Utilization of the i/c (intracameral) route of antibiotic administration to prevent postoperative endophthalmitis (POE) in 18 European countries and Australia, Canada, India, Japan and the USA in 2015

Session Details

Session Title: Cataract I
Session Date/Time: Friday 26/02/2016 | 10:30-12:30
Paper Time: 12:09
Venue: MC3 Room
First Author: : P.Barry IRELAND
Co Author(s): :                  

Abstract Details

Purpose:

The licensing by the European Medicines Agency in 2012 of a product for use in cataract surgery, Aprokam (Thea, France) eliminated the risks of 'kitchen' pharmacy. The subsequent increased uptake in the different European countries requires documentation together with analysis of the reasons why/why not and comparison with non-European countries.

Setting:

18 European countries were surveyed as were Australia, India, Japan and the US. Only India has a licensed product (moxifloxacin) outside of Europe.

Methods:

The countries were ranked according to the annual number of cataract operations performed and surveyed to determine the reasons for use/non use of the i/c route of administration. The relevant guidelines were identified and referenced.

Results:

The range of cataract operations performed in the European countries is 50 000 (Finland) - 768 000 (France). The utilization of the i/c route ranges between 20%(Germany) - almost 100%(Fance, Spain, Sweden). The mean across Europe is about 80%. In France and Denmark it is specifically recommended by Government Health Agencies and by National Society Guidelines in 8 of the remaining 16 countries. India has a licensed product of moxifloxacin and a utilization of 80%.Australia has no product and a 75% use, the US no product and a 30% use and Japan no product and a 12% use.

Conclusions:

In Europe i/c antibiotic prophylaxis is now the norm and topical antibiotic drops alone have largely vanished. The approval of Aprokam by the EMA is the main reason followed by Government guidelines in France and Denmark, the law of the land in Spain and ESCRS and National Society guidelines elsewhere. Outside of Europe India has a licensed product, Japan no apparent need and the US desperately seek approval from their FDA.

Financial Disclosure:

One or more of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented