It’s another day in the O.R. with another day of surprises. Lately, however, the revelations aren’t the medical complexities of the patient or the cause of O.R. delay (never anesthesia, of course). For too long, the primary question has been, “what medications will I not have available today?” Further questions related to the ethics of drug shortages subconsciously arise, and these questions will be answered in this article.

How did the United States get into this chaos? ASA has a variety of information available to answer this question, so a discussion of the how is not part of this article. Suffice it to say, it’s complex and multifactorial, and a solution will not be coming any time soon. Complicating the baseline challenges are unexpected events such as Hurricane Maria, which led to a number of facilities becoming unable to produce products. Puerto Rico, one of the world’s largest centers for pharmaceutical manufacturing, is responsible for the production of 10 percent of all pharmaceutical products consumed in America. Damage from the storm and continued issues with power outages across the island have decreased manufacturing plant output and worsened pharmaceutical shortages around the world. A problem that most have experienced due to the disaster in Puerto Rico is an intravenous fluids shortage. When it comes to these shortages, the American Hospital Association (AHA) asked in a letter to the FDA to push manufacturers making these products to invest in creating more supplies in the future, as well as find suppliers within the U.S. that aren’t as susceptible to natural disasters. “We are concerned that the shortages of widely-used and critical products are quickly becoming a crisis and looming threat to the public’s health,” Thomas Nickels, Executive Vice President of Government Relations and Public Policy at the AHA, wrote to the FDA.

Drug shortages arise, in part, from choices the U.S. has made about the organization of its markets, regulatory systems and health services. The ASA Syllabus on Ethicshas a chapter dedicated to drug shortages that contains more information about causes and possible solutions.⁵ If we want to prevent drug shortages, we need to keep in mind that any proposed solution will likely threaten the ideals and corporate values of other stakeholder groups. This may include asking pharmaceutical companies to avoid the pursuit of maximizing profits, asking medical plans and health care systems to voluntarily spend more on pharmaceutical products, or completely rewriting federal legislation and regulations with regard to monopolies, antitrust guidelines and safe harbors regarding anti-kickback laws. A reordering of priorities will be needed in order to make the difficult choices to solve the problem of drug shortages. Thus, the initial ethical issue is not one of bioethics but of political and business ethics (not always an oxymoron)! However, until Washington, D.C. and the private sector have the stomach to tackle this, most ethical issues will be of the bioethics variety.

Bioethics encompasses four pillars of ethical principles (autonomy, beneficence, nonmaleficence and distributive justice), and all four play a role when it comes to medication shortages. For example, when one must decide whether to tell a patient about the specific institution’s shortages, the anesthesiologist is internally balancing patient autonomy and nonmaleficence. Does the patient want/need to know about unavailable medication(s)? If they do know, how much angst will it cause? A second example of ethical conflict is when a provider is forced to decide between withholding a shortage medication from a patient for whom there is felt to be a low probability of clinical success in order to preserve its availability for a future patient. This dilemma is about making decisions involving triage. Therefore, a conflict arises between patient beneficence and distributive justice. One thing every anesthesiologist is encouraged to do is report drug shortages to the FDA at www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm and to the ASA at form.jotform.com/81783710213149. Reports of shortages and associated less-than-ideal patient outcomes keeps the pressure on the government to work on solutions.

Preemptively addressing ethical issues associated with shortages will allow more streamlined care and decision-making when urgent situations arise. Based on the current way medications are supplied along with lobbying efforts of these entities and their (rightful) pursuit of profit, a complete solution to the problem is unlikely any time in the near future. The search for a way out must be attempted for the sake of patients – not just current patients, but for those in the future as well. However, until that occurs, ethical preparation is an imperative. Your ASA Committee on Ethics has created a statement related to the ethical issues with drug shortages to help streamline and organize your thoughts and preparation. Beyond these ideals, we welcome your thoughts and input.

STATEMENT ON THE ETHICAL CONSIDERATIONS WITH DRUG SHORTAGES⁶

Committee of Origin: Committee on Ethics

(Approved by the ASA House of Delegates on October 16, 2013)

Shortages of drugs necessary for the practice of anesthesiology, critical care, and pain medicine create patient safety and public health hazards. Anesthesiologists have ethical responsibilities to participate in the development of solutions to this societal problem.
Anesthesiologists, as well as surgeons and other proceduralists, should consider postponing an elective procedure when the risks of proceeding might outweigh the risks of using medications that are alternative to those in short supply or unavailable.
If the anesthesiologist judges the risk of increased morbidity or mortality by using alternative medications to be negligible, then there is no need to discuss this issue when obtaining informed consent. However, if the anesthesiologist judges the added risk to be significant, then the discussion of alternative plans should be part of the informed consent process.
The collection of adverse events occurring as a result of drug shortages provides important information useful in the pursuit of a solution. Anesthesiologists should report these events to the appropriate entities for this purpose.
In the face of specific drug shortages, anesthesiologists should reassess customary practice patterns of drug usage to minimize drug wastage and safely maximize any limited supply.
Flexibility and adaptability in patient care may obscure the reality of potential harm created by drug shortages and should not be a substitute for pursuing a permanent solution.
Anesthesiologists should collaborate with colleagues, pharmacists, appropriate committees, institutional administrators, professional societies, and government agencies to manage issues, policies, and procedures related to drug shortages.
While stockpiling medications may be beneficial for a given institution, excessive accumulation and storage of drugs can result in shortages to other institutions and may be unethical.
Collectively, anesthesiologists have an ethical obligation to examine and manage shortages of drugs essential to safe practice. Therefore, professional medical organizations should identify statutes, regulations, and guidelines that impact the adequate supply of medications, and advocate for appropriate evidenced-based changes that would optimize their availability.

References:

1. Drug shortages. American Society of Anesthesiologists website. https://www.asahq.org/advocacy/federal-activities/regulatory-activity/drug-shortages. Last accessed September 10, 2018.

2. Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s continued assistance following the natural disaster in Puerto Rico [press announcement]. Silver Spring, MD: U.S. Food & Drug Administration; October 6, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm579493.htm. Last accessed September 10, 2018.

Mazer-Amirshani M, Fox ER . Saline shortages—many causes, no simple solution. N Engl J Med. 2018;378(16):1472-1474.

3. Ramsey L. We’re running out of commonly used drugs—and hospitals say it’s ‘quickly becoming a crisis.’ Business Insider. November 10, 2017. http://www.businessinsider.com/drug-shortages-are-getting-worse-american-hospital-association-2017-11. Last accessed September 10, 2018.

4. Jacobs JS, Michaelis MA. Ethical implications of drug shortages. In: Jericho BG, Jacobs J, eds. American Society of Anesthesiologists Syllabus on Ethics. http://www.asahq.org/resources/ethics-and-professionalism. Last accessed September 10, 2018.

American Society of Anesthesiologists Committee on Ethics. Statement on the ethical considerations with drug shortages.

Drug Shortages and Physician Ethics

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