Ethics of Disclosure Regarding Drug Shortages That Affect Patient Care.

Abstract

As hands-on deliverers of health care, should our informed consent discussion include the risks from health care decisions, such as the availability of medical supplies, which are invisible to the patient but could have profound impact on patient outcomes? An example in perioperative medicine is the recurring problem of drug shortages. In an apt metaphor, Dutton and Cohen1 referred to the anesthesiologist facing drug shortages as an “Iron Chef, challenged to produce a tasty dish (a safe patient outcome) using a limited set of tools and ingredients.” With the dramatic increase over the past decade in the number of drug shortages, including essential drugs such as propofol, neostigmine, succinylcholine, and resuscitation drugs such as ephedrine and vasopressin, anesthesiologists wrestle regularly with the bedside question: “Will the absence of a certain drug impact this patient’s safety?” This is not only a clinical question for the iron chef to tackle but also a profound ethical question. Substituting a less familiar drug for a commonly used drug threatens patient safety.2 In 2011, De Oliveira et al. showed multiple instances of patient harm resulting from drug administration errors caused by substitution of alternate drugs or concentrations during drug shortages. These included fentanyl overdose from substituting a 5-mL vial for a 2-mL vial, a ketamine overdose from substituting a 50-mg/mL vial for a previously available 10-mg/mL vial, and a sufentanil overdose from substitution of sufentanil for fentanyl.3 Similarly, when confronted with medication shortages, practitioners or institutions may be tempted to use large-volume single-dose vials multiple times. Single-use sterile injectable drugs are vulnerable to contamination unless handled properly. In 2008, an endoscopy suite in Nevada used propofol drawn from 50-mL vials in multiple patients, contradicting the label guideline, and resulting in the transmission of hepatitis C and exposing another 40,000 patients to human immunodeficiency virus, hepatitis B, and hepatitis C.3,4 The problem is widespread. In a 2010 hospital survey, 89% of the responding hospitals reported drug shortages that may have caused a medication safety issue or an error in patient care.5 A follow-up survey released in December 2013 assessed the effect of drug shortages on pharmacy directors. Of the respondents, 38% reported a history of patient complaints felt to stem from drug substitutions in the face of shortages.5 Within anesthesia, substitution of alternate drugs can also lead to a variety of subtle, adverse patient outcomes such as slower emergence, postoperative delirium, and postoperative nausea and vomiting. These result in longer postanesthesia care unit stays and even hospital admission. Multiple hospitals have begun to add additional pharmacy staff simply to manage and address problems relating to drug shortages.6 Drug shortages have numerous implications for clinicians, patients, and the hospital. These include adversely affecting choices for drug therapy, delaying medication therapies or treatments, escalating costs of product and resources to manage shortages, and increasing risk for medication errors and untoward patient outcomes. There is also the potential for an emotional component to the drug shortages of frustration, anger, anxiety, and mistrust that results in strained relationships between patients and providers.7 To address these problems, and as acknowledgement of them, the Food and Drug Administration has created a drug shortage websitea that includes a searchable database. Ethically, drug shortages create a dilemma of scarce resource allocation, including the potential need to limit access to some health services.8 Much of the ethical literature regarding drug shortages has been developed in the field of oncology. The authors have advocated evaluating the patient pool using the ethical principles of beneficence, nonmaleficence, and justice. The goal is to guide prioritization of drug distribution before a shortage actually occurs, avoiding potentially unfair and unethical distribution of resources once the shortage becomes a reality.9 A similar approach may be needed in anesthesia. Drug shortages can be anticipated. It may be necessary to institute protocols triaging and rationing perioperative services in the face of drug shortages. Other approaches have been advocated, such as “first-come” and “lottery” approaches. However, these approaches preclude the ability to make fine, individual patient-centered decisions and do not discriminate between what kinds of patients and what types of uses may be more deserving or reasonable than others.1 Few anesthesiologists would draw up the last vial of phenylephrine for the 40-year-old patient undergoing knee replacement, when the next patient was 80 years old and had aortic stenosis. Every day physicians allocate scarce resources, including their time, based on the patient need. When drugs are scarce, they need to be rationed to those patients who will receive the most benefit.10 The approach chosen needs to be transparent and should acknowledge the difficulties it presents to patients and physicians alike.11 The most uncomfortable ethical issue may be how much of this should be disclosed to patients? In their important and timely study in this month’s issue of Anesthesia & Analgesia, Hsia et al.12 examine patients’ desire to be informed regarding drug shortages before elective surgery. Their data demonstrate that “most patients want to be informed of drug shortages that might affect their surgical care, even if the severity of potential side effects is as small as the difference between acetaminophen and aspirin prescribed for headache.”12 This suggests that we have a duty to inform patients. It is not clear how we can disclose drug shortages without appearing antagonistic to the health care system. It is also not clear what can be explained to patients that would help guide a decision. How, exactly, do you explain to a patient the increased risk of reversing neuromuscular blockade with edrophonium because neostigmine is not available? In the case of an emergency, no consent is legally or ethically required. However, for the nonelective procedure that cannot be delayed long enough for a drug shortage to be rectified, informing a patient about a drug shortage that could theoretically increase perioperative risk may only increase patient anxiety. This may be unwise if performing the procedure now, despite the shortage, is clearly and convincingly in the patient’s best interest. In the current practice environment, anesthesiologists often meet their patients the day of the scheduled procedure, frequently immediately before the procedure. Without resorting to Google, could you quickly explain to one of your colleagues the increased risk of adverse events from substituting edrophonium for neostigmine? If not, then how can you expect to explain this to an anxious patient in the few minutes before surgery? The difficulty of providing informed consent and shared decision-making in medicine has been well established. Studies have shown that even physicians, when recruited as subjects of clinical research, cannot demonstrate sufficient understanding of the implications of their voluntary consent for it to be meaningfully considered “informed.”13,14 In nonelective cases, the potential harm from disclosure and the likely impoverished nature of consent means that disclosure about subtle issues such as the impact of drug shortages on their care is not ethically required. An elective case is different. The findings of Hsia et al. make a compelling prima facie case for disclosure. Patients want to know and they should know. As they note, “the paternalistic approach to medical decision-making for patients is becoming less common. Modern medicine encourages active participation of patients and their families in their own health care decisions.”12 Clinicians and patients together will need to decide how they will augment care in the face of drug shortages. Clinicians and patients together must decide when the risks are great enough to wait until the shortage is resolved. Patients and families are already challenged to understand the direct risks from surgery and anesthesia. It is an additional burden on patients and families to rapidly understand failures in the supply chain of modern medicine. However, as health care becomes an increasingly complex, societal-wide system, informed consent requires that a patient understand some of the complexities of health care delivery. In addition to understanding potential risks from the drug an anesthesiologist gives, patients need to understand potential risks from drug shortages that impede the ability of the anesthesiologist to give the best possible care. There is no ethical ambiguity. Drug shortages and their implications need to be clearly disclosed so that the health care providers and the patient can engage in the shared decision-making that anchors the ethical practice of medicine. DISCLOSURES Name: Danton S. Char, MD. Contribution: This author helped write the manuscript. Attestation: Danton S. Char approved the final manuscript. Name: David Magnus, PhD. Contribution: This author helped write the manuscript. Attestation: David Magnus approved the final manuscript. This manuscript was handled by: Steven L. Shafer, MD.