Framing the Conversation
A common adjective used to describe the global medical supply chain is “complex,”1 due to its length and interdependence not only among supply chain segments, but among nation states. Myriad international experts exchange ideas about vulnerabilities of medical supply chains and how to make them more resilient. But why should clinicians care about a topic seemingly so far removed from patient care? And why is this an ethical issue?
One reason is that all clinicians should be aware of weaknesses in medical product supply chains because breaks in those chains generate drug shortages; increase prevalence of substandard, falsified, or counterfeit medicines; and compromise availability of devices and personal protective equipment. When medical supply chains break, clinicians’ ethical decisions are made more fraught by threats to their abilities to meet care standards as they manage patients’ care and try to respond to patients’ needs. This issue of the AMA Journal of Ethics explores this and kindred problems and questions.
Global Medical Supply Chain Complexity
Understanding risks to and resiliency of drug supply chains is inherently interdisciplinary and requires diverse perspectives, multiple stakeholders’ input, and global coordination. A sufficiently integrated approach to medical supply chains’ management requires understanding how those chains are enmeshed in a global context. For example, the SARS-CoV-2 pandemic highlighted medical supply chains’ interconnectedness and complexity, which was heightened by nation states’ interdependence and, often, fraught geopolitical relationships.2,3 The interconnectedness of global medical supply chains became remarkably apparent during the pandemic when many frontline health care professionals did not have personal protective equipment, such as surgical masks and gowns, because of shortages driven by pandemic-related supply disruptions and increases in demand. Supply shortages and increased global demand also caused surges in these items’ prices when, if ever, they became available.3
This complexity leads to—as clinicians who worked during the pandemic know well—drug shortages that, although increasingly more noticeable due to media attention, have been pervasive problems for many years.4,5,6 For example, older sterile injectable medicines have been in short supply frequently over the past several years despite their need and use as first-line, essential medicines to provide support care for and treat many conditions, including pediatric oncology.5 Clinicians and their patients should be able to trust that they will have access to basic, quality medicines, but this is no longer reliably the case, even in wealthy areas of the world.
Additional questions include these: Why do supply chain disruptions happen? Who should be responsible for their smooth operation when so many patients and clinicians rely on them? How should known present risks be mitigated? How should supply chain participants be positioned to better anticipate and respond to unknown future risks? Good responses to these questions must address supply chains’ vulnerabilities. Given the complexities just named, assigning responsibility to any single entity would likely be as shortsighted and oversimplified as a failure to draw on the plurality of perspectives needed to generate possible solutions.
Need to Build Resilience
Many groups are evaluating how to bolster medicines supply chains in their respective countries, regions, or industries.1,7,8,9,10,11,12,13 Dozens of reports and publications have been released in recent years that focus on supply chains for medical products, including drugs, biologics, personal protective equipment, devices, and other equipment.1,7,8,9,10,11 (See also Supplementary Appendix.) Some reports were written in the early days of the SARS-CoV-2 pandemic and focused on ramifications of significant, rare events, including supply disruptions, especially those stemming from importation policies and practices.14,15,16 Other publications, many written during later stages of and recovery from the pandemic, reported on unexpected spikes in demand for medicines and medical products and commented on preparedness, essential medicines, and renewed consideration of emergency stockpiling.10,16,17,18,19,20,21,22 More recent reports have evaluated long-standing vulnerabilities in medical supply chains that were worsened by events of the past several years.7,23,24 These reports—authored by government agencies, academicians, think tanks, consulting companies, and other supply chain stakeholders—identify supply chain vulnerabilities and offer recommendations to improve domestic and global medical product supply chain resilience. Importantly, improvements suggested in these reports tend to reflect their sponsors’ or authors’ vantage points, which focus narrowly on what they can do to advance supply chain resilience. These many initiatives emphasize the need for progress, while underscoring the pressing need for better coordination and more effective forging of solutions that fit together and meaningfully address key gaps in medical supply chains.
When Supply Chains Vulnerabilities Compromise Clinical Practice
This theme issue considers clinical and ethical demands faced by clinicians trying to care well for patients, manage drug shortages in a hospital, ration limited supplies of key medicines and equipment, and manage consequences of quality control failures or compromised stockpile access. Contributors to this issue attempt to reframe essential medicines conversations and ask, Why don’t essential medicines lists take supply chain security risks into account? Health care policy and supply chain experts discuss implications of importing medicines, how currently siloed data can be more effectively and efficiently shared to promote understanding of risks to medical supply chains’ integrity, and obstacles to supply chains’ security, even in the final miles of getting medicines to patients.
Clinicians can reasonably be expected to be experts in caring for patients, not in managing global medical supply chain security. However, since clinicians and their patients feel the effects of compromised supply chains, this issue is intended to be a resource for clinicians looking to better understand how supply chains inform their capacity to care well for patients. Hopefully, this issue will support clinicians’ appreciation of a bigger picture behind challenges they will continue to face until health care system infrastructures bolster the security, resilience, and reliability of global medical supply chains.
References
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Mulcahy AW, Kareddy V. Prescription drug supply chains: an overview of stakeholders and relationships. RAND Corporation; 2021. Accessed February 19, 2024. https://www.rand.org/content/dam/rand/pubs/research_reports/RRA300/RRA328-1/RAND_RRA328-1.pdf
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Nelson C, Bruse A, Cooray A, et al; Office of Technology Evaluation. Reliance on Foreign Sourcing in the Healthcare and Public Health (HPH) Sector: Pharmaceuticals, Medical Devices, and Surgical Equipment. US Department of Commerce; 2011. Accessed July 27, 2022. https://www.bis.doc.gov/index.php/documents/other-areas/642-department-of-homeland-security-dhs-assessment-impact-of-foreign-sourcing-on-health-related-infra/file
- Burki T. Global shortage of personal protective equipment. Lancet Infect Dis. 2020;20(7):785-786.
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Phuong JM, Penm J, Chaar B, Oldfield LD, Moles R. The impacts of medication shortages on patient outcomes: a scoping review. PLoS One. 2019;14(5):e0215837.
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US Pharmacopeia; Vizient; Angels for Change. Quantifying drivers of supply chain resilience in pediatric oncology medications. US Pharmacopeia; 2021. Accessed May 9, 2023. https://www.usp.org/sites/default/files/usp/document/supply-chain/pediatric-oncology-drugs-and-supply-chain.pdf
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American Society of Health-System Pharmacists. Severity and impact of sterile injectable drug shortages. American Society of Health-System Pharmacists; 2022. Accessed August 12, 2023. https://www.ashp.org/-/media/assets/drug-shortages/docs/ASHP-Sterile-Injectable-Drug-Shortages-March2022.pdf
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Hopp WJ, Brown L, Shore C, eds; National Academies of Sciences, Engineering, and Medicine. Building Resilience Into the Nation’s Medical Product Supply Chains. National Academies Press; 2022.
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Colvill S, Roades T, Kroetsch A, McClellan M. Supporting resilient drug supply chains in the United States: challenges and potential solutions. Duke Margolis Center for Health Policy; 2021. Accessed July 13, 2021. https://healthpolicy.duke.edu/sites/default/files/2021-10/Supporting%20Resilient%20Drug%20Supply%20Chains%20in%20the%20United%20States.pdf
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US Department of Commerce; US Department of Energy; US Department of Defense; US Department of Health and Human Services. Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth: 100-Day Reviews Under Executive Order 14017. The White House; 2021. Accessed August 20, 2021. https://www.whitehouse.gov/wp-content/uploads/2021/06/100-day-supply-chain-review-report.pdf
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Next Foundry for American Biotechnology; Advanced Regenerative Manufacturing Institute; Nexight Group. Essential medicines supply chain and manufacturing resilience assessment. US Department of Health and Human Services; 2022. Accessed November 6, 2023. https://www.armiusa.org/wp-content/uploads/2022/07/ARMI_Essential-Medicines_Supply-Chain-Report_508.pdf
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Health Canada. COVID-19: new tools to prevent and alleviate drug shortages related to the pandemic. Drug Establishment Licensing Bulletin No. 98. Government of Canada; 2020. Accessed November 6, 2023. https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/new-tools-prevent-alleviate-drug-shortages.html
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Takagi L. A year’s struggle: how Japan is recovering damaged generic supplies after quality violations. Citeline. April 12, 2020. Accessed November 6, 2023. https://scrip.pharmaintelligence.informa.com/SC146218/A-Years-Struggle-How-Japan-Is-Recovering-Damaged-Generic-Supplies-After-Quality-Violations
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Ghangurde A. India-Japan partnering momentum: regulatory alignment is key. Citeline. April 25, 2022. https://pink.pharmaintelligence.informa.com/PS146066/India-Japan-Partnering-Momentum-Regulatory-Alignment-Is-Key
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Kilpatrick J, Barter L. COVID-19: Managing Supply Chain Risk and Disruption. Deloitte; 2020.
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Drug Shortages Task Force. Drug Shortages: Root Causes and Potential Solutions. US Food and Drug Administration; 2019. Updated February 21, 2020. Accessed March 10, 2020. https://www.fda.gov/media/131130/download
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Lal A, Lim C, Almeida G, Fitzgerald J. Minimizing COVID-19 disruption: ensuring the supply of essential health products for health emergencies and routine health services. Lancet Reg Health Am. 2022;6:100129.
- Mattingly TJ 2nd, Conti RM. Ensuring a high-quality and resilient supply chain of essential medications means paying more. J Manag Care Spec Pharm. 2022;28(5):573-576.
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TRACIE: Healthcare Emergency Prepredness Information Gateway. Partnering with the healthcare supply chain during disasters. TRACIE: Healthcare Emergency Prepredness Information Gateway; 2022. Accessed August 12, 2022. https://files.asprtracie.hhs.gov/documents/aspr-tracie-partnering-with-the-healthcare-supply-chain-during-disasters.pdf
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Broadbent M. Covid-19 demand shock and preparedness response—securing medical supply chains: the trusted trade partner network. Center for Strategic and International Studies; 2020. Accessed August 11, 2022. https://csis-website-prod.s3.amazonaws.com/s3fs-public/publication/201221_Broadbent_Covid19_Shock.pdf
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Sardella A, De Bona P. Safeguarding the United States pharmaceutical supply chain and policy considerations to mitigate shortages of essential medicines. Washington University in St Louis; 2021. Accessed August 12, 2022. https://wustl.app.box.com/s/wpqr6704f02eywivqsz7h1vfn8seb848
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FAQs: the Pandemic Fund. World Bank. Updated March 3, 2023. Accessed July 29, 2022. https://www.worldbank.org/en/topic/pandemics/brief/factsheet-financial-intermediary-fund-for-pandemic-prevention-preparedness-and-response
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McDonnell A, Pisani E, Singhvi S, Chalkidou K, Yadav P. A path to resiliency: mitigating the impacts of COVID-19 on essential medicines supply chains. Center for Global Development; 2021. CGD policy paper 213. Accessed August 10, 2022. https://www.cgdev.org/sites/default/files/Mitigating-impact-covid-essential-medicine-supply-chain_0.pdf
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MSD; Avalere Health. COVID-19 global regulatory agilities: multi-stakeholder virtual workshop. MSD; 2022. Accessed December 18, 2023. https://www.msd.com/wp-content/uploads/sites/9/2022/06/COVID-19-Global-Regulatory-Agilities.pdf
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Sardella A. The US active pharmaceutical ingredient infrastructure: the current state and considerations to increase US healthcare security. Washington University in St Louis; 2021. Accessed May, 2022. https://wustl.app.box.com/s/rjo1i7yews99hdr8zeo5fp0u71g47m0i