EyeWorld Asia-Pacific March 2015 Issue
March 2015 13 EWAP FEATURE 2014 ASCRS endophthalmitis prophylaxis survey highlights • 67% said intracameral antibiotic prophylaxis is “important” • 47% already inject intracameral antibiotics or plan to start in the next 6 months • 49% of those not using intracameral antibiotics cite compounding or mixing risk • 75% said having an approved commercial intracameral antibiotic is “important” • 84% would inject an intracameral antibiotic if Aprokam were available at a reasonable cost has sold more than 1.3 million units with no significant safety issues. The ESCRS published endophthalmitis prophylaxis guidelines in 2013 that reviewed the literature supporting direct intracameral injection of cefuroxime. 8 In light of these developments, the ASCRS Cataract Clinical Committee recently published a paper reviewing the off- label options for intracameral antibiotic use in the U.S., where no commercial product is approved. 9 We also resurveyed our membership regarding endophthalmitis antibiotic prophylaxis practice patterns. Most of the same questions from 2007 were repeated so that differences and trends could be analyzed. The 2014 survey was conducted in August 2014. The link to a 2-minute online survey was emailed to the ASCRS membership and 1,147 members responded (a 15% response rate). A unique response URL was generated so that it was impossible to complete the survey more than once. Most of the respondents (65%) were from the U.S., with the rest coming from Latin/South America/ Mexico (13%), Europe (9%), Africa (7%), Canada (5%), and Asia/Aus¬tralia (1%). The respondents were active surgeons, with 67% doing at least 300 cases/year, and 41% per¬forming more than 500 cases/ year. The survey found that perioperative topical antibiotics are used by 90% of the respondents (unchanged from 91% in 2007) (Figure 1). Those preferring latest generation topical fluoroquinolones (gatifloxacin or moxifloxacin) decreased from 81% in 2007 to 60% in 2014. This change mirrored a shift to greater use of ofloxacin or ciprofloxacin (21% compared to 9% in 2007). Preoperative topical antibiotics are used by 85% of respondents and are initiated on arrival at the ambulatory surgery center by 20%, 1 day preoperatively by 32%, and 3 days preoperatively by 48%. These distributions are virtually unchanged from the 2007 survey, which registered 22%, 26%, and 52%, respectively, among the three timeframes. Postoperative topical antibiotics are used by 96% of the respondents (essentially unchanged from 98% in 2007). They are initiated on the day of surgery by 73% and on postop day 1 by 23% (compared to 65% and 33% in 2007). They are discontinued within 1 week (no taper) by 72%, after several weeks (no taper) by 21%, and tapered over the course of several weeks by 7%. This is virtually identical to the results from 2007. Use of intracameral antibiotics has increased to 50%, compare d to 30% in 2007. Among these respondents, the proportion of those directly injecting antibiotic (as opposed to placing it in the infusion bottle) is now 84%, compared to 52% in 2007 (Figure 2). The choice of antibiotic for intracameral use is also changing. Moxifloxacin is used by 33%, vancomycin is used by 37%, and cefuroxime is used by 26%. Looking at American surgeons only, these same agents are used by 31%, 52%, and 14%, respectively. At the conclusion of surgery, 36% of respondents are now directly injecting an antibiotic, which is up from 14% in 2007. When tabulated by region, 70% of European respondents inject intracameral antibiotic, compared to only 30% of American surgeons. For those using intra-cameral antibiotics, 5% are using Aprokam, 6% prepare it themselves, 65% have the operating room nurses prepare the drug, and 24% use a hospital (14%) or outside (9%) compounding pharmacy. A total of 47% either already use or are planning to initiate direct intracameral antibiotic injection in the next 6 months (Figure 3). What are the reasons that 53% still do not plan to inject an intracameral antibiotic? Cost was cited by 19%, lack of convincing evidence by 65%, and 49% worried about the risks of mixing or compounding these drugs. Among surgeons not injecting antibiotic in 2007, these reasons were cited by 17%, 89%, and 45%, respectively. Respondents who did not have access to Aprokam were asked whether they would use it if it were available to them. Assuming reasonable cost, 69% said “yes,” 17% said “no,” and 14% would use a different intracameral antibiotic. In 2007, a nearly identical 18% said they would not use a commercially approved intracameral antibiotic. How important is intracameral antibiotic prophylaxis? Fourteen percent said “not necessary,” 41% said “very important,” and 26% said “important, but other methods are sufficient.” When asked specifically whether it is important to have an approved antibiotic commercial preparation for direct intracameral injection, 75% said “yes,” 9% said “no,” and 16% were not sure. This was a significant difference from 2007 when the responses were 54%, 11%, and 35%, respectively. In conclusion, there has been a distinct trend toward greater use of intracameral antibiotic by ASCRS members since 2007. The majority of this is by direct intracameral injection, and fewer are placing the antibiotic in the irrigating solution. Direct intracameral injection at the conclusion of surgery has risen from 15% (2007) to 36% of respondents currently. It appears that half of those not injecting intracameral antibiotics are concerned about mixing or compounding risks because no approved commercial product is available to them. The percentage of respondents saying that it is important to have a commercially available antibiotic for direct intracameral injection has risen from 54% (2007) to 75%, and roughly 7/10 say that they would use the commercial formulation, Aprokam, if it were available to them at a reasonable cost. Clearly, there is a strong desire to have an approved commercial intracameral antibiotic in the U.S. We are in the process of sharing the results of this survey with the pharmaceutical industry and with the U.S. Food and Drug Administration. EWAP continued on page 15
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