In this issue of Anesthesia & Analgesia, Drs. De Oliveira, Theilken, and McCarthy outline the scope and implications of medication shortages affecting anesthesiologists.1 It is clear, as far as the scope of the manuscript goes, that they are aiming at a moving target. Their manuscript was already modified once in the review process to include mention of a neostigmine shortage that became apparent in the spring of 2011. Since that time, there have been new announcements of shortages of phenylephrine and vasopressin. With ephedrine already on the list, the lack of available IV vasopressor agents has the potential to create a truly dangerous situation. Before angiotensin-converting enzyme inhibitors and related medications, lack of vasopressin was trivial, but as patients appear in large numbers with hypertension that is well controlled by these agents, hemodynamic stability is not easily achieved by ephedrine or phenylephrine, even when these drugs are available.
How often does a medication shortage impact our standard of care? As anesthesiologists, we are masters of adaptation, and incomparably successful masters of patient safety. Major adverse events in routine anesthesia care are vanishingly rare, and anesthesiology is the only medical specialty that approaches the “six-sigma” standard of quality outcomes. One of the reasons for this is our ability to titrate medications used during anesthesia from moment to moment in response to differing patient physiology, genetic tolerance, and the stresses of surgery. To do this, we work from a “pantry” of multiple medications in multiple classes. Within a broad class of drugs, such as IV vasopressors, we are able to choose the specific medication that offers the best onset time, duration, and potency for the clinical situation. As clinicians, each of us is a Master Chef, using a combination of art and science to “cook” each patient's anesthetic, or perhaps more accurately, to complete intraoperative medical care, to achieve the best possible outcome. As scientists, we have devoted more than 100 years to the development of ever more refined and precise medications, to enable our culinary skills.
Medication shortages make us unwitting contestants in a bad episode of “Iron Chef,” challenged to produce a tasty dish (a safe patient outcome) using a limited set of tools and ingredients. And unlike reality television, failure in these episodes has the potential to produce real harm. When we go to the medication drawer and find it as bare as Mother Hubbard's cupboard, what is there to prevent an unsatisfactory outcome? Drugs are the parachutes we use to bail our patients out of physiological crashes. If we don't have them when we need them, a soft landing becomes very unlikely. Myocardial infarction or cardiac arrest due to lack of available IV pressors is an indefensible outcome.
In most cases, of course, the complications will be more subtle. Use of an unfamiliar induction agent or muscle relaxant might lead to slightly slower emergence or a mildly prolonged stay in the postanesthesia care unit. And prolonged emergence, we now know, is associated with an increased risk for postoperative cognitive dysfunction. This is an important concern in our ever-aging population, although attribution of harm can be challenging. When serious complications occur, there are many potential or contributing causes, and attributing the event to a single variable, such as absence of a desired medication, is challenging or impossible.
What we can recognize, however, is the generic risk of any change from the norm in concentration or packaging of a medication. Any change can be expected to increase the number of errors we make. We are creatures of habit, and familiarity with the medications we use every day allows us to devote our conscious thought to bigger issues. Thus, every shortage, with the resulting therapeutic substitution of another agent, increases our risk of causing harm. The activity level during a complex case is like working in a short-order restaurant with too many customers, short supplies, and one cook. The meal we cook just might not taste as good as we'd like it to. Disappointing when it is just a meal; devastating when it is your patient's life.
And not all of the therapeutic substitutions are equivalent. Propofol is superior to thiopental in many ways as an agent that facilitates tracheal intubation, but it has an increased susceptibility to bacterial contamination. Change from thiopental to propofol in emergency intubation protocols, trauma care, and obstetrics might lead to increased risk of mis-dosing, but also to increased risk for infectious complications and sepsis, which would be even harder to quantify. Change from succinylcholine to rocuronium risks prolonged “cannot intubate/cannot ventilate” scenarios. Change of relaxants as well as shortage of reversal agents might lead to increased incidence of hypoventilation in the postanesthesia care unit and an increase in patients requiring postoperative reintubation. And as with the pressors, complete absence of entire classes of drugs creates the potential for even more grievous harm.
How should our profession respond? De Oliveira and colleagues have outlined the simple steps we can take right now. Anesthesiologists should report serious medication shortages to the Food and Drug Administration (firstname.lastname@example.org) so that they can be followed on a national basis and presented in turn to elected officials and regulators. The American Society of Anesthesiologists has had some limited success in working with the Food and Drug Administration on these problems, most notably the fast-tracked approval for importation of propofol from Europe. Making elected officials and the public at large aware of this crisis is a necessary first step in resolving it. To do this, we must motivate Congress to provide the necessary statutory authority to tame the chaos in the drug supply.a
Cases in which medication shortage may have contributed to an adverse outcome can be reported to the Anesthesia Quality Institute. Participating practices can do this now through their link to the National Anesthesia Clinical Outcomes Registry; soon, any anesthesia provider in the country will have the ability to report anesthesia incidents online to the Anesthesia Incident Reporting System (which will “go live” in October 2011). In time, the systematic collection of data will provide us insight on the risks of medication shortages, and will provide a baseline we can use to test the effect of various interventions.
In the meantime, however, one hard question remains: When should the unavailability of a desired medication lead us to postpone or cancel a scheduled case?
Given the wide variety of patients we care for, a single, concrete answer to this question is unlikely. Instead, we must fall back on the principle of risk versus benefit. As with many such decisions, the answer will depend on numerous factors: How important is the surgery to the patient? How great is the danger posed by a missing anesthetic agent? What alternatives exist? When the risk is significant, of course, we should include a discussion of these issues in our informed consent. Last year, anesthesiologists convinced the Joint Commission that we need not explain each and every drug, its risks and benefits, to our patients as part of the preoperative informed consent. Things may be different now, and it appears that we may instead need to let the patients know what “foods” are not available on the menu the day of surgery, and what this lack of drug availability may mean to them. In anesthesia, no one wants the medication version of the “chef's surprise.”
In general, case cancellation is unlikely; we are, after all, the Iron Chefs! But, in carrying on despite the lack of desired medications, we should recognize the risks to which we are exposing our patients, and the danger of coenabling an intolerable situation. We must not continue to expose patients to these risks, when we know that proper action on the part of industry, our policy makers, and ourselves, can reduce it. Facilitating the care of the individual patient is best accomplished by our professional obligation to speak out in defense of all future patients. Doing anything less means we will become our patients' worst enemies, and the enemies of patient safety.
Name: Richard P. Dutton, MD, MBA.
Contribution: This author wrote the manuscript.
Name: Jerry A. Cohen, MD.
Contribution: This author wrote the manuscript.