Article
Are quality standards being reduced as eye drops are classed as devices?
In March 2009, the Royal Pharmaceutical Society published "Practice
guidance: medical devices" (PDF 130K). In this guidance it advised that
pharmacists, when deciding to purchase a medical device for retail sale,
should ensure 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.
Ophthalmic specialist pharmacist Lucy Titcomb argues that pharmacists need further guidance before recommending that these products be used for more than four weeks. She recalls a number of withdrawals of ophthalmic devices because of bacterial and fungal contamination and expresses concern that the efficacy tests for preservatives in ophthalmic preparations are becoming less stringent.
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