April 15, 2024
Andrew Neukirch, OD
The relationships my team and I cultivate with parents is built on trust. It’s my responsibility to protect their child’s eye health. Indications and all that’s behind them matters — a lot.
Photo Credit: iStock, Getty Images
In today’s practice environment, we have many treatment choices at our disposal, whether they be on-label or off-label. But let’s pause here for a moment because there is more to these distinctions than we might be considering. Everything approved by the Food and Drug Administration (FDA) in the U.S. market has a specified indication for use, making it on-label for a particular purpose. The FDA specifically labels this indication, categorizing something as “on-label” after a rigorous process to ensure safety and efficacy. A physician’s clinical decision to use a medical device or drug off-label for its original indication should be evidence-based and well-thought-out for the best interest of the patient. This is why the International Myopia Institute Industry Guidelines and Ethical Considerations for Myopia Control1 advises using an on-label treatment to slow the progression of myopia as the first choice.
Let’s remember why the FDA exists. It is “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.” Just like providers, the FDA needs to “help the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”2 This reads just like a part of the optometric oath.
Recently, devices in the myopia management space have been considered on-label for their parameter range, and providers and parents may be confusing this with on-label for slowing the progression of myopia — when it really isn’t. Most orthokeratology designs are on-label for the temporary reduction of myopia (NUU) and extended wear of a gas-permeable contact lens (MWL).
And then there’s compounded low-dose atropine. Technically, using 1% atropine with the intent to slow myopia progression would be off-label from its original indication for cycloplegia, mydriasis, and penalization of the healthy eye in the treatment of amblyopia. Once you’re in the compounding space, experts agree that this would be what’s called “no-label.”
There are certainly situations where off-label myopia management treatments may be appropriate, i.e., specific circumstances when a patient’s unique condition requires tailored intervention. I may opt for off-label treatments when evidence suggests potential efficacy and safety, and when benefits outweigh potential risks. These decisions are made following a thorough assessment and where an on-label option is simply not available for the patient. Off-label treatments should adhere to ethical guidelines, with practitioners regularly monitoring patient progress and adjusting treatment plans as necessary.
Considering all of the above, my informed consent document, which I use when initiating myopia management, has become longer to accurately describe the definitions and indications for on-label and off-label for slowing the progression of myopia. To make sure we’re providing parents and caregivers the facts, it’s our responsibility to understand the differences ourselves.
As a parent of two young daughters and even as a patient myself, I need to know the correct information. I’m certain that most of us could benefit from dusting off our informed consent documents to make sure we’re accurate and not misleading.
The reality is, we can’t go back in time to course-correct, especially when young children with myopia worsen at such a rapid rate. I sleep better at night knowing my patients are treated with the only on-label treatment indicated by the FDA to slow the progression of myopia (QIT). It also takes me much longer to explain the nuances of off-label for the slowing of myopia progression than to lead with my first, on-label choice.
The relationships my team and I cultivate with parents is built on trust. It’s my responsibility to protect their child’s eye health. Indications and all that’s behind them matters — a lot.
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Andrew Neukirch, OD, received his Doctorate of Optometry from Indiana University in 2008. In 2014, he was a recipient of the Vision Monday Optometric Business Innovator Award and was the recipient of the 2017 Illinois Optometric Association Young Optometrist of the Year award. He frequently travels and lectures on the topics of contact lenses and practice management, has been published in a number of optometric journals, and is presently involved in multiple myopia management clinical trials. He is the leading provider for myopia management treatment in the North Shore of Chicago and is the leading prescribing MiSight optometrist in the United States.
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References
1 Jones L, Drobe B, González-Méijome JM, Gray L, Kratzer T, Newman S, Nichols JJ, Ohlendorf A, Ramdass S, Santodomingo-Rubido J, Schmid KL, Tan D, Tan KO, Vera-Diaz FA, Wong YL, Gifford KL, Resnikoff S. IMI – Industry Guidelines and Ethical Considerations for Myopia Control Report. Invest Ophthalmol Vis Sci. 2019 Feb 28;60(3):M161-M183. doi: 10.1167/iovs.18-25963. PMID: 30817831.
2 https://www.fda.gov/about-fda/what-we-do
