Eyeworld

Contact information Name: Name: by ASCRS NEWS 18 | EYEWORLD | APRIL 2019 of Ophthalmic Cognitive Knowledge exam taken every 10 years. Diplomates choose five peer-reviewed journal articles from an ABO-curated list and answer questions related to these articles. The completion of Quarterly Questions can earn 8 CME/self-assessment credits and does not cost ABO dip- lomates an additional fee outside the $200 annual certification maintenance fee. According to the ABO's program specs for the Quarterly Questions, diplomates with ABO certification that expires on Dec. 31, 2020 "need to meet the annual pass- ing standards for Quarterly Questions 3 times" before their certificate expires. Those with ABO certificates expiring on Dec. 31, 2021 need to meet this annual passing standard five times before this date. ABO diplomates who are not required to seek recertification because they received their certification before 1992 can still participate in ABO's Quarterly Questions program for $200 annually. NBPAS requires initial certification through an ABMS member board, a valid, unrestricted state medical license, and completion of at least 50 CME hours within a 24-month period, among other stipulations. Initial NBPAS certification is $169 for MDs and $189 for DOs; recertification is $145 for MDs and $165 for DOs. Members of the U.S. military and fel- lows/physicians-in-training can receive discounted certification. NBPAS sees several benefits associated with certification through CME completion. "CME can provide education in both established knowledge and also future directions that keep the physician on the 'cutting edge.' CME offerings are highly competitive and provide choice. There are numerous organizations offering high value CME activities. If physicians do not perceive value in a particular CME offering, they will go elsewhere. Additionally, most states require CME activities to maintain licensure. Therefore, using CME to fulfill life- long learning requirements provides efficiency and minimizes redundant activities." Many employers and insurers require board certification, and as such, there is not universal acceptance of NBPAS certi- fication. In an effort to address questions around the options, ASCRS has prepared an online toolkit, where members can find information as well as form letters for those looking to initiate the acceptance process with their hospital system. The toolkit is available at https://nbpas.org/ascrs-members. "Through our research and discussions, we think that ABO has made meaningful strides over the last couple of years at MOC reform, but we also think that competition is good and alternative recertification options, like that provided by NBPAS, should exist," Dr. Berdahl said. Questions? ASCRS and NBPAS created a toolkit detail- ing the different options for lifelong learning programs and board recertification, available at https://nbpas.org/ ascrs-members. Read more. EyeWorld reported on some of the perspec- tives surrounding board recertification in January 2018. Search "Taking a hard look at board certification and recertification" on www.eyeworld.org. BRIEF SUMMARY: Please see the DEXTENZA Package Insert for full prescribing information for DEXTENZA (11/2018) 1 INDICATIONS AND USAGE DEXTENZA ® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery (1). 4 CONTRAINDICATIONS DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis. 5 WARNINGS AND PRECAUTIONS 5.1 Intraocular Pressure Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. 5.2 Bacterial Infection Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection [see Contraindications (4)]. 5.3 Viral Infections Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex) [see Contraindications (4)]. 5.4 Fungal Infections Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate [see Contraindications (4)]. 5.5 Delayed Healing The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. 6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Intraocular Pressure Increase [see Warnings and Precautions (5.1)] • Bacterial Infection [see Warnings and Precautions (5.2)] • Viral Infection [see Warnings and Precautions (5.3)] • Fungal Infection [see Warnings and Precautions (5.4)] • Delayed Healing [see Warnings and Precautions (5.5)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation; delayed wound healing; secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera [see Warnings and Precautions (5)]. DEXTENZA was studied in three randomized, vehicle-controlled studies (n = 351). The mean age of the population was 68 years (range 43 to 87 years), 62% were female, and 85% were white. Forty-six percent had brown iris color and 31% had blue iris color. The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (9%); intraocular pressure increased (5%); visual acuity reduced (2%); eye pain (1%); cystoid macular edema (1%); corneal edema (1%); and conjunctival hyperemia (1%). The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%). 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate or well-controlled studies with DEXTENZA in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, administration of topical ocular dexamethasone to pregnant mice and rabbits during organogenesis produced embryofetal lethality, cleft palate and multiple visceral malformations [see Animal Data]. Data Animal Data Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethality and a high incidence of cleft palate in a mouse study. A daily dose of 0.75 mg/kg/day in the mouse is approximately 5 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis. In a rabbit study, topical ocular administration of 0.1% dexamethasone throughout organogenesis (0.36 mg /day, on gestational day 6 followed by 0.24 mg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A daily dose of 0.24 mg/day is approximately 6 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m 2 basis. 8.2 Lactation Systemically administered corticosteroids appear in human milk and could suppress growth and interfere with endogenous corticosteroid production; however the systemic concentration of dexamethasone following administration of DEXTENZA is low [see Clinical Pharmacology (12.3)]. There is no information regarding the presence of DEXTENZA in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production to inform risk of DEXTENZA to an infant during lactation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEXTENZA and any potential adverse effects on the breastfed child from DEXTENZA. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients. 17 PATIENT COUNSELING INFORMATION Advise patients to consult their surgeon if pain, redness, or itching develops. MANUFACTURED FOR: Ocular Therapeutix, Inc. Bedford, MA 01730 USA PP-US-DX-0072 continued from page 16

• Blank Page
• Blank Page (1)