Homeland Security Watch

News and analysis of critical issues in homeland security

April 8, 2014

How the quest for short-term efficiency creates vulnerabilities in public health and medical service; and what to do about it.

Filed under: Public Health & Medical Care — by Christopher Bellavita on April 8, 2014

Today’s post was written by Jeff Kaliner.  Kaliner works in health security and preparedness at a state health department. He holds a Master of Arts degree in Security Studies from the Naval Postgraduate School as well as a Master of Science degree in Education from Northern Illinois University.

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The other day I checked the American Society of Health-System Pharmacists (ASHP) website for current drug shortages. The ASHP uses the following criteria to determine if a drug qualifies under the “new shortage” heading:

“A drug product shortage is defined as a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”

The ASHP also states that:

“Shortages can adversely affect drug therapy, compromise or delay medical procedures, and result in medication errors.”

I must admit I was a little surprised to find approximately 250 Current Drug Shortage Bulletins listed on the site.  Is this an average day’s shortage?  I don’t know, and to be fair, some drugs are listed more than once because different predetermined measurements of the same drug may have their own bulletin. For example, Sodium Chloride 0.45% and Sodium Chloride 0.9% are both listed. It’s actually my interest in Sodium Chloride (normal saline solution) that brought me to the ASHP website in the first place.

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A few months back some of our healthcare partners started to inform us that they were at low levels for 0.45 1000cc bags of saline. These types of shortages are not necessarily unusual and can normally be resolved through internal sharing protocols within larger healthcare systems. We had heard that the shortage was nationwide and was due to increased demand on the three major manufacturers (Baxter, Braun and Hospira). This reason is also the one indicated on the ASHP website.

However, this instance was anything but normal; the situation was becoming critical. For instance, a few of our health care partners stated that patient diversion due to lack of the needed supplies was possible. Another facility activated alternative treatment guidelines, consolidated saline supply and verified necessity prior to patient distribution.

After a little probing, we began hearing that some of the larger saline vendors had contracts with hospitals that prohibited them from purchasing product from a different vendor. In other words, the hospitals were restricted from purchasing saline outside of their initial vendor agreements. Even if the hospitals could contract with other vendors, we were also hearing that the vendors themselves were running low. And, it turns out that there are vendor restrictions on adding new clients when products are under allocation.

We also learned that larger systems will sometimes purchase directly from the manufacturer. Of course buying in volume reduces the amount paid but these types of contracts may also prohibit the larger facility from selling product to partner systems to discourage possible profit making.

Regardless, the option for some systems to purchase product at different points in supply chain influences overall supply availability and may leave smaller hospitals and systems at a disadvantage.

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Another problem with these overly efficient supply chain models is that the practice of just-in-time ordering does not allow for a large enough buffer if there is a legitimate emergency. In an effort to decrease costs by reducing the number of storage points in the network, just in time ordering leaves a facility vulnerable in case of a catastrophic hit to the regular supply chain.

For example, in the case of an earthquake that takes out road access to a healthcare facility, a just in time policy may exacerbate an already challenging situation. A policy that relies on receiving product when it is needed instead of keeping large quantities readily available is at greater risk in an event where the supply chain is compromised.

Additionally, hospitals are often times unable to store these types of products in-house due to limited space.  Actual “storage wars” between hospital departments are not uncommon. Even if a hospital does have available storage areas, product rotation can also become an issue. Depending on when saline is manufactured, it will probably need to be rotated every six months to a year to keep  the supply fresh. Thus, the critical dependency on vendors to keep the supply change moving.

Regardless, the usual protocol for a health care facility when they are unable to receive product from their vendor or their own internal systems is to reach out to other nearby facilities and initiate formal or informal mutual aid agreements. However, due to the nationwide shortage, requests to other facilities for product were being denied. If a facility only carries three days worth of saline, sharing one day’s worth of product with another facility during a shortage would only leave the lending facility more vulnerable. In this type of situation, it’s not worth the risk to a lender to assist a partner agency in need.

Ultimately, after about a week of intense consternation and consideration, our emergency saline situation subsided (at least for the short-term). The few hospitals that were critical were finally able to get the product they needed from their vendors…just in time. In the end, the system work perfectly.

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It was also about this time that it finally hit me.  While state and local public health emergency preparedness programs focus on building public and private capabilities to handle the added systemic stress of an emergency, such as a patient surge during the aforementioned earthquake scenario, many health and medical partners in the private sector are undermining the effort by creating just in time systems that could possibly leave healthcare facilities and their patients more vulnerable during their greatest time of need.

Using the saline example, if a surge in patients created a need to use excess product during an emergency, the just in time system of product delivery would not allow for the most effective patient care. As the situation narrated above outlined, many hospitals are already operating on slim product stockpiles (usually a maximum of three days). If they were unable to receive product for longer periods of time because of an event, patient care would be compromised.

As it occurs to me, the manufacturers, vendors and healthcare facilities share responsibility in this scenario. I have to believe that building in added risk during a crisis is not intentional on the part of our private partners.  However, creating such efficient systems is working at odds with the greater public health. Hospitals that are unwilling to add robustness to their systems by adding extra storage space are basically averse to stockpile necessary product.  Manufacturers and vendors operating on just in time delivery schedules are also seemingly more concerned with the bottom line than the needs of the patient. In all cases, profits win out over patients.

Ted Lewis describes this phenomenon as self-organized criticality (SOC). In his book Bak’s Sandpile (2011), Lewis write:

“I propose a unifying theory that explains how accidents, disasters, and catastrophes are intensified by the way modern society has evolved into a collection of highly connected, optimized, and cost-efficient systems. Everything has been optimized—principally by eliminating surge capacity that allows a given system to deal with any overload it experiences. Add to this optimization of capacity the fact that modern just-in-time systems have squeezed out any tolerance for error, and you have the ingredients of what the Danish physicist Per Bak called self organized criticality. This has brought modern society to the brink, and it is our own fault. Modern systems weren’t designed to be resilient, self-correcting, and secure, but rather to be low-cost, efficient, and optimized for profitability. As a consequence, the critical infrastructures supporting modern civilization have evolved over the centuries into fragile, error-prone systems. We have reaped the benefits of short-term efficiency, but now we are suffering from it. Efficient, optimal, and cost-effective systems are why $#^! happens.” (Pgs. 8-9)

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Although there has been much talk about private/public partnerships within the ESF 8 landscape, I have never heard (at least at the state or local levels) any of these conversations put within the context of self-organized criticality.  Using the SOC lens to view the problem makes it clear to me that when Public Health encourages partners to come together and discuss increasing surge capacity within our health and medical systems, we must include product manufactures and vendors.

Leaving these partners on the sideline of the health and medical system during preparedness and response conversations focused on surge planning will only lead to the creation of more unnecessary fantasy documents. If collaboration is the key, all players in the supply chain must be at the table and all the accompanying issues, including SOC, must be honestly and directly addressed.

However, when one player in a system is trying to maximize economic gain, while the others have more altruistic goals in mind, the possibility for overall systemic collapse would seem to be amplified as public and private agencies work at their opposing missions.  Thus, these types of conversations would ideally need to take place at the highest policy levels. In other words, tackling problems that impact free market behaviors need to be addressed at the federal level so that any resulting policy or regulations can be implemented on a national basis. In this way, entire national health and medical supply chain systems are addressed in any proposed solution.

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What has also become clear is that the Public Health Emergency Preparedness enterprise needs to reevaluate how it trains and educates its practitioners. Encouraging professionals to take the latest Incident Command class will not help problem-solvers at all levels to identify and apply concepts such as SOC to supply chain and other systems related problems. Understanding and using these types of theory based concepts in relation to increasingly wicked problems needs to be at the foundation of the 21st century homeland security practitioner’s tool kit. Otherwise, professionals in the field will not have a fertile soil to ground their practice.

Yet entering into conversations without 21st century knowledge tools is exactly what I see happen on an almost daily basis. Most everyday I witness emergency management and homeland security professionals discuss problems and propose solutions that have no grounding in any type of researched or scientific theory. In this context, meetings dominated by assumption, personal preference and group think can easily become the status quo.

An inability by professionals in the field to understand systems, network and other related theories is no longer acceptable in an enterprise that has now been in existence for over ten years.  Although Public Health Emergency Preparedness may not have its own specific and unique set of concepts to apply to the field, borrowing these types of ideas from other disciplines (including Public Health!) must be encouraged and supported.

To be clear, I am not suggesting that an understanding of concepts like SOC is all it will take to solve difficult issues like the saline supply chain situation. A complex problem like this will need any number of solutions (at all levels) interacting together to achieve the desired outcome for both the short and long term.

However, redesigning a 21st century Public Health Emergency Preparedness training and education curriculum that provides practitioners at all levels these types of cognitive tools is crucial so that players at all points in the system can view problems though a common lens. If we do not make these fundamental changes in how we develop these professionals, the millions of dollars we have endowed into the human resources of this nascent field will certainly provide a more than disappointing return on investment. In a knowledge based economy, critical and independent thinking, intellectual courage and beliefs based on facts and evidence are our stock-in-trade.

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Good intentions, an understanding of the Incident Command system and an ability to mimic “grant jargon” is no longer enough to confront our ever changing and increasingly complex world. It’s now time that Public Health Emergency Preparedness programs provide up to date evidence based and research supported professional development opportunities to its practitioners.

If we don’t move in that direction, the next time you need some basic saline solution, it just might not be there.

 

 

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12 Comments »

Comment by Arnold Bogis

April 8, 2014 @ 1:16 am

This is a very important issue. Unfortunately, it is also a very complicated one.

I don’t believe education will ever be the answer. The cross section of types/classes of people involved (in terms of career or industry) is too varied.

And market forces are too strong, unless the government is ready to engage in a very, very deep manner. And given the current circumstances at the federal level, this will not happen before a catastrophic disaster occurs.

These same market forces are also not to entirely blame in terms of a “just in time” logistical situation. The drugs most important to emergency medicine are not very profitable. And, as the author pointed out, they aren’t designed to be stored for long periods of time. So in the past spikes in demand could be met by the existing system. But as drug companies turned to more profitable lines (after the next big earthquake you may lack for saline solution but I’ll bet you can score some Viagra…), a couple of market disruptions can set the entire emergency medicine field back years. A closure of a production line here for upgrades isn’t coordinated with a closure over there for regulation failure leads to a cascade. Attempts at stocking up for future demands would strain the overall system even worse.

And exactly who should or would pay for a backstop that could have avoided this mess? We currently argue about providing insurance or even assistance to the underprivileged. Who is willing to suggest new taxes to warehouse low cost, non-profitable, soon-to-be useless, emergency medicine?

In a limited way, the federal government has tried to help over the past few years.

Here is a report from the Association of State and Territorial Health Officials that was funded by ASPR:
http://www.ems.gov/pdf/2013/ASTHO_Shortages_of_Emergency_Meds.pdf

And here is a short paper from HHS’ Emergency Care Coordination Center summarizing a stakeholder meeting on this subject held in 2012:
http://nasemso.org/documents/ImpactOfTheNationalDrugShortageOnEmergencyCareApril2012.pdf

I do not mean to be too gloomy about this subject, or take anything away from the author’s conclusions about the importance of improving ESF8-related education. I just wished to highlight some of the work already done in this arena and suggest that when the private sector is so heavily involved in an issue such as this, simple answers are likely to never be the answer.

Comment by Quin

April 8, 2014 @ 7:06 am

Jeff and Arnold,

Great points. Now if someone could figure out an effective way for the markets to value long term resilience against catastrophic events…

Comment by William R. Cumming

April 8, 2014 @ 7:22 am

Great post Jeff and comment Arnold! As I think I revealed earlier on this blog was pre-med for first two years of college [my father's dream not mine] and did well but knew enough about the medical world to not want to join it. And offered an opportunity to leave Uncle Sam and work for the health care industry during Nixon’s wage, price and rent freeze and controls [1973]!

The health care lobby is a highly skilled one in Washington and most states. I have applied the word “vicious” to that lobby because IMO they have no interest in the healthcare of all Americans and in fact have accomplished their goal of no real regulation of the health care sector. The Health Care Financing Administration of HHS is concerned about financing and does not regulate otherwise. And no other component of HHS does regulate and no states.

Saline solution is important but try the blood supply of the nation. YUP! After grid failure, the health care of injured and sick Americans in disasters and catastrophes and the lack thereof will shock the survivors.

But one piece of good news, the growth worldwide of the field of Emergency Medicine continues to advance. The numbers of those with that expertise is extremely limited as are trained EMTs [refugees from the FIRE SERVICE?]!

Comment by Jeff Kaliner

April 8, 2014 @ 7:32 pm

Arnold –

Appreciate your thoughts and the opportunity to clarify my position.

First off, I am very aware that this is a complex problem. As I stated:

“…I am not suggesting that an understanding of concepts like SOC is all it will take to solve difficult issues like the saline supply chain situation. A complex problem like this will need any number of solutions (at all levels) interacting together to achieve the desired outcome for both the short and long term.”

There are no simple answers here and I am not suggesting that education alone will solve the problem.

What I am saying is that many folks in the homeland security (HS) field need certain types of education to even begin to understand the complexity of the issue. Most folks at the local levels do not have these skill sets. Thus, they are many times unable to understand the larger systemic context of the situation.

In turn, the “solutions” that are generated act as more of a symbolic offering than an actual operational fix. If folks around the table had more and better tools to truly understand the complexity of these types of problem…well at least they would have a better idea of what they are dealing with.

I’m not interested in teaching people what to think…I’m interested in teaching people how to think. Especially, when it comes to complexity and systems thinking.

I would argue that most folks with a Bachelor’s degree were not provided with these types of analytical tools. However, they are needed if we are truly serious about tackling 21st century HS issues.

Over the years I have witnessed many good intentioned people trying to solve these types of complex problems with insufficient cognitive tool sets. The result is inefficiency that usually produces really nicely formatted fantasy documents (plans) because of a lack of real situational and contextual awareness.

My argument is that education focused on providing these types of tools will at least help us to see the entire elephant. Otherwise we grab the tail and think the problem is just a snake.

JK

Comment by Jeff Kaliner

April 8, 2014 @ 7:40 pm

My apologies to local folks…

The line should have read…”Most folks at ALL levels do not have these skill sets.”

*This is based on my observation after 12 years in the field working with people at all jurisdictional levels.

Comment by William R. Cumming

April 8, 2014 @ 10:48 pm

Did I mention regulation of doctors and nurses is state by state if at all? Finally the issue of mandatory testing for drugs of physicians has arise! Impairment a huge problem in medical professionals.

Comment by Arnold Bogis

April 10, 2014 @ 12:32 am

I guess I just can’t get my head around even considering homeland security as an undergraduate educational issue.

Riddle me this:

What is homeland security?

Who is involved in homeland security? Specifically, what fields of study?

What are all the 21st century homeland security issues?

What specific type of complexity theory or systems thinking should be taught to what undergraduates in what homeland security-related fields? Ted Lewis comes from computer science. An interesting steel cage match would be some computer scientists, physicists, biologists, engineers, etc. All go into the steel cage, whoever gets out gets to define complexity for homeland security…

I’m not trying to be a jerk, though I feel I’m also failing in that regard. I simply have a hard time grasping what educational benefit there could be to funnel young students into “homeland security” tracks during their undergraduate years. No one can even definitely define the subject area. How can we imagine improving their thinking skills?

Whatever homeland security ends up being, it will require both hedgehogs and foxes. If you had difficulty explaining the issues behind drug shortages, perhaps a different mix of professionals would benefit your office/operational area. Or some opportunities for continuing education.

However, as I’m very familiar with the drug shortage issue I also feel pretty confident in my assessment that education wouldn’t change either the underlying issues or the approaches in response to the problem.

Comment by Arnold Bogis

April 10, 2014 @ 12:39 am

Also, I’m curious what defines 21st century issues from late 20th century issues. Did 9/11 change reality or perception?

Is emergency management separate from homeland security?

Finally, most of what happens in this general space does not, and probably can never really have, a grounding in science. It can in the specific knowledge areas or disciplines, but when you pull out to a strategic view one is left to hopefully grasp at straws and cross one’s extremities.

Comment by Philip J. Palin

April 10, 2014 @ 7:43 am

Jeff and Arnold:

Jeff’s post and the exchange with Arnold could prompt a hundred more posts. Some impressions, more than thoughts.

In December I hosted a small meeting of emergency management senior officials with leaders from a few key supply chains, including pharma and medical goods. The topic was catastrophe preparedness. After the meeting I got an email from one of the private sector participants (“you did not receive this from me…”) detailing the saline solution shortage Jeff outlined. The forwarded internal memos were classic examples of what the supply chain sometimes calls tears-in-the-tiers or gaps between the different segments of the supply chain. Even (especially?) from inside the beast the real cause was not clear, so solution(s) were proving elusive.

My insider-correspondent noted, “This is a product-line with ongoing (usually predictable) velocity. It is not difficult to produce. There is no external crisis. But the failure emerges suddenly and from seemingly nowhere. Think about the implications for a catastrophic context.”

Indeed. The insider would probably agree with Jeff’s insights relating to JIT and SOC. He might also have a few things to say about expectations. I have talked with him enough to learn he is rigorous phenomenologist. He assumes that most of what he expects — even perceives — is illusion. He is constantly seeking contrary evidence. He is constantly aware of his OODA and the OODA of those around him. He is also generous and self-effacing and a good human being (at least in my experience).

As far as I know the insider who wrote me has a typical undergraduate business education. But I am prompted to recall Cardinal Newman’s aphorism that any topic is susceptible to “liberal” or “illiberal” learning (such as motorcycle maintenance). For Newman a liberal perspective is open, critical, imaginative, experimenting, creative and self-correcting. The illiberal tends toward rote mastery of inert ideas. By education or personality, the insider is, in Newman’s meaning, a very liberal man (free and self-mastering).

Today I am working on my chapter in a new textbook being produced in the UK. I’m not sure where I may end up, but I am going to start with the argument that given the nature of the modern supply chain and the characteristics of Self-Organized-Criticality (SOC) supply chain catastrophes are inevitable. We may be able to practice mitigation, but we can no more practice prevention than I can defy gravity. (The analogy purposefully raises ambiguities). I was pre-disposed to such realism or fatalism or restraint or whatever by Homer and Cicero and the gospels. I have met farmers, vintners, cheese-makers, and carpenters who are similarly predisposed without reading much at all.

Once upon a time I was sure a meaningful, relevant, rigorous liberal education was the best investment we could make in any life and in the health of our society. I probably still believe this, but only if we are mindful of Newman’s insight. The content of formal education probably ought bend to the interests of the learner, it is the methods and attitudes that matter more.

Supply chains might be approached as engineered systems to be controlled or complex adaptive systems to be experienced. Yossi Sheffi at MIT recently explained that the supply chain is nothing less than “life itself.” Strikes me as a topic that might be worthy of a liberal education.

Comment by William R. Cumming

April 10, 2014 @ 11:17 am

ALL: Given today’s theology of SUPPLY CHAIN and JUST IN TIME INVENTORY almost impossible to mobilize the nation’s resources for national needs in crisis and emergency.

WE HAVE MET THE ENEMY AND ITS US! POGO

Comment by Jeff Kaliner

April 10, 2014 @ 8:37 pm

Hey Arnold -

Thanks again for giving me an opportunity to clarify and refine my thinking.

First off, I never suggested funneling “…young students into ‘homeland security’ tracks during their undergraduate years.”

My point is, regardless of how we define homeland security, folks who operate within the enterprise (LE, Fire Service, Public Health, Emergency Management, etc.) should have a basic skill set that includes an understanding of ideas such as systems theory.

Although, like homeland security, systems theory does not have one wholly agreed upon definition, the concept has been successfully applied to disciplines such as biology and engineering. My attempt was to view the saline supply chain as a system that moves raw materials to an end user and to describe the downsides of system efficiencies in light of a catastrophic event.

As you probably know, one of the major capabilities of public health in an emergency is medical materiel management and distribution. To make this happen, many individuals, from the locals on up to the feds, need to be involved in the process of both planning and response. My argument is that it would benefit all individuals in this system to have some awareness of systems (and network) theory during all stages of the emergency management cycle.

My experience has shown me that many of these folks, although having undergraduate or even graduate degrees, do not have a background in these types of concepts. Thus, I believe that along with the Federal funds that power state and local Emergency Management and Public Health Emergency Preparedness programs, it is necessary to include an educational component (beyond Incident Command) that will provide tools to these folks that will give them the best shot at understanding and addressing the problem.

Again, and to be clear,education will not solve this complex problem.

However, exposing these players to concepts such as systems and network theory occurs to me as a way to address this knowledge gap. Your idea of continuing education is certainly in line with my thinking. Maybe an on-line FEMA ISP course?

My objective in sharing this post was to provide some observations from the field, learn from others and refine my thinking. You have definitely assisted me with the latter.

However, if we are to continue, I would appreciate a more civil and respectful tone.

Thanks,

JK

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