As common as latex gloves and used just as often, intravenous (IV) systems and products can usually be found in abundance throughout most hospitals and healthcare facilities. For the most part, this was true until 2018. That’s when Hurricane Maria hit Puerto Rico and severely impacted production of many IV-related products, which only added to existing short supplies that were already in tall demand. While the healthcare industry waited patiently for daily-use supplies to be refilled to prior levels, healthcare workers carefully utilized their limited supplies as sparingly as possible, ignorant of the even bigger impact yet to come in 2020.
Like the second part of a “one-two punch,” there was no way the healthcare industry could have predicted the impact the COVID-19 pandemic would have on already-limited IV-related supplies. Global pandemic demands exacerbated domestic product shortages even more, so much so that IV product manufacturers are still trying to catch up with demands from 2018 that were never completely met. As such, today’s healthcare industry professionals are exploring available options in their attempt to ensure future deliveries of essential IV products, both to meet daily patient needs and to prepare in advance for another potentially deadly medical crisis.
Increased demands, decreased supplies
Among the most in-demand medical supplies in hospitals and healthcare facilities, IV-related products arguably rank as high as gloves, masks, and since 2020, hand sanitizer. However, manufacturing requirements are higher for IV bags than other daily-use items. This means the time it takes to produce IV bags has the potential to create shortages that can have an even greater impact on healthcare facilities. Much like the saline often found in IV bags, extensive production requirements could find supply chain departments watching in-stock supplies drip away as they wait for product replenishment.
Medical supply shortages are nothing new to the healthcare industry. Even as the amount of high-demand products often remains high enough to meet average usage and needs, when unexpected events occur, the same products that were in abundance can quickly dwindle to low and concerning levels. In the case of Hurricane Maria, the domestic impact on supplies of IV-related products was bad enough in itself, but the global impact of the COVID-19 pandemic increased demands and shortages to levels unseen in prior years. Today, manufacturers are still playing catch-up with IV-related products that are still in short supply, as the rest of the healthcare industry anxiously waits for products to arrive before they’re needed for another potential pandemic. But is there more that can be done now to prevent shortages in the future?
He continued, “There are numerous examples of these solutions. It could be our Orchid SRV (safety release valve) technology, which prevents IV dislodgment, enhanced IV securement, or technology that enables needle-free blood draws, or even ultrasound-guided catheter insertion. In a perfect scenario, methodical use of some/all of these solutions can help in creating a complete continuum of care. Additionally, training on these enhanced vascular access techniques can help generate efficiencies, by educating care providers on the best practices to reduce waste.”
Along with more efficient product use, Clark pointed out the role that cost plays when it comes to ensuring hospitals and healthcare facilities have the required amount of IV-related products available.
He said, “Cost does have an impact, but only considering cost ignores down-stream impacts on clinical workflows and, most importantly, patient outcomes. An IV set that doesn't require replacement, but costs slightly more than the competing status quo, creates a lot of value further along the line. It enables smoother workflows in the clinic, uninterrupted therapy for the patient, and ultimately creates cost savings from not having to replace the IV system – alongside easing the burden on the healthcare supply chain.”
Clark added, “This broader perspective provides better potential to address cost impacts as a complete solution, in comparison to individual component carve outs. We need to be assessing the complete cost of care alongside the individual pricing impacts.”
In an effort to safeguard against future supply shortages, James Zacha, director of marketing, enteral feeding, at Avanos, said, “Global supply has continued to improve and while Avanos was impacted by supply disruptions driven by the pandemic and one-time events, we are now in stronger inventory positions across our entire supply chain. We continue to take active measures to minimize risk of future supply chain disruption.” The company’s measures include:
· Ongoing scrutiny of global geopolitical events for the purpose of getting ahead of potential shortages
· Active identification of weaknesses in the supply chain for critical raw materials implementation of solutions to strengthen availability now and in the event of future widespread shortage
· Focus on curating alternate suppliers for critical materials
· For domestic operations, deepening partnerships with industry and government associations, all of which have programs focused on ensuring supply of critical raw materials
Related IV product shortages
In addition to supply chain issues with IV bags, the healthcare industry is still facing shortages of drugs and nutritional solutions as well. With many of the fluids administered for quality of life and life-sustaining reasons, the current shortages are raising industry causes for concern.
“As the mass media has been reporting this summer and early fall, the U.S. is still in the throes of major drug shortages in the IV and nutritional (dextrose, saline, electrolytes) solution areas. Most critical are the adult and pediatric oncology drug shortages, as well as the shortages of diabetes injectables like Ozempic-semaglutide. Maybe less public, but no less important, are the many drug categories associated with operating room procedures which include sedatives, antibiotics, electrolytes, and pain medications. Over 240 drugs remain on the FDA drug shortage list as of September 2023; the American Society of Health Systems also has committed resources to track and report on drug shortages,” Kerr said.
When asked about the causes of the shortages, Kerr reported, “Several key causes of shortages are listed here, and the challenges remain in difficult mode as we enter the fall season.” Asserted as reasons for shortages of drugs and nutritional solutions, Kerr listed four important points:
“Manufacturer plant closings drive shortages, as plan shutdowns are usually due to quality issues and also business decisions centered on profits and shareholder obligations. The closings are often sudden, and there is apparently no ‘central’ repository or library of drug sources, alternative options, etc. that is managed or overseen by a ‘regulatory body.’
Natural disasters like the July tornado at the Pfizer plant in North Carolina triggered many critical-essential responses as hospitals and health systems scrambled to find alternate supplies of the impacted injectables. The hurricanes in recent years at Puerto Rico manufacturing plants also created many crises in the U.S. as an inordinate percentage of the U.S. sourcing of select injectables came from facilities on the island.
The U.S. arguably has a dramatic over-reliance on sourcing via overseas suppliers for raw materials and active pharmaceutical ingredients (API) also. India, China and Italy represent the top three out of 42 suppliers of API to the U.S.
Make or buy decisions at health systems and hospitals are occurring more frequently than ever as an unprecedented National Pharmacy Technician Shortage continues. Pharmacy Technicians are an essential piece of hospital pharmacy operations as they are the primary admixers of injectable solutions usually in bag or syringe ready-to-administer form.”
Kerr added, “Without that support, administrators may move products to ‘buy’ triggering unanticipated demand at the manufacturer. This is a cost decision that intertwines labor, supplies, and the drug itself, and can play out across hundreds of line items.”
Looking ahead at what more could be done to ensure IV-related product availability, Kerr said, “I am always struck by the power of new innovators, and patient-specific stories. Capitol Hill could be an effective listener and problem solver here. Incremental change is better than none at all."
He continued, “Drug manufacturers are trying to get specific drug and volume commitments from the largest purchasers. This is often made more difficult by the swings in hospital demand and the financial state of affairs at so many health systems; post-pandemic fiscal headwinds continue to plague many. Creating domestic pharmaceutical sourcing of raw materials and API versus relying on overseas trade partners is very difficult to operationalize especially on a short timeline.”
For hospitals and healthcare facilities, the current challenge of IV product shortages is a problem with no quick solution. However, strides towards much-needed progress are being made. With the FDA pursuing domestic and international IV product-securement options, and many manufacturers expanding their locations and production, the healthcare industry may soon see a welcome infusion of essential IV products with reliable availability.