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Vulnerability of the medical product supply chain: the wake-up call of COVID-19

Fiona A Miller ‍ ‍, 1 Steven B Young, 2 Mark Dobrow, 1 Kaveh G Shojania ‍ ‍ 3

1 Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada 2 School of Environment, Enterprise and Development, University of Waterloo, Waterloo, Ontario, Canada 3 Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada Correspondence to Dr Fiona A Miller, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada; ​fiona.​miller@u​ toronto.​ca

acquire. Many shortages seen during the COVID-19 crisis clearly affect safety, and they can exacerbate widespread problems with equity. Just as critical incidents afford the opportunity to identify not just obvious active errors but also latent safety prob- lems, 6 crises such as COVID-19 expose general supply chain weaknesses. In fact, product shortages often exhibit the combination of active and latent errors (or ‘system problems’) seen in investiga- tions of critical safety incidents. Hurricane Maria in 2017, for example, converted a chronic shortage of sterile saline solu- tions (for intravenous administration) into an acute shortage when manufac- turing capacity concentrated in Puerto Rico was damaged. 7 The current ampli- fied risk of generic drug shortages follows from several decades of chronic shortage associated with fewer firms and concen- trated sites of production. 8 These crit- ical incidents are unlikely to abate, given the continued threat of future infectious disease outbreaks, 9 and the accelerating climate crisis, which will increase extreme weather, violent conflicts and other events that provoke acute shortages. 10 The vulnerability of medical product supply—and its converse, resilience—has historically attracted little interest from clinicians, healthcare executives or those engaged in improving healthcare quality. Yet, as the COVID-19 pandemic has made obvious to even the casual observer, product shortages affect clinical practice, organisational performance and patient outcomes. In this article, we outline what is known from the extensive literature on supply chain resilience and medical product shortage and use examples from both healthcare and non-healthcare

INTRODUCTION The COVID-19 pandemic has brought the long-standing vulnerability of the medical product supply chain into sharp focus. Global shortages of medical prod- ucts accompanied the global spread of the disease, joined by high prices, the proliferation of suspect dealers and dramatic interventions by governments, philanthropy and industry in oftentimes-­ unsuccessful attempts to secure solutions. Much attention has focused on personal protective equipment (PPE). But reported shortages have extended much further—to testing supplies, dial- ysis materials, pharmaceuticals and a wide range of commodities essential for daily care delivery—both for patients with and without COVID-19. 1 2 PPE shortages have received partic- ular attention because they endanger the healthcare workforce. 3 But all product shortages endanger patients due to delays in care, rationing or denial of care, the use of substandard products, or heightened risk of error when using replacement products—risks that extend to increased mortality. 4 Medical product shortages threaten the goal to deliver the right care to the right person at the right time—and have done so for decades. 5 The COVID-19 pandemic has highlighted more than ever that these systemic risks can no longer be ignored. It may also mean that new solu- tions have become more possible. Why care about medical supply chains? Unexpected shortages of medical prod- ucts do not fit neatly into any single quality domain, but can affect all of them. We cannot provide effective, efficient or timely care when medicines and other supplies required for crucial elements of care become difficult or impossible to

Received 2 August 2020 Revised 17 October 2020 Accepted 22 October 2020 Published Online First 2 November 2020

© Author(s) (or their employer(s)) 2021. No

To cite: Miller FA, Young SB, Dobrow M, et al . BMJ Qual Saf 2021; 30 :331–335. commercial re-use. See rights and permissions. Published by BMJ.

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Miller FA, et al . BMJ Qual Saf 2021; 30 :331–335. doi:10.1136/bmjqs-2020-012133

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