Addressing the Ethical Complications of Drug Shortages

Publication
Article
Pharmacy Practice in Focus: OncologyJune 2024
Volume 6
Issue 4

Incorporating ethical principles at all levels can ensure the best possible outcomes under difficult circumstances.

Chemotherapy IV drip -- Image credit: zlikovec | stock.adobe.com

Image credit: zlikovec | stock.adobe.com

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

Ethical Considerations at the Institutional Level

At the institutional level, the ethical principles of beneficence and nonmaleficence to a single patient must be broadened to values that consider the common good, such as stewardship and justice.7,12 A concerted effort to develop institutional strategies that are fair, legitimate, and effective is imperative.11 To minimize inequities, allocation of scarce medications should take place through a committee of stakeholders and at the highest administrative level.13,14 Ideally, a thoughtful collaboration between oncologists, pharmacists, bioethicists, other members of the health care team, and patients should be undertaken.13

The accountability for reasonableness (A4R) framework was proposed in the 1990s as an ethical decision-making tool that can provide direction to institutions during such shortages.4,5,11,14 The A4R framework includes the following 4 key principles:

  1. Relevance. The principle of relevance states that decisions regarding prioritization of drug usage should be made based on objective reasons that fair-minded people can agree are clinically relevant under the specific circumstances.
  2. Transparency. This principle implies that the development and implementation of the allocation process must be open to all stakeholders to review.
  3. Revision. Revision requires that a mechanism for individual appeal of a decision is included in the allocation scheme and is a routine component of adjustments to the allocation policy.
  4. Enforcement. Enforcement of the policy is a guarantee that the rules will be followed by all providers.

The A4R framework has been recognized in published literature and is incorporated into the American Society of Clinical Oncology guidelines on the allocation of scarce resources.14 A key advantage of the A4R framework is that it can be adapted by individual institutions, as has been described by Valgus et al during a shortage of methotrexate.11

Once a strategy for drug allocation has been developed at a given institution, the strategy must be clearly communicated and consistently applied. However, the strategy should be routinely reviewed and adjusted based on information obtained from appeals and in response to further fluctuations in drug supply.13,14

Application to Practice

About the Author

Karen M. Fancher, PharmD, BCOP, is an associate professor of pharmacy practice at Duquesne University School of Pharmacy in Pittsburgh, Pennsylvania, and clinical pharmacy specialist—oncology at University of Pittsburgh Medical Center Passavant.

Shortages of essential anticancer and supportive care medications will continue to be a significant issue in the treatment of patients with cancer. Oncology practitioners should seek to improve their own knowledge of bioethical principles as they pertain to the rationing of resources. Institutions should be cognizant of the emotional and psychological impact of these tragic choices on health care providers and offer strategies for managing this distress. At the institutional level, a standing committee that implements a fair, structured, and effective framework for drug allocation in advance of a particular shortage can minimize the ethical toll of such challenging situations. By incorporating robust ethical principles at all levels, the oncology community can work to ensure the best possible outcomes under difficult circumstances.

References

1. Frequently asked questions about drug shortages. FDA. Updated October 11, 2023. Accessed April 15, 2024. https://www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages
2. FDA drug shortages. FDA. Accessed April 15, 2024. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
3. Development and update of guidelines. National Comprehensive Cancer Network. Accessed April 15, 2024. https://www.nccn.org/guidelines/guidelines-process/development-and-update-of-guidelines
4. Jagsi R, Spence R, Rathmell WK, et al. Ethical considerations for the clinical oncologist in an era of oncology drug shortages. Oncologist. 2014;19(2):186-192. doi:10.1634/theoncologist.2013-0301
5. 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;172(19):1494-1499. doi:10.1001/archinternmed.2012.4367
6. Char DS, Magnus D. Ethics of disclosure regarding drug shortages that affect patient care. Anesth Analg. 2015;121(2):262-263. doi:10.1213/ANE.0000000000000842
7. Lipworth W, Kerridge I. Why drug shortages are an ethical issue. Australas Med J. 2013;6(11):556-599. doi:10.4066/AMJ.2013.1869
8. Varkey B. Principles of clinical ethics and their application to practice. Med Princ Pract. 2021;30(1):17-28. doi:10.1159/000509119
9. Blair K. Law and Ethics: What the Pharmacy Professional Should Know. Pharmacy.EliteCME.com. Accessed April 15, 2024. https://s3.amazonaws.com/EliteCME_WebSite_2013/f/pdf/RPUS03ETI15.pdf
10. Physician stewardship of health care resources. American Medical Association Code of Medical Ethics. Accessed April 15, 2024. https://code-medical-ethics.ama-assn.org/ethics-opinions/physician-stewardship-health-care-resources
11. Valgus J, Singer EA, Berry SR, Rathmell WK. Ethical challenges: managing oncology drug shortages. J Oncol Pract. 2013;9(2):e21-e23. doi:10.1200/JOP.2012.000779
12. Johnson LM, Levine D. Allocation of drugs in short supply. Virtual Mentor. 2013;15(8):645-648. doi:10.1001/virtualmentor.2013.15.8.ecas2-1308
13. Hantel A, Peppercorn J, Abel GA. Model solutions for ethical allocation during cancer medicine shortages. Lancet Haematol. 2021;8(4):e246-e248. doi:10.1016/S2352-3026(21)00055-7
14. Hantel A, Spence R, Camacho P, et al. ASCO ethical guidance for the practical management of oncology drug shortages. J Clin Oncol. 2024;42(3):358-365. doi:10.1200/JCO.23.01941
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