3

Delivering the Assets: Supply Chain Issues Between the SNS and State and Local Public Health

Looking down the supply chain relative to the SNS, a second panel focused on recipients of the stockpile’s assets: state and local governments, hospitals, and clinicians. In his introduction to the session, Irwin Redlener emphasized the extreme complexity and breadth of the global medical supply chain in which the SNS participates, while urging participants to keep in mind the lives at stake at its terminus.

PERSPECTIVES ON THE ROLE OF THE SNS

As they introduced themselves and their institutions, panelists briefly described their roles pertaining to the SNS.

DSNS director Greg Burel defined the purpose of the SNS through the words of its mission statement: “the right thing at the right place at the right time.” The stockpile is commonly misperceived as “stuff on the shelf” that goes where it is needed in a timely manner, he noted, but acquiring “the right thing” for a spectrum of disaster responses that now ranges far beyond the stockpile’s original CBRN target, and getting enough of it when it is needed, is a complex and demanding process.

Moving the necessary products to the right place may involve transporting a finished product, or obtaining it from manufacturers or distributors, before a predicted disaster (e.g., Hurricane Harvey) obstructs transit, Burel explained. It may also entail overcoming obstacles—such as a longshoremen’s strike that once disrupted the shipping of latex into western U.S. ports—to ensure that raw materials reach manufacturers of those products.

Determining the right time to deliver the needed product can also be

complicated, according to Burel. For well-characterized infectious diseases, the timeline is firm, he said; however, timing the delivery of MCMs for emerging infectious threats, or medical supplies following natural disasters, can be difficult. For example, he described the strategy for supporting Houston in the wake of Hurricane Harvey as a balance between being close enough to arrive quickly afterward, but far enough away to safeguard the incoming supplies.

Albert J. Romanosky said his state, Maryland, assumes extra responsibility for emergency preparedness due to its proximity to the nation’s capital. He described the role of the SNS as a source to supplement Maryland’s emergency response supply chain, and also as a liaison between state and local governments and medical manufacturers, distributors, and their representative organizations, such as HIDA.

“We would not call on [the SNS] immediately, but it’s in our toolbox of responses for health and medical surge,” Romanosky reported. Therefore, the SNS figures prominently in an operational plan that his office has developed and tested. “I like the idea of looking at [the] SNS as a strategy,” he added, “because so much of what we learned . . . from [the] SNS . . . is applicable to just about everything else we’re doing from a public health emergency preparedness perspective.” That includes working relationships with emergency response partners such as the U.S. Marshals Service, the Maryland Air and Army National Guards, and the Maryland State Police, he stated.

Laura Runnels asked two Standing Committee members—Paul Petersen, director of the Emergency Preparedness Program for the Tennessee Department of Health, and Karen Remley, executive director and CEO of AAP—to comment on their perceptions of the role of the SNS at local and clinical levels.

Every local jurisdiction in Tennessee has an SNS plan at the core of its emergency response program, Petersen said, and these preparedness programs improved through their use of an evaluation tool developed by DSNS. “We hold our local [emergency response] representatives accountable for being prepared,” he stated. “They’re highly engaged in that process.” Remley also emphasized the importance of preparation at the local level on a broader scale, noting that as large health care systems increasingly become the norm in urban areas, it is important to remember the role of local health in rural areas and the building of relationships among clinical experts at the federal, state, and local levels prior to an emergency.

Each of Maryland’s 24 local jurisdictions (Maryland Manual On-Line, 2018) has also developed its own plan for distributing and dispensing stockpile assets, according to Romanosky. The state’s role is mainly to encourage continual improvement of local plans through exercises, evaluation, and the application of DSNS assessment tools, he said.

SNS AND THE DOWNSTREAM “SYSTEM OF SYSTEMS”

Within the context of the “system of systems” model of the SNS, Runnels asked the panelists to identify systems with which their public health and health care organizations interacted. Their responses, summarized below, included systems for national emergency response, manufacturing, distribution, research and development, warehousing, and inventory management, which in turn depend on critical infrastructure such as transportation, water, and power; all of these systems are influenced by the economy and national security interests.

Burel placed the SNS within the Public Health and Medical Services component—denoted Emergency Support Function Eight (ESF#8)—of the National Response Framework, led by HHS. ESF#8 “provides the mechanism for federal assistance to supplement local, state, tribal, territorial, and insular area resources in response to a disaster, emergency or incident that may lead to a public health, medical, behavioral, or human service emergency, including those that have international implications” (FEMA, 2016).

In the course of delivering materiel to areas affected by natural or humanmade emergencies, the SNS interacts with the medical distribution system. For large-scale events, the SNS adopts existing distribution models or becomes part of the normal supply chain, acting as a traditional distributor—albeit of large quantities of product to a limited area, Burel observed. However, he added, when supplying a unique MCM, such as a threat-specific biologic, the SNS assumes the role of a specialty distributor.

The SNS also engages with the manufacturing system as a developer and tester of products to address specific threats, working with manufacturers to optimize their products; their supply logistics, including surge; and their operations. Burel said the SNS works with manufacturers to find blind spots from both perspectives, such as factors affecting the availability of raw materials. Downstream of manufacturing, the SNS interacts with systems leading all the way to finished product dispensing, upstream to the provision of raw materials, and in research and development.

Setting aside the broad logistical system that Burel described, Romanosky characterized the SNS from the perspective of operations. The stockpile, he observed, fits a “specialized logistics distribution paradigm, one that is outside of traditional business, because [the] SNS may not have the same economic and legal constraints . . . [as] a traditional logistics or distribution system.” Unlike state or local government, he said, the SNS engages directly with traditional business distributors, manufacturers, and logistics, to operate as a sort of public–private hybrid.

GUIDANCE DURING SHORTAGES AND EMERGENCIES

When a key medical product is in short supply, or a crisis prevents access to it, “Who would be the organization who tells the health care system . . . ‘you can’t have [medication A], you should use [medication B] instead?’” Tara O’Toole asked. Posing questions for discussion, she also wondered, in the event of an attack or a novel emerging infectious disease, who answers questions from clinicians and health care providers about never-before-used MCMs provided by the SNS regarding use, applicability, and liability issues.

State and Local Public Health

State public health officials turn to the SNS when shortages arise during emergencies, Burel said. However, he noted, “we’re not positioned to intervene in day-to-day drug shortage situations.” When shortages occur, or are anticipated, because of an emergency event (e.g., the PPE shortage associated with the 2014–2016 Ebola epidemic), DSNS rapidly initiates efforts to find substitutes and develop protocols for their use.

The Office of Preparedness and Response at the Maryland Department of Health has distributed clinician advisories and memos to its ESF#8 partners in the event of shortages, Romanosky reported. His office has also provided information related to non-emergency shortages (which, he agreed with Burel, is not the responsibility of the SNS). For example, after learning from a hospital emergency planner about a shortage of intravenous fluids and normal saline from 2013 to 2015, Romanosky researched the problem online, consulting the FDA website as well as media outlets. He shared his findings with his office and with their ESF#8 partners. For several months thereafter, Romanosky published a weekly or biweekly report on the status of the shortage and how his office was responding to it. Thus, he observed, the members of the partnership overcame a breakdown of communication at the state level, which also affected clinical guidance being distributed to local partners and the health care system.

In assessing shortages, Romanosky asked, who is responsible for calculating the immediate and long-term risks involved: decision makers at the local health department or those at the state level? He noted that in 2015, during a shortage of seasonal flu vaccine in Maryland, his office instituted emergency operations, including functioning as a broker between hospitals or health care facilities with an excess of the vaccine, and those without it. The state connected the parties but did not distribute the vaccine due to reimbursement complications.

For information on national shortages, Tennessee’s emergency preparedness program relies on notices from FDA, according to Petersen.

They also gather and disseminate information on local shortages through a network of relationships with organizations that include the Tennessee Pharmacists Association, the state Board of Pharmacy, and various health care coalitions, and through the Tennessee Health Alert Network, which reaches approximately 40,000 health care providers. Health associations in the state’s Joint Information Center (JIC) (FEMA, 2016) attempt to address shortages likely to affect clinical care, and the state reaches out to DSNS and CDC for guidance, he said, with the understanding that CDC will not be able to solve every shortage.

Lewis Grossman, professor of law at Washington College of Law, American University, said the SNS distributes assets to the state in most instances. Burel said the SNS encourages each state to designate a coordinator authorized to distribute those items, and that some states also appoint SNS coordinators at the local level, at least in an informal capacity. In Tennessee, local public health workers are entirely responsible for implementing emergency plans, including distributing SNS assets, Petersen noted. The state conducts some warehousing operations, which are staffed in part by local public health workers. However, he observed, such policies vary from state to state. Some completely assume responsibility for warehousing, while in others, home-rule counties may run their own warehouses, in which case the state delivers items to a county warehouse, from which they are distributed to local health care centers or health department clinics. Dispensing SNS assets is primarily the responsibility of local health departments in Tennessee, he added.

O’Toole pointed out that an event had yet to occur on a scale that required the “system of systems” to engage the entirety of the medical and health care delivery system within the United States. Anticipating such a challenge, she suggested that directions be prepared in advance to inform state and local public health agencies, as well as hospitals and health care providers, on the use of novel MCMs (acquired by BARDA, or the Biomedical Advanced Research and Development Authority, a component of ASPR) against certain biological threats that are included in the SNS. “We had enough confusion in H1N1 about how to use flu vaccine and Tamiflu,” she recalled.

O’Toole also urged development of “the HIDA equivalent of medical care,” a systematic process for analyzing the global supply chain to inform the use of substitutions for critical medications. She stressed that clinicians should be consulted on these recommendations, which could have grave implications for patients.

Burel replied that CDC had prepared clinical guidance for novel MCMs acquired by BARDA, to be distributed during or immediately prior to their use (the improvement of this plan is discussed in the next chapter of this proceedings). He agreed with O’Toole that the SNS should not be direct-

ing clinicians to make specific substitutions; however, in conjunction with HIDA, DSNS is attempting to assemble a list of acceptable substitutes for key products likely to be scarce under various emergency scenarios.

Health Care Providers and Institutions

The issue of liability is potentially significant at the federal level during drug shortages, Romanosky pointed out, and it represents a major concern for health care providers and hospitals in the absence of formal guidance on the use of alternative products during a shortage.

Lewis Rubinson, professor of medicine at the University of Maryland and assistant chief medical officer for Critical Care at the university’s Medical Center, remarked that his hospital was constantly adapting to shortages, and that federal or state involvement in that process under normal circumstances would slow it down, as it would draw attention to liability. “We have a patient in front of us right now, so while everyone is talking about the liability issues, we’re solving it,” he said.

On the other hand, in the case of novel MCMs, federal guidance is both welcome and necessary, Rubinson said; unfortunately, one-page instructions available from CDC are too general. “I think for these very specific countermeasures, the playbooks that are on the shelf and that are going to get dusted off aren’t enough,” he argued. At best, they are a starting point to be followed up with specific guidance issued by federal and state entities.

Remley noted that millions of medications are currently being used off-label in every children’s hospital and pediatrician’s office for lack of guidance from FDA on treating children with drugs approved specifically for adults. To make those decisions, pediatricians are guided by consensus opinions from AAP’s Committee on Infectious Disease—as is CDC, she reported. Similar expert groups could be used to develop guidance on the use of drug substitutions and novel MCMs during emergencies, she suggested.

Skip Skivington, vice president, Healthcare Continuity & Support Services, Kaiser Permanente, observed that during many emergencies, and particularly during the recent Ebola epidemic, various sources have disseminated conflicting information about the availability and use of medical supplies and PPE. In fact, he added, this happens so often that Kaiser Permanente’s emergency planning protocol specifies that such information be carefully evaluated.

Romanosky observed that as a clinician, researching and publishing information on alternatives to address medical shortages is among his major responsibilities. As a clinician in an emergency preparedness office, he does not issue directives, he added, but does publish findings backed up with data to support decision making by individual clinicians.

Davidson stated that in order to ensure adequate supplies where they are most needed, retail pharmacy companies need to know how deep a shortage is, and how long it is expected to last. Pharmacists also need compounding instructions for alternatives to medications they cannot get, she said, as during the H1N1-induced shortage of Tamiflu; at that time, Walgreens worked closely with the manufacturer and CDC to devise instructions for compounding Tamiflu for pediatric use.

A distinction should be made between information and advice provided to address a shortage, Jacobson noted. Experience as a consultant has taught him that people value advice, or guidance, more than information, because it offers them a path to action. This idea is further explored in the next session (see Chapter 4), which focuses on the information and advice needs of SNS stakeholders, and how they might be met.

Remley noted that local health care often proves self-sufficient in responding to community emergencies such as tornadoes. However, she added, because care in rural areas is increasingly delivered through large health systems, clinical leaders can link rural populations with state and federal public health. In Virginia, when the H1N1 epidemic caused a shortage of N95 masks,¹ clinicians were convened from across the state to develop consensus advice on alternatives. “On a state and local level . . . you can get key clinical leaders to get engaged and involved to be part of the communication,” she concluded.

Sara Roszak, senior director of research programs at the National Association of Chain Drug Stores (NACDS), asked: In cases where a critical medical product is derived both from the commercial supply chain and the SNS, is it ever important to maintain separate stocks and identify them by source? Sometimes, Burel replied, but not in a mass prophylaxis campaign, when the vast majority of people will receive a product distributed by the SNS. On the other hand, when SNS supplies are used to supplement commercial stocks of MCMs, such as antivirals, their separate identities are currently maintained. This is particularly important for SNS assets that have been approved for emergency use beyond their marked shelf life, he noted; consumers who receive those products need to be made aware of that. However, he added, as the SNS increasingly represents a distribution strategy rather than a physical stockpile, all assets should eventually be regarded as flowing through the commercial operating chain.

That is a problem, Romanosky commented, if it appears that the SNS

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¹ An N95 respirator is a particular type of protective device that blocks at least 95 percent of very small test particles, providing better filtration capabilities than a typical face mask. For more information on N95 respirators, see https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/PersonalProtectiveEquipment/ucm055977.htm (accessed January 24, 2018).

is supplanting commercial activity through the subsidized release of a product. Such a concern arose when the SNS released antivirals for H1N1, he noted, so there is a sensitivity about this. Burel responded that this is an important reason for the SNS to distribute assets as often as possible through the commercial supply chain.

GATHERING AND SHARING INFORMATION ON SHORTAGES

Several participants noted gaps in the collection and dissemination of information on shortages and suggested ways to address this issue.

Rubinson, recalling government experience in his recent past, described a lack of data streams adequate to reflect critical resource needs at the hospital level. Hospitals tend not to share data, and electronic health records are noisy with regard to reflecting supply signals, he observed. He questioned whether any progress has been made toward improving and interpreting such data at the hospital level. Not yet, Burel replied, although DSNS certainly recognizes its value.

In Maryland, a program called HC Standard allows public health officials to query hospital inventories for specific drugs and equipment, Romanosky noted. The state also employs syndromic surveillance; emergency departments throughout the state automatically upload their patients’ chief complaints, clinician impressions, final diagnoses, and other relevant information, some of which is linked to electronic medical records. Syndromic surveillance is now being used to track opioid overdoses and deaths in near real time, he reported, but accumulated data can be queried for any condition of interest. Surveillance can also be pushed closer to real time during significant events, such as the presidential inauguration, he added.

Trade associations represent an important conduit of information during shortages, Roszak observed. NACDS can connect state or federal officials with representatives of nearly 100 chain drug stores, who in turn could alert stores in affected areas about a shortage, she advised. This is exactly what happened during the H1N1 epidemic, when NACDS spearheaded an effort to distribute vaccine to chain pharmacies that resulted in the rapid administration of approximately 12 million doses of vaccine, she reported; a similar recent effort targeted Zika.

Since 2012, FDA has been mandated to maintain a drug shortage list on its website (FDA, 2018), and manufacturers have been required to report drug shortages to the agency, Grossman stated; the same statute allows health care providers and third-party organizations to report drug shortages to FDA. Unfortunately, he said, FDA’s presentation of shortage information lacks suggestions for substitutions; is organized according to manufacturer; and in the case of drugs not under patent, does not indicate whether every manufacturer is experiencing a shortage. Also, it fails to identify local short-

ages. On the positive side, Grossman noted, the website has an email feed and an android application with an alert function. Grossman observed that it is important for the entire health care community to become aware of this resource, and he said that improving FDA’s timeliness in updating the list could better serve the needs of health care providers and third-party distributors.

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