Self-Imposed Use Cessation Dates for Eye Drops Can Lead to Significant Medication Waste, Increased Costs, and Drug Shortages

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Newswise — Self-Imposed Use Cessation Dates for Eye Drops Can Lead to Significant Medication Waste, Increased Costs, and Drug Shortages
Mount Sinai study suggests adhering to FDA-regulated expiration dates could prevent this

Journal: Ophthalmology - published July 1, 2024
Ophthalmic drop waste due to self-imposed use cessation dates - Ophthalmology (aaojournal.org)

Title: “Ophthalmic drop waste due to self-imposed use cessation dates”

Author: Gareth Lema, MD, Associate Professor of Ophthalmology at the Icahn School of Medicine at Mount Sinai

Bottom line: Academic medical centers and health care systems throw away multi-use eye drop bottles well before the Food and Drug Administration (FDA)-regulated expiration dates printed on the bottle. A Mount Sinai study showed that these so-called self-imposed use cessation dates (SUCD) lead to significant medication waste, plastic waste, and increased costs for hospital systems. The researchers believe that following the FDA-regulated expiration dates could save hospitals millions of dollars a year nationally, and potentially prevent nationwide eye drop shortages such as a recent shortage of dilating eye drops.

Why this study is important: SUCDs are arbitrary "expiration dates" which are earlier than the FDA-regulated expiration date printed on the bottle. They often fall within a month after the bottle is initially used. SUCDs are arbitrarily assigned by health systems, seemingly to reduce the risk of contamination and infection. However, SUCDs are not based on evidence and they do not prevent contamination, since infections from FDA-regulated dropper bottles used in clinical settings have not been reported. Proper training of medical and technical staff in the eye clinic has been shown to significantly lower rates of contamination of dropper bottles. 

FDA-regulated expiration dates are based on extensive testing of the drop in the marketed container with appropriate preservatives. Thus, the FDA expects the strength, quality, and purity of these medications will be maintained up until the labeled expiration date, assuming proper handling and storage. The source of SUCDs is unclear and they can be highly inconsistent. Two of the authors polled their colleagues and found SUCDs ranging from one day to four months.

Why the study is unique: This the first study to report and quantify the waste of ophthalmic eye drops in a non-surgical clinic setting due to SUCDs.

How the study was conducted: Researchers analyzed 297 discarded ophthalmic eye drops from three ambulatory sites within the Mount Sinai Health System in New York City over a six week period. These multi-use eye drops were labeled with a SUCD of 14 or 28 days from the open date, and collected by the researchers at the end of the SUCD period. Researchers measured the volume that remained in each bottle and estimated the number of drops that each represented. They could then measure the amount of waste in the bottle during the study period and calculate annual values. 

Study results: On average, 72 percent of the medication remained in the bottles at the time the drops were discarded when using SUCDs. If FDA expiration dates had been adhered to, 91 percent of the discarded bottles could have been fully depleted by the expiration date. Across three ophthalmology clinics within the Mount Sinai Health System, 297 bottles were discarded over a six-week period. Researchers calculated that this would amount to 2,581 discarded bottles annually for the three clinics, with a total plastic mass of 17.7 kilograms, or 39 pounds). Using FDA dates, they calculated that the number of discarded bottles could be reduced by 72 percent (731 bottles). Reducing this waste could lead to a 73 percent reduction for annual hospital costs for eye drops (the study shows this would reduce costs by more than $80,000 for the three hospitals studied) if FDA dates were used as the discard date rather than SUCDs.

What this means for clinicians/hospitals: Ophthalmic medications used in eye clinics are costly and prone to drug shortages. Using FDA expiration dates can improve efficiency, make drug shortages less likely, and therefore improve patient care. 

Quotes:

"We had a rough idea that there would be tens of thousands of dollars' worth of drops discarded each year, but I could not predict just how much was being wasted. I was surprised that almost three-fourths of the medication was being wasted," says corresponding author Gareth Lema, MD, PhD. "We are currently working with the Health System to consider using FDA-regulated expiration ddates as the discard dates for our drops and have also instituted measures to reduce the number of bottles that are opened and ultimately wasted. Our team plans to do a follow-up study this summer to determine if these measures have reduced drop waste."

“Given all the challenges with resource allocation, increased costs, and supply chain issues in the current healthcare environment, this important study helps guide our understanding of potential areas of waste that can be addressed in the eye care field,” says James C. Tsai, President of New York Eye and Ear Infirmary of Mount Sinai.

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