Ethical Dilemmas Related to Drug Shortages

2017 - 2 April – Sepsis
Ahmed A. Mahmoud, PharmD, BCCCP; Ryan Hakimi, DO, MS; Jessica L. Elefritz, PharmD, BCCCP
Read about ethical dilemmas related to drug shortages.

Prescribers often are faced with ethical dilemmas regarding allocation of scarce medications among the most critically ill patients. This challenge is further compounded when alternatives do not exist, the medication is being used as salvage therapy with low probability of clinical success, or there is a paucity of evidence supporting clinical benefit. This article aims to summarize the principles of bioethics and strategies for applying an ethical framework to the allocation of drugs on shortage.

Ethics, as it relates to the field of medicine, is referred to as bioethics and encompasses four pillars of ethical principles: beneficence, nonmaleficence, autonomy and justice.1,2 Beneficence and nonmaleficence dictate that the best medical care should be provided while avoiding harm. Autonomy refers to respecting the patient’s right to make medical decision when applicable.3 Within the fourth pillar of justice, the responsibility lies with the healthcare provider to allocate medical resources as deemed responsible by the provider and the institution, and to the greater society. The healthcare professional must always balance justice for the individual patient with societal justice (allocation of resources for the good of society as a whole). An example of this principle is when a provider is forced to decide between withholding a medication on shortage from a patient for whom there is felt to be a low probability of clinical success or for whom treatment is deemed futile so that the medication may be available for a future patient. Thus, it is not uncommon for conflict between a patient’s beneficence and distributive justice to occur.

The concept of withholding a medication due to a drug shortage was initially surprising and hard to accept for many providers, especially when there are shortages of potentially lifesaving medications used commonly in the intensive care unit. Healthcare professionals have learned to adapt to drug shortages, but specific guidance for allocation of drugs on shortage as it pertains to the critically ill remains scarce. Consensus statements have been published to assist with overall institutional resource management and conflict resolution in such situations, but they do not specifically address medications.4–6 The oncology and anesthesiology specialties have published literature addressing the ethical considerations for managing drug shortages, which may be applied to the critically ill patient. 

Early identification of an impending drug shortage is key; institutions should have a drug shortage committee that is responsible for identifying experts to determine if alternatives exist, explore drug conservation and develop guidelines within the institution for drug allocation.7,8 Ideally, institutions should involve the public; however, previous experiences raise doubts regarding public integration, recognition and acceptance of healthcare constraints.9

The institution must have an ethical, systematic and evidence-based framework to approach patient allocation of scarce medications.7,8 Such frameworks as previously described should have four basic constituents: transparency, relevance, an appeal process and enforcement.7,8 Transparency refers to how the process for allocation was developed within and outside the institution. Relevance ensures that the guideline is specific to the medication shortage at hand and how that drug should be utilized; it is arguably the key component. Approaches to how a drug can be utilized include first-come, first-served, sickest first (promoting the well-being of the worst off), saving the most (focuses solely on quantity), or benefitting the most (ensuring equitable maximization based on both quantity and quality).10 Experts agree that distribution of scarce supplies on a first-come, first-served basis is unethical and unfair and does not incorporate social justice.7,8 Treatment should not be withheld due to age, ethnic background or socioeconomic class.

If the approach of benefitting the most is applied to drug shortages, then medications should be limited to approved indications and for those patients with the highest probability of success or lowest risk of futility.10 This poses a moral and medical dilemma for the clinician because a standardized definition for futility is lacking.2,6,11–14 Some have suggested that a futile treatment is when a treatment will not accomplish the intended goal or when an intervention is highly unlikely to result in meaningful survival.6,13 An example of this principle is in practice in how some hospitals managed use of intravenous immunoglobulin during its shortage, reserving it for patients with approved indications.15,16 However, in the case of unapproved indications or inconclusive evidence supporting clinical benefit, this raises two questions: Should the healthcare provider withhold therapy? And who determines futility?

Uniform enforcement and an appeal process are other key components to developing a policy for ethical allocation of drugs. A simple appeal process must be in place should the patient’s surrogate request it, but if a review concludes that therapy does not fit the criteria for beneficence, enforcement of the policy must be upheld. As emotionally difficult as this is, the enforcement of the drug allocation process is key; otherwise there is no benefit in the relevance and no element of fairness.17

Healthcare providers have sworn to provide their patients with the best care. However, in this resource-limited healthcare environment, it is imperative to recognize that potentially inappropriate therapy with a drug on shortage may have the potential to negatively impact the greater society. With unclear guidelines and processes, tackling complex ethical medical questions becomes extremely difficult. Institutions need to corroborate their guidelines, educate the public, involve patients’ proxies in medical decisions, and continue to revisit the appropriate approach to deal with this complex issue.

1.       Luce JM, White DB. A history of ethics and law in the intensive care unit. Crit Care Clin. 2009;25(1):221-237.

2.       Center for Practical Bioethics. What is Bioethics? Kansas City, Mo: Center for Practical Bioethics. https://practicalbioethics.org/what-is-bioethics. Accessed March 27, 2017.

3.       American Medical Association. Code of Medical Ethics of the American Medical Association. Chicago: American Medical Association; 2008.

4.       Teres D. Civilian triage in the intensive care unit: the ritual of the last bed. Crit Care Med. 1993 Apr;21(4):598-606.

5.       Gillon R. Justice and allocation of medical resources. Br Med J (Clin Res Ed). 1985 Jul 27;291(6490):266-268.

6.       Bosslet GT, Pope TM, Rubenfeld GD, et al; American Thoracic Society ad hoc Committee on Futile and Potentially Inappropriate Treatment; American Thoracic Society; American Association of Critical-Care Nurses; American College of Chest Physicians; European Society for Intensive Care Medicine; Society of Critical Care Medicine. An Official ATS/AACN/ACCP/ESICM/SCCM Policy Statement: Responding to requests for potentially inappropriate treatments in intensive care units. Am J Respir Crit Care Med. 2015 Jun 1;191(11):1318-1330.

7.       Rosoff PM. Unpredictable drug shortages: an ethical framework for short-term rationing in hospitals. Am J Bioeth. 2012;12(1):1-9.

8.       Rosoff PM, Patel KR, Scates A, Rhea G, Bush PW, Govert JA. Coping with critical drug shortages: an ethical approach for allocating scarce resources in hospitals. Arch Intern Med. 2012 Oct 22;172(19):1494-1499.

9.       [No authors listed]. A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA. 1995 Nov 22-29;274(20):1591-1598.

10.   Beck JC, Smith LD, Gordon BG, Garrett JR. An ethical framework for responding to drug shortages in pediatric oncology. Pediatr Blood Cancer. 2015 Jun;62(6):931-934.

11.   Green MJ, Fong S, Mauger DT, Ubel PA. Rationing HIV medications: What do patients and the public think about allocation policies? J Acquir Immune Defic Syndr. 2001 Jan 1;26(1):56-62.

12.   Fleck LM. Just caring: health reform and health care rationing. J Med Philos. 1994 Oct;19(5):435-443.

13.   Damghi N, Belayachi J, Aggoug B, et al. Withholding and withdrawing life-sustaining therapy in a Moroccan emergency department: an observational study. BMC Emerg Med. 2011 Aug 12;11:12.

14.   [No authors listed]. Medical futility in end-of-life care: report of the Council on Ethical and Judicial Affairs. JAMA. 1999 Mar 10;281(10):937-941.

15.   Boulis A, Goold S, Ubel PA. Responding to the immunoglobulin shortage: a case study. J Health Polit Policy Law. 2002 Dec;27(6):977-999.

16.   Schrand LM, Troester TS, Ballas ZK, Mutnick AH, Ross MB. Preparing for drug shortages: one teaching hospital’s approach to the IVIG shortage. Formulary. 2001 Jan 1;36(1):52-59.

17.   Unguru Y, Fernandez CV, Bernhardt B, et al. An ethical framework for allocating scarce life-saving chemotherapy and supportive care drugs for childhood cancer. J Natl Cancer Inst. 2016 Jan 29;108(6):djv392.

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