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ASCRS issues alert about preservative-free epinephrine shortage
There is an impending shortage of preservative-free epinephrine for ophthalmologists due to a formulation alteration from a common provider, according to an alert issued by the American Society of Cataract and Refractive Surgery.
The new formulation, from PAR Pharmaceutical, contains 0.457 mg of sodium metabisulfite and 2.25 mg of tartaric acid per mL and is not for intraocular use.
“Currently, there is no published data or experience with intracameral administration of solutions containing tartaric acid. ASCRS has become aware of several reports of [toxic anterior segment syndrome] that appear to have resulted from inadvertent use of the PAR product. The updated PAR product is not for intraocular use, and the indication of induction and maintenance of mydriasis during intraocular surgery has been removed from the prescribing information,” the ASCRS Cataract Clinical Committee said in the alert.
While PAR has sent out updated prescribing information to providers and its 30 mL bottles are labeled “Not for Ophthalmic Use,” its smaller 1 mL single-use vials do not contain the warning, the alert said.
“We advise surgeons to check with their centers to ensure that the PAR Pharmaceutical epinephrine is not being ordered for intracameral use,” the ASCRS wrote.
This has led some to seek out other sources of epinephrine or alternatives for maintaining mydriasis, especially for patients with intraoperative floppy iris syndrome. According to the ASCRS, many of these products contain bisulfite 0.1%, and corneal endothelial damage has been seen after exposure to bisulfite 0.1%.
“We currently recommend not using epinephrine with tartaric acid (even in dilution) until more studies and information becomes available,” the committee said.
Reference: http://www.ascrs.org/about-ascrs/news-about
Perspective
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Uncertainty and inconsistency in the supply of epinephrine for intraocular infusion in cataract surgery create a significant risk of toxic anterior segment syndrome for ophthalmic surgeons. Avoiding the risk of TASS by not using epinephrine raises risks of pupillary constriction, particularly in cases of intraoperative floppy iris syndrome or pseudoexfoliation or other cases in which pupillary dilation is difficult or unstable. Because of this uncertainty, I began routinely using commercially available phenylephrine/ketorolac (Omidria, Omeros) about 2 years ago for all my cataract cases. Clinical studies and our own experience have shown Omidria prevents pupillary constriction in cataract surgery better than epinephrine, and it reduces by half the use of mechanical pupil-expanding devices (iris rings and retractors) among surgeons who use it. Moreover, the product is FDA approved specifically for this application, is preservative free and is produced using good manufacturing practices, virtually eliminating the TASS risk. Finally, Omidria is reimbursed by Medicare and most private carriers as a pass-through surgery center expense, so it is “free” to both the doctor and the patient. All surgeons in our center now use Omidria and have no plans to switch back to the risks of epinephrine.