According to the United States Federal Food, Drug and Cosmetic Act, a drug shortage is “when the total supply of all versions of a commercially available product cannot meet the current demand, and a registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary uses at the patient level.”1 Drug shortages may occur with any class of drugs, but the shortages of cisplatin and carboplatin in 2023 thrust the issue of oncology medication shortages onto the national stage.
There are currently more than 30 oncology medications listed in the FDA Drug Shortages database, with the majority of these products recommended as category 1 or 2A treatments by the National Comprehensive Cancer Network.2,3 Despite the frequency and severity of these shortages, training regarding appropriate mitigation strategies is lacking, and very few tangible resources are available to guide health care providers on how to manage these complicated situations.4,5
There are numerous practical implications of oncology drug shortages, including delaying critical treatments, the need to provide alternative and potentially less effective agents, increasing drug acquisition costs, undesired adverse effects and outcomes, and increased potential for medication errors.6 Equally important, shortages of critical medications can present various acute ethical dilemmas to practitioners.7
The Ethics of Drug Shortages
General bioethical principles such as beneficence, nonmaleficence, stewardship, veracity, and justice are all notable in shortages of critical medications. Beneficence is the obligation of the provider to act in the patient’s best interest and to promote the patient’s welfare. Conversely, nonmaleficence is the obligation of a provider to do no harm to a patient.8 Stewardship implies the thoughtful and responsible management of a shared societal product or resource, whereas veracity, or truth telling, is essential to creating a solid relationship between the provider and patient.9,10
Additionally, the bioethical principle of justice is the fair, equitable, and appropriate treatment of persons. Although there are several types of justice, the one that is most pertinent to medical ethics is “distributive justice,” which is the fair, equitable, and appropriate allocation of health care resources.8 Such ethical conundrums can affect both individual health care providers and health care institutions, as shortages can impede the ability to provide benefit, minimize harm, and ensure equity among patients.7
Individual Ethical Conflicts
Individual health care providers may experience complex ethical struggles during medication shortages. Feelings of anger, frustration, and anxiety are common and expected, and the mistrust that results from strained relationships with patients can further affect practitioners’ wellbeing.6 Decisions about drug allocation in such scenarios have been recognized as classic “tragic choices” that may result in significant psychological distress.4,5 Originally described by Guido Calabresi and Philip Chase Bobbitt in 1978, the concept of tragic choices describes how societies cope with decisions between 2 equally viable options that will ultimately bestow a benefit that can only be given to 1.5
In many institutions, policies for drug use are based on utilitarian principles and rely on cost-effectiveness analysis for final decisions.4 However, in situations of limited resources, practitioners are faced with the uncomfortable reality that it will not be physically possible to provide an intervention to all who might benefit. Health care providers may struggle with balancing their fiduciary responsibility to the welfare of each individual patient (beneficence) with their accountability to other patients in their practice and in the medical community at large (distributive justice).4 Furthermore, maintaining a utilitarian approach directly conflicts with respect for individual patient dignity and autonomy, which is particularly valued in US culture and our approach to medical practice.4 Practitioners may also wrestle with the unspoken implication that they must choose which patient is more deserving of a particular treatment.5
Oncology practitioners should be mindful that decisions regarding drug shortages should not be made on a case-by-case basis or in isolation from other practitioners.4 Practitioners should also be educated on how to recognize and seek assistance in the management of emotional distress that can arise from such difficult choices. Additionally, an institutional interdisciplinary team should be established to guide immediate actions as well as long-term planning beyond any practitioner’s individual decisions.11