HA400 Unit 2 Drug Shortage Ethics Case Analysis Example

Enough Immune Globulin for Six of Ten: An Ethics Case Analysis Testing an Across-the-Board Dose Cut Against Priority by Indication at a Composite Academic Hospital Through the Four Principles

[Student Name]

Purdue University Global

HA400: Health Care Ethics, Law, and Governance

Unit 2 Ethics Case Analysis

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[Date]

The hospital, the patients and the supply figures are composite and bracketed; the clinical details are simplified for an ethics exercise and are not treatment guidance.

Facts

The hospital's supplier has cut allocations by [40] percent for at least [four] weeks, and no other supplier can fill the gap. Ten outpatients are scheduled for infusions in that period:

1. Two adults with primary immunodeficiency who receive replacement therapy every four weeks and have no alternative treatment.

2. One adult admitted with Guillain-Barré syndrome, for whom plasma exchange is an alternative if the hospital can arrange it.

3. Three adults with chronic inflammatory demyelinating polyneuropathy on maintenance, each stable for more than a year.

4. One adult with multifocal motor neuropathy, for whom immune globulin is the main proven treatment.

5. One adult with immune thrombocytopenia before planned surgery, for whom steroids are an alternative.

6. Two adults receiving immune globulin for off-label uses where the evidence is limited.

Two proposals are on the table. The attending neurologist proposes reducing every dose by about a third so every patient receives some treatment. The clinical pharmacist proposes giving full doses to patients with strong evidence and no alternative, using alternatives or longer intervals where they exist and pausing off-label uses until supply returns.

The Ethical Question

Which patients should receive the hospital's immune globulin during the next four weeks, and at what dose?

Framework

Four principles set out by Beauchamp and Childress (2019) frame this analysis: justice, beneficence, nonmaleficence and respect for autonomy. They suit an allocation question because the case involves benefit and harm to identifiable patients, consent and a fair way to divide a scarce good. The principles do not rank themselves; the analysis must weigh them against the facts. Neither proposal is selfish; the conflict is between two ideas of fairness, sharing equally and giving first to those with the most to lose.

Respect for Autonomy

Under either proposal, patients will receive less than they expected, and autonomy requires telling them. The equal-cut proposal hides the change inside a smaller bag; patients may never learn that their dose was reduced. The priority proposal pauses some patients entirely, which they will notice. Both proposals need a disclosure plan. Autonomy does not give a patient the right to a scarce drug, but it does give each patient the right to know what is being decided and why, and to discuss alternatives.

Nonmaleficence

A reduced dose is not simply a smaller benefit. For patients on replacement therapy, a dose below the level that protects against infection may expose them to serious infection without the full protective effect. For patients with an alternative, a pause carries less risk than an inadequate dose with no alternative. The equal cut therefore spreads a risk of harm to every patient, including those for whom any reduction may be dangerous. The priority proposal concentrates harm on patients whose use is least supported, where harm from a pause is less likely.

Beneficence

Beneficence asks which plan does the most good. The supply is enough for about six full courses. If six full courses go to patients with strong evidence and no alternative, the expected benefit is high. If ten patients receive two-thirds doses, some may receive too little to benefit at all. Guidance on managing earlier shortages of immune globulin recommended prioritizing approved indications with strong evidence and reviewing each request through pharmacy rather than first come, first served (Decker & Gouveia, 1998).

Justice

Justice is where the two proposals differ most. The neurologist's view is a form of equality: each scheduled patient receives a share. The pharmacist's view is a form of need and expected benefit: patients who will suffer most without the drug, and who have nothing else, come first. An ethical framework for short-term rationing in hospitals argues that decisions should be made by a group rather than individual clinicians, using transparent criteria applied consistently, with an appeals process and attention to patients with no alternatives (Rosoff, 2012). Under that framework, the equal cut is simple and transparent but ignores differences in need, while the priority plan is fairer if its criteria are public and consistently applied.

Where the Principles Conflict

Autonomy and justice pull against each other for the two patients on off-label uses: each may value the treatment, but a fair allocation pauses it. Beneficence and equality conflict for the patients on maintenance therapy: extending their interval may slightly increase their risk, but it frees supply for patients with no alternative.

Synthesis

Taken together, the principles favor the pharmacist's proposal, modified in three ways. First, the two patients with primary immunodeficiency and the patient with multifocal motor neuropathy receive full doses. Second, the patient with Guillain-Barré syndrome is offered plasma exchange if it can be arranged in time; if not, he receives immune globulin. Third, the three stable patients on maintenance receive full doses at a longer interval, chosen by the neurologist for each patient, rather than reduced doses. The patient with immune thrombocytopenia receives steroids with the surgical team's agreement, and the two off-label uses are paused.

Process, Not Only Outcome

The decision should not rest with the neurologist and pharmacist at the bedside. The pharmacy and therapeutics committee, or a small shortage team that includes a physician, a pharmacist, an ethicist and a nurse, should approve the criteria, apply them to each patient and review them weekly. Each patient should hear from their clinician what is changing, why and what alternatives exist, and should be told how to ask for review.

Objections

A patient on an off-label use might argue that the hospital is choosing for her. The answer is that the hospital is choosing among patients because it must, using criteria applied to everyone. The neurologist might argue that an equal cut avoids judgments about whose need is greater. But an equal cut also makes a judgment: that a partial dose is worth giving to everyone, which the evidence does not support for every patient.

Resolution

Adopt the modified priority plan for four weeks, approved by the committee, with disclosure to every affected patient, an appeals route and a weekly review of supply. If the supplier restores allocations sooner, return all patients to their usual schedules.

Conclusion

The case shows that a fair allocation is not always an equal one. When a drug is scarce, the principles point toward full treatment for patients who need it most and have nothing else, a transparent process for everyone else and honesty with all of them.

References

Beauchamp, T. L., & Childress, J. F. (2019). Principles of biomedical ethics (8th ed.). Oxford University Press.

Decker, E. L., & Gouveia, W. A. (1998). Managing the shortage of intravenous immune globulin. American Journal of Health-System Pharmacy, 55(20), 2090-2093. https://doi.org/10.1093/ajhp/55.20.2090

Rosoff, P. M. (2012). Unpredictable drug shortages: An ethical framework for short-term rationing in hospitals. The American Journal of Bioethics, 12(1), 1-9. https://doi.org/10.1080/15265161.2011.634483