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Decreased postoperative endophthalmitis rate after institution of intracameral antibiotics in a northern california eye department

Decreased postoperative endophthalmitis rate after institution of intracameral antibiotics Neal H. Shorstein, MD, Kevin L. Winthrop, MD, Lisa J. Herrinton, PhD PURPOSE: To evaluate post-cataract-surgery endophthalmitis rates in relation to changing practicepatterns in antibiotic administration.
SETTING: Kaiser Permanente, Diablo Service Area, California.
DESIGN: Ecological time-trend study.
METHODS: During 2007 through 2011, 3 time periods were identified based on increasing adoptionof intracameral injections after phacoemulsification cataract surgery. In 2007, patients primarilyreceived postoperative antibiotic drops without intracameral injection. During 2008 and 2009, inaddition to the surgeons’ usual postoperative topical drop regimen, patients received intracameralcefuroxime unless contraindicated by allergy or posterior capsule rupture (PCR). During 2010 and2011, all patients received an intracameral injection of cefuroxime, moxifloxacin, or vancomycinwhile topical antibiotics were used according to surgeon preference. The rates of postoperativeendophthalmitis during these 3 periods were calculated. Also evaluated separately were consecutivepatients without PCR from a subgroup of 3 surgeons who used intracameral injection alone withoutperioperative topical antibiotics.
RESULTS: Nineteen cases of endophthalmitis occurred in 16 264 cataract surgeries. The respectiverates per 1000 during the 3 time periods (2007, 2008 and 2009, 2010 and 2011) were as follows:3.13 (95% confidence interval [CI], 1.43-5.93); 1.43 (95% CI, 0.66-2.72); 0.14 (95% CI, 0-0.78).
One case of endophthalmitis was observed in 2038 patients without PCR who received intracameralinjection only without topical antibiotics (rate per 1000: 0.49; 95% CI, 0.01-2.73).
CONCLUSIONS: The adoption of intracameral antibiotic injection coincided with a decline in the rateof postoperative endophthalmitis, and a low infection rate was observed with intracameral injectionalone.
Financial Disclosure: No author has a financial or proprietary interest in any material or methodmentioned.
J Cataract Refract Surg 2013; 39:8–14 Q 2012 ASCRS and ESCRS Although endophthalmitis after cataract surgery is rare surveys of ophthalmologists practicing in the U.S. sug- in the United States and Europe, these infections can be gest that few have adopted intracameral antibiotic visually devastating. Recent reports of the rate of post- operative endophthalmitis after cataract surgery have In 2007, the rate of clinical endophthalmitis in our ranged from 0.40 to 2.65 per Antibiotic pro- department (Kaiser Permanente Diablo Service Area) phylaxis to prevent endophthalmitis after cataract sur- was similar to that in the control group in the ESCRS gery is well accepted and recommended; however, in study. With the success of that study in mind, our de- the U.S. there is no consensus on the most preferred partment adopted intracameral injection of cefurox- agents or routes of administration.The European ime in uncomplicated, nonpenicillin-allergic patients Society of Cataract & Refractive Surgeons (ESCRS) in late 2007. Here, we report our evolving experience study of intracameral cefuroxime was the first random- with intracameral injection alone and in combination ized clinical trial showing the efficacy of antibiotic pro- with postoperative topical antibiotic agents from phylaxis to prevent Despite this evidence, PROPHYLAXIS FOR POSTOPERATIVE ENDOPHTHALMITIS or PCR. Cefuroxime continued to be the first-line drug; mox- ifloxacin 0.1%/0.1 mL was injected into patients allergic toa penicillin or cephalosporin analogue; and vancomycin This ecological time-trend study, which was approved by 1 mg/0.1 mL was injected into patients allergic to all the the Kaiser Permanente Institutional Review Board, was above antibiotic classes. This algorithm was implemented based on a consecutive case series of patients who had cata- in cases with or without PCR, and topical antibiotics were ract surgery during 2007 through 2011 in the Diablo Service used according to surgeon preference. For reinforcement Area Department of Ophthalmology at Kaiser Permanente.
and monitoring, the policy required operating room staff The department is 1 of 31 cataract centers in the Kaiser Per- to report to the Risk Department any event of failure to inject manente Northern California health plan, which provides 1 of these agents during a cataract procedure.
care to more than 3.2 million members. The department con- Three of 14 surgeons injected an intracameral antibiotic sists of 15 staff surgeons performing approximately 3000 cat- without prescribing additional perioperative antibiotic aract surgeries yearly. The study included patients of 14 of drops. Cefuroxime was injected in consecutive patients not the 15 surgeons; 1 surgeon (670 surgeries) was excluded allergic to penicillin with intact posterior capsules between because he was not available to provide information on his September 2007 and December 2009. Beginning in 2010, these 3 surgeons followed the department’s algorithm of in- During the study period, all surgeons performed phaco- tracameral injection in every patient. However, patients with emulsification using a clear corneal approach. Other than PCR or corneal relaxing incisions performed at the time of outlined in this article, there were no additional significant surgery were prescribed postoperative topical antibiotic department-wide practice changes during the study period drops in addition to the intracameral injection.
of which we were aware. Povidone–iodine 5% was adminis-tered for at least 3 minutes before eyelid preparation to allpatients without a history of allergy to topical iodine.
Before September 2007, cataract patients in the depart- All Kaiser Permanente members who had phacoemulsifi- ment received topical postoperative antibiotic drops accord- cation cataract surgery in the Diablo Service Area by the 14 ing to the preferred practice of the surgeon. No surgeon used surgeons under study during 2007 through 2011 were iden- tified by searching Kaiser Permanente electronic medical Beginning in September 2007 and continuing through records for procedure codes indicating cataract surgery December 2009, the department adopted and began the prac- (Current Procedural Terminology codes 66850, 66940, tice of injecting intracameral cefuroxime 1 mg/0.1 mL at the conclusion of surgery to most patients. Intracameral injec-tion was not performed in patients who were allergic toa penicillin or cephalosporin analogue or if there was posterior capsule rupture (PCR) because of concern about potential retinal toxicity. Most surgeons added intracameral biotic dispensing was obtained from the computerized med- injection to their usual postoperative topical antibiotic regi- ical records and the pharmacy information management men, although 3 replaced their usual topical regimen with system. In addition, practice patterns were confirmed with intracameral injection in most patients. Licensed pharma- cists compounded all intracameral antibiotic agents on themorning of surgery.
Identification of Suspect Endophthalmitis Cases In January 2010 through the end of this study in December 2011, the department expanded the policy of intracameral in- eligible cataract surgery cases, a search of the electronic jection to include every patient, including those with allergy medical records was performed for endophthalmitis diagno-sis codes (outpatient or inpatient International Codes ofDiseases-9 codes 360.00, 360.01, 360.03, 360.13, 360.19) for12 months after the date of cataract surgery. Patients with1 or more of these codes were considered suspect cases. In addition, operating surgeons as well as the Infection Control, Final revision submitted: July 26, 2012.
Risk, and Quality departments were queried for reports of endophthalmitis during the study period.
From the Department of Ophthalmology (Shorstein), Kaiser Perma- Confirmation of Endophthalmitis Cases Using Medical Record nente, Walnut Creek and Division of Research (Herrinton), Kaiser For all suspect endophthalmitis cases, the lead au- Permanente Northern California, Oakland, California; Division of thor (N.S.) manually reviewed the electronic medical records Infectious Diseases, Ophthalmology, and Public Health (Winthrop), to confirm the diagnosis and obtain additional details for Oregon Health and Science University, Portland, Oregon, USA.
each case, including risk factors for endophthalmitis suchas surgical complications (eg, PCR), demographics, notes Vitas Alekna, MD, and Kelly Siu, MD, cooperated in the injection- about antimicrobial therapy, and microbiological testing of only study. Ellen Nguyen, Pharm D, created the injection com- aqueous or vitreous samples. The medical record review pounding protocols. Carren Sena performed data abstraction. The included progress notes from appointments with an Permanente Medical Group, Inc., Oakland, California, USA, pro- ophthalmologist, optometrist, and other clinical health care vided administrative support for this project.
providers at any Kaiser Permanente facility in NorthernCalifornia as well as results from microbiological testing.
Corresponding author: Neal H. Shorstein, MD, Department of Oph- The medical records were closely reviewed for the 8 weeks thalmology, Kaiser Permanente, 320 Lennon Lane, Walnut Creek, after surgery; the review was extended to 1 year if needed J CATARACT REFRACT SURG - VOL 39, JANUARY 2013 PROPHYLAXIS FOR POSTOPERATIVE ENDOPHTHALMITIS A suspect endophthalmitis case was considered con- firmed if clinical endophthalmitis was diagnosed by a KaiserPermanente retinologist based on time of onset, visualacuity, degree of inflammation, vitreous cells, clinical ap-pearance, and the administration of intravitreal antibioticsfor treatment. On querying the retinologists for this study,no cases were believed to represent toxic anterior segmentsyndrome. Cases were considered culture-confirmed if aque-ous or vitreous cultures were positive.
Incidence rates were calculated for each of the 3 practice periods (no intracameral policy, 2007; intracameral in thosewithout allergy or PCR, 2008 to 2009; and intracameral in ev-ery patient, 2010 to 2011) and for the subgroup of 3 surgeons Figure 1. Trends in intracameral injection, postoperative topical ga- who replaced topical antibiotic use with intracameral injec- tifloxacin, and endophthalmitis in 16 264 phacoemulsification proce- tion in their patients without PCR during 2007 through dures performed by 14 surgeons during 2007 through 2011 in the 2011. Rates were computed using the number of cases of Kaiser Permanente Diablo Service Area. The percentage of topical postoperative endophthalmitis as the numerator and the gatifloxacin is the percentage of patients prescribed topical gatiflox- number of cataract surgeries as the denominator. In a sepa- acin postoperatively, with the remainder being topical tobramycin, rate analysis of the 3 surgeons who replaced topical antibi- ofloxacin, less common agents, or nothing. From 2007 through otic use with intracameral injection, patients who received 2009, intracameral injection was used in only patients without both intracameral injection and a topical antibiotic were ex- PCR and without allergy to penicillin and cephalosporin. In 2010 cluded. Exact 95% confidence intervals (CIs) and P values and 2011, intracameral injection was used in all patients (with and Also during the study period, 5 surgeons switched The study evaluated 16 264 consecutive phacoemulsi- postoperative prescribing from tobramycin to gatiflox- fication surgeries. The median patient age was 74 acin drops (Zymar). Of the patients who received post- years. Of the 16 264 surgeries, 12 609 (78%) involved operative topical antibiotic, the proportions who intracameral injection. Cefuroxime was injected in received gatifloxacin were as follows: 2007, 42% 10 644 cases (84%), moxifloxacin in 1890 cases (15%), (1210 cases); 2008, 75% (2324 cases); 2009, 80% (2568 and vancomycin in 75 cases (1%); 2038 patients (13%; cases); 2010, 77% (2645 cases); and 2011, 78% (2868 median age 76 years) received intracameral injection cases) (). The increase was sharp between alone. No adverse drug reactions were reported from 2007 and 2008 but stable thereafter.
administration of intracameral antibiotics during theentire study period, and there were no Risk Depart- ment reports of failure to administer an intracameralantibiotic injection in 2010 or 2011, the period during The intracameral policy was introduced in Septem- which the policy dictated 100% injection.
ber 2007. After this, when intracameral cefuroxime be-gan to be injected except in penicillin/cephalosporinallergic and PCR patients, the endophthalmitis rate de- clined by a factor of 2.2 in 2008 and 2009 to a rate Intracameral injection (cefuroxime during 2007 of 1.43 cases per 1000 (95% CI, 0.66-2.72) ).
through 2009; cefuroxime, moxifloxacin or vancomy- During 2010 and 2011, when intracameral cefuroxime, cin during 2010 and 2011) increased from 2007 to moxifloxacin, or vancomycin was provided to all 2011. The proportions of patients who received intra- patients including those with PCR, the infection rate cameral injection were as follows: 2007, 11% (308 declined by a factor of 10.2 to 0.14 per 1000 (95% CI, cases); 2008, 80% (2459 cases); 2009, 86% (2734 cases); 2010, 100% (3430 cases); and 2011, 100% (3678 cases) Over the 5-year study period, the group of patients (The increase was especially sharp between who received intracameral injection at the time of cat- 2007 and 2008, when cefuroxime injection was com- aract surgery had 4 cases of endophthalmitis, all cul- pletely adopted by all ophthalmologists in the group ture negative, for an infection rate of 0.32 per 1000 but limited to nonpenicillin-allergic, non-PCR pa- (95% CI, 0.09-0.82). The corrected distance visual acu- tients. It rose sharply again between 2009 and 2010, ity (CDVA) after infection resolution was 20/30 in 3 of when an intracameral injection of antibiotic was pro- the 4 cases. One patient with preexisting post- exudative macular degeneration in the index eye J CATARACT REFRACT SURG - VOL 39, JANUARY 2013 PROPHYLAXIS FOR POSTOPERATIVE ENDOPHTHALMITIS Table 1. Incidence of postoperative endophthalmitis in relation to practice patterns during 3 time periods, Kaiser Permanente Diablo ServiceArea.
Individual surgeon’s preference without IC injection IC injection with or without topical in patients without PCR; topical only in patients with PCR IC injection in all patients, with or without topical depending on surgeon’s preference Three surgeons, IC alone in patients without PCR CI Z confidence interval; IC Z intracameral; PCR Z posterior capsule rupture achieved an improved postoperative CDVA after in- who had PCR were treated with gatifloxacin topical fection resolution of 20/70. During this same period, eyedrops but not intracameral injection.
the group of patients who did not receive intracameralinjection had 15 cases of endophthalmitis, an infection rate of 4.20 per 1000 (95% CI, 2.35-6.78). The post-infection CDVA was 20/20 to 20/40 in 8 patients We examined changing trends in cataract surgical (53%), 20/50 to 20/70 in 3 patients (20%), and no light prophylaxis and computed the endophthalmitis rates perception in 3 patients (20%). One patient with preex- in a large community-based ophthalmology practice isting proliferative diabetic retinopathy and retinal de- over a 5-year period. During this time, we docu- tachment had enucleation after the infection episode mented an increase in the use of intracameral antibi- otics from 11% to 100% and a concurrent 22-fold Three surgeons used intracameral injection without decline in the rate of clinical endophthalmitis. The topical antibiotic in 2038 consecutive surgeries uncom- patients who received intracameral injection over the plicated by PCR. Among these surgeries, there was course of the 5-year study had a 13-fold lower rate 1 case of clinical endophthalmitis, a rate of 0.49 per of infection, were culture negative, and had a good vi- sual outcome, factoring out preexisting ocular disease.
In addition, we documented a low incidence rate ofendophthalmitis with the use of intracameral anti-biotics alone in the absence of preoperative or post- operative antibiotic drops. Our study supports the During the study period, 19 cases of endophthalmi- findings in the ESCRS randomized controlled trial tis were identified. shows the characteristics of and other studies that found intracameral antibiotic these cases. The median time to onset after cataract ex- use was associated with lower endophthalmitis traction was 6 days (range 1 to 47 days). Regimens used for antibiotic prophylaxis varied for these cases; A key element of the study that provides a critical 10 (53%) received postoperative gatifloxacin drops, clue about the relative effectiveness of gatifloxacin 8 (42%) postoperative tobramycin, and 3 (16%) intra- and intracameral injection stems from the timing of cameral antibiotic plus topical therapy, and 1 (5%) in- the practice changes under study. The marked increase in the adoption of gatifloxacin from tobramycin oc- Of the 19 cases, 8 (42%) were culture positive. None curred in late 2007. During that same time, intracam- of these patients received intracameral antibiotic injec- eral cefuroxime injection was initiated in patients tion. The organisms cultured were coagulase-negative without PCR or allergy to penicillin or cephalosporin Staphylococcus, Streptococcus viridans, S pneumoniae, analogues. The rate of endophthalmitis declined by methicillin-resistant S aureus, and Enterococcus faecalis.
a factor of 2, although the decrease was not statistically Five patients (63%) had received postoperative gati- floxacin drops and 3 patients (38%) tobramycin drops.
From 2010 to 2011, gatifloxacin-prescribing prac- Six (75%) of the 8 culture-positive endophthalmitis pa- tices remained essentially constant. In January 2010, tients were uncomplicated (no PCR). Of the 6, half re- after a review of the available literature on the safety ceived gatifloxacin and half received tobramycin. The of intracameral antibioticsthe group changed its 2 patients (25%) with culture-positive endophthalmitis practice to begin injecting all cataract surgery patients, J CATARACT REFRACT SURG - VOL 39, JANUARY 2013 PROPHYLAXIS FOR POSTOPERATIVE ENDOPHTHALMITIS Table 2. Detailed characteristics of 19 endophthalmitis cases that developed in a consecutive series of 16 264 phacoemulsification surgeriesin 2007 through 2011, Kaiser Permanente Diablo Service Area.
CDVA Z corrected distance visual acuity; coag neg Z coagulase negative; Enteroc Z Enterococcus; Enuc Z enucleated; IC Z intracameral; ID Z identifier;MRSA Z methicillin-resistant Staphylococcus aureus; NLP Z no light perception; PCR Z posterior capsule rupture; Strep Z Streptococcus; Staph Z Staphylococcus*Endophthalmitis was diagnosed 22 days after surgery after a fingernail scratch.
including (and especially) those with PCR. The addi- the number of patients receiving this prophylactic reg- tion of moxifloxacin as a second-line alternative and imen was too small to allow us to draw a clear conclu- vancomycin as a third-line alternative to cefuroxime sion. This rate is very similar to, although less precise brought the percentage of patients injected to 100%.
than, the rate of 0.45 per 1000 reported in Sweden, With this change, the risk for endophthalmitis de- where 95% of 225 471 patients received intracameral clined 10-fold (P!.01). This suggests that adoption of intracameral injection was the key practice change reducing endophthalmitis rates and that intracameral An advantage of intracameral injection is that the injection may be especially effective in patients with dose of antibiotic achieved in the anterior chamber PCR, which is important because the risk for infection is much higher than with topical administration increases by 5- to 10-fold after PCR.It was because for dose-dependent antibiotics, this provides a higher of this increased risk that the subgroup of 3 surgeons kill. The use of topical fluoroquinolones is not with- whose usual practice was to inject intracameral antibi- out problems. Topical therapy itself may pose risks.
otics as the only means of prophylaxis for infection prescribed additional topical antibiotics in cases com- dropper tipmay contact the eye,and topical fluo- roquinolones have been implicated in emerging This raises the question of whether topical antibi- otics, when combined with intracameral administra- The better cost effectiveness of intracameral cefur- tion, offer any marginal effectiveness. The subset of oxime over topical fluoroquinolones has been patients who received intracameral injection as the shThe additional cost of a fourth-generation sole means of prophylaxis without topical agent had fluoroquinolone over intracameral cefuroxime is a low endophthalmitis rate (0.49 per 1000), although approximately $75 per bottle.With 1.82 million J CATARACT REFRACT SURG - VOL 39, JANUARY 2013 PROPHYLAXIS FOR POSTOPERATIVE ENDOPHTHALMITIS cataract procedures performed in the U.S. Medicarepopulation,the cost to Medicare is $136 million an- nually for postoperative topical agents alone. This  Intracameral antibiotic injection in the prevention of post- figure may be a conservative estimate because some operative endophthalmitis has not generally been adopted surgeons administer additional antibiotic units imme- in the United States. Skepticism about the design of the diately before or after surgery. This estimate also ESCRS study and difficulties compounding cefuroxime does not include patients receiving their surgeries  There have been no published data describing a link Although the choice of cefuroxime as first-line in- between posterior capsule rupture and intracameral injec- tracameral agent in our department was driven by tion for prevention of endophthalmitis.
the results in the ESCRS study when we first em-barked on this practice improvement, moxifloxacin  There have been no published data on the endophthalmitis may have advantages as a first-line drug because it rate in patients who receive intracameral injection and no offers broader spectrum coverage and is available other perioperative antibiotic drops.
for injection without dilution. Its cost effectivenessin intracameral injection may approach that of cefur- oxime as the number of doses obtained from 1 bottleincreases. As our experience with cefuroxime as  Systematic adoption of intracameral antibiotic injection at a first-line agent appears to be successful, no change the end of the cataract surgery was associated with in our current algorithm of antibiotics is being con- a lower rate of endophthalmitis at a large surgery center templated at this time. Vancomycin, however, should in Northern California. This has not been demonstrated not be injected as a first-line drug to reduce the risk  Intracameral injection may be particularly effective in pa- The design of this study is a potential weakness.
Ecologic studies, such as country-level comparisonsand time trends, use data collected at the population  Intracameral injection alone, without additional perioper- level rather than the patient level. They are often ative antibiotic drops, may be highly protective against used to generate hypotheses and provide supportive evidence rather than show causality. Ecologic time-trend studies, such as this one, do not account for otherpopulation shifts that may be explanatory. It was be- cause of this limitation that we carefully assessed 1. Taban M, Behrens A, Newcomb RL, Nobe MY, Saedi G, trends in topical gatifloxacin use. Nonetheless, sur- Sweet PM, McDonnell PJ. Acute endophthalmitis following cat- geon factors, such as wound constructionstromal aract surgery; a systematic review of the literature. Arch hydration,and concluding intraocular pressor Ophthalmol 2005; 123:613–620. Available at: systemic factors, such as declines in the PCR rate and improvements in environmental cleaning, may be im- 2. West ES, Behrens A, McDonnell PJ, Tielsch JM, Schein OD.
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Assessment of progression of COPD: report of a workshopheld in Leuven, 11–12 March 2004M Decramer, R Gosselink, M Rutten-Van Mo¨lken, J Buffels, O Van Schayck, P-A Gevenois,R Pellegrino, E Derom, W De Backer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

July 2013 ta report jb update 13.8.13.xls

QVH NICE Technology Appraisal Report Report generated from local_bnf provided by FormularyComplete (www.pharmpress.com). Accessed 16 05 2013 updated 13 08 2013 Items/TAs marked as non-formulary are not relevant to the services provided by the Queen Victoria Hospital NHS Foundation Trust TA Number Medicine Title Formulary Status Comments Formulary for NICE indications as recommended

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