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
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.
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