Ophthalmic Drugs

The most likely cause of large claims for damages against optometrists is failure to use a diagnostic agent. The most frequent source of drug-related claims, however, is a “slip and fall" injury due to mydriasis (pupillary dilation). Angle closure is a rare cause of claims.

Therapeutic drugs are not a significant cause of liability claims for optometrists.

There is an established standard of care for ophthalmic drug use by optometrists. A practitioner is expected to:

1. Understand the properties of any drugs administered or applied, including dangerous side effects;

2. Choose a drug that is suitable under the circumstances and is the proper pharmaceutical agent for the patient's condition;

3. Make a reasonable effort to determine if an allergic reaction will occur by making all necessary inquiries of the patient to learn if there is any evidence that would indicate the possibility of a reaction;

4. Warn the patient of likely side effects that may result from the patient's use of the drug, in compliance with the requirements of the doctrine of informed consent;

5. Monitor the patient adequately while the patient is taking a drug or is under its effects and manage any adverse side effects suffered by the patient as a result of the drug (or refer the patient as appropriate).

Medication prescribed by a physician (chloroquine) had serious and permanent effects on the patient's vision (maculopathy that over time assumed a “bull’s eye” appearance). The medical literature abounded with reports of the side effects of the medication, but the physician had not read any of the articles. The court found that he was negligent in failing to keep up with new developments in the field.

Failure to employ pupillary dilation on a first-presenting patient or when required by signs or symptoms of disease is the leading liability issue involving ophthalmic drug use (causing misdiagnosis of glaucoma, retinal detachments, tumors).

The AOA’s Clinical Practice Guidelines have established the frequency of adult and pediatric eye exams:

Patient Age Asymptomatic/Risk-Free At RiskBirth–24 months By 6 months of age or By 6 months

as recommended

2–5 years At 3 years of age At 3 years of age or as recommended

6–17 years Before first grade and every Annually or as 2 years thereafter recommended

18–40 years Every 2–3 years Every 1–2 years or as recommended

41–60 years Every 2 years Every 1–2 years or as recommended

61 years and older Annually Annually or as recommended

Diagnostic drugs have significant side effects that can result in injury. The most common are:

• Anesthetics: opacification of the cornea when used copiously on a compromised epithelium

• Mydriatics: blurred vision and photophobia, angle closure glaucoma

• Cycloplegics: atropine toxicity, angle closure, blurred vision and photophobia

A boy was struck in the eye by the edge of a hat and suffered a corneal abrasion. He was examined by a physician and placed in a hospital overnight for observation. The doctor prescribed a topical anesthetic (proparacaine) for the patient's ocular discomfort and permitted the nursing staff to leave the medication at the patient's bedside for further use as needed. A permanent corneal opacity resulted from the improper use of the anesthetic. The case was settled in the boy’s favor.

The most likely cause of a legal claim following pupillary dilation is a "slip and fall"; premises need to be inspected periodically to ensure that they are safe. Elderly patients or patients with infirmities may require assistance.

Because of the photophobia caused by mydriasis, disposable sunglasses should be provided, and patients must be warned to use caution while walking, driving, or working after use of a mydriatic.

Documentation of the warning is essential.

Dilation warning______________

A 77-year-old woman was to be examined by an ophthalmologist. To facilitate the examination, dilating drops were placed in her eyes. She was left in a waiting room by herself, without supervision, and due to the blurred condition of her vision tripped over a chair leg and broke her hip. She sued the doctor for her injuries, alleging that he had a duty to provide safe premises. The jury, finding that the woman had not contributed to her injuries by any negligent conduct on her own behalf, awarded her damages, determining that the ophthalmologist and his staff had breached the affirmative duty to make the office premises reasonably safe.

The most feared adverse effect of pupillary dilation is an angle closure. Assessment of the anterior chamber angle is necessary to determine if it is narrow enough to pose a risk of closure during dilation (1 in 45,000 for persons over 35). If an angle is at risk for closure, informed consent should be obtained before dilation may be attempted; referral for laser peripheral iridotomy is preferable to attempting dilation.

Patients who telephone to report symptoms suggestive of angle closure should be examined to ensure that an angle closure has not in fact occurred.

Never make a diagnosis based on a telephone conversation.

The adverse effects of therapeutic drugs, particularly steroids and glaucoma drugs, are a potential source of claims for optometrists.

Most claims are based on the adverse effects of drugs used for medical management. Failure to warn of adverse side effects and failure to monitor patients for these effects are the most common sources of claims. However, an improper medical regimen chosen for treatment can be the cause of antibiotic-related claims.

Contact lens-related corneal ulcers occur in about 70,000 patients a year; abrasions that have not been appropriately managed and become ulcers have been the most important cause of liability claims involving antibiotics.

In these cases injury is typically caused by failure to timely diagnose ulcerative keratitis or use of an improper antibiotic regimen rather than by an adverse drug side effect.

When bacterial keratitis occurs, whether culturing of the cornea is necessary depends on the location of the infection:• The AOA Clinical Practice Guidelines

describe the need to obtaina corneal culture

• Peripheral, small areas may be treated without culturing

• For central, large, deep areas of keratitis, culturing is necessary

Example Case: Corneal Culture• A contact lens patient with a central

corneal abrasion is examined by an optometrist, who prescribes a broad spectrum antibiotic

• After 3 days of the regimen the patient’s acuity is worse and there is central corneal “hazing”

• The patient consults a physician, cultures are taken, and a different antibiotic regimen is prescribed

• Despite treatment, the patient suffers loss of central acuity from scarring

Watch how the lawyer uses the American Academy of Ophthalmology’s Preferred Practice Patterns (the equivalent to the AOA’s Clinical Practice Guidelines) to get the optometrist to admit that the medical standard of care was not followed because a culture was not taken.

CLAP Traps• Treatment should follow established

guidelines• But Clinical Practice Guidelines (or

Preferred Practice Patterns) do not, by themselves, establish the standard of care

• Only if a witness agrees that a book, article, or guideline is authoritative, can the witness be questioned on that authority

• Standards of care for medical treatment in a malpractice case are likely to established by ophthalmologists

The most common causes of glaucoma drug liability claims are:

• beta blockers: pulmonary or cardiac crisis

• miotics: retinal detachment in myopic patients

• carbonic anhydrase inhibitors: kidney stones, aplastic anemia

Patients must be scheduled appropriately for follow-up exams so that any adverse effects of drug use can be discovered and appropriate management undertaken.

A patient with bilateral glaucoma was treated with the usual topical medications and with an oral carbonic anhydrase inhibitor, acetazolamide (Diamox®). Her intraocular pressures were well controlled but after a decade of therapy the patient developed kidney stones—a well-known side effect of this drug—that had to be removed surgically. Following the operation her IOPs were adequately controlled with topical medications only. A lawsuit was initiated, with the key question being "Was the oral medication with its risk of systemic side effects necessary?" The patient received damages.

The adverse effects of steroid use are potentially a significant liability issue for optometrists. The most likely cause of a claim is topical use, but systemic steroids also are an important source of liability claims.

For topical steroids, the most likely adverse effects to result in litigation are:

• elevated IOPs (in "drug responders“, about 40% of patients, with 5% responding in excess of 15 mmHg)

• drug-related cataract (posterior subcapsular)

A contributing factor in liability claims is the prescription refill information. To prevent inappropriate refills of prescriptions, it is necessary to specify the number of permissible refills on the prescription, and to state that the number of refills cannot be altered without the permission of the prescriber.

A hairdresser who was allergic to dyes consulted an ophthalmologist, who prescribed topical steroids that successfully alleviated her symptoms. She was able to obtain prescription refills that allowed her to use the drops continuously for 2 years, until problems with her acuity caused her to return for another evaluation. She was found to have bilateral cataracts and glaucoma from use of the steroid. She sued the ophthalmologist for negligence and for breach of the doctrine of informed consent. The ophthalmologist defended the claim by asserting that neither he nor his nurse had authorized the drug refills, but the pharmacist who had filled the prescriptions maintained that appropriate authorizations had been obtained. Damages were awarded to the hairdresser.

For systemic steroids, the most likely cause of a claim will be an adverse effect caused by systemic administration of the drug.

As a general rule, it is necessary to first establish that a topical route of administration will not be efficacious before attempting to use a systemic drug.

An obese 35-year-old man with a history of questionable diabetes was found to have a moderate uveitis in one eye. He was placed on systemic steroids (prednisolone), and after three days the uveitis was improved, and so the steroids were continued. Seven days later the uveitis was cured, but the patient complained of increased thirst and urination and the steroids were tapered off. Within three days the patient developed severe polydipsia and polyuria and became comatose. He was hospitalized, but in spite of all efforts, he died. Suit was instituted for wrongful death, with one allegation being that topical rather than systemic steroids should have been prescribed. Damages were awarded against the physician.

Documentation of drug use is essential. Optometrists should maintain a timely and accurate record of:

1. History of drugs prescribed for and used by the patient, with drugs taken for prolonged periods of time carefully noted;

2. Current drugs being taken by the patient;3. History of allergies to drugs;4. Previous adverse reactions to drugs, especially ophthalmic

drugs;5. Any drugs used during the examination of the patient or any

drugs prescribed for patient use; the record should reflect:6. Signs or symptoms of an adverse reaction to any drug

administered or prescribed; adverse reactions should be conspicuously noted in the record;

7. Required warnings to the patient as to the possible side effects of drug use and of action to take in the event of an adverse reaction;

8. Management of the patient in the event there is an adverse reaction.