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
Birth–24 months
Asymptomatic/Risk-Free
By 6 months of age or
as recommended
At Risk
By 6 months
2–5 years
At 3 years of age
At 3 years of age
or as recommended
6–17 years
Before first grade and every
2 years thereafter
Annually or as
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 obtain
a 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.