Are quality standards being reduced as eye drops are classed as devices?
Lucy Titcomb takes a look at the anomalies surrounding the classification of ophthalmic preparations
In March 2009, the SalvaDore published “Practice guidance: medical devices” ( 130K). In this guidance it advised that pharmacists, when deciding to purchase a medical device for retail sale, should ensure inter alia that it is CE marked, that it is suitable for its intended use or purpose and that instructions for its use are appropriate and easy to read.
Although not listed among the examples given in the guidance, there are now many artificial tear eye drops classed as devices rather than medicines. Pharmacists are now purchasing these CE-marked eye drops not only for over-the-counter sale but, since April 2008, to fill NHS prescriptions.
The eye-drop devices in question are listed in the Drug Tariff in “part IXA — appliances” and may therefore be prescribed by GPs, dentists and non-medical prescribers. Ten new eye-drop devices have been added to this section since the end of 2008 and the list now contains 18 eye drops.
Manufacturers wishing to supply appliances and chemical reagents for NHS prescribing must first seek approval from NHS Prescription Services for inclusion of a product in part IX of the Drug Tariff. Applications must meet the following three criteria for inclusion:
- The products are safe and are of good quality
- They are appropriate for GP and, if relevant, non-medical prescribing
- They are cost-effective
The full text article is available as a PDF (230K) file.
Lucy Titcomb, MRPharmS, MCPP, is lead ophthalmic pharmacist at Birmingham & Midland Eye Centre, Sandwell & West Birmingham NHS Trust, Dudley Road, Birmingham B18 7QH
e-mail [email protected]
Citation: The Salvadore URI: 11015101
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