Ethics involved in using anti-VEGFs for pediatric patients

April 1, 2016

Parents must be given a full understanding of the treatment risks and potential alternatives in pediatric ROP cases.

Reviewed by R.V. Paul Chan, MD

Chicago-Although new technologies and treatments are emerging for retinopathy of prematurity (ROP), there are certain ethical consideration for their use, said R.V. Paul Chan, MD, Illinois Eye and Ear Infirmary, University of Illinois at Chicago and member of the American Academy of Ophthalmology’s Ethics Committee.

“Adequate informed consent, adequate pre-treatment assessment, and appropriate postop care in the use of anti-VEGF treatments are required in order to comply with the Code of Ethics,” Dr. Chan said.

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When discussing treatment options for ROP, it is imperative not to discount the role of informed consent, he said.

“This is extremely important, especially for anti-vascular endothelial growth factor (VEGF) treatment,” he said. “Do the parents understand what you’re talking about? There’s a trend these days to think that injections may not need all the descriptives about the risks, benefits, and alternatives.” As it turns out, that is not the case-in fact, it is not enough to only have the parent sign a piece of paper.

Case example

“Signed documents do not mean you’ve given a good informed consent,” he said.

For example, he cited a hypothetical case with a pediatric ophthalmologist in a major metropolitan area who is responsible for teaching residents, fellows, and medical students, and who oversees ROP care throughout his metropolitan area. A baby with active ROP presents having failed conventional therapy with laser and has progressing disease.

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“We now have the option of injecting with anti-vascular endothelial growth factor (VEGF) treatment,” Dr. Chan said. In this case, the physician, Dr. A, plans to use intravitreal bevacizumab off-label to treat the patient’s progressing ROP.

“Dr. A tells the parents the only hope for their child is intravitreal injection and that the treatment can be considered standard of care because of all the studies that have been published on its use,” Dr. Chan said.

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Herein lies the dilemma, he said-the parents inherently trust the physician and will likely follow the advice.

A better approach

 

“This is not the best way to approach this scenario,” he said. “Just because something seems easy to do and you think it's going to work and you think it’s the best option, doesn’t mean that’s what you should always do without having a detailed discussion with the parents.”

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In the example, Dr. A did not explain in understandable terms the condition and the treatment, nor did he explain that the use of this anti-VEGF agent was off-label.

“Did Dr. A understand whether or not the parents understood what was happening? That’s a key consideration we cannot overlook,” he said.

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Using the same patient presentation, in a second scenario, Dr. A reviews risks, benefits, and alternatives; he explains that it is off-label and what that means; he explains that there are unknown potential adverse events if injection is used; he addresses all the parents’ concerns; and discusses this with the neonatology team.

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“It’s not always convenient to have a long discussion with families. It’s not going to take less time. It’s actually going to take a lot of time, and I have the conversation regarding treatment well before a child reaches treatment-requiring ROP, especially for children who I think are high risk,” Dr. Chan said. Physicians need to give parents ample time to understand what is happening, and with multiple treatment options, parents need the additional time to evaluate and comprehend the recommendations physicians provide.

Useful resources

 

Useful resources

For pediatric ophthalmologists and retina specialists who may be “nervous” about the process of ensuring a complete and thorough informed consent process, Dr. Chan recommends accessing the Ophthalmic Mutual Insurance Co. (OMIC) website, where there is a detailed informed consent document that covers many aspects of what should be included in the discussion about ROP treatments.

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“OMIC has good documentation for us,” he said.

Ultimately, “the informed consent process is just that-it’s a process. It’s open communication, and you have to ensure the parents understand,” Dr. Chan said.

“A written-only informed consent is advisable for risk management reasons,” he said. “But it must be coupled with discussion (or conversation) for it to be properly ethical. Another good resource for physicians is the AAO Code of Ethics. You can refer to Rule 2 of the code which deals with informed consent.” In the burgeoning era of anti-VEGF being used for ROP, Dr. Chan believes this written consent remains necessary.

“It’s not just a piece of paper that the parents sign, but again its about the conversation and the documentation in the chart that you had this discussion with the parents and they understood,” he said. “We’re asking them to make a decision on treatment within the next 24 to 72 hours, and it’s crucial they understand the risks involved. And finally, always make sure that for anti-VEGF treatment you explain that this is off-label use. Be truthful. Be forthcoming. Provide the families with all the information.”

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R.V. Paul Chan, MD

P: 312/413-1783

This article was adapted from Dr. Chan’s presentation at the 2015 meeting of the American Academy of Ophthalmology. Dr. Chan declared no financial interests in his comments.