Risk Management



Warn Patients about Side Effects of Dilating Drops

Anne M. Menke, RN, PhD OMIC Risk Manager

Dilating drops are used on countless patients daily during diagnostic examinations and surgical procedures. They are essential in order to obtain an adequate view of the retina and fundus. Indeed, failure to perform a thorough examination of the eye could lead to significant patient harm such as delay in diagnosis or failure to diagnose, as well as surgical complications due to poor visibility. However necessary, drops have also precipitated lawsuits, as discussed in this issue’s Closed Claim Study. These claims are usually based upon the ophthalmologist’s failure to warn of the risks of ambulating and driving following the insertion of dilating drops. While the Closed Claim Study discussed fall prevention, this article will focus on driving issues.

Q  Do I need to obtain the patient’s informed consent before administering dilating drops?

A  Having been taught that informed consent is not required for simple procedures whose risks are commonly considered to be remote—drawing a blood sample or taking a chest x-ray are the usual examples—an ophthalmologist might conclude that dilating drops fall into this category. It is important to remember, however, that the legal doctrine of informed consent is based not upon what an ophthalmologist feels should be disclosed but rather upon what a “reasonable person” would want to know prior to undergoing a procedure or taking a new medication. A quick review of the ocular and systemic side effects might lead this hypothetical reasonable person to feel informed consent is needed. Dilating drops cause vision to be blurred for a period of 4 to 8 hours and induce photophobia, lack of accommodation, glare, and decreased contrast threshold and high-contrast visual acuity. For elderly patients whose vision and mobility are already compromised, these visual changes can be dangerous. Dilating drops can also provoke allergic reactions, angle closure attacks, and systemic reactions such as increased blood pressure, arrhythmias, tachycardia, dizziness, and increased sweating. A jury might reasonably conclude that informed consent should be obtained.

Q  What specifically do I need to tell the patient? Can I delegate this duty to my staff who administer the drops?

A  The patient needs to understand that the drops will cause blurry vision for 4 to 8 hours, and that he or she should wear sunglasses and avoid driving and operating machinery until the effects wear off. Staff may be assigned the task of warning patients and offering sunglasses.

Q  Do I need to have the patient sign a consent form?

A  Not necessarily. Document the offer of sunglasses (or reminder to wear them) and the warning about side effects, especially the possible impact on walking, driving, and operating machinery. It is helpful to advise new patients as they are making their appointment that their eyes will be dilated. The first time patients’ eyes are dilated, ask them to sign a form acknowledging that they have been apprised of the risks (see OMIC’s sample consent form at www.omic.com).

Q  Do my staff members need to warn the patient each time?

A  Yes. To remind them to do so and to expedite the documentation process, you may want to use a chart stamp (see sample following this article and under risk management recommendations for dilating drops at www.omic.com). Consider placing a sign in your waiting room reminding patients whose eyes are dilated not to drive, to wear sunglasses, and to let the staff know if they need assistance walking while their eyes are dilated.

Q  Some of my patients feel safe driving home, even right after their appointment. Others tell me that no one is available to drive them to the office for their regular retina appoint- ments. Should I refuse to dilate the eye if a patient insists on driving?

A  Not necessarily. Use your medical judgment, taking into consideration such factors as the patient’s pre-dilation visual acuity and driving ability, driving conditions, the reason for the patient’s visit, and how urgently you need to diagnose and/or treat the presenting condition. Involve the patient in the decision-making process and document the discussion. Patients who need to be dilated but will be driving themselves can be offered morning appointments and encouraged to stay in the waiting room until the effects of the drops have worn off. If in doubt, err on the side of patient safety. In general, lawsuits against physicians have been dismissed if the physician warned the patient and documented the warning.

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