Guidance on Erythromycin Eye Ointment Shortage

January 25, 2024 Dear Colleague/Hospital Chief Executive Officer: This letter contains information on how to address the current and on going shortage of e ry th romyc in (0.5%) ophthalmic ointment for the prevention of ophthalmia neonatorum caused by N. gonorrhoeae. Under Section 12.2 of Title 10 of the Compilation of Rul es and Reg ulatio ns of the State of New York, it is t he duty of an attending physici an, licensed midwif e, lice nsed nurse, o r other auth orized pr ovid er in att endanc e at the delivery of a newborn to place into the eyes of the infa nt, on d eliv ery, an agent effective f or preventing purulent conju nctiviti s, s uch as eryt hromy cin eye ointment. Eye prophylaxis is a universal requirement because the treatment is safe and effective for the prevention of gonococcal infection of the eyes. Due to the ongoing shortage of erythromycin (0.5%) o phthalmic ointment, t he Department ha s adopted the following guidance from the American Academy of Pediatrics: “If erythromycin ointment is not available, a birthing parent who is at risk for exposure to N. gonorrhoeae * or who had no prenatal care, should be tested for N. gonorrhoeae in the immediate peripartum setting using a nucleic acid amplification test (NAAT). If the birth parent’s test is positive for gonorrheal infection or if the test result is pending at time of discharge with concerns for lack of follow-up, the neonate should receive ceftriaxone, 25 to 50 mg/kg of body weight, IV or IM, not to exceed 250 mg in a single dose; if ceftriaxone is unavailable or contraindicated, a single dose of c eftazidime or cefepime may be substituted”. 2-4 According to the American Academy of Pediatrics, at -risk birthing parents include “women < 25 years old, and those 25 years or older who have a new partner, more than one sex partner, a sex partner with concurrent partners, or a sex part ner who has a sexually transmitted infection (STI), or live in a community with high rates of gonorrhea; practice inconsistent condom use when not in a mutually monogamous relationship; have a previous or coexisting STI; have a history of exchanging sex for money or drugs; or have a history of incarceration ”. 1, 2 For furt her guidance, please see: AAP Erythromycin Ointment Shortage.

2 The Centers for Disease Control and Prevention recommends notifying your local health department of any challenges in procuring the product. Additional information regarding the availability of erythromycin (0.5%) ophthalmic ointment is available on the FDA Drug Shortage page. Please be advised that the Department will not take any enforcement actions in situations wh ere a documented erythromycin ointment shortage prevents a provider from complying with the directive in 10 NYCRR § 12.2 and where supplemental measures, as recommended by the A merican Academy of Pediat rics, are taken to minimize the risk o f ophthalmia neonatorum. However, ho spital s an d he althc are pr ovid ers m ust make e very effor t to provi de eye pro phyla xis to new bor ns at ris k f or ex posur e t o N. gonorrhoeae, as t he conseq uenc es of not ad mini steri ng an eff ective prop hylacti c ag ent ca n be c atastr ophic. Sincerely, Marilyn A. Kacica, M.D., M.P.H. Stephanie Shulman, Dr.PH., M.S. Medical Director Director Division of Family Heath Division of Hospitals & Diagnostic & Treatment Centers References: 1. US Preventive Services Task Force. Screening for Chla mydia and Gonorrhea: US Preventive Services Task Force Recommendation Statement. 2021 Sept 14;326(10):949- 956 2. Sexually Transmitted Infections Treatment Guidelines, 2021. Cen ters for Disease Control and Prevention. Available at: www.cdc.gov/std/treatment- guidelines/gonorrhea-neonates.htm 3. Nolt D, O’Leary ST, Aucott SW; AAP Committee on Infectious Di seases, AAP Committee on Fetus and Newborn. Risks of Infectious Diseases in Newborns Exposed to Alternative Perinatal Practices. Pediatrics. 2022;149(2):e2021055554 4. American Academy of Pediatrics. Gonococ cal Infections. In: Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book: 2021 Report of the Committee on Infectious Diseases. 32nd ed. American Academy of Pediatrics; 2021:338- 34 4