Ординатура / Офтальмология / Английские материалы / Risk Prevention in Ophthalmology_Kraushar_2008

he was told to return the next day. His vision at this initial examination was 20/20 in the unaffected eye and 20/50 in the injured eye. The patient returned the next day with vision of 20/40, and no aqueous leakage from the anterior chamber was seen. The patch was stopped, the antibiotics were continued, and he was told to return in 4 days.

The next day, the second day after the accident, the patient referred himself to an ophthalmologist when his vision decreased. Vision was noted to be hand motions now, and no leakage was seen from the wound. There was no view of the anterior chamber, and the patient was referred to a retina specialist who did a B scan. A reflective image in the vitreous was noted, but no retinal detachment was detected. It was felt that the reflection in the vitreous could represent a foreign body, and a CT scan confirmed an intraocular foreign body. The patient underwent a lensectomy, vitrectomy, and an unsuccessful attempt at removal of the foreign body. He was given intraocular antibiotics and 2 days later was taken back for further surgery to remove the foreign body. A pars plana vitrectomy with membrane peeling, partial retinectomy, and foreign body removal was done. Eventually the patient had an enucleation for uncontrolled endophthalmitis.

Comments

In this case the emergency room physician who saw the patient could not be defended, as he did not do a CT scan, x-ray, or B scan at the initial visit. Although there was no aqueous leak, with a full-thickness laceration and a hyphema, it was essential to do the appropriate examination of the posterior pole to rule out an intraocular foreign body. Despite the attempts at foreign body removal, which were unsuccessful at first, the endophthalmitis that had ensued made it more difficult to remove the foreign body.

Most of the liability in this case was placed in the hands of the initial physician who did not order the appropriate tests on the initial visit. Obtaining an x-ray, CT scan, or B scan when a full-thickness laceration is evident in the cornea or corneoscleral area should be routine to rule out the possibility of a retained intraocular foreign body.

Case 3

A 10-year old boy presented to the emergency room with tearing, conjunctival injection, and slight blurred vision in one eye. This condition had been present for 2 days prior to the emergency room visit. The physician in the emergency room, who was not an ophthalmologist, used a penlight and diagnosed conjunctival injection and follicular hypertrophy, but as the cornea appeared clear during the penlight

examination, the patient was told that the cornea was not involved. The patient was treated as a possible bacterial conjunctivitis or an allergic conjunctivitis. The patient was given Blephamide drops to use four times a day. Blephamide is a combination of sulfacetamide 10% and prednisolone 0.25%. The patient was told to return in 2 days to the emergency room.

When the patient returned, the eye was still infected, the vision was slightly reduced, and the patient still had discomfort. At this point, the emergency room physician referred the patient to an ophthalmologist for treatment. On examination that afternoon, the ophthalmologist found acute dendritic keratitis, with a dendritic ulcer in the cornea. Two days use of Blephamide probably made the dendritic lesion worse, as steroids are contraindicated with herpetic dendritic keratitis. Unfortunately, this patient went on to form stromal and disciform keratitis, with loss of vision and the necessity for chronic treatment of his herpetic stromal keratitis. Whether this would have occurred without the use of Blephamide is not clear, but the emergency room physician was sued.

Comments

There is really no defense for any physician who starts topical steroids, even if combined with antibiotics, for anyone who has an acute red eye if there has been no slit-lamp examination to definitely rule out herpes simplex virus infection. If the emergency room physician had prescribed just an antibiotic and sent the patient to the ophthalmologist a day or two later, there would have been far less issue about treating this patient inappropriately, even if he did not improve. The important lesson here is that every emergency room physician, whether ophthalmologist or nonophthalmologist, must use a slit lamp to rule out herpes simplex virus infection if topical steroids are going to be used on the eye.

Ophthalmologists seeing patients for external disease problems, either in their offices or in an emergency room, must not take short cuts in their diagnoses. Patients seen in the emergency room with corneal abrasions must have a full slitlamp examination with fluorescein dye, or a similar diagnostic dye, and they should not be patched but rather treated with antibiotics and seen appropriately in a day or two to determine how the disease course is going. Nonophthalmologists who do not use a slit lamp in the emergency room must never treat a patient with topical steroids, even though steroid, antibiotic combinations such as Blephamide, TobraDex, or Vasocidin are tempting to use to treat both the infectious part of the problem and the inflammatory component as well. These medications should be reserved for only those patients who have had a slit-lamp examination with appropriate diagnostic dye to rule out possible viral keratitis. Emergency room physicians/ophthalmologists must always order the appropriate tests, with x-ray, CT scan, or B scan, to rule out posterior segment involvement.

With the slit-lamp appearance of a full-thickness scar, a posterior examination always should be done. A dilated fundus examination is not enough, as the foreign

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body may be in the far periphery or may have slipped behind the iris so that it is not visible on indirect ophthalmoscopy after dilated pupil examination. The last point to be made is the fact that physicians should err on the side of seeing the patients sooner rather than later. Follow up of a patient is particularly important for any ocular inflammation but particularly for possible infections, whether they be bacterial, fungal, Acanthamoeba, or viral. It must be impressed upon the ophthalmologist that if patients do not keep their follow-up appointments, they should be called, and this should be documented on the chart. Chart documentation of calls to the patient is critically important in the defense of lawsuits.

With these precautions, the ophthalmologist can feel comfortable in diagnosing and treating appropriately and not fearing a lawsuit for a bad outcome. If the physician follows the standard of care, and if there is a bad outcome, it is a much easier case to defend.

Acknowledgment I would like to thank OMIC (Ophthalmic Mutual Insurance Company) for providing background information. Further information can be found at www.omic.com.

References

1.Clemons CS, Cohen EJ, Arentsen JJ, Donnenfeld ED, Laibson PR. Pseudomonas ulcers following patching of corneal abrasions associated with contact lens wear. CLAO 1987;12(3):161–164.

2.Khor WB, Aung T, Saw SM, et al. An outbreak of Fusarium keratitis associated with contact lens wear in Singapore. JAMA 2006;295:2867–2873.

3.Chang DC, Grant GB, O’Donnell K, et al. Multistate outbreak of Fusarium keratitis associated with use of a contact lens solution. JAMA 2006;296:953–963.

for relevant clinical articles; (3) critically appraise the evidence for its validity and usefulness; and (4) implement useful findings in clinical practice. Such a conscientious and explicit practice of using the best external evidence when making medical decisions is called evidence-based practice.

In an evidence-based review of available clinical studies, the highest rating is given to randomized trials and metaanalyses. However, clinicians must understand the limitation of the published literature in terms of its generalizability and applicability to their patients and integrate clinical expertise and patient’s choice into the clinical decision.3,4 Evidence-based reviews of current topics in medication use in ophthalmology are conducted and published in major journals to provide up-to-date information for ophthalmologists. Both for-profit and nonprofit organizations are providing evidence-based reviews in a wide variety of topics in medicine, many of which are accessible through the Internet or available to clinicians by subscription. One such nonprofit organization is the Cochrane Collaboration, founded in 1993 and named for the British epidemiologist Archie Cochrane. It is an international independent organization, dedicated to produce and disseminate up-to-date evidence-based reviews of health care interventions worldwide. The major product of the Collaboration is the Cochrane Database of Systematic Reviews, which is published quar-

terly as part of “The Cochrane Library” on the website www.cochrane.org.

Another source of relevant information for prescribing in ophthalmology is the rigorous medical practice guidelines developed by the American Academy of Ophthalmology. Practicing ophthalmologists should be familiar with them. The practice guideline and the evidence-based approach may provide a basis for correct prescribing of medication and turning down patient demands for high-cost or questionably beneficial intervention and offer a refuge from malpractice litigation.5

What Is the Role of the Physicians’ Desk Reference in Prescribing?

The Physicians’ Desk Reference (PDR) contains warnings issued by drug manufacturers of all relevant adverse information about all products they market. If a drug company has given such warnings and the physician has not heeded them, then the physician is clearly not on solid ground. However, clinicians should not rely on the PDR as the last word on product information, especially related to the safety of therapy. Some rare but severe side effects may be recognized only after market approval.4

What Medications Are Implicated the Most in Lawsuits

Against Ophthalmologists?

Corticosteroids and antibiotics are the two classes of medications most often implicated in claims against ophthalmologists. The reasons that these two classes of medications are linked to lawsuits are probably related to the severity of the diseases that require their use and their systemic effects and side affects.1,2,6

What Kind of Medical or Drug Information Should Ophthalmologists Be Aware of When Prescribing?

Allergy

Prescribing a medication to a patient with a documented allergy to that medication is one of the most common causes of 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 other reports or notes.

It is always a good practice before writing out a prescription to ask again if the patient has any known drug allergies. Because many prescriptions are handled over the phone, assistants should be trained 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. The telephone conversation and prescription should be documented in the medical records.

Update of Medication Administration

Before procedures that carry a significant risk, the proper techniques of drug administration, such as subtenon injection of steroid depot and topical application of silver nitrate, should be carefully reviewed. One may choose to consult a colleague who is experienced in the procedure to assist or supervise the first several times.

Drug Interaction

We must be aware of interactions of drugs we prescribe with those that the patient is already using. Some of the interactions may have severe outcomes. For example, the potentiating effect of acetazolamide on warfarin sodium may result in a major hemorrhage.

How Much Documentation Is Necessary?

In analyzing malpractice claims against ophthalmologists that were closed with patient indemnification of at least $250,000, altered records, poor documentation, and informed consent problems are among the most frequent factors influencing the decision to seek a settlement.7 Appropriate documentation is never too much.

Adequate notations should be made in office records of what was prescribed and why. Diagnosis correlated to prescribed therapy is a must. A notation about

follow up should also be included. Documentation in cases that require prolonged treatment should include that a discussion has taken place regarding the reasons for the prolonged treatment, the side effects and complications of treatment, and the consequences of not using the drug. Any pamphlets and fact sheets describing the risks of long-term drug therapy given to the patient should be documented, as well as telephone or email communication between the office and the patient. One may consider using a duplicated prescribing pad that automatically produces an extra copy of the prescription for filing either chronologically or as a part of the patient’s chart.

How Can Charts and Medical Records Help Avoid

Prescription Errors?

Keeping information regarding the current condition of the patient up to date can help ophthalmologists avoid possible adverse drug–drug or drug–medical condition interactions. A built-in system in the initial examination or follow-up forms or electronic medical record template to require obtaining the patient’s current list of medications or changes in medical condition, recent hospitalization, new medications, or newly developed allergies can serve such purpose.

Some medications and medical conditions may affect the way we prescribe medications. Important examples are system anticoagulation therapy and decrease of pulmonary or cardiac function. A newly known allergic drug reaction may require a change in the ocular therapy.

One way to alert the ophthalmologist is to place information regarding the allergic reaction and important systemic medical condition or medication on an area of the chart that is obvious or flashed on the initial page of the electronic medical record. For instance, a patient with chronic obstructive pulmonary disease or asthma, a sulfa allergy, or on systemic anticoagulation therapy would have this information listed on the chart in an obvious location.

How to Avoid Errors in Writing Prescriptions

Although there are limited data on the rate of prescribing errors on an outpatient ophthalmic basis, such errors in an eye hospital setting may serve as a reference. In a single specialty eye hospital in the United Kingdom, 8% of prescription sheets were found to have errors. Errors consisted of incorrect patient details such as patient name, hospital number, or date of birth, illegibility, incorrect format, prescriptions for which the prescribing doctor could not be identified, and incorrect drug dosage, timing, or route of administration.8 Prescribing ophthalmologists should review and be familiar with the correct format of prescription writing as required by the pharmacy law and always write legibly.

Prescribing errors regarding drug dose, schedule, or route of administration may be minimized with computerized medical record keeping. In a study of the impact of computerized prescribing on the outpatient prescribing errors in adult primary care practice, physician reviewers judged that advanced computerized prescribing with decision support (such as drug-dose checking and drug-frequency checking) could have prevented 97% of prescribing errors and 95% of potential adverse drug events.9

Other than error in prescription writing, failure of communication between physician and patient and among physicians caring for the same patient is another major source of malpractice claims in medication error. An analysis of medication error claims by the PIAA in which indemnity payments were made, problems in communication accounted for approximately 18% of all claims. They include communication failure between physician and patient (6.7%), inadequate medical history (4.7%), failure to note previously listed allergy (3.7%), and communication failure between physician and other provider (3.0%).10

How Should Ophthalmologists Handle Medication Refills?

Refills are authorized by the physician or, more often, by the office personnel. Ophthalmologists should develop and train office workers to adhere to the policy of authorization of refill with appropriate documentation. In some instances, pharmacists have refilled the prescription and claimed they had been given a verbal order by the physician, and patients have lied to pharmacists by saying approval had been given by the physician when in fact it had not been given. It is not unusual to have patients miss follow-up appointments for a long period of time (months to years) but continue receiving refills of medications from different physicians and pharmacies. Patients who have missed follow-up appointments should be advised to return to be evaluated before further authorization of refill is given to the pharmacist.

How to Handle Drug Samples

A sample is defined as a unit of drug intended not to be sold but rather to promote the sale of the drug. Samples from manufacturers and distributors may be distributed only to practitioners licensed to prescribe.

When a sample is given to a patient, no charge should be incurred. Although samples are not required to be labeled as medication dispensed by a pharmacist, clear instruction of use should be given.

Some physicians dispense medication directly to the patients as a way to supplement their incomes. Pharmacists asked the U.S. Food and Drug Administration (FDA) to stop such practice and apply the Durham-Humphrey Amendment’s standard to physicians as well. However, the FDA took the position that the labeling requirements

of the law apply only to pharmacists, not physicians. On the other hand, many states enacted legislation in the 1980s mandating that dispensing physicians meet the same or similar dispensing requirements as pharmacists.11

Should Generic Eye Medication Be Used?

Supposedly, a generic drug is a drug that has the same composition quantitatively as well as qualitatively of the active compound as the original drug. It also has the same pharmaceutical mode of action and the same bioavailability, as determined in bioavailability studies. However, this may not be the case with ophthalmic drops.12

The Drug Price Competition and Patent Term Restoration Act of 1984 laid the foundation for current generic drug policy. This act requires that the bioequivalence of the generic drug to the parent compound be demonstrated. Bioequivalent drug products are products that contain the same active ingredients; are identical in strength or concentration, dosage form, and route of administration; and have comparable bioavailability when studied under similar conditions. For bioequivalence to exist, bioavailability (the rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body) of the various products must be similar when administered at the same dosage and under similar conditions. However, bioavailability studies do not usually measure drug availability at the site of action, but only their concentration in blood or body fluids. It is obviously difficult to assess drug penetration and bioavailability by the eye. Animal testing also is unable to address the compliance issues that may result from generic substitution.12

According to Title 1 of the Drug Price Competition and Patent Term Restoration Act, exception excipients (or inactive ingredients) may differ from the referencelist drug. For a topical ophthalmic solution, exception excipients include preservatives, pH adjusters, antioxidants, thickening agents, buffers, and substances to adjust tonicity. In other words, essentially all excipients in a topical ophthalmic solution are considered exception excipients and can differ from the reference-list drug. Generally, if the exception ingredient in the generic product does not have a concentration that is greater than that in another approved product administered in a similar fashion, then it will be presumed safe. A quantitative difference is defined as a concentration greater then ±5% compared with the reference-list drug.12 In the case of ophthalmic products, considerations with respect to “generic equivalence” may also include the delivery device, namely, the bottle and droplet tip.13

Recent problems with generic ophthalmic products do suggest inequivalence to the brand products. For example, (1) some generic formulations of prednisolone acetate 1% were noted to have poorly suspended constitutions, and caking of the drug precipitated product clogging the dropper tip; and (2) generic diclofenac has been associated with many cases of corneal toxicity, ranging from superficial punctate keratopathy to full corneal melting.13

Problems with bioequivalence can be more severe in developing countries. Twenty percent of generic ciprofloxacin eye drops sold in India were underpotent.