Medication shortages are a global challenge with ethical and economic consequences. There is ongoing debate on how to make decisions and implement clinical strategies to address such situations in the most equitable way. Rationing polices differ by country, state, health care system, and institution. As a new global health threat, the COVID-19 pandemic and any future waves of infection may additionally complicate issues of medication supply. Recommendations have been published around the globe on how to fairly ration therapeutics and vaccines, but little has been said about the allocation of new medicines and critical care resources (DeJong, 2020).
Ethical principles are important considerations in all public health crises. Several factors contribute to healthcare ethics, including the interaction between commercialism and consumerism. When there is a medication shortage, for instance, it becomes necessary to identify which patients should receive the medication. Consequently, scarce medicine and supplies should be allocated fairly to prevent discrimination and mitigate health disparities. Furthermore, greater transparency and accountability is needed in allocation policies. Michael Ganio, Director of Pharmacy Practice and Quality at the nonprofit American Society of Health-System Pharmacist (ASHP), says that beyond the FDA, which announces only limited information on drug shortages, there is “no [legal] requirement for patients to be notified about a [drug] shortage…. In fact, there is no requirement for pharmacies to be notified of a shortage” (Scipioni, 2020).
Allocation policies should be determined given the best available data and revised as new data arises. A recent article by a USCF team argues that policies should be “responsive to the concerns of those affected, and proportionate to the situation, including the trajectory of the epidemic and the supply of medications relative to the need” (DeJong, 2020). In practice, first-order considerations include a patient’s ability to benefit and survive from the treatment, but assessing the likelihood of short-term survival is a sizeable challenge in itself, especially when it comes to relatively new diseases such as COVID-19 (McGuire, 2020).
A 2019 report by the U.S. Food and Drug Administration (FDA) suggests there are three root causes of medication shortages: a lack of incentives to produce less profitable drugs, failure to recognize and reward manufacturers for good manufacturing practices, and logistical and regulatory barriers that make it challenging for the market to recover after a disruption (“Drug Shortages”, 2019). The report calls for better characterization of shortages and quantification of their consequences, greater data-sharing and risk management by the FDA, greater transparency of contracting practices in the private sector, as well as a rating system and financial incentives to encourage drug manufacturers to invest in quality practices (“Drug Shortages”, 2019). Furthermore, a different paper calls for the importance of ongoing monitoring and the use of computerized inventory management systems to reduce medication shortages (Modisakeng, 2020).
Though the U.S. is a world leader in drug discovery and development through its investment in biomedical research, drug manufacturing has shifted out of the U.S. in recent decades, pitting domestic manufacturing companies against foreign ones and casting doubt on their ability to promise a stable supply of drugs to U.S. patients (Woodcock, 2019). The FDA believes, however, that advanced manufacturing technologies aimed at improving drug quality, addressing medication shortages and accelerating time-to-market could bring the U.S. back to the forefront of pharmaceutical manufacturing (Woodcock, 2019). At the same time, with the need for COVID-19 medications projected to exceed available supply, it is important to develop plans aimed not only at raising productivity and mitigating shortages but also at distributing medical supplies in ways that best adhere to ethical principles.
References
- DeJong C, Chen AH, & Lo B. An Ethical Framework for Allocating Scarce Inpatient Medications for COVID-19 in the US. JAMA. 2020;323(23):2367–2368. doi:10.1001/jama.2020.8914
- McGuire AL, Aulisio MP, Davis FD, et al. Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force. The American Journal of Bioethics, 2020;20(7):15-27, doi:10.1080/15265161.2020.1764138
- Drug Shortages: Root Causes and Potential Solutions. (2019). Retrieved September 30, 2020, from U.S. Food and Drug Administration website: https://www.fda.gov/drugs/drug-shortages/report-drug-shortages-root-causes-and-potential-solutions
- Modisakeng C, Matlala M, Godman B, & Meyer JC. Medicine shortages and challenges with the procurement process among public sector hospitals in South Africa; findings and implications. BMC health services research, 2020;20(1):234. doi:10.1186/s12913-020-05080-1
- Scipioni J. (2020, March 25). Drug shortage experts: What consumers need to know during the coronavirus pandemic. Retrieved September 30, 2020, from https://www.cnbc.com/2020/03/25/drug-shortage-experts-what-consumers-should-know-in-covid-19-pandemic.html
- Woodcock J. (2019, October 30). Safeguarding Pharmaceutical Supply Chains in a Global Economy (Rep.). Retrieved September 30, 2020, from U.S. Food and Drug Administration website: https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019