Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008

and knowledgeable manner can strengthen the patient’s confidence in the original physician’s impression and plan.

There are several key points of discussion during a cosmetic consultation. Patients should understand that plastic surgery is about improvement, not perfection or transformation. Using a mirror, underlying subtle or obvious asymmetries and challenging anatomy should be demonstrated to the patient. Patients are often unaware that every human, including themselves, has subtle asymmetry. It should be explained that while improvement is possible, patients should still expect some asymmetry after surgery. After careful assessment of their skin type, patients should be given a realistic prediction of how their skin will heal and what type of scar to expect. Common risks, such as dry eye symptoms after blepharoplasty, should be thoroughly reviewed. Rare risks should be mentioned, and the patient’s reaction can often serve as a psychological test of their expectations: an informed patient with a balanced outlook should not be overly rattled by discussions of severe complications.

As in other areas of ophthalmic plastic surgery, there is great importance for photodocumentation of the preoperative status of the patient. Not only do photographs serve a valuable purpose in demonstrating before and after results to both the patient and physician, they also can serve as a reminder to patients of asymmetries and irregularities that were present before surgery. It is common for a patient who has never noticed their relative right-sided mild blepharoptosis to focus on it extensively during postblepharoplasty self-examination. For this patient, demonstrating the preexisting ptosis in a preoperative photograph can prevent the patient from believing that the surgery caused the ptosis.

An expanding area of the cosmetic ophthalmic practice includes the usage of paralytic agents (e.g., botulinum toxin A) and fillers (e.g., collagen, hyaluronic acid). Risks to discuss in detail with patients undergoing injection of paralytic agents should include the possibility of temporary ptosis and lagophthalmos. Patients receiving paralytic subcutaneous injections should be monitored for these complications and treated accordingly. Botulinum toxin A may spread inadvertently to an adjacent area and cause unwanted paralysis that can appear as if the patient has had a stroke. These unwelcome effects will occur in rare instances but can be devastating for the few patients to whom it does occur. The effects can last up to 3 months with no satisfactory treatment. For these reasons, a thorough informed consent is valuable.

The multitude of facial fillers flooding the market has expanded options for facial sculpting; however, fillers can result in granuloma formation in select patients, as well as dissatisfaction with the result. If the filler is a nonabsorbable material, these problems may become significant chronic issues. The patient undergoing facial fillers should be informed of these risks.

With the increasingly complex palette of laser skin resurfacing technologies, some ophthalmic plastic surgeons perform laser facial skin rejuvenation. Some risks are to the type of laser technology, ablative or nonablative, that should be discussed with patients. Ablative lasers may induce irregular pigmentation in patients with even mild to moderate skin pigmentation; dark-skinned patients should have pretreatment

testing of a concealed skin patch to assess specific postlaser pigmentation results. Ablative lasers denude the epithelium and thus carry a risk of infection; consideration for viral and/or bacterial prophylaxis should be made for patients at risk. Carbon dioxide lasers have the specific risk of causing a fire in the procedure room. In our practice, we stop oxygen delivery, and remove all oxygen tubing from the patient. In addition, we outline the face with wet towels and keep a basin of water available in the event of a fire. These prophylactic maneuvers are recorded in the operative report. Nonablative lasers do not directly bare the dermis but can deliver significant energy to the specific dermal structures. Risks of posttreatment pigmentation abnormalities should be discussed, and full-thickness burns are possible. Occasionally, nonablative procedures can be quite painful, and patients should be informed of this reality.

In this time of ubiquitous cosmetic facial surgery, there is an everexpanding subset of patients who have had a poor result. Either the patient is unhappy with the cosmetic outcome of the surgery, or the patient is experiencing dysfunction as a result of surgery. Ophthalmic plastic surgeons frequently encounter patients who present with the “overdone blepharoplasty,” who demonstrate signs of lagophthalmos and exposure. Other presentations include increased asymmetry after surgery, eyelid contour abnormalities, and periocular hollowness. It is challenging to treat this subset of patients, as they have preexisting resentment before even encountering the specialist. In these cases, it is appropriate to spend extra time assessing psychological status, educating patients, and dispelling false beliefs. A patient in this category may manifest strongly unrealistic expectations; the patient may say, “My previous doctor was terrible, but I know you can fix all my problems.”

Unhappy patients seeking specialty consultation after previous surgery can manifest anger toward their previous physician or even openly express their litigious intentions. “My previous surgeon was a butcher.” It is inappropriate and detrimental to deride previous surgery or to encourage patients to seek legal counsel. No good can come of it, and surely it does nothing for managing the patient’s current functional and cosmetic complaints. A supportive attitude and a positive proactive affect may steer a patient away from continuing a spiral of negativity that may incite legal action.

Anesthesia Administration and Medications: Prevent Problems with Vigilance and Diligence

Pain is alleviated during ophthalmic plastic surgery by the administration of anesthetic agents from a qualified, dedicated, anesthesia provider. The aspects of every surgical case that must be analyzed in great detail include the patient’s history and physical evaluation prior to the development of an anesthesia care plan.

Close inspection of the patient’s underlying health should precede any surgical procedure or decision for pharmaceutical treatment. Complete preoperative evaluation by a generalist physician should precede elective surgery. Not only does this fulfill a legal recommendation that the examination be performed but also the examination may uncover important diagnoses pertinent to surgery, such as liver

failure (which may increase bleeding time), hypertension (which might exacerbate intraoperative bleeding), or cardiac risk factors. In addition, the generalist may perform an assessment of the risk of preoperative cessation of aspirin and clodoprigel. The surgeon is best to avoid counseling the patient to stop these medications without the approval of the generalist or cardiologist.

In perioperative care, there are numerous occasions in which the surgeon prescribes or administers drugs. Drug-related incidents of morbidity are the root cause of multitudes of malpractice cases. There have been many lawsuits for complications relating to the administration of local anesthesia. Perforation of the globe during the injection of local anesthetic agents is a most feared complication and has been successfully brought to trial. Injection of local anesthetic directly into an extraocular muscle belly can cause restrictive strabismus.7 Ophthalmologists should also be cognizant of drug interactions, such as the potentiation of warfarin by acetazolamide. Oral glucocorticoids are prescribed frequently for facial surgery and the treatment of orbital disease. Significant side effects are possible, including exacerbation of glycemic control for diabetics, inhibition of gastric protection, femoral head necrosis, and even psychiatric side effects. Often, eyelid and orbital disease is treated with triamcinolone suspension injection. These injections are performed so frequently that often informed consent is omitted, and even verbal explanation of complications is omitted. Complications such as glaucoma, systemic absorption, skin depigmentation, subcutaneous fat atrophy, and vascular occlusion do occur. The legal culpability of these complications of drug administration fall to the prescribing physician, and so physicians must maintain due diligence in prescribing medication and explain these risks to patients prior to administration.

Ophthalmic plastic surgery is distinct from surgery of the other ophthalmic specialties by the relatively larger nature of the surgeries with greater potential for bleeding.8 Larger volumes of local anesthetic are often required, increasing the potential for systemic effects of injected agents. There have been several well-publicized cases of mortality from overdosage of injectable anesthetics in cosmetic surgery. Surgeons should maintain a working knowledge of the maximum dosages of lidocaine, Marcaine, and epinephrine to stay out of trouble. In addition, the recognition and treatment of local anesthetic toxicity is vital. A crash cart is generally a requirement for surgery centers and should be considered for any clinic situation where minor surgery is performed without intravenous anesthesia. Surgeons should maintain their certification in Advanced Cardiac Life Support for the safety of their patients, as well as for their own legal protection in the event that cardiopulmonary resuscitation care is required.

Conclusion: Conscientiousness and the “Art” of Medicine

While practicing ophthalmic plastic surgery, it is easy to become bogged down with legal details, implications, and defensive practice maneuvers. However, this chapter and even this entire textbook can be distilled down to the following statement: avoid malpractice by running a conscientious practice and perfecting the “art” of medicine and surgery.9–14

A physician who is diligent, thorough, and thoughtful will stay out of trouble in diagnosis and management. This is achieved by combining the cumulative knowledge of a physician’s training and ability with an attentive work ethic. Staying out of “trouble” is the key to avoiding lawsuits. After all, “trouble” is a maloccurrence that leads a patient to blame and leads a case to a court of law. Without “trouble,” there can be no lawsuit.

Perfecting the art” of medicine is a complicated, esoteric subject. Yet it is essential to the practice of every physician and a crucial cornerstone in prophylaxis against malpractice. The art of medicine requires sensitivity and the ability to listen, which allow the establishment of rapport. The art of medicine is also engaging the patient in a detailed discussion of the clinical findings and treatment plan, empowering the patients to understand their clinical status and potential management options, which leads to realistic expectations. In the end, connecting with a patient as a fellow human being builds a relationship that does not break down, even in the face of adversity.

References

1.Brooten KE. Malpractice: A Guide to Avoidance and Treatment. 1987. Orlando: Grune & Stratton; 1987.

2.Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians (How to Avoid, How to Win). Boston: Little, Brown; 1977.

3.Kraushar MF, Robb JH. Ophthalmic malpractice lawsuits with large monetary awards. Arch Ophthalmol 1996;114(3):333–337.

4.Lobe TE. Medical Malpractice, A Physician’s Guide. New York: McGraw-Hill; 1995.

5.Shorr N, Seiff SR. The four stages of surgical rehabilitation of the patient with dysthyroid ophthalmopathy. Ophthalmology 1986;93(4):476–483.

6.Bettman, JW. Ophthalmology: The Art, The Law, and a Bit of Science. Birmingham, AL: Aesculapius; 1977.

7.Ando K, Oohira A, Takao M. Restrictive strabismus after retrobulbar anesthesia. Jpn J Ophthalmol 1997;41(1):23–26.

8.Sarwer DB, Pruzinsky T, Cash TF, Goldwyn RM, Persing JA, Whitaker LA. Psychological Aspects of Reconstructive and Cosmetic Plastic Surgery. Philadelphia: Lippincott Williams & Wilkins; 2006.

9.Campion FX. Grand Rounds on Medical Malpractice. Chicago: American Medical Association; 1990.

10.Kraushar MF. Medical malpractice experiences of vitreoretinal specialists: risk prevention strategies. Retina 2003;23(4):523–529.

11.Kraushar MF. Recognizing and managing the litigious patient. Surv Ophthalmol 1992;37(1):54–56.

12.Kraushar MF, Turner MF. Medical malpractice litigation in cataract surgery. Arch Ophthalmol 1987;105(10):1339–1343.

13.Leaman TL, Saxton JW. Preventing Malpractice: The Co-Active Solution. New York: Plenum Medical Book Co.; 1993.

14.MacKauf SE. Advanced Medical Malpractice: Anesthesiology, General Surgery, and Neurology. New York: Practicing Law Institute; 1977.

It is most unlikely that a child would on his or her own initiative report for an examination, especially one likely to include the dreaded “blurring drops,” against the express wishes of a parent. However, it would be hazardous to rely on this “real life” inference of parental consent. The safest course is to require written authorization or consent by telephone. The latter requires a reasonable good faith belief that the consenting person at the remote location is the appropriate individual.

For problems that are more urgent but not true emergencies, relatives or an adult sibling may stand in for an absent guardian. Here, too, the circumstances should be such that there is reason to accept what is represented as to the accompanying adult’s identity.

Duty to Third Parties

We have a duty of care to our child patients, exercised through their parents or guardian. The responsible adult legally is a stand in for the child. Can there somehow be an additional duty to third parties, one that usually does not exist toward those who may accompany or even assist a competent adult in a medical care setting? The following illustrations are derived from actual cases

A young child received a poliomyelitis vaccination. Her principal care giver was a parent whose own resistance to infection was reduced by recent surgery. The child’s pediatrician did not inform the parent of the precautions to be taken in handling the child’s waste and secretions. The parent contracted the disease and successfully sued the physician for negligence in failing to provide the pertinent information.1

A psychiatrist was informed by a disturbed patient of intent to kill another person, whom the patient named. The psychiatrist concluded that warning the intended victim would violate physician–patient confidentiality. The patient accomplished the killing. The victim’s family successfully sued the doctor for the victim’s wrongful death resulting from the negligent failure to warn.2

The law distinguishes different degrees of closeness between third parties and patients, either child or adult. Those who are either responsible for the minor or for an incapacitated patient’s general welfare and have decisional power and regular interaction with such a patient, or those emotionally close to the patient but who may not be formally responsible, have been included within the duty to warn assumed by the physician, which arises when the third party is known to be at risk from a specific threat and when the harm is readily foreseeable.

Accordingly, as just one example, the discovery by the pediatric ophthalmologist of a retinoblastoma as the explanation for a white appearance to the pupil, especially when bilateral, calls for investigation of parents, siblings, and perhaps close relatives in order to establish, by the detection of spontaneously regressed lesions and by modern genetic analysis, the likelihood of very young children of the family and its extension and of as yet unborn children being similarly afflicted. Omission of such widely practiced counseling and analysis could be regarded as negligent care, because there is a specific, foreseeable threat of harm to ascertained individuals. Once again, protection for the physician enhances overall quality of care.

Promises

“This operation will cure the glaucoma.” “These glasses will straighten your child’s crossed eyes.”

Such absolute declarations should be avoided. We know from experience that such statements are not always true. They are promises of results and if relied on by the patient in accepting treatment can be viewed as making a contract. This is not the same as malpractice and has the strategic advantages of not requiring expert testimony, and a longer statute of limitations.

The physician should studiously avoid any discussion that could be construed as an express promise. Expressing confidence that falls short of a promise in an outcome based on reliable evidence or your own experience (“therapeutic assurance”) is consistent with good medical practice and a much safer course.

Abandonment

A physician–patient relationship can be terminated by the physician for any reason or for no reason provided it is done with adequate notice and an offer to furnish the patient’s record to a successor physician. However, bad consequences from abandonment of a patient during a course of treatment would be difficult to defend.

Suppose you have under your care a child with an established diagnosis of juvenile rheumatoid arthritis. On one or more prior occasions, your examination has shown no uveitis. The patient does not appear for the next scheduled visit.

Now suppose alternatively that in a similar situation, you have detected uveitis and prescribed treatment. As proposed above, this child too is a “no show.” In both instances, you have appropriately counseled the responsible adult of the necessity for periodic follow up. Is your risk different in the two situations?

Abandonment applies when the patient is under an active course of care, which does not include merely a series of checkup visits for a certain diagnosis. Regardless, although the first scenario is essentially a periodic screening, best medical practice calls for at least a reasonable attempt to reschedule the appointment. Especially if such an effort is documented in the patient’s record, the risk of liability for a subsequent poor outcome is rather low. For the second child, a more vigorous attempt (again with documentation) to reestablish care is called for, as the child is in the midst of treatment for a potentially destructive disease. In another context familiar to the pediatric ophthalmologist, a child on an occlusion program for amblyopia, whose vision is periodically checked and the regimen adjusted, probably is under active treatment that may include the danger of occlusion amblyopia of the previously preferred eye, whereas the same child, undergoing interval vision checks once occlusion is discontinued, probably is not.

There is no rigorous definition of what constitutes a “reasonable” or sufficiently “vigorous” attempt. These determinations are fact specific and will be decided by a jury, if matters go that far. Properly documented efforts are not only medically correct but the best defense against the necessity for a jury to consider the question at all.

The Consultant

Most pediatric ophthalmology patients are referred for care, not merely for guidance. The ophthalmologist may report to the referring physician, but this is largely informational. A referral for diagnosis and treatment by a physician who is not a member of our specialty clearly implies that the patient (through his or her guardian) and the ophthalmologist understand that they are in a mutual undertaking.

Consider the following: you attend grand rounds or you are with a colleague in the staff dining room or at the scrub sink. You comment on a case. Your advice is followed; harm to the patient results, and you are sued. What is your risk of liability in this setting? As shown in several courts,3 reasonable jurors probably would not find any implication of a physician–patient relationship in this type of encounter, the existence of which most likely is even unknown to the patient.

In another context involving an unaware patient, the outcome could be different. Suppose now that you are the ophthalmologist on call for your hospital’s pediatric emergency room, and you are informed of a patient with an eye problem. Must you see the patient, or is telephone advice sufficient?

Several cases have indicated that it would be a departure from the standard of care to not personally attend a patient in these circumstances when indicated by the communicated findings.4 In the end, it is a matter of judgment; the response involves a weighing of the likely consequence of the injury if not immediately attended by a knowledgeable specialist against the inconvenience of your personal participation. Although the patient has not consulted you or even necessarily knows your identity, he or she has presented for care by the hospital, of which you are the understood designee to carry out the hospital’s obligation. When in doubt, go.

There also are occasions when you as the treating ophthalmologist seek consultation for your patient. What if in this instance you do not accept the consulted ophthalmologist’s recommendations? Given that you found it necessary to go beyond your own capabilities in the first place, are you at risk for a malpractice verdict if you ignore the advice and the case has a poor result?

Ultimately, you are not bound to follow a consultant’s recommendation, but your reasons for rejecting it should be documented. What is important is that these reasons be sound and preferably based at least in part on your own experience and that it is clear that you considered the consultant’s suggestions.

Right Eye or Left Eye?

Imagine the disaster (it has happened) when a mistake as to side occurs in an enucleation, even though in most cases the eye indicated for that operation is readily apparent. The possibility of error for interventions of a less critical nature also cannot be ignored; should correction of strabismus involve the only good eye of an amblyopic patient or one with a structural defect in one eye, other than in limited special circumstances (e.g., null-point motor nystagmus)?

Surgical facilities have increasingly become aware of the necessity to guard against such errors. Marking the operative site on the patient and “time outs” for verbal review of the proposed procedure among all participants are now institutional policy at many facilities, reinforced in some instances by state law or regulation.

Errors of this type usually occasion much finger pointing, but the last clear chance for prevention lies with the surgeon. No source, including the patient’s impression, the hospital’s operation schedule, and the insurance company’s authorization, other than your own record establishes the ultimate facts.

It is my practice to have my entire record available at the procedure and affix the sheet stating my plan to the wall or an instrument stand for ready reference rather than to bring only a short summary prepared as a brief admission note, because other questions about examination details may arise during the operation, especially in repeat strabismus procedures. The risk avoidance value of observing this ritual exceeds by far any slight inconvenience.

Novel Treatment

There are occasions when the physician finds justification for treatment that is neither established nor experimental, such as disinsertion and reattachment of all four horizontal rectus muscles for motor nystagmus.5 In such situations, the actual surgical handling may be entirely conventional; it becomes “novel treatment” by application in a novel setting.6 What risk-limiting precautions are appropriate here?

Professional common sense should prevail. Most important, there should be no increase in the expected occurrence rate of dangerous complications. Second, the remedy should relate logically to what is known about the abnormal condition. Published experience with the treatment by other ophthalmologists is valuable for this purpose. If there is no such prior evidence and the treatment is essentially untried, this calls for adherence to a full investigational protocol. Again, whatever lessens risk has a positive effect on quality of care.

Off-Label Prescribing

The term off label refers to the use of drugs and devices not authorized by the U.S. Food and Drug Administration (FDA), usually because they have not been evaluated for safety and efficacy in certain populations or in certain dosages. The package inserts for such drugs typically contain the warning “not approved for children” or a similar message. This situation is changing somewhat. Since 1998, the FDA has had a “pediatric rule” that requires studies on children as part of a new drug application unless children do not contract the disease the drug treats or the outcome is already known.

Among the most serious conditions leading the pediatric ophthalmologist to prescribe off label are certain forms of childhood glaucoma, retinoblastoma, and severe uveitis from various causes. In such cases there are few effective alternatives, so it is even possible that failure to prescribe off label could be deemed malpractice.

What liability exposure attaches to off-label prescribing? The FDA provides a Practice of Medicine Exemption under which it is lawful to vary the conditions of use of a drug from those detailed in the package insert without FDA approval, provided that the unapproved use is based on reasonable medical evidence, without fraudulent intent and that it requires the same judgment and prudence as exercised in medical practice in general.

The items of prudence considered critical are a good faith effort to evaluate all that is known about the drug and informed consent from the child’s caregiver, many of whom will notice the “not approved for children” warning. I have found it best to anticipate their hesitation by pointing out the difference between disapproved and nonapproved and that what is known about the drug’s effects, as well as prior experience, reasonably indicates that its use is appropriate.

Retinopathy of Prematurity

Experience has shown retinopathy of prematurity (ROP) to be a leading risk setting for the pediatric ophthalmologist. Modern concepts of appropriate care for premature infants are based on the premise, firmly supported by recent technical advances and a body of sound clinical studies, that the disastrous consequences of ROP can be avoided in most cases. The key is timely detection.7 Legal action mostly involves a break in the screening sequence once the infant is discharged from the nursery.

Consider the following actual occurrence: A pediatric ophthalmologist provides ROP screening services to the neonatal intensive care unit (NICU) of a regional hospital. The NICU has sole responsibility for identifying the infants at risk requiring screening. Examination of one such infant results in a properly charted note stating a diagnosis of “immature retina” in zone 2 and recommending a repeated screening in 2 weeks. The attending neonatologist misinterprets the note as conclusively ruling out ROP and transmits this information in his discharge note to the infant’s succeeding pediatrician, who considers the follow up to be only routine and elective. The parents arrange the next appointment by a delayed effort and cannot secure an appointment until several weeks later. At this examination, advanced ROP is evident, with a poor visual outcome. The pediatric ophthalmologist is named as one of the defendants in the subsequent lawsuit.

This is a rather typical scenario for ROP incidents that result in malpractice lawsuits. Omitting discussion here of how liability might be apportioned between the hospital neonatologist and the successor pediatrician, what was the ophthalmologist’s exposure, and how might it be minimized?