Proceedings of a Workshop
Medical Product Shortages During Disasters: Opportunities to Predict, Prevent, and Respond
Proceedings of a Workshop—in Brief
In response to the shortage of intravenous (IV) saline solution that was exacerbated during the 2017 hurricane season, the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the Department of Health and Human Services (HHS) asked the National Academies of Sciences, Engineering, and Medicine to convene a workshop to better understand the gaps that led to cascading effects in patient care throughout the U.S. health care system. On September 5–6, 2018, in Washington, DC, the Health and Medicine Division of the National Academies convened the workshop Medical Product Shortages During Disasters: Opportunities to Predict, Prevent, and Respond.
W. Craig Vanderwagen of East West Protection, LLC, and former Assistant Secretary for Preparedness and Response, explained the workshop’s objectives: explore the current evidence base on the causes and effects of medical product shortages that result from disasters or other public health emergencies; discuss current efforts and innovative approaches to better predict, prevent, and respond to medical product shortages that result from disasters or other public health emergencies; examine strategies to ensure public health and health care providers can provide high-quality patient care during shortages of medical products; and identify research needs and opportunities to provide public health officials and the general public with accurate information to support policy making and decision making to improve patient care.
Vanderwagen explained the workshop would discuss shortages of medical devices, drugs, and supplies in the context of disaster. He explained that the workshop was structured to begin by presenting the shared understanding of what a shortage is and its causes and effects on patients, providers, and other stakeholders. The workshop would then explore some of the challenges and gaps in response to these shortages and conclude with panels that would discuss how best to improve prediction, prevention, and response to shortages in the future.
The opening keynote was delivered by Kevin Yeskey, Principal Deputy Assistant Secretary for Preparedness and Response at ASPR. He emphasized that ASPR’s work requires coordination among a broad spectrum of federal agencies; state and local public health departments; emergency managers; law enforcement; and private-sector partners in health care, pharmaceutical, academic, and nongovernmental organizations. During and following disasters, ASPR must also work with infrastructure factors such as electrical power, transportation, and water systems. Yeskey said that disasters and shortages are intrinsically linked. Everyday disasters in health care and emergency response occur, he explained, when there is a demand that exceeds supply, but disasters can also cause shortages. Day-to-day shortages in the health system impact the collective ability to respond to a disaster, he added, and strengthening the system’s day-to-day functioning to prepare for disasters is both a public and private responsibility.
CAUSES AND EFFECTS OF MEDICAL PRODUCT SHORTAGES
Workshop participants explored the causes and effects of shortages of medical devices, drugs, and supplies on disaster response and health care service delivery. The objectives for each session of the workshop were developed by the workshop planning committee. The first session’s objectives were to provide an overview of the supply chain for medical products, focusing on common disruptions that contribute to shortages and their causes; consider how public
health emergencies exacerbate existing disruptions in the supply chain; discuss the economic drivers contributing to medical product shortages; examine the current state of medical product shortages in the United States and how these shortages impact various stakeholder groups, including patients, caregivers, providers, and other vulnerable populations; and explore how medical product shortages during a public health emergency may contribute to medical errors, decreased health care quality, compromised patient and provider safety, provider resource allocation, and increased cost.
During the panel on establishing a shared understanding of the complex challenge of medical product shortages, Douglas Throckmorton of the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research explained that FDA has a critical role in the prevention and mitigation of medical product shortages.1 FDA, for example, focuses on maintaining availability while minimizing risk to patients by facilitating temporary and long-term strategies, coordinating timely and comprehensive risk and benefit decisions, and distributing information. He noted that FDA cannot require a company to make a product or make more of a product, nor can it control how much and to whom the product is distributed. He described two different ways to define shortages. FDA’s definition centers on national-level demand, defining a shortage as a period when the demand or projected demand for the product within the United States exceeds the supply of the product. The American Society of Health-System Pharmacists (ASHP) uses a pharmacy-focused definition: a product is in shortage once the shortage is “verified with manufacturers; when supply issues affect how a pharmacy, hospital, or store prepares or dispenses a product; or when supply issues influence patient care requiring prescribers to use an alternative therapy.”2 He explained that the product-specific metrics the groups report may differ because of their definitions, but the overall trends are consistent. The annual number of new shortages decreased more than five-fold between 2011 and 2013, which he attributed to the impact of Congress’s 2012 requirement that manufacturers notify FDA if they are unable to fill orders or meet expected demand.3 Each year since 2012, the United States has had fewer than 50 new shortages and has avoided between 100 and 150 product shortages, he said.4
Ernst Berndt, Massachusetts Institute of Technology (MIT), said that due to FDA’s more stringent definition, it generally reports fewer shortages than ASHP.5 ASHP reports that the number of U.S. drug shortages has fallen to an average of 150–175 per year, after peaking at 267 in 2011, he said; however, the number of active shortages has increased by about 30 percent since 2014, indicating that many drug shortages are persistent. Shortages are widespread across multiple therapeutic areas and in 2017, more than half of the shortages had unknown causes, with manufacturing problems (30 percent) and business supply and demand (8 percent) being the most commonly reported reasons.6 Berndt emphasized the distinction between oral solid drugs and parenteral drugs,7 noting that most shorted8 products are injectables and multi-sourced generics.9 Although time trends for parenteral and non-parenteral drugs are similar and highly correlated, the average age of unresolved shortages for parenteral drugs is roughly double that of non-parenteral drugs.10 Per FDA data, sterile injectables represent almost 80 percent of shortages.11 Berndt explained that injectable drugs are more dif-
1 More information about the Food and Drug Administration Safety and Innovation Act is available at https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/default.htm (accessed September 18, 2018).
2 More information about the FDA and ASPH shortage parameters is available at https://www.ashp.org/Drug-Shortages/Current-Shortages/FDA-and-ASHP-Shortage-Parameters (accessed September 24, 2018).
3 According to the Requirements to Industry for Early Notification, manufacturers are required to notify FDA of “a change in production that is reasonably likely to lead to a reduction in the supply” of a covered drug in the United States (“At least 6 months in advance of … but in no case later than 5 business days after the … interruption in manufacturing occurs”); regardless of market share, or number of companies marketing, or wholesaler volumes and not limited to medically necessary products. They are asked to communicate at the time of any change in manufacturing that may lead to a reduction in supply of a product (for example, plans for upgrade or remediation, manufacturing issues, raw material batch failures, particulate issues, or sterility issues).
4 From the FDA Drug Shortage Report to Congress (2017), available at https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM610662.pdf (accessed September 10, 2018).
5 In collaboration with the University of Utah, the Drug Shortage Programs at FDA and ASHP maintain websites that identify and provide detailed current and historical information on drugs in short supply. http://pharmacyservices.utah.edu/drug-information/drugshortages.php (accessed September 13, 2018).
6 Berndt, E. 2018. Economic issues underlying recent but persistent drug shortages in the US. PowerPoint presentation at the Medical Product Shortages During Disasters workshop in Washington, DC. http://www.nationalacademies.org/hmd/~/media/Files/Activity%20Files/PublicHealth/DisasterScience/DrugShortagesWorkshop/Berndt%20Ernst.pdf (accessed September 13, 2018).
7 Parenteral drugs are medications administered by a route that bypasses the digestive tract, such as drugs administered via inhalation, infusion, instilled, implanted or injectable means.
8 In this instance, “shorted” refers to products that experience shortages.
9 IMS Institute for Healthcare Informatics. 2011. Drug shortages: A closer look at products, suppliers and volume volatility. http://eyeonfda.com/wp-content/uploads/2011/11/IMS-IHI-Drug-Shortages-Report-Final.pdf (accessed September 11, 2018).
11 ASPE Issue Brief, October 2011, Appendix A, Table 1, p. 16. 2013 updates from American Society of Health-System Pharmacists, 4/21/13; FDA Current Drugs Shortages List, 4/21/13; 2014 FDA data. http://www.accessdata.fda.gov/scripts/drugshortages (accessed September 11, 2018).
ficult to manufacture, require more rigorous process controls, and their high manufacturing costs are a barrier to generic entry. Len Singer of Clinical Consequence Strategies, LLC, suggested that planning should also differentiate cold-chain products that are sensitive to temperature and require additional considerations around distribution and storage.
The normal supply chain has a “just-in-time” inventory system that increases efficiency and decreases waste, inventory storage, and cost, said Scott Knoer, Cleveland Clinic. However, the system makes unexpected shortages difficult to prevent, requiring quick and effective management to decrease the impact. He explained that shortages can have manufacturing causes (such as production problems or halting production), regulatory causes, and marketplace causes related to competition, secondary production capacity, and consolidation. Improved product forecasting and quickly identifying alternative sourcing options for products can help to prevent and predict shortages, he said, and strategies to respond to shortages include managing inventory, collaborating with drug manufacturers, optimizing compounding practices, and leveraging collaboration across the pharmacy enterprise. He added that legislative assistance could ease entry into a marketplace to increase competition and allow importation into normal supply chains during a shortage. Knoer noted that formulary changes caused by shortages create a burden of clinical practice changes, coupled with laborious adjustments to the electronic health records (EHRs) order system.
James Callahan, AmerisourceBergen,12 reported that in terms of product shortages, the number of unavailable or allocated items due to industry issues nearly doubled to almost 5,400 between 2017 and 2018, with the most significant increase in unavailable products (31 percent) occurring from October 2017 to January 2018. He explained that industry challenges around routine product shortages stem from supplier manufacturing issues, manufacturer pricing constraints, overall industry pressures, and regulatory obligations. He said that during response to an emergency industry partners encounter additional infrastructure challenges related to the availability of power, telecommunications, and fuel, as well as barriers to access such as curfews, roadblocks, and credentialing. Communication issues and private-sector partners’ lack of awareness can impede coordination.
Noting that effective planning is contingent on full and transparent information about manufacturing capacity, Vanderwagen highlighted the tension in trying to expand a common operating picture and promote situational awareness within a market predicated on competitive forces. Nate Peaty of OrbitalRX commented that situational awareness for shortages should not be limited to incidence metrics. He proposed bringing in more scope and scale through metrics to capture the impacts of patient safety, financial constraints, hospital operations, and the potential changes in volume of doses. Monique Mansoura, MITRE,13 described an instructive model from the aviation industry of data sharing and collaboration in a highly regulated, competitive, international industry rife with proprietary information. The Aviation Safety Information Analysis and Sharing14 program is an ecosystem for collaborating and sharing information in a safe harbor, where it is analyzed and fed back as benchmarks while proprietary information is protected.
The next panel explored the effects of medical product shortages on patients, providers, and systems. The pediatric population is uniquely affected by shortages from a supply perspective, said Steven Krug, Northwestern University Feinberg School of Medicine and American Academy of Pediatrics. He explained that most pediatric medications are dosed on weight and many generic injectable formulations come in different concentrations requiring dilution. Overdosing is a serious risk, he added, but subtherapeutic dosing also carries the risk that the patient will not respond adequately to a critical treatment.
Mike Bowen, Secure Mask Supply Association and Prestige Ameritech, the largest surgical mask producer in the United States, described how his company significantly ramped up production to meet the demands of U.S. government agencies and hospitals countrywide during the H1N1 pandemic. This is not sustainable practice, he said, because the orders ceased immediately when the pandemic ended, leaving them with a huge glut of product and serious financial difficulty. Profit margins are very low, he said, and they operate at a loss when they need to ramp up during an emergency to avoid perceptions of price gouging.
Allen Vaida is the Executive Vice President at the Institute for Safe Medication Practices, an independent nonprofit medication safety organization that runs a national medication error reporting program. He cautioned that patient care is being jeopardized by routine drug shortages and rationing of potassium chloride, sodium bicarbonate, magnesium, and other critical products and is also compromised by shortage-related provider errors in dosing or compounding alternative products with different sizes, strengths, and concentrations.
12 AmerisourceBergen is a multinational corporation that works to strengthen and improve drug and health care products’ supply chain distribution.
13 MITRE’s report on threats to the pharmaceutical supply chain is available at https://www.dhs.gov/sites/default/files/publications/2018_AEP_Threats_to_Pharmaceutical_Supply_Chains.pdf (accessed September 11, 2018).
Bonnie Levin, MedStar Health, described how communication about medical product shortages is a challenge in a system that spans thousands of providers, but they gather information as quickly as possible to develop and disseminate strategies for alternative options and conservation. She described a “whack-a-mole” effect in routine saline shortages: moving from one product to the next as each becomes short, with providers becoming inured to the large number of alerts they receive. James Robinson, Denver Health Emergency Medical Services (EMS), said that his EMS system also looks for suitable alternatives and ways to reduce usage during a shortage; however, EMS have a limited formulary and the typical fee-for-service funding model does not cover preparedness and limits surge capacity. He added that the mobile work environment creates extra challenges and that shortages during disasters exacerbate the system’s existing burden when EMS must change protocols, retrain providers, and adjust EHRs.
Robinson remarked that health care coalitions can promote situational awareness and a common operating picture while providing a venue to discuss issues such as the ethics of rationing products to maximize their impact. Sara Roszak, National Association of Chain Drug Stores (NACDS), also suggested that health care coalitions and strategic partnerships can help to ensure clear, consistent communication about shortages during a disaster. Robinson noted that the transience of shortages impedes public messaging and can cause communication fatigue. Sheri Fink, author of Five Days at Memorial: Life and Death in a Storm-Ravaged Hospital,15 underscored the ethical implications of issues like rationing and alternative drugs, which warrant public input. She added that public messaging is the only way to build awareness about the impact of shortages. Robinson replied that messaging needs to impart a basic understanding of the processes that underlie shortages, so the public can better appreciate their consequences.
Karen Remley, de Beaumont Foundation, cautioned that medical product shortages in institutions across the country are undoing decades of work on delivering the right dose to the right person at the right time.16 Krug added that shortages have also disrupted work on patient safety and evidence-based clinical guidelines. Health care systems should adopt a proactive, prevention-focused public health approach to shortages, said Remley. To demonstrate the risk that shortages pose to the health and well-being of the public, she suggested that providers should keep track of alterations to standards of care and quantify the errors and near misses that occur.
Amy Kircher, University of Minnesota, suggested mapping raw materials and delivery mechanisms to identify the predictable elements that underpin manufacturing-related shortages. Throckmorton noted that the amount of information available is directly related to the likelihood of accurately predicting a supply interruption in the broader manufacturing ecosystem.
PREDICTING, PREVENTING, AND RESPONDING TO MEDICAL PRODUCT SHORTAGES: CURRENT EFFORTS AND CHALLENGES
The objectives of this session were to provide an overview of the strengths and limitations of current efforts used to monitor, prevent, and control medical product shortages; discuss the advantages and disadvantages of the complex and multisector nature of medical product manufacturing; examine different stakeholder roles and evidence needs to support decision making; and identify the shared goals, challenges, and gaps to predicting, preventing, and responding to shortages.
The first panel of the session featured current efforts to predict, prevent, and respond to shortages. Roszak explained that NACDS represents drug stores of all types across the country and has been deeply engaged in preparedness and response efforts for years. Keagan Lenihan, FDA, described the agency’s recent charge to look at drug shortages from an expanded perspective beyond its typical scope through the new FDA Drug Shortages Task Force,17 which will report back to Congress with regulatory and legislative recommendations by the end of 2019. The Task Force brings together partners from the Department of Defense (DoD), the Department of Veterans Affairs, and the Centers for Medicare & Medicaid Services, which collectively care for tens of millions of Americans. She said the Task Force will examine systemic forces that underlie shortages—from the procurement of raw materials to patient delivery—by looking at incentives, competition, market entry, government regulations, consolidation, and capacity building.
Mary Kosinski, Pharmaceutical Research and Manufacturers of America (PhRMA), explained that PhRMA represents the country’s leading innovative biopharmaceutical research companies. Hurricane Katrina highlighted the critical role of communications in disaster preparedness and response, she said, and motivated PhRMA and its sister industry associations to create a platform called Healthcare Ready to convene across the medical supply chain to communicate and coordinate
15 Fink, S. 2013. Five days at Memorial: Life and death in a storm-ravaged hospital. New York: Crown Publishers.
17 Information on FDA’s Drug Shortages Task Force is available at https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm (accessed September 10, 2018).
response efforts. Because PhRMA member companies work closely with FDA, the platform can centrally communicate with the front lines during response to support patients. Shortage management during a disaster depends on relationships fostered through routine interactions, she added, so PhRMA will continue to build on its partnerships with federal agencies and the medical supply chain ecosystem.
Karla Miller, Hospital Corporation of America (HCA), said that HCA carries out active monitoring and surveillance for all medically necessary products on a day-to-day basis; when supply becomes critically low, the focus shifts to clinical utilization (i.e., identifying appropriate use and ways to decrease overuse). The organization has a robust supply chain with central distribution centers that enables it to quickly mobilize products to address critical shortages during emergency responses, she said. For example, she said, it developed guidance to support clinical decision making about saline at the point of order entry, because analysis of clinical utilization patterns revealed that many providers did not realize the magnitude of the shortage.
Patrick Byrne, Biomedical Advanced Research and Development Authority (BARDA) within ASPR, HHS, described BARDA’s mission of developing medical countermeasures (MCMs) to national security threats such as pandemic influenza; chemical, biological, radiological, and nuclear (CBRN) weapons; and emerging infectious diseases. BARDA and ASPR can support responses to these threats, he said, but planning must also engage with HHS, the Department of Homeland Security (DHS), the Department of Commerce, the DoD, and other agencies with insights about manufacturing and its limitations.
François Sallans, International Society for Pharmaceutical Engineering (ISPE) and Johnson & Johnson, provided an overview of the dimensions of ISPE’s report on drug shortage prevention plans,18 which includes instilling a corporate culture of preventing shortages; building robust quality systems; using meaningful metrics; creating business continuity plans (during disasters and “blue skies”); providing transparent communication with authorities; and building knowledgeable capabilities in facilities. ISPE has developed a gap assessment tool and webinar to support the assessment of these dimensions to guide companies preparing prevention plans, he said.
Matt Rosenberg, an FDA economist, remarked that proactively preventing drug shortages requires prioritizing the drugs that have the greatest potential impact and the highest risk of shortage. He explained that setting these priorities is contingent on insight into the supply chain with respect to manufacturers’ capacities and volumes, business decisions driving discontinuation, and relative profitability of certain drugs. As was mentioned by Throckmorton, FDA is unable to direct specific manufacturers’ production or profit decisions but their effect on shortages is established so knowing more about why and when those decisions are made would help all stakeholders to plan, prepare, and prevent. Vanderwagen said that in the context of disasters, ASPR and FDA could take the lead in that type of prioritization.
The second panel discussed gaps and challenges in predicting, preventing, and responding to medical product shortages. Brad Noe, Becton Dickinson (BD), described BD’s public–private partnership with BARDA, the Healthcare Industry Distributors Association (HIDA), and the Strategic National Stockpile (SNS) to discuss market usage data and generate potential solutions through tabletop exercises. Greg Burel, Centers for Diseases Control and Prevention (CDC),19 HHS, explained that the HIDA tabletop exercise brought together partners that may typically be competitors in a response scenario to explore the manufacturing details of products such as needles, gloves, and personal protective equipment. Noe said BD is developing disaster playbooks with the SNS to provide guidance about mustering resources, sequestering items, and distributing products; with BARDA and others, it is working to develop consistent shared messaging for clinicians to ameliorate disruptions and improve transparency.
Michael Ganio, ASHP, said that due to pervasive shortages, pharmacists are burdened by the constant need to pursue second-line alternatives and other strategies for rationing that can compromise patients’ care. His organization provides management guidelines and other resources20 about shortages that affect patient care. Shortage management has improved, he said, but at the expense of the resources, personnel, and time required. Eric Goralnick, Brigham Health, noted that clinicians are inundated with best practice advisories for different types of medications and fluids, resulting in alert fatigue and clinician burnout. He described how Brigham Health addresses such EHR system vulnerabilities. Data are analyzed to identify patients who could potentially have their IV medications or fluids converted to non-parenteral formulations, then a pharmacist calls each patient’s ordering provider. This innovation has been productive, he said, but also has had an adverse effect on relationships among pharmacists and clinicians who may find the calls disruptive. Matthew Wynia, University of Colorado Denver, raised the issue of clinicians’ moral distress, which can also lead to burnout when
18 Information about the ISPE shortages initiative is available at https://ispe.org/initiatives/drug-shortages/publications-tools (accessed September 10, 2018).
19 On October 1, 2018, the SNS management will transfer to ASPR.
20 ASHP drug shortage resources are available at https://www.ashp.org/Drug-Shortages/Shortage-Resources (accessed September 10, 2018).
systemic barriers prevent clinicians from doing what they know is right—for example, informing patients that they are receiving inferior care due to a shortage.
James Grant, Beaumont Health and the American Society of Anesthesiologists, remarked that the landscape has changed profoundly in a short time, with drug and medical supply shortages now pervasive on a day-to-day basis and not just during emergencies. Product rationing and substitutions have direct consequences for patients that increase exponentially during disaster times, he added. Goralnick said that patient advocacy groups should be brought to the table, particularly for conversations about changing pain medications to better understand potential impact. He suggested creating new measurement methods to capture patient-related outcomes, frailty scores, and other patient-related measurements.
Elizabeth Jungman, The Pew Charitable Trusts, described a report from Pew and ISPE21 that examined how companies’ decisions about manufacturing, maintenance, and facility upgrade affect drug shortages. Given that quality issues continue to drive most drug shortages, the report focused on other contributing factors such as continuity planning, market withdrawals, and dual sourcing.
Sheldon Jacobson, University of Illinois at Urbana-Champaign, asked whether the supply chain’s problems are metaphorically chronic or acute. Grant replied that as with many diseases, the problem can begin as acute and become chronic. Jungman added that shortages do not have a single etiology, compounding their complexity. Vanderwagen remarked that the supply chain’s underlying “chronic disease” is undercutting the resiliency needed to withstand disasters. He reflected, “we need to think about shortages writ large as a backdrop against which we are trying to work, as we try to create resiliency and recovery in communities affected by disaster events.”
PERSPECTIVES FROM INVITED DISCUSSANTS AND OTHER SECTORS
The objectives of the first session on day 2 of the workshop were to reflect on the first day’s discussions with invited discussants and workshop participants, as well as explore lessons learned and discuss best practices from other sectors about how they predict, prevent, and respond to shortages. During the first panel, Christopher Hoff, DuPage County Health Department (Illinois), suggested engaging with local coalitions before an event happens, not when it is imminent or already under way. Coalitions can also support planning and response for smaller health systems without the resources to support full-time shortage pharmacists or other capabilities of larger systems, he added. He underscored ethical decision making and the importance of planning ahead for crisis standards of care.22 Cheryl Petersen-Kroeber, Minnesota Department of Health and the Association of State and Territorial Health Officials (ASTHO), said that health coalitions can expand and coordinate engagement with local and state health departments, the private sector, and communities.
Linda Rouse O’Neill, HIDA, said there is much work to be done around “who communicates what and when and how, and who needs to know what information.” She suggested that HIDA could facilitate collaboration with other associations, coalitions, and government entities to collectively express their voices. She noted that the supply chain has struggled to understand true demand in the face of hoarding, over-ordering, and sourcing from multiple distributors; solutions will be complex because factories are mostly at capacity and emergency stock is insufficient. The aim should be a slightly higher level of constant elevated demand so that product does not expire unused, she said. Aisha Liferidge, George Washington University School of Medicine & Health Sciences and the American College of Emergency Physicians, remarked that in this age of quality metrics in medicine, a mandate to link quality to measures of inventory adequacy should be applied broadly.
During the next panel on learning from other fields, Jarrod Goentzel, MIT, explored how fuel and power23 can impact the health supply chain. In Puerto Rico, for example, diesel sales surged 10-fold to fuel alternative power sources after Hurricane Maria made landfall. He reported that a recent roundtable on supply chain resilience24 found that networks optimized to maximize efficiency are fragile and unable to adapt during a crisis, human and technological systems are deeply interdependent, and there are many potential cascading effects of supply chain failures that become apparent during a crisis. He added that the Federal Emergency Management Agency has sponsored a consensus study at the National Academies to find better ways to work with the private sector in restoring the supply chain.25
21 Available at http://www.pewtrusts.org/-/media/assets/2017/01/drug_shortages.pdf (accessed September 10, 2018).
22 More information about crisis standards of care can be found in earlier National Academies’ publications: http://nationalacademies.org/HMD/About-HMD/Leadership-Staff/HMD-Staff-Leadership-Boards/Board-on-Health-Sciences-Policy/CrisisStandardsReports.aspx (accessed September 13, 2018).
23 Meyer, A., and D. Meyer. 2018. Supply chain resilience: Restoring business operations after a hurricane. Roundtable Report, MIT Center for Transportation & Logistics. https://ctl.mit.edu/resilience-operations-hurricane (accessed September 10, 2018).
24 Meyer, A., and D. Meyer. 2018. Supply chain resilience: Restoring business operations after a hurricane. Roundtable Report, MIT Center for Transportation & Logistics. https://ctl.mit.edu/resilience-operations-hurricane (accessed September 10, 2018).
25 More information about this study is available at http://sites.nationalacademies.org/PGA/ResilientAmerica/PGA_188024 (accessed September 13, 2018).
Prashant Yadav, Harvard Medical School and the Bill & Melinda Gates Foundation, said that synchronized financing is a powerful lever for reducing national stockout risks and allowing the rest of the system to flow synchronously. Yadav and colleagues26 used a simulation model to test potential interventions and synchronized financing led to the most significant reduction in stockout risk. Yadav explained that when a disaster strikes, governments often face a liquidity gap that leads to sub-optimal allocation of resources and reduced investment in stockout prevention. Insurance and financial innovations27 can resolve some of the liquidity challenges, he added, noting that such innovations were discussed at the National Academies’ Global Health Risk Framework workshop on pandemic financing.28 To reduce stockout risks through improved supply chain visibility and collaborative planning, he added, the Visibility and Analytics Network29 aggregates data to support decision making by national supply chain managers, financiers, and manufacturers. Goentzel suggested capturing “blue sky” operations for critical commodities in the health sector by mapping upstream supply chains and using analytics to identify signal points to track during a crisis. Yadav added the mapping will require primary data collection, but some information about suppliers and declared capacity sits in drug master files, to which federal agencies could grant research access. Both Yadav and Goentzel emphasized their concerns surrounding the often unknown origins of active pharmaceutical ingredients and the complex factors that arise because these suppliers are often international.
Özlem Ergun, Northeastern University, said a recent survey30 evaluating the impact of disruption found three strategies for mitigating supply chain disruptions: inventories, sourcing and demand flexibility, and facility location. She explained that disruptions are multi-dimensional (for example, length of time period, size, breadth, and periodicity) and driven by a combination of exogenous shocks, human decision-making behavior, and operational constraints. Her research group has created a systems dynamics model that can be used to characterize and address the variation of different disruption patterns, as well as a general simulation framework that models the entire supply chain system and how it is shaped over time by human decision making.
Eric Choy, DHS, explained that the Office of Infrastructure Protection coordinates and leads national programs and policies on critical infrastructure security and resilience and its Chemical Sector Coordinating Council membership includes 15 industry trade associations that can collaboratively leverage their cooperative expertise with respect to large global supply chains.
POTENTIAL PREDICTIVE, PREVENTION, AND RESPONSE IMPROVEMENTS
The objectives of the next session were to identify existing or novel methods, investments, and incentives to prevent shortages; discuss opportunities and priorities to improve the prediction and prevention of and response to shortages to ensure an ethical and compassionate response; and consider best practices for early, effective, and ongoing communication of shortages across stakeholders.
During the panel on potential predictive improvements, Julie Swann, North Carolina State University and the Center for Health and Humanitarian Systems at Georgia Tech, surmised that the public would demand action if it knew the frequency and extent to which people receive a non-preferred form of care. She argued that greater visibility and transparency of information can increase the performance of the entire supply chain, improve predictability, and strengthen the ability to manage shortages; however, it requires building trust and a willingness to share information. Swann said that improving prediction should be the primary focus, because the need for prediction and management will only decrease when a supply chain is sufficiently agile and adaptable, with incentives aligned across the system. She suggested mapping to identify the most at-risk supply chains, allowing suppliers to more effectively manage their inventory to prepare for disasters. She emphasized the importance of cascading effects in the system, some of which relate to substitutable demand at the national level (i.e., shortages that will impact other products). Aleda Roth, Clemson University, cautioned that substitutions can change real demand when false orders31 cascade in a way that does not reflect the true demand. Because substitutions are not exact, she added, they may also cause a cascading effect on hospital readmissions if people have adverse reactions to the substitute’s coating, for example. She suggested creating a detailed database on substitutions as part
26 Gallien, J., I. Rashkova, R. Atun, and P. Yadav. 2017. National drug stockout risks and the Global Fund disbursement process for procurement. Production and Operations Management 26:997–1014.
27 Examples of innovations include the Caribbean Catastrophe Risk Insurance Facility Segregated Portfolio Company, the African Risk Capacity, and the World Bank Pandemic Emergency Financing Facility.
28 NASEM (National Academies of Sciences, Engineering, and Medicine). 2016. Global health risk framework: Pandemic financing: Workshop summary. Washington, DC: The National Academies Press. https://doi.org/10.17226/21855.
29 Information about the Visibility and Analytics Network is available at https://www.jsi.com/JSIInternet/IntlHealth/techexpertise/display.cfm?tid=1000&id=79&xid=2351 (accessed September 11, 2018).
30 Snyder, L. V., Z. Atan, P. Peng, Y. Rong, A. Schmitt, and B. Sinsoysal. 2016. OR/MS models for supply chain disruptions: A review. IIE Transactions 48(2):89–109. http://dx.doi.org/10.2139/ssrn.1689882.
31 False orders are when health care providers order more product than they expect to need in an effort to avoid shortages.
of the prediction process. To make better predictions about product supply chains, Kircher suggested building bridges between stakeholders to ensure data sharing is secure, as well as mapping sources of raw materials and production capacity to identify likely threats. Getting ahead of a shortage curve will enable decision makers to be proactive rather than reactive, she added.
Drugs on the shortage list are easily accessible online to individual consumers, although virtually all of those websites operate outside of appropriate rules and regulations, said Dani Peters, Magnet Strategy Group. From the manufacturers’ side, she said that advanced market commitments are a powerful tool for enabling rapid response. She also suggested collaborating with other countries in sharing information, forecasting, and utilizing the shared manufacturing base in the event of an emergency. Roth warned that offshore manufacturing gives rise to quality risks. Erin Fox, University of Utah, suggested creating new quality metrics that would enable facilities to make quality-based purchasing decisions. Quality data might also help predict or prevent shortages by flagging factories that do not meet the necessary standard, Fox said. Peters noted that FDA’s Drug Shortages Task Force may look at importing products from other jurisdictions in certain circumstances and Fox replied that FDA already imports products during shortages, but the logistics are challenging and can impact prediction when companies receive products that do not match U.S. clinical practice (i.e., a product with a different color packaging or without a bar code).
During the panel on potential prevention improvements, Rena Conti, Boston University, contended that it is in the health and security interests of U.S. consumers to have an adequate supply of medical products when they are needed, but also for the quality of those products to be as high as possible. “The shortage issues we face are an issue of failure of supply to meet demand,” she said, “but also a failure to supply adequate quality products to be consumed by people who are sick.” The interests of members of the supply chain—maximizing profits and minimizing costs—are not completely aligned with the interests of the American public, she added, leading to insufficient supply and inadequate quality of medical products. Incentives must be adjusted to improve quality-assured supply in response to potential lumpy or inconsistent demand caused by disasters, she said; incentives should favor suppliers that consistently demonstrate a commitment to quality, transparency, and assured supply and penalize those who misrepresent quantity or reported capacity. Ensuring redundant supply, supplier quality, and full transparency will require rectifying the present failure of collective action across the complex supply chain, the health care system, and federal agencies, Conti argued. Robin Robinson, BARDA, HHS, stressed that market failure is the root cause of product shortages during disasters, which is compounded by market failures causing stockouts during non-crisis times that are not being addressed with the requisite core adjustments. He added that many of the shorted products have such low profit margins that companies relegate them to contract manufacturers, which creates quality issues that also contribute to market failure. Brenda Shaflei, GlaxoSmithKline, commented that drug manufacturers might be willing to contribute data to supply chain mapping or increase their safety stock inventory if there were regulatory incentives, like priority review vouchers or an extension of patent exclusivity.
Anita Patel, CDC, HHS, outlined forthcoming CDC guidance for an overall systems approach to preparedness that is applicable to any MCMs. Considerations include the quality of available products, clinical guidance, and the ability to put alternative products in place during an emergency. She added, provider acceptance is important because it is the system’s lynchpin and manufacturers must be willing to ramp up production with distribution systems to ensure access. She suggested eliminating centralized inventories for high-volume, daily-use products and instead creating bubbles of inventory situated throughout the supply chain to increase overall elasticity. Sharing risk through increased visibility into orders and true need for a product will also be critical going forward, she said. Evren Ozkaya, Supply Chain Wizard, LLC, pointed to a major ongoing transition in the pharmaceutical industry arising from regulatory requirements about serialization to prevent the escalating problem of drug counterfeiting. Compliance requires a large investment that is cost prohibitive for many small manufacturers. He predicted that many pharmaceutical companies will be driven from the market and that these regulatory measures, although well intended, will increase drug shortages.
During the panel on potential response improvements, Maryann Mazer-Amirshahi, MedStar Washington Hospital Center, suggested stockpiling products to prepare for disaster situations when possible. She reiterated that alternatives are often also shorted and when they are available providers may not be as familiar with the alternative and thus may be more prone to errors. Burel explained that the SNS was designed to prepare for CBRN threats. However, the SNS can serve as a bridge when natural events cause shortages in medical products. The SNS focuses on establishing connections with both the overall supply side and the overall demand side to facilitate information sharing and improve prediction and response strategies. Burel said the SNS is exploring ways to identify critical infrastructure pieces, such as manufacturing plants at risk during an impending disaster, and ways to keep the facility running or move products in advance.
Frank DeLuccia, Janssen Research & Development, described his company’s response to Hurricane Maria in Puerto Rico, where it has two large manufacturing facilities. The first priority was ensuring the safety of people, followed by assessing the impact of the disaster on its global product supply and sharing information with health authorities. He
discussed the role of suppliers and distributors in incident command and advised that a central group should coordinate communications to ensure that every relevant agency and stakeholder is consistently briefed with accurate information.
Laura Wolf, ASPR, HHS, explained that ASPR has three critical functions pursuant to its broad charge to enhance the security and resilience of the health care and public health system. To support ASPR’s work in analyzing and managing risks to the health care system, she said, it created a public–private network including federal, state, local, and tribal territory partners. She explained that ASPR’s main function during a disaster is providing insight-driven support to the public and private sectors to shape decision making by listening to all parties and finding ways to communicate information that may not be clearly conveyed through data. Wolf reported that the HHS division of Critical Infrastructure Protection (CIP) will soon release a risk assessment tool that is specific to the health care sector and developed in collaboration with its partners. CIP is also revising its sector-specific plan to incorporate manufacturing and distribution.
In his closing remarks, Robert Kadlec, Assistant Secretary for Preparedness and Response at HHS, emphasized the need for improved situational awareness about all elements of the supply chain to better predict, prevent, and respond to medical product shortages. He suggested that BARDA can contribute by validating the contents of the SNS—for which management responsibility will soon be transferred from CDC to ASPR—and by reviewing the supply chain from end to end. Kadlec also said that BARDA should consider how medical products are developed, procured, and sustained so, when needed, they can be accessed by care providers. Kadlec noted that BARDA’s Division of Research, Innovation, and Ventures initiative is planning to host a priority medicines on-demand summit to explore innovative ways to provide on-demand pharmaceutical production, which is aimed at revolutionizing the way products are delivered to patients. Vanderwagen concluded the workshop by encouraging all of the participants to continue to work to alleviate the day-to-day, “blue sky” shortages so as to make communities more resilient during catastrophic and disastrous events. ♦♦♦
DISCLAIMER: This Proceedings of a Workshop—in Brief was prepared by Anna Nicholson, Laura Runnels, Claire Giammaria, Lisa Brown, and Scott Wollek as a factual summary of what occurred at the workshop. The statements made are those of the rapporteurs or individual workshop participants and do not necessarily represent the views of all workshop participants, the planning committee, or the National Academies of Sciences, Engineering, and Medicine. The National Academies’ planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop—in Brief rests with the rapporteurs and the institution.
REVIEWERS: To ensure that it meets institutional standards for quality and objectivity, this Proceedings of a Workshop—in Brief was reviewed by Michael Ganio, American Society of Health-System Pharmacists; Mary K. Kosinski, PhRMA; and Matthew K. Wynia, University of Colorado. Lauren Shern, National Academies of Sciences, Engineering, and Medicine, served as the review coordinator.
SPONSOR: This workshop was partially supported by the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services.
For additional information regarding the meeting, visit http://www.nationalacademies.org/hmd/Activities/PublicHealth/DisastersScienceCommittee/2018-SEP-05.aspx.
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2018. Medical product shortages during disasters: Opportunities to predict, prevent, and respond: Proceedings of a workshop—in brief. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25267.
Health and Medicine Division
Copyright 2018 by the National Academy of Sciences. All rights reserved.