Medication Errors Result in Costly Claims for Ophthalmologists

By Dean C. Brick, MD

Digest, Winter, 1995

Surveys indicate that medication errors are a frequent cause of medical malpractice claims. Not surprising given the fact that prescribing medication is the most common therapeutic service provided by physicians. The National Center for Health Statistics (NCHS) reported in 1992 that new or continued medications are ordered or provided at 63% of visits to a physician’s office. For ophthalmologists, the figure is 41%, i.e., medications are ordered or provided at more than 19 million patient visits a year.

Claims Frequency

A review of data collected on 117,000 claims and lawsuits by the Physicians Insurers Association of America (PIAA) reveals that medication errors are the second most frequent reason for claims against physicians and result, cumulatively, in the second highest indemnity paid behind faulty diagnosis and evaluation. The high frequency and severity of claims involving medication errors prompted the PIAA to study the problem in 1993. This article will cite some of the findings from that study.¹

Jerome W. Bettman’s review of Seven Hundred Medicolegal Cases in Ophthalmology indicates that medication errors are the third most frequent complaint against ophthalmologists following claims arising from cataract surgery and treatment of retinal detachments.²

Although medication errors account for only 2% (10 claims) of all claims against OMIC insureds, they have been expensive to defend and more often than not have resulted in an indemnity payment.

Claims Severity

OMIC analyzes the severity, or impact, of a particular type of claim by examining the average indemnity payment, average defense costs, large losses (cases over $100,000), cumulative indemnity payments and defense costs, and frequency of indemnity payment to the plaintiff.

The average indemnity paid by OMIC for a medication error is $115,000 compared to $95,000 for all other types of claims. The largest single medication error-related payment by OMIC was $500,000; the lowest was under $20,000. Medication errors have also been costlier to defend and more likely to result in indemnity payments. It costs OMIC twice as much to defend claims involving medication errors as it does to defend all other types of claims ($22,000 versus $11,000). Of the eight closed claims involving medication errors, seven closed with an indemnity payment to the plaintiff. (Overall, less than one out of four OMIC cases closes with an indemnity.) Medication errors represent only 2% of all OMIC claims; however, 4% of all defense costs and 12% of all indemnity payments go toward these cases.

The PIAA, Bettman, and OMIC claim reviews indicate that corticosteroids and antibiotics are the medications most often implicated in claims against ophthalmologists. The following closed OMIC claims are representative of cases involving the misuse of these two medications and that of another drug, silver nitrate.

Case One: Glucocorticoids

A 35-year-old obese male presented to the insured in June 1986 with a history of severe chronic uveitis that had been treated by another ophthalmologist two months earlier with systemic and topical prednisone. When seen initially by the insured, the patient’s VA was 20/400 OU. Bilateral subtenon’s injections of Depo-Medrol were given with hourly topical steroids and cycloplegics. Systemic prednisone was added when this regimen failed to control the uveitis. While on systemic steroids the patient’s vision improved; however, attempts to withdraw the systemic prednisone resulted in a worsening of the patient’s vision and uveitis. Although a workup was performed for the uveitis and a chest x-ray showed calcified granulomas, the ophthalmologist never made a specific diagnosis.

The ophthalmologist followed the patient over a period of several years during which he tried varying doses of systemic prednisone to control the uveitis. Numerous side effects and complications developed, and in January 1987, the patient was referred to an internist to monitor the steroid’s effects because of obvious weight gain and borderline diabetes. The patient underwent bilateral cataract extractions in 1988, but despite continuing therapy, achieved a VA of only 20/70 OD and 20/40 OS. An attempt to switch the patient to chlorambucil failed due to side effects. The ophthalmologist also attempted to refer the patient to the National Institutes of Health for treatment with cyclosporin, but the patient declined to be involved in the study.

In late 1989, the patient developed frank diabetes and hypertension. Treatment with systemic steroids continued until 1991 when the patient was admitted to the hospital with adult respiratory distress syndrome (ARDS) and died. The cause of death was systemic candidiasis and ARDS probably caused by steroid therapy. The autopsy also revealed the patient was HIV positive. The patient’s family sued the insured ophthalmologist for wrongful death caused by negligent prescription management of steroid therapy. The case was settled prior to trial for less than $20,000.

Discussion

A number of issues make this case instructive. On the surface it appears the insured ophthalmologist did all he could to treat and monitor the patient appropriately, and in fact, most of the experts who were deposed in this case were not critical of the insured’s treatment. However, there are a number of things that ophthalmologists in these types of situations might do to minimize the risk of such claims.

First, when treating a patient with a severe recalcitrant disease, it is a good idea to bring in a consultant to help monitor the systemic effects of the treatment. It also is important to consult with an expert in the subspecialty involved to confirm that your course of treatment is the best one and that all other avenues of treatment have been explored. In this case, a confirmatory consult by a uveitis specialist would have further supported the prolonged treatment with high dose steroids. A referral back to the subspecialist after one or two years would have further shown that the insured was monitoring the need for continued treatment.

Second, document in the patient’s chart the reasons for the prolonged treatment and indicate that the side effects and complications of treatment have been discussed with the patient. This rebuts later claims by the patient or the patient’s family that they were not told of possible adverse reactions and outcomes related to a prescribed course of treatment. The PIAA Medication Error Study found that after “incorrect dose,” communication failure between physician and patient was the most common error associated with glucocorticoid therapy.

Although a written informed consent document signed by the patient may not be necessary, the physician should document that a discussion took place regarding the potential side effects of a prescribed drug and the consequences of not using the drug. If pamphlets and fact sheets describing the risks of longterm drug therapy are given to the patient, this should be documented.

The same applies when prescribing a drug with potentially severe and generally recognized complications (e.g., systemic steroids and immunosuppressive drugs). Obtain a second opinion to confirm that the drug is indeed the best choice for the patients in question and discuss the potential side effects of the medication with the patient, documenting that you did so.

Third, use established criteria to judge the response to therapy and record it in the patient’s record. If, after a sufficient trial of therapy, there is inadequate or no response, consider a second opinion or another form of therapy. Your best protection is evidence that you consistently acted in a timely and appropriate manner in the best interest of the patient.

Fourth, when co-managing patients with internists, such as rheumatoid patients on Plaquenil, orbital cellulitis patients, or patients in treatment for tuberculosis, make sure that the individual areas of responsibility are clearly documented in the patient’s record (e.g., who is managing the dosage and monitoring the response or complications). Report all test results to the co-managing physician, either in written form or with a documented phone call. Make sure the patient understands your role and any important symptoms that should be reported to you.

Case Two: Corticosteroids

A 65-year-old male, who had been followed by the insured for many years and had previously undergone a successful cataract and implant surgery in the right eye, presented to the insured with complaints of glare when looking at a distance and difficulty reading. Best corrected vision OS had decreased to 20/60. The insured elected to perform cataract surgery in the left eye.

Surgery was uncomplicated, and at the end of the surgery Celestone and Garamycin were injected subconjunctivally. The following day vision was limited to light perception and examination revealed a whitish area with hemorrhage in the retina. The ophthalmologist thought that some of the Celestone may have been inadvertently injected into the vitreous cavity and immediately referred the patient to a retinal specialist. A pars plana vitrectomy was performed and white crystalline matter was removed. The retina remained attached, but vision was limited to light perception initially and later diminished to no light perception as optic atrophy became evident.

The patient initiated a claim against the ophthalmologist, alleging negligence in injecting coricosteroid into the vitreous and causing irreparable damage to the eye. This case was settled for $50,000.

Discussion

The risk of an intraocular injection is always present, and extreme care must be used when giving injections around the eye. There can be a tendency to relax and lose concentration, or “let down your guard,” after completing the difficult part of a surgery or a procedure. This is dangerous. Any injection around the eye must be administered carefully and preferably where the tip of the needle is visible, or with a large bore needle which is less likely to penetrate the globe.

Case Three: Antibiotics

The patient was a 37-year-old male who presented with complaints of left lower lid swelling of three days duration. The patient’s written history noted that he was not on any medications, but had a known penicillin allergy. The ophthalmologist diagnosed a hordeolum and prescribed warm compresses and ampicillin 250 mg TID for five days. After two doses of ampicillin, the patient called the ophthalmologist’s office to complain of skin rash and generalized itching. He was instructed to discontinue the ampicillin and was switched to tetracycline 500 mg TID for five days. Meanwhile, the patient went to an employee health clinic and was treated with Benadryl and a Medrol Dose-Pak.

Five days after seeing the ophthalmologist, the patient was admitted to the hospital with confluent, erythematous rash over his entire trunk and extremities and was treated with intensive IV steroids, H1 and H2 blockers, and topical steroids. He improved rapidly and was discharged three days later on tapering doses of oral steroids, topical steroids, and Benadryl with instructions to avoid the sun for one month. Subsequently, the patient developed severe episodes of skin rashes and had a skin biopsy showing nonspecific chronic dermatitis.

The patient sued the insured ophthalmologist, alleging negligence in prescribing ampicillin to a patient with a known penicillin allergy, which resulted in the patient requiring hospitalization. The patient further alleged that he had residual dermatological photosensitivity and an increased risk of severe anaphylactic reaction if exposed to penicillin again. The case settled for $25,000.

Discussion

The prescription of a medication to a patient with a documented allergy to that medication is one of the most common causes for medication error claims. For this reason, all allergies to common medications used in the practice of ophthalmology should be recorded in a prominent place on the front of the chart, or in another location that will not be concealed by lab reports, etc. Before writing out a prescription, ask again if the patient has any known drug allergies. Since many prescriptions are handled by phone, train your assistants always to check for drug allergies in the patient’s chart or verbally with the patient prior to finally issuing a prescription over the phone. That telephone conversation and prescription should then be documented in the medical record.

Case Four: Silver Nitrate

A fifty-eight-year old male consulted the insured ophthalmologist for an opinion concerning the insertion of punctal plugs for a dry eye condition. Examination revealed a best corrected vision of 20/30 OU. External examination revealed no evidence of thyroid ophthalmology and slit lamp examination demonstrated hyperemia of the superior bulbar conjunctiva OU and papillary hypertrophy of the superior tarsal conjunctiva OU. The cornea demonstrated some fluorescein staining and a few corneal filaments superiorly. The ophthalmologist diagnosed superior limbic keratoconjunctivitis OU and proceeded to treat the right eye with silver nitrate, a procedure he had never performed before. Dacriose was used to dilute the silver nitrate on the end of a silver nitrate stick. The stick was applied to the everted upper lid of the right eye, the lid was allowed to return to normal position, and a “silver sheen” to the cornea was noted. When the patient complained of burning, the insured immediately irrigated the eye with dacriose for at least one minute.

Later that day, the patient was seen in a clinic with severe eye pain OD and referred to a hospital ER where the insured ophthalmologist saw the patient and diagnosed a severe chemical burn. The insured continued to treat the patient for several months until the patient left his care. The insured’s final examination of this patient revealed a visual acuity of 20/200 OD with a hazy cornea and moderate conjunctival injection.

The patient brought suit and alleged that the ophthalmologist negligently administered silver nitrate to his right eye, causing a severe corneal burn and loss of vision OD. The case was settled with a large indemnity payment.

Case Five: Silver Nitrate

The patient was a 35-year-old male who presented with complaints of a sandy itchy sensation in both eyes and decreased vision. The ophthalmologist diagnosed keratitis sicca and superior limbic keratoconjunctivitis, and treated the patient with a moistened silver nitrate stick applied to the conjunctiva at 12 o’clock. A drop of the silver nitrate dripped on the cornea, immediately causing a chemical burn which the ophthalmologist treated with lavage, cycloplegia, and antibiotics.

After the incident, the ophthalmologist followed the patient at regular intervals. He tried treating the SLK with Tobradex, but this caused increased IOP and was discontinued. Silicone plugs were inserted to treat the keratitis sicca. Eventually, a small posterior subcapsular cataract developed in the right eye. The patient was referred to a corneal specialist, who was able to alleviate the SLK with a conjunctival resection on both eyes. Currently, the patient is being evaluated for photorefractive keratectomy to remove the anterior stromal scar. A claim brought by the patient against the insured ophthalmologist was settled for $20,000.

Discussion

Diagnosis of SLK is sometimes missed by the general ophthalmologist. In the cases cited here, the ophthalmologists promptly and accurately diagnosed SLK; however, the poor outcome and resultant claims were allegedly related to the techniques used to treat the problem. To help avoid such claims, general ophthalmologists should take the time to review the proper technique for using silver nitrate. When doing a procedure for the first time or one that you have not done since your residency years ago, especially if it is a procedure that carries a significant risk, check and double-check the proper technique before proceeding. If indicated, ask a colleague who is experienced in the procedure to assist you the first several times you do it. Our profession recognizes the need to document recent training in new procedures such as laser sclerostomy and ALK, but sometimes fails to be equally cautious about procedures that are not normally a routine part of general practice.

Medication-related errors can cause serious injury and result in costly claims. Drug therapy is an integral aspect of ophthalmology and cannot be avoided. However, the following risk management suggestions may help prevent medication maloccurrences and provide a strong defense if a claim arises:

• Be humble enough to use consultants and to obtain second opinions when appropriate.
• Be vigilant in all procedures, including the administration of medications and injections and what may seem to be innocuous procedures or prescriptions.
• Consistently and conspicuously post medication allergies in the patient’s chart, and review the chart before prescribing any medication.
• Discuss the potential side effects of drug therapy with the patient and document that this discussion occurred.
• Make it easy for you and your staff to avoid medication errors by making patient medication information and informed consent documents readily available. Train and oversee your staff to ensure that medication guidelines and precautions are followed.

Notes:

1. Medication Error Study. Physician Insurers Association of America, Washington, DC. June 1993.
2. Bettman JW. Seven Hundred Medicolegal Cases in Ophthalmology. Ophthalmology. 1990;97: 1379-84.

Wrong Power IOL Inserted During Cataract Surgery

By Randy Morris, JD
OMIC Claims Associate

Digest, Summer 2000

Allegation

Wrong power IOL insertion led to complicated lens exchange surgery.

Disposition

Case settled on behalf of insured ophthalmologist and ophthalmic group.

Case Summary

A 59-year-old female patient presented to the insured with complaints of glare and significant decrease in her visual acuity OS. Corrected VA was 20/20 OD, 20/25 OS. Glare testing showed decreased VA of 20/80 OD and 20/100 OS. After a discussion with the patient, the insured performed what he thought was an uncomplicated cataract surgery OS. One day post-op, VA with pinhole was 20/150. Anterior chamber showed 2+ cells. The patient was started on Tobradex four times daily and told to return in one week. Later that day, the operating room nurse informed the insured that the wrong IOL had been delivered into the field. The insured had inserted a 17.0 diopter lens instead of a 20.5. The insured contacted the patient to explain what happened and suggested a lens exchange.

During the lens exchange surgery, the iris was caught in the scissors when the implant was being cut in the anterior chamber. A slight cut to the iris was noted at 12:00. The next day, VA OS was LP with marked corneal edema. Over the course of approximately two months, the patient’s VA improved to 20/150. The insured referred the patient to a corneal specialist, who performed a corneal transplant. The patient eventually had a VA with refraction of 20/25 OS, although she continued to complain of residual cloudiness due to posterior capsule haze.

Analysis

The insured maintained that responsibility for the incorrect lens insertion lay primarily with the nurse because the insured had performed the correct tests, specified the correct lens in his records, and inserted the lens properly. However, under the “captain of the ship” doctrine, the surgeon is deemed to be the person in charge in the operating room and is ultimately the one held responsible for any complications of surgery, even those caused by the actions of others. While the use of this doctrine is on the decline in many jurisdictions, plaintiff attorneys are still able to use it occasionally in situations such as this. Furthermore, the plaintiff could argue that it is the surgeon’s responsibility to verify that the correct lens is being inserted at the time of surgery. In light of this, the defense team and the insured agreed to settle the case on behalf of the insured ophthalmologist, the ophthalmic group, and the nurse codefendant.

Risk Management Principles

Fortunately, this kind of error does not occur frequently and can be avoided with due diligence and efficient sign-off procedures. Effective communications among surgical personnel, augmented by a system of checks and double checks, can go a long way toward preventing mix-ups. Many surgery centers require that the lens power be checked against the medical record and signed off by two people prior to surgery, then verified again visually and verbally by the assistant and the surgeon when the lens is handed to the surgeon for insertion. While such redundancy may sound inefficient or unnecessary, this attention to detail may well help prevent the captain from going down with the ship.

Negligent Telephone Care of Postoperative Patient

By Anne M. Menke, RN, PhD OMIC Risk Manager

ALLEGATION  Delay in diagnosis and treatment of retinal detachment following cataract surgery.

DISPOSITION  Defense verdict at trial.

Case Summary

A 58-year-old female with lattice degeneration had uncomplicated cataract surgery. Three months post-operatively, the patient called the surgeon to report seeing branches and black spots of one day duration and was told to come in. She denied seeing flashing lights. BCVA was 20/25, and a dilated fundus with scleral depression examination of the right eye revealed vitreous hemorrhage and floaters. The macula and peripheral retina were flat without holes, tears, or evidence of retinal detachment. The ophthal- mologist prescribed bed rest (with the head of the bed elevated at 30 degrees) and advised the patient to follow up in 1 to 2 weeks or sooner if she developed increasing floaters, photopsia, or a veil/curtain formation.

The patient said she called the office four days later to report that she could barely see through a dark bubble. She claimed to have spoken to the receptionist, who consulted with the ophthalmologist, and was told not to worry. There was no documentation of the call. In deposition, the insured recalled being told only that the patient wanted to know when the floaters would resolve. She believed that she either asked the receptionist to call the patient back and verify the lack of new symptoms or that she called the patient herself. Five days later, the patient called again and said she was coming in. At the visit, she reported fluctuating vision and was noted to have a VA of CF, with both a horseshoe tear and a macula-on retinal detachment in the superotemporal quadrant. The insured spoke with a retinal specialist, who agreed to see the patient the next day; the call was not documented and the specialist had no recall of the conversation. When the patient was seen the next day, the detachment had progressed to macula-off. The patient had a scleral buckle, vitrectomy, air/fluid gas exchange, and endolaser surgery. At the time of trial eight months later, the retina was still attached, with vision pinholed to 20/60; the patient reported multiple visual problems.

Analysis

Plaintiff experts focused on the increased risk of retinal detachment in patients with lattice degeneration and cataract surgery. They doubted the ability to visualize the retina in the presence of vitreous hemorrhage and criticized the delay in referral to the retinal specialist then and when the detachment was diagnosed. Defense experts supported the insured’s examinations and treatment; more- over, they felt strongly that an experienced cataract surgeon, who had explicitly warned the patient about retinal detachment, would never ignore reports of a dark bubble. The lack of documentation, especially of the phone calls with the patient and the retinal specialist, became the focal point of the trial. Jurors who returned a defense verdict later explained that the plaintiff lost credibility when she refused to pursue the recommendations of a blind vocational rehabilitation expert. Nonetheless, they had sharp criticism for the insured’s call screening process and failure to document telephone care.

Risk Management Principles

Telephone screening of eye complaints, especially in postoperative patients, is an extremely risky aspect of ophthalmic practice and a regular feature of malpractice lawsuits. Physicians need written protocols, including contact forms that prompt them and their staff to ask crucial questions and document the responses, as well as guidelines to determine when the patient needs to be seen. Such sample forms and protocols are available online and from OMIC’s Risk Management Department (see cover article). The physician’s screening process is intended to gather the information necessary to develop a differential diagnosis that includes the worst case scenario for the patient’s presentation. In this case, the ophthalmologist clearly identified the risk of retinal detachment, but she could have been more proactive in managing it by making an early referral to a retina specialist to verify her examination in the presence of hemorrhage and by scheduling frequent follow-up visits before the patient left her office.