The High Cost of Refused Care

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

Digest, Winter 2013

A patient calls to report symptoms suggestive of endophthalmitis but refuses to drive to a satellite office where the ophthalmologist is working that day. A patient who recently had cataract surgery calls the surgeon to complain of headaches unrelated to the surgery but won’t go see her primary care physician. A glaucoma patient refuses to come in for a follow-up visit to perform visual fields and check the optic nerve but wants the ophthalmologist to keep refilling her prescription. A comprehensive ophthalmologist refers a patient to a glaucoma expert for surgery but the patient won’t go. The parents of a minor patient with retinoblastoma won’t agree to surgery. These narratives are just a few of the many examples of situations where patients of OMIC-insured physicians, or patients’ representatives, have refused care. These patients and parents gambled that they could beat the odds of not only vision-threatening but life-threatening conditions. All patients sustained harm, and all sued their ophthalmologist when they did. In this issue of the Digest, we explore the high cost to patients and physicians alike when care is refused, and we propose ways to reduce this risk.

Who may refuse?

Physicians may be uncomfortable when care is refused, but recognize that adult patients have the legal right to consent to, or refuse, recommended care. Indeed, this right is the premise behind informed consent discussions, where the physician explains the patient’s condition, proposed treatment, and its risks, benefits, and alternatives, including no treatment. In order to make a meaningful choice, however, adult patients must have decision-making capacity (DMC). Adult patients are presumed to have DMC if they appear to understand their condition and the risks associated with the recommended treatment, and are able to communicate their wishes. In the Fall 2010 issue of the Digest, we addressed the need to screen for dementia, especially in older patients. Patients who seem “difficult” and miss appointments or refuse care may actually be suffering from dementia, so the first step in assessing a patient’s refusal of care is to consider cognitive impairment. Such patients should be referred to a primary care physician for evaluation. See “Older Patients Need Additional Informed Consent Consideration” for a discussion of dementia screening tools and surrogate decision-makers.

Clarify why care is refused

Having ruled out cognitive impairment or lack of decision-making capacity in adult patients, the ophthalmologist will next want to ascertain the reason for the patient’s refusal. Ophthalmologists and staff are often quite frustrated when patients refuse recommendations, and just as often make assumptions about the reasons. The healthcare team members may lose important opportunities to intervene if they do not take the time to discern the patient’s motives. A simple, straightforward approach can be very effective: “You’re not willing to have the surgery? That is certainly your choice, but I would like to understand your decision. Can you tell me more about it?” Sometimes, patients disagree with the diagnosis: “I don’t need the surgery because that is not what’s wrong with me!” Keeping an open mind, the physician can ask the patient “What do you think is wrong?” Staff can play an important role by anticipating problems with compliance, and letting patients know that it is acceptable to ask questions.

Educate the patient about the disease process and treatment recommendations, targeting the education to the reason for the refusal. When possible, identify social service resources that may help, such as pharmaceutical companies that may provide free or reduced-cost medications. Have information available about the enrollment criteria and process for obtaining state and federal assistance, and be aware of transportation services for patients. If the care is not authorized by the patient’s insurance, act as an advocate and appeal the decision. If the main reason behind the refusal is an unwillingness to pay for care, a different approach is needed. See the Hotline article for suggestions on how to handle this.

Duty to warn

If the patient persists in declining recommended treatment, the physician must then obtain what is referred to as “informed refusal.” While courts have recognized the patient’s right to refuse treatment, they have consistently ruled that the decision must be an informed one. OMIC’s claims experience has shown that experts and juries alike consider the patient to be “ignorant until proven educated.” To ensure that patients have adequate information on which to base their choice, physicians are thus required to warn patients of the foreseeable consequences of refusing treatment, such as reduced vision or blindness.

Some refused care situations are straightforward, prompting physicians and their staff to warn patients. In the lawsuit featured in this issue’s Closed Claim Study, a postoperative patient with symptoms highly suggestive of endophthalmitis was asked to come in to a satellite office where a physician could see him immediately since the office he usually went to was closed that day; the patient refused to drive to the other office, claiming it was too far away. Staff and the ophthalmologist were concerned and repeatedly warned the patient that a delay in treatment could lead to serious vision loss or blindness in that eye—all to no avail.

Physicians can only warn of consequences they foresee. About eight days after cataract surgery and the implantation of a premium intraocular lens (IOL), a patient reported that she had experienced migraine-like headaches since the procedure and had been awakened at 3 am by one the night before her appointment. When the eye exam was unremarkable and the only finding was a tender area in the right sub-occipital area, the eye surgeon informed the patient that the IOL was not causing her headaches and instructed her to contact her primary care physician (PCP) to explore other causes. The headaches persisted to the point that the patient called the ophthalmologist five days later and asked to have the IOL removed. The physician again advised her to see her PCP or go to the emergency room. She refused to do either, convinced they would only prescribe more pain medication. The patient was worked in to the ophthalmologist’s schedule several hours later and was so ill that she vomited twice while in the waiting room. The eye exam was again normal. Concerned, the ophthalmologist contacted the PCP himself and arranged for the patient to be seen right away. She saw her PCP that day and a CT was performed. The patient collapsed and died the next day right after a return visit to the PCP. The CT showed a large, chronic subdural hematoma, confirming that the cause of the headaches was not related to the cataract surgery. The ophthalmologist was criticized by both plaintiff and defense experts for not examining the optic nerve or ordering a sedimentation rate, since the patient had no history of migraine headaches but did have hypertension. The defense expert acknowledged, however, that the eye surgeon did arrange for the patient to see her PCP and confirmed that her death was unrelated to the eye surgery. The ophthalmologist settled for a nominal amount, and the case continued against the PCP.

Ongoing and repeated noncompliance

OMIC’s claims data shows that ophthalmologists who treat glaucoma patients frequently confront noncompliance and refused care, but often do not adequately warn their patients of how such noncompliance puts them at risk. One patient with chronic primary open-angle glaucoma had homes in both the Northeast and the South. Citing a planned trip to her other home as the reason, she declined to come in for her follow-up examination during which visual field testing was scheduled. She nonetheless asked the ophthalmologist to renew the prescription for her glaucoma medication. The physician agreed to the patient’s request, not just once, but over many months. By doing so, he operated on the assumption that the medication was controlling the patient’s disease and so did not warn her that the medication might not be effective or that, without an examination, her disease could progress despite treatment. Unfortunately for both the patient and the physician, this is exactly what happened. When she suffered visual loss as the result of progressive glaucomatous changes, she sued her ophthalmologist. Defense and plaintiff experts agreed that the patient’s refusal to come for follow-up care was a factor, but felt that it was below the standard of care for the physician to continue to prescribe without examining the patient and warning her of the consequences of refusing to be examined. OMIC settled the case.

Sometimes, the patient provides no reason for refusing to follow treatment recommendations. One such patient changed her appointments at will, coming only when it was convenient for her, as evidenced by several pages in her medical record devoted to the dozens of missed and rescheduled appointments. Despite written instructions and regular documented warnings from her physician about the importance of administering her glaucoma and steroid drops as instructed, she continued to take them as she pleased, leading to sustained increased intraocular pressure over a six-month period during which time she kept missing appointments. It was only when signs of glaucoma progression were noted that the comprehensive ophthalmologist referred her to a glaucoma surgeon. She allegedly refused, but there was no documentation in this instance of the warning. The patient denied that she had refused to see the glaucoma specialist but, since she also denied that she had missed appointments, defense counsel challenged her credibility, and the defense expert pointed to the patient’s noncompliance as a significant cause of her diminished vision. Experts on both sides insisted that regardless of the patient’s behavior, the eye MD had a duty to take more decisive action in the face of this patient’s repeated unwillingness to partner in her care, such as referring the patient much earlier and documenting a warning when she declined the referral. Not surprisingly, the plaintiff did not cooperate any better with her attorney than she had with her ophthalmologist. She “no showed” for her own deposition and eventually decided not to pursue the case. See “Noncompliance: A Frequent Prelude to Malpractice Lawsuits” for detailed recommendations on prescription refill policies, how to manage missed appointments, track tests, and reduce the risk of noncompliance.

Duty to report neglect

Patients who have not reached the age of majority, generally 18 years of age, do not usually have the legal authority to consent to or refuse care (see Policy Issues for more information on minor consent). Eye surgeons often have questions about how to handle a parent or legal guardian’s refusal to give consent for the treatment of a minor. The concern is warranted, for the physician has both a duty to the child to provide needed care, as well as a duty to report suspected child abuse or neglect. State laws generally include in the definition of neglect a situation in which the child’s health may be endangered by the failure to provide medical care, demonstrating that a parent’s right to refuse certain types of care is restricted. For example, an OMIC-insured ophthalmologist diagnosed retinoblastoma, and explained to the distraught parents that surgery was urgently indicated in order to preserve the child’s life. The parents declined. The same advice was given by a series of physicians who were asked by the parents to see the child. Eventually, the parents were reported to the state’s child protective services department, and the child had the surgery after being removed from the parents’ home. The surgery occurred too late to save the child’s life. The parents proceeded to sue each physician who had examined the child; their suit was unsuccessful.

Ophthalmologists who care for minor patients should seek risk management assistance when parents refuse care. Physicians should have a low threshold for reporting refused care as possible child neglect if the minor patient risks significant loss of vision or harm. Consistent with this recommendation, OMIC has amended its sample letters to parents of infants being screened for retinopathy of prematurity, for example, to state that if the parent refuses screening or treatment for ROP, the ophthalmologist will discuss the refusal with the other physicians involved in the infant’s care and with the state’s child protective services.

These case examples demonstrate that physicians put their professional well-being and the patient’s health at risk if they do not manage patients and parents who refuse care. Physicians may improve the likelihood of patients getting the needed care, and reduce their malpractice exposure, by exploring the reasons care is refused, by warning patients of the consequences of refusing care, and by documenting that discussion. When a surrogate decision-maker is refusing care, the physician should consider whether the refusal constitutes neglect and whether there is a duty to report the refusal to adult or child protective services. OMIC policyholders needing assistance with these issues are encouraged to contact our confidential risk management hotline by phone at 800.562.6642, option 4, or by email at riskmanagement@omic.com. 

Telemedicine

Welcome to OMIC’s Telemedicine risk management resource library. We are committed to providing you with the resources and templates necessary to adequately inform your patients about the risks, benefits, and alternatives of this procedure.

• COVID-19: News and Resources from the American Telemedicine Association
• COVID-19: Easing of HIPAA requirements while practicing telemedicine
• HHS Information on telemedicine
• Surfers, Charlatans, and Teleophthalmology
• Risk Management Concerns of Satellite Offices
• Hidden Costs of Non-traditional Revenue Sources
• Teleophthalmology Across the Miles

Visit OMIC’s Practice Administration library to view other resources for Telemedicine including risk management articles, closed claim studies, and recommendation and procedure guides.

Compounded Products: Use, Regulation, and Risk

Kimberly Wynkoop, OMIC Legal Counsel

Digest, Fall 2012

The recent meningitis outbreak and resulting patient deaths have driven compounding pharmacies into the spotlight, with calls for greater federal government oversight and regulation. This article will explore the role compounding pharmacies play in the delivery of drugs in our health care system, their regulation, and the issues that may lead to change in this supply mechanism.

The Food and Drug Administration (FDA) considers pharmacy compounding “the extemporaneous combining, mixing, or altering of ingredients by a pharmacist in response to a physician’s prescription to create a medication tailored to the specialized medical needs of an individual patient.”[1] This traditionally has been done for medically necessary reasons, such as avoiding a non-essential ingredient due to patient allergy, or voluntary reasons, such as adding flavor to a child’s medication. More and more, however, other factors have influenced the demand for compounded products. One is the shortage of brand-name drugs from FDA-approved manufacturers.[2] Another factor is price. Compounding pharmacies often charge much lower prices than major manufacturers for essentially the same product.[3] These clinical factors have driven many pharmacies out of traditional one-off compounding to larger scale production.

While physicians are granted broad discretion in prescribing drugs for individual patients, whether off-label, unapproved, or customized, the manufacturing and distribution of drugs is more strictly controlled. With typically manufactured drugs, the FDA has broad regulatory oversight. Compounding, however, falls in a grey area where oversight is shared. Like traditional pharmacies, compounding pharmacies are regulated by state boards of pharmacy, which oversee all aspects of licensure and adherence to practice requirements. These requirements vary by state. For instance, some states allow compounding pharmacies to fill general prescriptions for “office use,” while others strictly require a patient-specific prescription for each substance compounded and supplied.

The federal government’s authority over compounding pharmacies is more complicated. The FDA has the authority to inspect compounding pharmacies to ensure the drugs and active pharmaceutical ingredients they use are safe. But what about FDA control over the finished product? The Food, Drug, and Cosmetic Act (FDCA) establishes FDA jurisdiction over “new drugs.” The FDA’s position, with supporting judicial authority, is that compounded drugs fall under the new drug definition. As “new drugs,” the FDCA generally prohibits compounded drugs from being introduced into interstate commerce since they lack any FDA finding of safety and efficacy.[4] Despite the unapproved status of compounded drugs, the FDA has long recognized that traditional pharmacy compounding serves an important public health function and has not often enforced this prohibition.[5]

 Compounded Trypan Blue and Avastin Contaminated

However, instances of compounded drugs endangering public health have given rise to concern within the FDA. One such instance occurred in 2005 at a Washington, DC, Veterans Administration hospital where bacteria-contaminated Trypan Blue Ophthalmic Solution, compounded for use in cataract surgery, blinded two patients and damaged vision in several others.[6] A more recent example: In the summer of 2011, at least a dozen patients in the Miami area contracted streptococcus endophthalmitis from tainted compounded Avastin.[7]

The FDA may not necessarily know about all instances of public harm since, unlike commercial drug manufacturers, pharmacies aren’t required to report adverse events associated with their products. The Limited FDA Survey of Compounded Drug Products, published in 2006, found quality problems in compounded drugs, including potency issues and contamination. The active pharmaceutical ingredients passed inspection, so the failures of the finished drug products were considered likely due to the compounding processes themselves. The FDA concluded that, given their widespread use and the potential for serious injury, the quality of compounded drugs constitutes an important public health concern.[8]

Adding to the complexity of federal regulation of compounding pharmacies, there are two different analyses for regulation depending on the applicable judicial circuit. In 1997, Congress passed the Food and Drug Administration Modernization Act (FDAMA), which added section 503A[9] to the FDCA exempting compounded drug products from the adulteration, misbranding, and new drug provisions of the FDCA as long as certain requirements were met.[10] In 2002, the US Supreme Court found that some of the requirements for the exemptions were unconstitutional.[11] The Fifth Circuit Court of Appeals thereafter ruled that this didn’t invalidate the rest of section 503A.[12] So in the Fifth Circuit (Texas, Louisiana, and Mississippi), the FDA applies the section 503A exemptions.

In the rest of the Unites States, the FDA maintains its original reach and does not apply section 503A. Instead, it follows the revised FDA compliance policy guide (CPG) on pharmacy compounding.[13] The CPG sets forth a non-exhaustive list of nine factors (many drawn from Section 503A) that the FDA considers in determining whether to take enforcement action against a pharmacy when the scope and nature of its activities raise the kind of concerns ordinarily associated with drug manufacturing. These factors include the compounding of drug products that (1) have been pulled from the market because they were found to be unsafe or ineffective; (2) are essentially copies of commercially available drug products; or (3) were compounded in advance of receiving prescriptions, except in very limited quantities relating to the amounts of drugs previously compounded based on valid prescriptions.

Through the CPG, the FDA assures compounding pharmacies that its main concern is those pharmacies that are effectively engaging in multi-patient “manufacturing” under the guise of compounding.[14] The FDA prioritizes enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud. However, the FDA has recently stated that this doesn’t mean that the FDA will take enforcement action only if the agency identifies a particular safety problem.[15] It may also take action when copies of FDA-approved drugs are being created in large volumes for no apparent medical need.

Brilliant Blue G Linked to 33 Endophthalmitis Cases

A look at the recent Brilliant Blue G recall provides insight into how the FDA is applying its enforcement discretion and the factors it is taking into consideration. In Los Angeles in March 2012, nine cases of fungal endophthalmitis were diagnosed in patients who had undergone vitrectomies with epiretinal membrane peeling using the Brilliant Blue-G (BBG) dye from Franck’s Compounding Lab (“Franck’s”) in Ocala, Florida. Local and state health departments, the Centers for Disease Control and Prevention (CDC), and the FDA collaborated in the investigation. It was expanded to include injectable drug products containing triamcinolone due to reports of eye infections in patients who received it during eye surgery. As of April 30, 2012, there were a total of 33 endophthalmitis cases in seven states. In May, the CDC advised health care providers to avoid use of any compounded products labeled as sterile from Franck’s during the ongoing investigation.

The FDA issued a warning letter to Franck’s on July 9, 2012, based on its March–May inspection of the lab.[16] The FDA identified various microorganisms in samples of the compounded BBG that matched the clinical isolates from patients who developed fungal endophthalmitis. Multiple bacterial and fungal species were found at Franck’s in several locations where sterile drugs were compounded and other unsanitary conditions were also identified. The FDA determined that Franck’s BBG injection drug product was adulterated under the FDCA due to the contaminants present. Further, this drug and all sterile drugs compounded by Franck’s were found to be adulterated in that they were prepared, packed, or held under unsanitary conditions. The FDA also concluded that the BBG products were misbranded because their labeling was false or misleading since the drugs were labeled incorrectly as being sterile. The FDA advised Franck’s that failure to promptly correct these deficiencies could result in legal action. In May, Franck’s stopped compounding sterile drugs.[17]

 NECC’s Ophthalmic Drugs Also Under Scrutiny

Only four months later, a new illness outbreak based on compounded drugs quickly overshadowed the BBG debacle and precipitated intense scrutiny of the compounding industry. What began as a single reported case of meningitis September 21, 2012, in Tennessee, has burgeoned, according to the CDC’s November 19, 2012, report[18], to 490 cases of fungal disease, including 34 deaths spread across 19 state—all linked to contaminated epidural steroid injections compounded by the New England Compounding Center (NECC), Framingham, Massachusetts. The CDC traced the meningitis outbreak to three lots of the compounded steroids that were distributed to 75 medical facilities in 23 states, affecting as many as 14,000 patients.[19] On October 15, 2012, the FDA further advised health care providers to follow-up with patients who received any NECC injectable product after May 20, 2012, including injectable ophthalmic drugs and those used in conjunction with eye surgery.[20]

The recalls and investigation have been a coordinated effort between the NECC, FDA, CDC, and Massachusetts Department of Public Health (DPH) Board of Registration in Pharmacy, which has state regulatory authority over the NECC. At the request of the DPH, the NECC agreed to voluntarily surrender its license to operate during the investigation; it now has been permanently revoked. The DPH Board of Pharmacy report released October 23, 2012, identified serious deficiencies and significant violations of pharmacy law and regulations by the NECC.[21] Evidently, the NECC solicited bulk orders and distributed large quantities of product for general use rather than requiring a prescription for each individual patient as state law requires.[22] The NECC did not follow proper sterilization standards and shipped some orders of drugs before waiting for the final results of sterility testing. The Board found many unsanitary conditions at the NECC site as well.

The meningitis outbreak, following shortly on the heels of the BBG endophthalmitis cases, has prompted health officials and lawmakers to call for immediate changes in the oversight of compounding pharmacies arguing that, because no one entity has full responsibility for overseeing compounding pharmacies, they essentially slide through the cracks.[23] The Governor of Massachusetts has already declared that the state will begin making unannounced inspections of pharmacies that prepare injectable medications and require that they submit annual reports detailing what they produce, how much, and where it is distributed. As of November 19, 2012, fifteen states were implementing new, or increasing enforcement of existing, regulations on compounding pharmacies. These states require an individual patient prescription for every compounded medication order. This concerns the American Academy of Ophthalmology and American Society of Retina Specialists because it limits an ophthalmologist’s ability to purchase bulk quantities of commonly-used compounded ophthalmic drugs. These groups are working together to keep the focus of reform on improved patient safety (i.e., sterility issues), rather than distribution regulations that have the potential to limit drug availability.[24]

On the federal level, Congress is investigating the outbreaks and is considering legislative action to strengthen federal drug safety regulations. On November 1, 2012, the VALID Compounding Act was proposed to preserve state regulatory authority over traditional small compounding pharmacy activities, while ensuring that compounding pharmacies operating as drug manufacturers are regulated by the FDA.[25]

Lawsuits against the NECC and its executives have been filed in several states and patients have begun suing their providers as well. As we have seen in the cases of Trypan Blue, Avastin, BBG, and the NECC’s ophthalmic products, the drugs and devices that ophthalmologists obtain from compounding pharmacies are not without risk. Please see the Policy Issues article for a discussion of liability risks and policy coverage and the Hotline article for steps ophthalmologists can take to limit their liability and minimize the risks to the patients they treat when utilizing compounding pharmacies.

Denise Chamblee, MD selected for the Academy’s Leadership Development Program (LDP) XV

OMIC Board Member Denise Chamblee, MD was recognized at the American Academy of Ophthalmology’s Joint Meeting with the Asia Pacific Academy of Ophthalmology in Chicago for her selection to the Academy’s Leadership Development Program XV, Class of 2013. Dr. Chamblee was nominated by OMIC to join a select group of twenty participants chosen from among a large group nominated by state, subspecialty and specialized interest societies.  The class also includes one international from Vietnam who is jointly representing the Asia Pacific Academy of Ophthalmology and the Vietnam Ophthalmology Society.  The incoming LDP class had an Orientation Session in Orlando where they were introduced to their classmates as well as heard project presentations from the graduating LDP XIV, class of 2012.

In January 2013, Dr. Chamblee will take part in a 2 ½ day interactive session in San Francisco with a visit to AAO headquarters to hear from AAO physician leadership on a wide variety of leadership topics.   Next will be a trip in April 2013 to attend the AAO’s Mid-Year Forum in Washington D.C. where she will have scheduled visits with Senators and Representatives to discuss issues important to the medical profession.  During an advocacy session dedicated to LDP XV participants , Dr. Chamblee will also hear from a member of the US Congress and key health staff about building effective relationships with legislators and how best to advocate on behalf of patients.  The final LDP session for the class of 2013 will take place in conjunction with the Academy’s Annual Meeting in New Orleans.

Patient Education Check-Up Project

The Academy and OMIC are jointly sponsoring the fourth annual Patient Education Check-Up Project. This campaign encourages MDs and office administrators to audit all of their Academy patient education materials and informed consent documents to ensure they are current. While the connection between patient education and patient compliance is widely known, the connection between accurate, timely patient education and informed consent materials in reducing malpractice risk may not be. The primary message of this campaign is risk mitigation through up-to-date patient education materials and informed consent documents.

Download the checklist to help you review your existing patient education materials.

Visit OMIC’s library of informed consent forms to make sure you have the most current version.

For more information on the Academy’s patient education products e-mail patientinfo@aao.org.

For information on OMIC’s informed consent documents, contact the OMIC Risk Management Hotline at 800.562-6642, extension 641.

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