EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/153099
8 EW NEWS & OPINION August 2013 ASCRS continued from page 3 Payment Advisory Board (IPAB), permanently fixing Medicare's sustainable growth rate (SGR) formula, and enacting a viable private contracting option—several longstanding, high-level priorities for ASCRS and the Alliance. "Those of us here are advocating on behalf of our profession, in this case, ophthalmology, on behalf of our other ophthalmology colleagues and, most importantly, on behalf of our pa- tients," said Dr. Chang, former president and current member of ASCRS. Speaking to an audience of groups representing 25 states, most of the legislators present said they were in favor of repealing the SGR, a formula used in the U.S. to control Medicare spending on physician services. Sen. Rand Paul (R-KY), a practicing ophthalmologist and an original co-sponsor of the private contacting bill, declared that Medicare's SGR is "no way to run a government." "We need to get rid of the SGR and put in its place a system that will pay doctors appropriately," Rep. Tom Price (R-GA), an orthopedic surgeon, told a standingroom only crowd. Other speakers addressed the repealing of the IPAB, a 15-member unelected, unaccountable board appointed by the President to control Medicare spending. ASCRS and the USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects: Pregnancy Category C. Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day (6 times the maximum daily clinical dose). Oral treatment of rats during Brief Summary: Based on full prescribing information. organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/ kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb at embryotoxicity (increased post-implantation losses at 100 mg/kg/day and 1-800-323-0000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day). Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose) INDICATIONS AND USAGE during organogenesis did not result in any reproductive toxicity. Loteprednol LOTEMAX is a corticosteroid indicated for the treatment of post-operative etabonate was maternally toxic (significantly reduced body weight gain during inflammation and pain following ocular surgery. treatment) when administered to pregnant rats during organogenesis at doses DOSAGE AND ADMINISTRATION of ≥5 mg/kg/day. Invert closed bottle and shake once to fill tip before instilling drops. Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from Apply one to two drops of LOTEMAX into the conjunctival sac of the affected the start of the fetal period through the end of lactation, a maternally toxic eye four times daily beginning the day after surgery and continuing treatment regimen (significantly decreased body weight gain), gave rise to throughout the first 2 weeks of the post-operative period. decreased growth and survival, and retarded development in the offspring CONTRAINDICATIONS during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol etabonate had no effect on the duration of gestation or parturition when LOTEMAX, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes administered orally to pregnant rats at doses up to 50 mg/kg/day during the fetal period. simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. There are no adequate and well controlled studies in pregnant women. LOTEMAX should be used during pregnancy only if the potential benefit WARNINGS AND PRECAUTIONS justifies the potential risk to the fetus. Intraocular Pressure (IOP) Increase Prolonged use of corticosteroids may result in glaucoma with damage to the Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. If this product is used for 10 could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress days or longer, intraocular pressure should be monitored. growth, interfere with endogenous corticosteroid production, or cause other Cataracts untoward effects. Caution should be exercised when LOTEMAX is administered Use of corticosteroids may result in posterior subcapsular cataract formation. to a nursing woman. Delayed Healing Pediatric Use The use of steroids after cataract surgery may delay healing and increase the Safety and effectiveness in pediatric patients have not been established. incidence of bleb formation. In those diseases causing thinning of the cornea Geriatric Use or sclera, perforations have been known to occur with the use of topical No overall differences in safety and effectiveness have been observed steroids. The initial prescription and renewal of the medication order should between elderly and younger patients. be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, NONCLINICAL TOXICOLOGY fluorescein staining. Carcinogenesis, Mutagenesis, Impairment Of Fertility Bacterial Infections Long-term animal studies have not been conducted to evaluate the Prolonged use of corticosteroids may suppress the host response and carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was thus increase the hazard of secondary ocular infections. In acute purulent not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in conditions of the eye, steroids may mask infection or enhance existing a chromosome aberration test in human lymphocytes, or in vivo in the single infection. dose mouse micronucleus assay. Treatment of male and female rats with up to 50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (600 Viral Infections Employment of a corticosteroid medication in the treatment of patients with and 300 times the maximum clinical dose, respectively) prior to and during a history of herpes simplex requires great caution. Use of ocular steroids may mating did not impair fertility in either gender. prolong the course and may exacerbate the severity of many viral infections PATIENT COUNSELING INFORMATION of the eye (including herpes simplex). Administration Fungal Infections Invert closed bottle and shake once to fill tip before instilling drops. Fungal infections of the cornea are particularly prone to develop coincidentally Risk of Contamination with long-term local steroid application. Fungus invasion must be considered Patients should be advised not to allow the dropper tip to touch any surface, in any persistent corneal ulceration where a steroid has been used or is in as this may contaminate the gel. use. Fungal cultures should be taken when appropriate. Contact Lens Wear Contact Lens Wear Patients should be advised not to wear contact lenses when using LOTEMAX. Patients should not wear contact lenses during their course of therapy with Risk of Secondary Infection LOTEMAX. If pain develops, redness, itching or inflammation becomes aggravated, the ADVERSE REACTIONS patient should be advised to consult a physician. Adverse reactions associated with ophthalmic steroids include elevated FOR MORE DETAILED INFORMATION, PLEASE READ THE PRESCRIBING intraocular pressure, which may be associated with infrequent optic nerve INFORMATION. damage, visual acuity and field defects, posterior subcapsular cataract Bausch & Lomb Incorporated formation, delayed wound healing and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there Tampa, Florida 33637 USA US Patent No. 5,800,807 is thinning of the cornea or sclera. ©Bausch & Lomb Incorporated The most common adverse drug reactions reported were anterior chamber ®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates. inflammation (5%), eye pain (2%), and foreign body sensation (2%). 9303400 Alliance of Specialty Medicine have both supported the repeal of IPAB. "IPAB is going to hurt medicine by having a lot of non-medical bureaucrats setting rates," said Dr. Yeh, an ASCRS member who serves on the ASCRS Government Relations Committee. "I, as a doctor, feel that I need to know all the latest things that are going to impact my practice and us as an entire specialty. The lawmakers are also looking for ideas from us, and that's something that I didn't realize. They don't have all the answers. Sometimes, a few critical comments from a few critical people may be the difference in massive policy changes that affect millions of us." Other important topics discussed included urging Congress to pass comprehensive medical liability reform legislation, improving the quality and effectiveness of patient care, and supporting medical innovation. The three-day conference included a host of other speakers, followed by scheduled visits between ASCRS members and lawmakers and their key healthcare staff. ASCRS Government Relations Committee member Marc Michelson, MD, said he came to the Fly-In to help preserve quality healthcare. "I've been in practice for 33 years, and I remember thinking to myself as a resident that I may not receive the same quality of care that we were delivering to our parents' generation 25 years ago," he said. "Unfortunately, I see that prophecy coming true, maybe prematurely, in the fact that our healthcare system is deteriorating very quickly and my ability to deliver quality service to my patients is slowly eroding." Several other ASCRS members said they also came to Capitol Hill to have their voices heard. "It's very important and it's a part of our responsibility—our advocacy responsibility—to get involved," said Dr. Bakewell, chair of the ASCRS Government Relations Committee. "It's important that people do get involved. At the very least, they need to give money to their PACs because we need to give money to political candidates that support our ideas." "Doctors being involved in the legislative process is not a choice anymore, " said Rep. Kevin Brady (R-TX), chair of the Ways and Means Health Subcommittee. "It is a matter of survival." EW Contact information Bryant: abryant@ascrs.org