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.
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.
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.
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.
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)
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.
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.
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.