Ординатура / Офтальмология / Английские материалы / Clinical Ocular Pharmacology 5th edition_Bartlett, Jaanus_2008

66 CHAPTER 5 Legal Aspects of Drug Utilization

Two rival standards have been applied to determine whether practitioners satisfy disclosure requirements: a “professional community” standard and a “reasonable patient” standard.

“Professional Community” Standard

The first court decisions applied the same legal test to informed consent cases that was applied to negligence cases: The practitioner was held to the standard of the reasonable person. Liability was imposed if the practitioner was found to have breached the duty to act as a reasonable practitioner would have acted under the same or similar circumstances. In determining the standard of care expected of the practitioner, the courts allowed other practitioners to testify concerning the warnings or disclosures that were necessary. Hence, the standard was a profession-set one, based on expert testimony and determined by the conduct of other practitioners. If the defendant practitioner provided that amount of information deemed to be reasonable by other practitioners, then a breach of duty did not occur.

A sample case may be used to illustrate the application of the “professional community” rule. A patient with a corneal foreign body was examined by an ophthalmologist, who removed the metallic foreign body and attempted to debride the rust ring that had formed around it. The procedure resulted in permanent corneal scarring. The patient sued the ophthalmologist, alleging that the risk of scarring had not been described and that the attempt to remove the rust ring had been undertaken without the patient’s consent. In determining that the ophthalmologist was not liable, the court held that the scope of the physician’s disclosure should be measured by the disclosures that would be made by an ophthalmologist in the community acting under the same or similar circumstances.The defendant was found to have met this requirement.

The “professional community” rule was adopted in a number of states (Box 5-2). However, it was soon challenged by another rule, which is found today in a majority of jurisdictions.

“Reasonable Patient” Standard

The“reasonable patient”standard is based on what a reasonable patient must know rather than on what a reasonable practitioner must divulge. Evidence is offered to establish what a prudent person in the patient’s position would have done if adequately informed of all significant risks. Patients no longer must obtain expert testimony, because the issue concerns what they need to know rather than what practitioners are reasonably expected to divulge.

The standard may be illustrated by a sample case. A patient with an eye laceration was treated by an ophthalmologist,who repaired the laceration but did not attempt to remove a metallic corneal foreign body. By the next day an infection developed, and the patient was referred by the ophthalmologist to another physician. Although treatment

Box 5-2 Jurisdictions Applying the “Professional

Community” Standard

Adapted from Ketchup v. Howard, 247 Ga. App. 54, 543 S.E.2d 371, 2000.

was instituted and the foreign body removed, the infection ultimately resulted in enucleation. The patient sued the ophthalmologist, arguing that the doctrine of informed consent required the ophthalmologist to inform the patient of the risk of delay in removing the foreign body. The court held that the ophthalmologist had a duty to disclose the risks or hazards that a reasonable person would need to know to make an informed decision concerning a medical or surgical procedure. Failure to make this disclosure, if it would have caused the patient to proceed differently, constituted a breach of the doctrine of informed consent.

The “reasonable patient” standard has become the subject of much discussion in the medical profession, although studies of professional liability cases have shown that physicians are rarely subjected to informed consent claims. Jurisdictions that have adopted this objective standard are listed in Box 5-3.

Box 5-3 Jurisdictions Applying the “Reasonable

Patient” Standard

Adapted from Ketchup v. Howard, 247 Ga. App. 54, 543 S.E.2d 371, 2000.

Duty to Disclose Risks of

Proposed Treatment

Practitioners may incur a duty to warn patients of the risks of ophthalmic drug use, both for drugs used diagnostically and for those used therapeutically. Of the two classes, the greater obligation arises when therapeutic agents are used. Patients may also need to be warned of the potential risks of refusing to allow a drug to be administered.

Diagnostic Agents

The common diagnostic drugs used by optometrists are anesthetics, mydriatics, cycloplegics, and dyes. Routine use of these drugs creates a risk of injury only in very unusual circumstances. Therefore informed consent is rarely a legal issue when they are used.

The use of topical anesthetics creates a small risk that patients will experience a toxic response resulting in the disruption or desquamation of the corneal epithelium. Because this is an idiosyncratic response and cannot be predicted, it does not create the kind of risk for which informed consent is necessary. Even if a toxic reaction does occur, the effect is transient and limited. Thus, informed consent should not prevent prudent practitioners from administering these drugs when clinically appropriate.

Dilation of the pupil is a diagnostic procedure with potentially serious side effects (i.e., angle-closure or pupillary-block glaucoma), but the risk of injury must be communicated only to patients for whom it is significant. Studies have determined that only 2% to 6% of the general population have angles anatomically narrow enough to close and that for the patient population most at risk— those older than 30 years—the chance of precipitating an angle-closure glaucoma is 1 in 45,000. These statistics indicate that for the great majority of patients the risk is minimal or nonexistent. Thus, when performing routine dilation, clinicians have no duty to discuss the potential complications of mydriasis.

For that small percentage of the population with anterior chamber angles narrow enough to be closed by pupillary dilation, however, the decision to dilate should be made jointly with patients after they have been informed of the benefits of dilation and of the risks and implications of angle closure. The determination of whether to use dilation should be made in light of the need for it (e.g., if ophthalmoscopy of the retinal periphery is deemed necessary) and after the risk of angle closure has been reasonably determined (e.g., through the use of gonioscopy). Patients’ decisions should be documented and retained in the record. Figure 5-1 shows a form suited for this purpose.

Cycloplegia is reserved for a limited number of conditions (e.g., suspected latent hyperopia, accommodative esotropia, amblyopia treatment). Hyperopic patients may have shallow anterior chamber angles that require

assessment before instillation of the cycloplegic. Because cycloplegia is most often needed for young patients, careful attention must be given to the concentration and dosage of the agent used, so that the risk of toxic effects can be minimized. Assuming that the angle is open and that the appropriate drug is selected for use, the risk of angle closure is no different from patients undergoing routine mydriasis. Consequently, clinicians do not have to obtain informed consent. If risk factors are present and clinical complications are a consideration, practitioners should discuss these factors with patients (or, for children, with parents or guardians) and obtain the necessary consent to administer the drug. The administration of atropine to infants to undertake a cycloplegic examination may also necessitate communication. Atropine can also be utilized for the diagnosis of patients 4 years of age or younger who are suspected of having accommodative esotropia, but it should be used conservatively in terms of concentration and dosage. In addition, atropine may be applied on a long-term basis to children undergoing treatment for amblyopia.# The signs and symptoms of atropine toxicity should be explained to parents in these cases to minimize the risk of an overlooked toxic drug reaction during drug therapy.

Dyes are used for diagnostic purposes; the most important is sodium fluorescein, which is used for the detection of retinal disease (e.g., diabetic retinopathy). Because of the risk of allergic response to the administration of dye (whether by injection or orally), patients must be advised of this potential adverse effect before consenting to the procedure. Forms are often used to document communication of risk and patients’ agreement to testing (Figure 5-2).

The preceding circumstances are not the only ones in which risks may have to be communicated to patients. Occasionally, patients refuse to allow a drug to be administered for diagnostic purposes. The usual circumstances involve mydriatics for dilation and topical anesthetics for tonometry. Patients have the right to refuse any test, and clinicians cannot obtain a lawful consent by coercion. Clinicians, however, are obliged to ensure that patients understand the potential ramifications of refusal. For example, elderly patients with visual field loss and optic disc cupping should be warned of the need for tonometry, and patients with reduced visual acuity who complain of floaters and flashes have an obvious need for funduscopy through a dilated pupil. Practitioners must weigh the need for the test in light of the clinical situation and must advise patients accordingly. Refusals should always be documented in the

#A study investigating the use of atropine for treatment of amblyopia indicated it was as successful as patching therapy. Subjects were less than 7 years old and tolerated 1% atropine daily for 2 years without adverse effects. See Pediatric Eye Disease Investigator Group.A randomized trial of atropine vs patching for treatment of moderate amblyopia in children. Arch Ophthalmol 2002;120:268–278.

patient record (Figure 5-3). Some practitioners use forms that are signed by patients and retained in the patient record, and these forms are a satisfactory means of documenting patients’ decisions. If patients refuse to undergo a procedure, the potential adverse consequences of that decision also must be explained (e.g., the symptoms of retinal detachment for patients reporting the acute onset of flashes and floaters).

Therapeutic Agents

The duty to inform patients of the potential toxic effects of drug therapy is greatest when therapeutic agents

are prescribed. The reason for this is due, in part, to clinicians’ lack of control over drug administration.Whereas the use of drugs for diagnostic purposes is carefully controlled by practitioners and is usually an in-office procedure, the prescribing of therapeutic agents results in extended drug use that is entirely within patients’ control. Abuse of therapeutic agents has been documented in the ophthalmologic patient population,and optometrists should be aware of this potential problem, especially when prescribing therapeutic agents such as steroids and antiglaucoma medications.

Patients should be warned of the adverse effects of extended use of therapeutic agents and should be required

to consult the prescribing clinician if additional prescription renewals are needed. As with diagnostic agents, the need to communicate with patients depends on the clinician’s assessment of risk. If a drug is used for only a brief time, the risk is far less than if an extended period of treatment is anticipated. Likewise, greater dosages create larger risks and greater necessity for disclosure. Optometrists must be familiar with the allergic and toxic effects of the therapeutic drugs they prescribe and should inform patients of potential risks under the appropriate circumstances (e.g., long-term use of topical steroids).

Of the commonly used therapeutic drugs, the greatest risks are encountered when clinicians prescribe topical steroids (for extended periods), systemic steroids, β-blockers, miotic antiglaucoma agents, and oral carbonic anhydrase inhibitors (CAIs). Optometrists should be aware of the adverse effects that attend the use of these drugs and should warn patients accordingly. Disclosures should be documented in the patient record.

Figure 5-3 Example of handwritten record entry to document informed consent when a patient refuses pupillary dilation. (DFE = dilated fundus examination; PVD = posterior vitreous detachment; RTC = return to clinic.)

Alternatives to Drug Therapy

The doctrine of informed consent may also be applied to situations in which optometrists fail to disclose alternatives to drug therapy. Disclosure requirements obligate clinicians not only to warn of the risks of treatment but also to describe alternatives to therapy. This duty may arise in various ways when drug use is contemplated. For example, if atropine therapy is recommended for the treatment of amblyopia in a young child, alternative treat- ment—such as patching—should be discussed as well. Another example involves patients suspected of having glaucoma. Patients with elevated intraocular pressure (IOP) and no optic disc damage or visual field loss should be apprised of the clinical alternatives: receive medical therapy or be monitored by the optometrist until disc damage or measurable field loss occurs. In these and analogous situations, clinicians should avoid dictating the mode of treatment and should ensure that the course of therapy is obtained with patient consent.

In clinical situations for which alternative treatments exist, optometrists should note in the patient record that the alternatives were discussed and that the treatment chosen was obtained with the patient’s consent.

Disclosure of Abnormalities

Not infrequently, diagnostic drug use discloses an ambiguous or suspicious finding. Clinicians must explain these findings so that patients can determine whether they wish to undergo further testing or treatment. A sample case illustrates how informed consent can be applied to such a situation.

A 58-year-old woman complaining of poor focus and gaps in her vision was examined by an ophthalmologist. These complaints were attributed to her contact lenses; however, during the course of the examination Schiøtz tonometry was performed, and readings of 23.8 mm Hg were obtained in each eye. Despite this result no dilated fundus examination or visual field assessment was

70 CHAPTER 5 Legal Aspects of Drug Utilization

performed, and the potential significance of the IOP findings was not discussed with the patient. During the next 2 years the patient was seen a dozen times, but it was not until the end of this period that she was diagnosed as having open-angle glaucoma. Despite medical and surgical therapy, her visual acuity decreased to 20/200 and she suffered profound visual field loss. She sued the ophthalmologist, alleging that he was negligent for failing to diagnose the disease and to warn of the elevated IOPs. Although a judgment in favor of the physician was rendered after trial, the woman filed an appeal.The state supreme court reversed the trial court’s decision, ruling that under the doctrine of informed consent the ophthalmologist was obligated to inform the woman of any abnormal findings and to advise her of any diagnostic procedures that could be undertaken to determine the significance of the findings.

Optometrists have a similar duty to discuss the results of diagnostic tests with patients and to advise patients of the availability of further testing to rule out the presence of disease. Ambiguous or suspicious findings should be resolved, and if patients do not return for recall appointments or do not wish to undergo further evaluation, these facts should be documented in the patient record.

Documentation of Warnings

Communications with patients required by the doctrine of informed consent should be documented in the patient record. Either a handwritten entry or a form signed by the patient is adequate for legal purposes. Failure to record communications or inadequate entries concerning such communications may result in a successful legal claim against the practitioner.

In a case involving a military optometrist, a middleaged military retiree complained of the acute onset of “black spots” in one eye. The optometrist found that the patient’s best-corrected acuity was 20/30 in the right eye and 20/40 in the left eye, which was due to cataracts. The optometrist performed a dilated fundus examination with a binocular indirect ophthalmoscope and diagnosed the patient’s condition as posterior vitreous detachment. The patient returned home, but 4 weeks later while climbing a ladder he experienced a bright flash of light in the affected eye. The man called the eye clinic and obtained an appointment for 6 days later. At that examination, his visual acuity was 20/200 because of a large retinal detachment that involved the macula. Despite surgery, vision in the eye remained greatly reduced. He sued the optometrist, alleging that the practitioner was negligent in failing to detect the retinal detachment and that he had breached the doctrine of informed consent by failing to warn the patient of the symptoms of retinal detachment.

At the trial the surgeon who repaired the eye testified that the retinal detachment could not have been present

at the time of the optometrist’s examination, which thereby exonerated the optometrist of the negligence claim. The key evidence concerning the informed consent claim came from the optometrist’s record. Although the optometrist testified that he had warned the patient of the symptoms of detachment, his record stated the following:“PVD. Reassure. RTC PRN.” The court found this terse entry to be inadequate to support the optometrist’s contention that a warning had been given and awarded a judgment in favor of the patient.

NEGLIGENCE

Although the doctrine of informed consent is an important legal consideration when ophthalmic drugs are used, the most likely source of a professional liability claim against an optometrist is negligence. As various reports have demonstrated, large liability claims against optometrists typically allege misdiagnosis. In most instances the misdiagnosis is due to failure to use the appropriate pharmaceutical agent, usually for anesthesia or pupillary dilation, rather than toxic or allergic drug reactions. Consequently, it may be argued that the likelihood of a negligence claim is highest when optometrists fail to use an ophthalmic drug that, when used appropriately, would permit a proper diagnosis. Claims most commonly allege failure to diagnose open-angle glaucoma, tumors affecting the visual system, or retinal detachment.

Misdiagnosis is also an important aspect of claims involving the use of therapeutic ophthalmic agents. Although the toxic effects of these drugs have been a common cause of liability claims against ophthalmologists, failure to make the correct diagnosis, followed by institution of an inappropriate therapeutic regimen, has become the major concern of optometrists. Because of the restricted nature of most optometry practice acts, which usually limit therapy to the anterior segment of the eye, claims against optometrists most frequently allege mismanagement of corneal problems.

Although negligence represents the most important legal complication of clinical practice, the exposure of optometrists to malpractice claims remains at a relatively low level, far below that of physicians. Within optometry there is no difference between diagnostic and therapeutic drug use with regard to the risk of malpractice, because professional liability insurance premium costs do not vary on this basis.** However, as optometry laws continue to be amended to enable optometrists to serve as primary providers of eye care, this increased clinical responsibility inevitably will result in increased litigation.

**The nation’s largest carrier of malpractice coverage for optometrists has monitored drug-related claims over the past two decades and has reported no significant liability risk associated with therapeutic drug use by optometrists. For a discussion, see Classé JG. Liability for the treatment of anterior segment eye disease. Optom Clin 1991;1:1–16.

Because the use of pharmaceutical agents is an integral part of these responsibilities, optometrists must be familiar with the concept of negligence and must understand how negligence may arise in clinical practice.

Proof of Negligence

The law holds every individual to a reasonable standard of conduct, and failure to exercise reasonable care creates liability if it results in harm to others. Accordingly, negligence may be defined as “the omission to do something which a reasonable person, guided by those ordinary considerations which ordinarily regulate human affairs, would do, or the doing of something which a reasonable and prudent person would not do.”

Optometrists have an obligation to adhere to a reasonable standard of care when rendering services to patients. This standard may be summarized by the question,

“What would a reasonable optometrist do under the same or similar circumstances?” From this question it is apparent that the defendant optometrist’s conduct is to be compared with the conduct expected of a hypothetical “reasonable optometrist.” If the defendant optometrist’s conduct fails to measure up to the conduct expected of this reasonable practitioner, a breach of the standard of care occurs. Proof of negligence, however, entails more than a demonstration that the defendant optometrist has violated the standard of care.There are, in fact, four elements to this tort,†† and to state a cause of action in a court of law the plaintiff-patient must offer evidence in support of each. These four elements are as follows:

1.A duty on the part of the practitioner to adhere to a reasonable standard of care, which is intended to minimize the risk of injury to the patient.

2.Breach of this standard of care by the practitioner.

3.Actual physical injury suffered by the patient.

4.A proximate relationship between the patient’s injury and the practitioner’s actions (or failure to act).

Duty

The duty to adhere to a reasonable standard of care is established by the doctor–patient relationship. Proof of the duty is rarely a problem for plaintiff-patients, because in the great majority of cases patients are examined by optometrists in an office or under circumstances that make the relationship apparent. The lack of formal surroundings, or even failure of the optometrist to charge

††A tort is a “breach of duty (other than a contractual or quasicontractual duty) which gives rise to an action for damages.’’ (Prosser WL. Law of torts, ed. 4. St. Paul, MN:West, 1971: 1.) This rather unsatisfactory definition leaves one with more of an indication of what a tort is not; it is not a crime, it is not based on contract, and it does not result in loss of liberty. It is a civil action, brought for the purpose of receiving monetary compensation for damages, and is based on a breach of duty.

for services, does not defeat the duty if a doctor–patient relationship has been formed. Once an optometrist has created the relationship, the optometrist is legally obligated to adhere to the standard of care expected of a reasonable practitioner acting under the same or similar circumstances. Because proof of this standard can be offered only by individuals actually familiar with it, expert testimony is required.

Breach of the Standard of Care

Expert witnesses, unlike other witnesses, are not limited to reporting the perceptions of their senses but may offer opinions. Such witnesses first must be “qualified,” which is a process intended to convince the trial judge that the individual being offered as an expert is competent to testify about the matter at issue. Traditionally, only practitioners of the same “school” have been considered competent to testify about the standard of care expected of defendant practitioners. However, the growing liberality of rules of evidence and the lessening distinction clinically between optometrists and ophthalmologists have combined to change this traditional pattern, and ophthalmologists are frequently deemed competent to testify concerning the standard of care expected of optometrists.This development has led to the imposition of a medical standard of care for optometrists in cases involving misdiagnosis or mismanagement of ocular disease.

The likelihood of testimony by physicians—and the imposition of a medical standard of care—is greatest in cases involving ophthalmic drugs because of the use of these agents to diagnose or treat disease. Of course, expert testimony on behalf of a defendant optometrist may allege that the optometrist acted in conformity with the standard of care. It is then left to the jury to determine liability.This element of proof is usually the most difficult for plaintiffs to establish and is frequently the most contentious aspect of a malpractice trial.

Injury

Assessment of patients’ injuries is also a matter requiring an expert’s opinion, and either optometrists or ophthalmologists may provide this testimony. Visual impairment is usually evaluated as loss of visual acuity, reduction of visual field, or diminished reading capacity. Other ocular impairments that result in loss of functions, such as defective color vision, diminished accommodation, and loss of binocular vision, may also be evaluated, as may deformities or disfigurements of the orbit or face. Optometrists who testify concerning the degree of injury suffered by patients should be familiar with the accepted standards used in legal proceedings.

Proximate Cause

The fourth element of negligence is proximate cause, sometimes referred to as legal cause, which serves to tie together the negligent act (or failure to act) and the resulting injury.

72 CHAPTER 5 Legal Aspects of Drug Utilization

For example, failure to use a mydriatic drug for a fundus examination may be the proximate cause of a clinician’s failure to detect an intraocular disease. Expert testimony is necessary to link together what the practitioner did (or did not do) and the injury.

Plaintiff-patients must prove each of these four elements by a preponderance of the evidence. As the preceding discussion has demonstrated, expert testimony is crucial to the presentation of this evidence, and it is equally important to defendant optometrists as they seek to refute plaintiffs’ allegations.The focus of a malpractice case is usually the standard of care, which has particular requirements when applied to the use of ophthalmic drugs.

STANDARD OF CARE

Optometrists are expected to display that degree of skill and learning that is commonly possessed by members of the profession who are in good standing and to exercise what is referred to as “due care.”‡‡ This obligation has broad implications whenever optometrists use ophthalmic drugs, because the standard of care requires that optometrists

1.Understand the allergic and toxic side effects of all drugs administered or prescribed.

2.Take an adequate history to determine whether there has been any previous allergic or toxic response to a drug, especially an ophthalmic agent.

3.Select the appropriate drug for patients’ needs or conditions.

4.Warn patients of side effects of drug use that may create a risk of injury.

5.Monitor patients while they are under the influence of the diagnostic or therapeutic agent so that complications can be managed in a timely manner.

To conform to these due care requirements, an

optometrist is expected to act in the same manner as a reasonable practitioner by observing the following clinical and legal guidelines.

Knowledge

Practitioners are under a legal duty to keep abreast of new developments, especially information that affects patient care, such as reports of drug toxicity. Therefore practitioners not only must understand the properties of any drugs that are used for patient care, but also must remain knowledgeable concerning more efficacious drugs or reports of adverse events. Failure to stay abreast of these developments has resulted in successful claims

‡‡Due care may be defined as “that care which an ordinarily prudent person would have exercised under the circumstances.’’ (Black’s law dictionary, rev. ed. 4. St. Paul, MN:West, 1968.)

against physicians and could also serve as a cause of action against optometrists.

History

The standard of care requires that an adequate drug history be taken, including

•The patient’s history of past drug use

•Drugs currently being taken

•Any allergic or toxic reactions to drugs, past or present

•History of ophthalmic drug use, including a determination of whether anesthesia and mydriasis have been used at previous examinations

Failure to take an adequate history that results in an

allergic or toxic response to a drug may render practitioners liable for this otherwise preventable injury.

Use of the Appropriate Agent

Adherence to the standard of care is necessary to minimize the risk of injury to patients. An optometrist is obligated to choose the pharmaceutical agent that fulfills this requirement and, in so doing, is expected to exercise the degree of skill and learning that is commonly possessed by like practitioners. The drug that is most appropriate for the patient’s condition and its most appropriate route of administration must be determined to minimize the risk of adverse effects. If an optometrist uses an inappropriate agent—such as a topical beta-blocker for a glaucoma patient who has chronic obstructive pulmonary disease, thereby precipitating an otherwise preventable injury— the optometrist has failed to meet this duty and is legally responsible for both transient and permanent effects of the drug’s use.The same would be true if an optometrist attempted to treat an anterior uveitis with a systemic steroid without first establishing that a topical route of administration was inadequate or inappropriate. In each instance the optometrist’s conduct must measure up to that of a reasonable optometrist; otherwise, liability may result.

Warnings

Because of the doctrine of informed consent, there are clinical circumstances under which optometrists must discuss the risks and possible side effects of drug use with patients. For example, if patients are to undergo prolonged treatment with topical steroids, the optometrist would be obligated to warn them of potential side effects, including glaucoma, ocular infection, and cataract.

Although the amount of information that must be communicated to patients varies among states due to different evidentiary requirements, the circumstances under which warnings are necessary generally do not vary. For example, all patients receiving a dilated fundus examination should be warned of the potential photophobia and blur caused by pupillary dilation.

Warnings are an essential aspect of drug use and should not be overlooked or ignored.

Management of Side Effects

If patients experience a drug-related allergic or toxic effect, clinicians must meet reasonable standards of detection and management. For example, a telephone call from a patient complaining of severe headache and blurred vision after undergoing dilation requires an examination instead of the proverbial “Take an aspirin and call me in the morning.” Likewise, patients who are being treated with topical steroids must be recalled with sufficient regularity to detect adverse events before they have significantly affected vision or ocular health.

For each of these due care requirements, optometrists must satisfy reasonable standards of conduct. Also, because the use of ophthalmic drugs is essentially a medical act, ophthalmologists may be competent to state the standard of care expected of optometrists under these circumstances.

Failure to use drugs when clinically indicated, particularly mydriatic agents for diagnosis, is a significant source of liability claims.A hypothetical example illustrates how the standard of care can be applied if drugs are not used appropriately for diagnostic purposes. If a patient has received a blow to the eye from a fist, ball, or other blunt object, the optometrist must rule out the possibility of a retinal break. To perform a reasonable examination, one that conforms to the expected standard of care, dilation of the pupil is necessary. In fact, it may be argued that examination of the retinal periphery with a binocular indirect ophthalmoscope is required under these circumstances.Therefore failure to dilate the pupil and view the retinal periphery falls below the standard of care. If for some reason the optometrist cannot perform a dilated examination, the patient must be referred to another clinician so that the appropriate evaluation can be performed.

MISDIAGNOSIS

Misdiagnosis of open-angle glaucoma, tumors affecting the visual system, and retinal detachment are the leading causes of large malpractice claims against optometrists. In the great majority of cases, failure to make the appropriate diagnosis is linked to failure to perform a key diagnostic test (e.g., tonometry or funduscopy through a dilated pupil). Therefore the legal problem most likely to be encountered by a clinician is failure to use an ophthalmic agent. Because of the significant role that pupillary dilation plays in the diagnosis of these conditions, clinicians should be familiar with standards for assessment of the interior of the eye (Table 5-1). Example cases may be used to illustrate how claims of misdiagnosis can arise when these three important disorders are encountered.

Open-Angle Glaucoma

The standard of care for the detection of open-angle glaucoma has been established by a series of cases involving ophthalmologists.The leading case involved a 22-year-old woman who was fitted for contact lenses and examined intermittently over the course of 10 years before the ophthalmologists discovered that she had open-angle glaucoma and that her visual field was reduced to less than 10 degrees. She sued the ophthalmologists for negligence, and at trial tonometry became the key issue. She alleged that the physicians had a duty to perform the test while she was a contact lens patient; they defended the claim on the basis that tonometry was not a routine test for patients younger than 40 years of age.

Although the ophthalmologists won the trial, the case was reversed on appeal, a decision that evoked a storm of commentary. Ironically, the court’s opinion proved to be a legal dead end, but the intense publicity surrounding the case succeeded in changing the standard of care in both ophthalmology and optometry.

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Precedent-setting cases brought against optometrists for failure to diagnose open-angle glaucoma almost uniformly allege failure to perform tonometry. Just as uniformly, defendant optometrists resort to procedural defenses that seek to avoid this issue. The result has been a standard of care that requires routine use of tonometry regardless of patient age. Evaluation of the optic nerve head, visual field assessment, and other appropriate tests for glaucoma (e.g., gonioscopy) are also necessary for diagnosis.

Tumors Affecting the Visual System

Tumors may be external, such as squamous cell carcinomas; intraocular, such as malignant melanomas; or intracranial, such as pituitary adenomas. All three types of tumors may be considered “ocular,” and all pose unique clinical challenges. The detection of intraocular tumors presents one of the most difficult diagnostic dilemmas encountered by optometrists. To make the diagnosis, a dilated fundus examination is needed, but patients with “silent” tumors may not evince symptoms that would lead a reasonable practitioner to determine that dilation is required. Practitioners are not legally obligated to discover all that may be wrong with patients but rather to perform an examination that is reasonable under the circumstances. Therefore failure to detect a silent tumor because dilation is not demanded by a patient’s complaints or history may not be construed as negligence. A precedent-setting case challenges this assumption, however, and imposes a medical standard of care for the use of pupillary dilation.

A 412⁄ -year-old child with accommodative esotropia was examined by a military optometrist, who found 20/30 acuity in each eye and good eye alignment with spectacles. Direct ophthalmoscopy performed through an undilated pupil revealed no evidence of posterior pole disease. The optometrist saw the patient on two other occasions over the next 7 months, but no pathology was observed. Approximately 13 months after the initial examination, the child was found to have leukocoria in the deviating eye. A dilated fundus examination by a base ophthalmologist revealed a 15-disc diameter retinoblastoma located at the equator of the eye and spreading anteriorly.The child was referred to a specialist for treatment, and irradiation was used successfully to destroy the tumor. The irradiation caused a cataract, however, and the tumor caused retinal detachment, which resulted in a best-corrected acuity in the eye of 20/300. A suit was brought against the optometrist, alleging that he was negligent for failing to perform a dilated fundus examination with a binocular indirect ophthalmoscope at the initial examination and periodically thereafter. After a trial found in favor of the optometrist, the case was appealed to a federal appellate court, which ruled that the optometrist had breached the standard of care in failing to perform a dilated fundus examination. The court relied exclusively on medical testimony in reaching its decision, and although the optometrist was

ultimately found not liable, the court’s opinion established a precedent for the use of pupillary dilation in patients with silent tumors.

The use of pupillary dilation is required for symptomatic patients, as illustrated by the following case. An optometrist employed by a multidisciplinary clinic examined a middle-aged woman who complained of reduced vision and found her best-corrected visual acuity to be 20/25 and 20/40. The optometrist attributed this to cataracts. Although refraction, tonometry, and ophthalmoscopy were performed, the optometrist did not dilate the patient’s pupils.After discussing his findings with the patient, he dismissed her. Two months later she realized that the vision in one eye was markedly reduced, and she returned to the clinic, where the diagnosis of retinal detachment secondary to a von Hippel-Lindau tumor was made. Despite surgery the patient was left with a permanent loss of acuity. She sued the optometrist, alleging that he was negligent for failing to make the diagnosis in a timely manner.Although the optometrist prevailed at the trial, the patient was awarded damages on appeal, with the court stating that “the evidence is overwhelming that the (plaintiff’s) eye should have been dilated” and that the optometrist should be held to “the same rules relating to the duty of care and liability as ophthalmologists.”

The rationale for the court’s opinion was that the diagnosis of cataract (a “disease”) required dilation of the pupil and that had dilation been performed at the time of the optometrist’s examination, the possibility of a retinal detachment could have been ruled out. In finding the optometrist liable, the court imposed a medical standard of care.Therefore a dilated fundus examination should be used whenever best-corrected visual acuity is reduced, and coexisting disease should be considered a possibility until an examination determines otherwise. Optometrists may be held responsible for the diagnosis of intraocular tumors—even those as rare as malignant melanoma—in symptomatic patients.

Retinal Detachment

The necessity for dilation of the pupil is probably most evident in cases in which retinal detachment is, or should be, suspected. Many patients are at risk for retinal detachment, and it can be argued that pupillary dilation is necessary whenever patients are found to have any of the following:

•Significant myopia

•Aphakia or pseudophakia

•Recent yttrium-aluminum-garnet capsulotomy

•Glaucoma therapy with strong miotic agents in myopic eyes

•Lattice degeneration

•Blunt trauma to the eye

•History of retinal detachment in the fellow eye

•Proliferative retinopathy (e.g., proliferative stage of sickle cell, diabetes, retinal vein occlusion)

Another important precursor of retinal detachment is acute-onset, symptomatic, posterior vitreous detachment. It has been reported that 7% to 15% of patients with acute symptomatic posterior vitreous detachment have a retinal tear. Approximately one-third of these tears progress to retinal detachment. If patients complain of spots, specks, floaters, or other entoptic phenomena that indicate the possibility of posterior vitreous detachment, optometrists must conduct a dilated fundus examination to rule out the presence of a tear. Although failure to detect the detachment may not be below the standard of care for an optometrist (due to the break’s size or location), failure to detect a detachment because pupillary dilation was not used for the retinal examination will be construed as negligent.

Symptoms of reduced visual acuity also require careful assessment of the interior of the eye. In a case involving a diabetic patient who complained of blurred vision, the defendant optometrist performed refraction and prescribed spectacles that he assured the patient would relieve her symptoms. Because of the patient’s history of diabetes and the complaint of reduced acuity, the standard of care required a dilated fundus examination. The optometrist did not dilate the pupil, however, and after dispensing spectacles to the patient did not undertake any further treatment. Six months later the patient consulted an ophthalmologist, who found that the patient had proliferative retinopathy due to diabetes and had suffered a retinal detachment in one eye and unmanageable complications in the other. A lawsuit was instituted against the optometrist for negligence in failing to make the diagnosis and to refer the patient for treatment. It is important to note that diabetic patients constitute an important and challenging clinical problem for optometrists because of the number of affected individuals, the frequency of ocular complications, and the long-term management required.

Although other causes of misdiagnosis have been alleged against optometrists, these three types of claims are the most frequent and represent the most significant clinical and legal challenges to diagnostic skill. Failure to diagnose these conditions poses the greatest risk of litigation for optometrists.

COMPLICATIONS OF DIAGNOSTIC DRUG USE

Optometrists must be familiar with the adverse effects of any ophthalmic drugs used for diagnostic purposes and must be prepared to manage these complications when they occur. This obligation is frequently encountered when using the common diagnostic agents: anesthetics, mydriatics, and cycloplegics.

Anesthetics

Topical anesthesia is necessary for applanation tonometry and gonioscopy. Proparacaine and benoxinate are most

commonly used. Because these agents may cause an allergic or toxic response, optometrists should determine whether patients have experienced a previous adverse reaction before using the drug. If optometrists observe such a reaction, this fact should be noted conspicuously in the patient record to prevent a second episode at a subsequent examination. Of course, optometrists may choose an alternative drug in this event, because proparacaine and benoxinate are structurally dissimilar and an allergic reaction to one drug does not mean that patients will be allergic to the other (see Chapter 6). If patients experience an adverse reaction, the worst result—desqua- mation of the corneal epithelium—is transient and the discomfort is not severe. Most episodes resolve within 24 to 48 hours, with no permanent effect on vision.There is little opportunity for negligence or for substantial damages.

Injury may be permanent, however, if a topical anesthetic is applied copiously to a compromised cornea. Anesthetics should never be dispensed to patients for use at home, and if other practitioners have dispensed anesthetics to patients for use on an “as needed” basis, these patients should be counseled concerning this potentially injurious use of topical anesthesia.

Mydriatics

These drugs constitute the most important class of diagnostic agents because of their widespread use for dilating the pupil for funduscopy. A history must be taken to ensure that patients have not experienced symptoms suggestive of angle closure after pupillary dilation by previous examiners, and the anterior chamber angle should be examined to determine the risk of precipitating an angle-closure attack. Because 94% to 98% of the U.S. population has angles incapable of closure by pupillary dilation, there is no requirement under the doctrine of informed consent to warn the great majority of patients of this risk. Only those rare individuals whose histories or anterior chamber angles indicate a risk must be informed of the possibility of angle closure, so that their consent can be obtained before performing the procedure. Clinicians should document that the warning was given and that consent was received (see Figure 5-1). The use of prophylactic laser peripheral iridotomy in lieu of pupillary dilation should also be considered and discussed with patients if management of angle closure would be inappropriate.

A clinical and legal issue of some importance is posed by the necessity for pupillary dilation. If there is litigation, the use of expert testimony is required to determine whether dilation was needed to conform to the standard of care in a specific instance. If a reasonable practitioner would maintain that a dilated fundus examination was necessary under the circumstances, then the patient must receive that evaluation or be referred to another practitioner so that it can be performed. There are numerous