Dilating Eye Drops Consent Form
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Please review the form, modify it to fit your actual practice, and place on your letterhead. Please offer the patient a copy of the form. The last page serves to verify that the surgeon has obtained informed consent from the patient; it can be copied and sent to the ambulatory surgery center if needed as verification of consent. This consent form is intended as a sample only and is provided as a risk management service. It is not intended to constitute a standard of care and should not be relied upon as a source for legal advice. If legal advice is desired or needed, an attorney should be consulted.
Version 12/2/2002
INFORMATION REGARDING DILATING EYE DROPS
Dilating drops are used to dilate or enlarge the pupils of the eye to allow the ophthalmologist to get a better view of the inside of your eye.
Dilating drops frequently blur vision for a length of time which varies from person to person and may make bright lights bothersome. It is not possible for your ophthalmologist to predict how much your vision will be affected. Because driving may be difficult immediately after an examination, it’s best if you make arrangements not to drive yourself.
Adverse reaction, such as acute angle-closure glaucoma, may be triggered from the dilating drops. This is extremely rare and treatable with immediate medical attention.
I hereby authorize Dr. and/or such assistants as may be designated by him/her to administer dilating eye drops. The eye drops are necessary to diagnose my condition.
Patient (or person authorized to sign for patient) Date
Witness Date
Medication Error Underlines Importance of Informed Consent
Digest, Summer, 1992
ALLEGATION Insured ophthalmologist was charged with negligence as a result of prescribing Betagan to an asthmatic patient which allegedly resulted in worsening of her asthma.
DISPOSITION Case was settled prior to instituting a lawsuit.
Background
The practice of ophthalmology calls for the use of very specific ophthalmic medication for the treatment of various eye conditions. However, it is important to consider a patient’s preexisting medical condition before prescribing some of these medications. Several OMIC claims have been identified where the ophthalmologist prescribed a beta-blocker for glaucoma therapy without considering its effect on the patient’s preexisting asthmatic condition. In these cases, the potential for the worsening of the asthma was alleged to have never been discussed with the patient prior to instituting a trial run of the medication.
Case Summary
The patient was an elderly female with a history of asthma which was noted by the OMIC insured on the first visit. On one visit, the insured noted elevated intraocular pressures of 29 OS and 16 OD and prescribed Betagan. The patient returned a month later complaining that her asthma had worsened since using the Betagan. The insured discontinued the medication and the patient improved. Later, the patient claimed she sustained “substantial” lung damage as a result of being on the medication for one month.
Outcome
Although the patient was never able to show “substantial” lung damage from the one-month use of the Betagan, it was believed that the drug aggravated her condition. Because there were no discussions with the patient indicating her asthma might be exacerbated while on this medication, the case was settled for a nominal amount.
Risk Management Principles and Commentary
This case demonstrates two very important principles in medication-error related claims and informed consent:
- Always review a patient’s medical history for preexisting medical conditions prior to prescribing any medication.
- Discuss the risks and adverse reactions associated with any prescribed medication.
If the patient is at least informed of the risks and complications associated with a particular medication and consents to try it, the ophthalmologist’s exposure is diminished.
Lack of Informed Consent for Use of Research Drug
By Mary Kasher, MSN, JD
OMIC Claims Manager
Digest, Fall 2000
Allegation
Lack of informed consent for use of investigational drug during cataract surgery.
Disposition
Plaintiff dismissed insured ophthalmologist from suit.
Case Summary
The plaintiff was a 57-year-old woman who had been a patient of the insured for several years during which time her refraction had changed every two or three years. At one visit, she complained of glare and a starburst effect along with a continued decrease in vision. VA OD was 20/70 and OS 20/80. After a discussion of the treatment options available (which included cataract surgery or continuing to adjust her refraction), the patient chose cataract surgery. She also agreed to participate in an ongoing research study on the effects of an experimental drug for cataract surgery after discussing the possible risks and complications of the drug with the ophthalmologist. The consent form was signed and witnessed and the patient was given a copy to take home.
The surgery was uneventful. Intraocular pressure in the surgical eye was normal at the end of the procedure in the surgical eye after the experimental solution was instilled. At the first postoperative visit the following day, intraocular pressure was again normal and vision was improved. Later, the patient recalled going to church and being amazed at how well she could see. About a week after the surgery, the patient began to notice that it took a long time for her eyes to adjust from bright outdoor light to dim indoor light and that her right eye appeared much hazier that the left one. She called the insured’s office the next morning. Upon examination, the insured found peripheral vision in the right eye to be extremely decreased. The patient was experiencing complete darkness or blindness from her outer vision to the center of her vision where she had a small “hole” of vision that appeared to be in focus. The dark area has not improved since this evaluation. The actual cause of vision loss was never determined, although there was conjecture that it was the result of an injury to the retina related to the investigational drug or transport solution.
Analysis
Every medical research project varies in purpose and design, but two areas consistently surface as primary issues under legal analysis: lack of informed consent and any breach in the research protocol. Anytime a procedure involves an experimental substance or process, the patient must be fully informed of the risks involved and sign the “approved” informed consent form for that particular program. Instructions for obtaining informed consent in a research situation must be followed without variation or the consent will be considered flawed and challenged for validity. The research protocol setting out the criteria by which patients are eligible for study and how the procedure is to be conducted also must be followed without exception.
In this case, the insured followed the consent protocol meticulously. All designated forms were signed and placed in the record, and the testimony of the office staff and the patient herself supported all signed informed consent documents. In addition, the insured made an exceptionally strong appearance at his deposition. He was well prepared and presented the facts and circumstances clearly and with appropriate concern. The plaintiff attorney was so impressed with the insured’s performance and clarity of his records that he decided it would be better for the plaintiff’s case to dismiss the insured.
Risk Management Principles
The insured’s dismissal from this legal quagmire demonstrates some sound legal principles for medical practice. When participating in a research study, it is extremely important to follow the protocols with particularity. If any patient harm develops from the study, the entire process will be scrutinized. Medical research study cases present unique documentation challenges since the record can give the plaintiff attorney many avenues for finding noncompliance. It is the completeness of the documentation that will prevail in proving that research protocols were followed as directed.
Discuss Potential Side Effects of Eye Drops
By Richard A. Deutsche, MD
Argus, January, 1992
Before routine eye examinations and refractions, what should you tell patients about cycloplegic or mydriatic eye drops? When should this information be given? How important is it from a risk management standpoint?
Fortunately, there have not been many liability actions related to the use of dilating drops, but in this litigious age it is wise to avoid surprising patients with even mildly distorted vision that they may blame as the cause of a problem after an eye examination.
A small, informal survey of ophthalmologists found that most do not discuss possible side effects of cycloplegic drops with their patients prior to instilling the drops. From a risk management point of view, however, I have found it prudent in my own practice to discuss the potential effects of glare, lack of accommodation and possible blurred vision, particularly with patients who drive to the office for their eye examination.
In my experience, most individuals have no problem driving following dilation as long as sunglasses are worn on bright days. However, if a patient is at all uncomfortable with the prospect of driving after dilation, I suggest to the patient that he or she reschedule the dilation or make other arrangements to get home. One way to avoid the inconvenience of rescheduling is to have your receptionist alert each patient at the time the appointment is made that dilation may cause side effects which might make driving difficult. This way the patient can arrange to have a friend or family member do the driving to and from the appointment.
Before instilling cycloplegic or mydriatic drops, it is also important to ask each patient about potential allergic reactions and, if there is a shallow anterior chamber, precautions should be taken to avoid acute glaucoma.
As with any aspect of patient care, each person should be treated as you would like to be treated yourself. Patients do not appreciate an unpleasant surprise. Malpractice actions can be avoided when new patients are properly informed.
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:
- Medication Error Study. Physician Insurers Association of America, Washington, DC. June 1993.
- Bettman JW. Seven Hundred Medicolegal Cases in Ophthalmology. Ophthalmology. 1990;97: 1379-84.
