device for £18.50 (plus VAT) — price negotiable depending on order size. The recommended retail price is £45 and the NHS reimbursement fee is £18.50.

The device comes with a three-year warranty (five years if prescribed), and can last for up to 10 years. Mr Haslam says the device can also save the NHS money when prescribed for patients on repeat antiviral prescriptions.

“If a patient has seven prescriptions for aciclovir ointment in one year, that is the equivalent of the prescription of one Cold Sore Machine,” he says.

As well as being stocked in a number of independent pharmacies, the device is expected to be available in Boots The Chemists stores from September 2008.

Further details can be found at www.vcs.eu.com

How to use the Virulite Cold Sore Machine

The device should be used as soon as the customer feels the “tingle” indicating that a cold sore is about to erupt. The customer holds the device against the affected area and presses the activation button.

A visible light indicator lets the customer know that invisible infra-red light is being delivered to the area. After three minutes a “beep” lets the customer know that treatment is complete.

Customers are advised to repeat the treatment 12 hours later. If the cold sore progresses, the device should be used four times a day for two more days.

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