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Update on fluorescein

24 May 2013

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This statement follows our statement of 21 March about fluorescein products, the supply of which is regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA).

The General Optical Council (GOC) is the regulator for optometrists and dispensing opticians in the UK. The MHRA regulates medicines and medical devices.

The MHRA has classified fluorescein ocular strips as a medicinal product1. This classification requires these products to be licensed for use in the UK.

Following the decision by Bausch and Lomb to withdraw its licensed fluorescein ocular strips (Fluorets) from the marketplace, we are aware that registrants are still seeking guidance on the use of fluorescein products.

We know Fluorets’ withdrawal from the market has a significant impact for both patients and practitioners. We continue to receive many enquiries from registrants seeking clarity about using other fluorescein products.

Optometrists and contact lens opticians can safely and legally use fluorescein Minims as this product is licensed for use in the UK. Guidance on the use of Minims is available on the College of Optometrists’ website: http://www.college-optometrists.org/en/utilities/document-summary.cfm/docid/CDF0FC76-D7A2-428F-B75D9BFB1DE99914

We are working with the optical professional and representative bodies to obtain evidence regarding the patient safety implications of using other alternative fluorescein products. We hope this evidence will inform the wider debate about whether other fluorescein products should be classified, in the future, as safe to supply and use in optical practice.

We would like to reassure registrants and the public that we will provide further information should there be any update to the situation.

Footnote:

1. http://www.mhra.gov.uk/home/groups/es-era/documents/publication/con007498.pdf

Note to editors:

Our statement of 21 March is available at http://www.optical.org/en/news_publications/news_item.cfm/goc-statement-on-fluorets

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