Smarter usage policies, conservation strategies, protect patients’ well-being
From adversity can come good things. Take the recent (and at press time, ongoing) shortage of IV solutions – particularly normal saline and dextrose solutions.
It’s true that distributors and manufacturers have their accounts on allocation. But as of press time, no adverse patient effects had been reported. And manufacturers were hustling to meet demand.
Meanwhile, healthcare providers were instituting conservation strategies that may change the way they use IV solutions in the future. “The exciting piece for me is interaction with medical staff – working with them on establishing approved policies for substitutions,” says Mary Beth Lang, R.Ph., MPM, Sc.D., vice president of pharmacy and supply chain management commercial operations, UPMC, Pittsburgh, Pa. “That has been the advantage of all these shortages – a very attuned medical staff being adept and agile in making clinical decisions based on what’s available.”
What’s going on?
While shortages of IV solutions and other pharmaceuticals are not new, the shortage of IV solutions was widespread and lingering. And it exposed a vulnerability in the U. S. system: Although the U.S. Food and Drug Administration can encourage manufacturers to step up production, it cannot require a manufacturer to produce anything.
As of early July, 0.9% sodium chloride injection (normal saline) and 5% dextrose injection were still listed in short supply by the FDA. (Lactated Ringer’s Injection and 0.45% sodium chloride injection, which had been in short supply early in the year, no longer appeared on the FDA’s drug shortage website in early July.)
The agency attributed the shortages to a range of factors, including an increased demand by hospitals, potentially related to the flu season. However, some observers blamed stepped-up quality inspections.
Baxter International, B. Braun Medical and Hospira Inc. reported working diligently to meet demand. In March, the FDA announced that it was “temporarily exercising enforcement discretion” and allowing Fresenius Kabi USA to distribute normal saline while needed. Then, in April, the agency reported that it would allow Baxter to temporarily distribute normal saline in the United States from its Spain manufacturing facility, to supplement the saline manufactured in its U.S. facility.
Approximately 20 million IV saline bags are used per month in the United States, according to the FDA.
UPMC
Providers were exhibiting creativity in coping with the IV shortage without compromising their patients’ well-being.
“This is the first time in a while we’ve seen this magnitude of a shortage in this area,” says Lang. “From time to time, we might have seen one SKU with production issues; but this large scale production issue – this is the first time.”
There are ebbs and flows, and there are times when a few SKUs might be in short supply, adds Matthew Benton, commodity manager, UPMC. “But rarely is there such a large scale shortage, or one that is talked about as much as this one.”
At press time, UPMC was on allocation, particularly with certain IV fluid bag volumes that vendors have temporarily discontinued. That said, the shortage has had “zero patient impact,” says Lang. That’s true for a number of reasons.
For one, UPMC self-contracts for much of its supplies, equipment and pharmaceuticals. “We tend to have direct contracts for these key categories, because we know they’re mission-critical,” says Lang. UPMC uses primarily one IV solutions vendor, but because it self-contracts pharmaceuticals, the IDN has relationships with all the suppliers, she says. “We are fortunate because of the contracting strategy and the model we’re practicing under.”
UPMC does use a national distributor for IV solutions for its non-acute sites. As shortages occur among those sites, UPMC has been able to augment their inventory with solutions from its med/surg consolidated service center and in-house pharmacy.
Despite the relatively stable supply of solutions flowing to UPMC, the IDN has implemented some conservation strategies. In fact, it was a participant in crafting the “Intravenous Solution Conservation Strategies” document, published in March by the American Society of Health-System Pharmacists and the University of Utah Drug Information Service.
“When we have a shortage, from a pharmacy perspective, we look at conservation and utilization very carefully,” says Lang. First question: Can the IDN move to a product that’s more readily available? In the current situation involving IV fluids, UPMC’s clinicians are trying to convert patients to oral hydration as quickly as is safe, she says. “Sometimes, you have fluid just to keep the vein open,” adds Lang, who originally worked as a pharmacy manager at UPMC’s flagship hospital. “But we’re evaluating, ‘Do we really need to do that?
“I think you’re seeing a lot of conservation across the country. As we look at cost-savings initiatives, I can’t help but think these strategies will become our new standard of practice.”
“This experience has served as a reaffirmation of the importance of the contracts to which we hold our suppliers accountable,” adds Benton. Are they truly partnering with the provider? Are they sharing the risk? “These are the types of experiences we refer to when we write contracts with other suppliers, he adds. “If they think our requirements are too high or too burdensome, we use scenarios like this to show them it’s important that our suppliers stand behind their contract.”
Geisinger
Shortages can help providers uncover opportunities for more efficient and appropriate use of medications that are in short supply, according to Dean Parry, R.Ph., director, pharmacy clinical programs, and Deb Templeton, R.Ph., MHA, chief of care support services, Geisinger Health System. “Creating a framework to analyze our usage and implement – in an appropriate manner – strategies to manage the appropriate usage have always been a part of the Geisinger approach to care.” The shortage of IV solutions is no different.
“We have experienced occasional spot shortages, but this is the first time that this has occurred in the way it has impacted the entire market and for the protracted amount of time the shortages have been experienced,” say Parry and Templeton. “Spot shortages usually impact a particular product and a particular size of IV solutions. This shortage has impacted an entire line of products, such as all presentations of normal saline.”
Geisinger began experiencing shortages in January, with normal saline, then expanded to include other solutions, including Dextrose 5%, D5-1/2 NSS, Plasmalyte, 1/2 normal saline and Lactated Ringers solution. “Some have been fairly consistent and some shortages have been intermittent over the past three and a half months,” according to Parry and Templeton. “All have resulted in some disruption of our normal process for caring for patients and have resulted in the need to make changes in our approach and use of these agents, including the careful monitoring of the stock situation to prevent patient-care-related issues.
“The biggest problem is there has been no predictability to the shortages, so it is difficult to implement any long-term planning solutions. Also, the solution to one shortage often becomes the driver for the next shortage that we have to deal with, as the alternative supply [to which] users move causes those products to go on backorder/stock out.”
Despite the shortages and adjustments, patient care remains unaffected. “We have had to take some steps to compensate for the shortage,” they say. Those steps include conserving product when appropriate, switching to alternative products where appropriate, and understanding the limitations of drug compatibility with the base IV solution when choosing alternatives.
“There are some drugs that must be mixed in normal saline to be stable, and others that can be mixed in Dextrose 5%, normal saline or other IV products,” according to Parry and Templeton. “Where possible we have switched the base solution to other products, reserving the limited amount of normal saline for those medications and/or patients that absolutely need normal saline. We have also switched to alternative delivery methods where possible. Many times, a medication can be given by IV infusion (IV piggyback) or IV push. With the shortage, we will utilize IV push where appropriate to save the number of bags of IV solutions needed. Constant communication and adjustments have been necessary in order to ensure adequate supplies as the availability changes.”
Geisinger maintains constant contact with manufacturers and distributors in order to understand the current supply situation and to determine what options, if any, are available to bridge the supply gap. “That information has helped us to be as proactive as possible in our plans for utilization/conservation, and to try and distribute that information in a timely manner to those who are providing direct patient care. It is very important to take a proactive approach in order to minimize the impact on direct patient care or to prevent delays in the delivery of care.”
If a silver lining exists, it is this: Taking a close look at current usage patterns and techniques “helps uncover some practices that can be improved or streamlined. In many cases, we will return to the previous usage, but where practices have been uncovered that do not necessitate the use of IV solutions or lead to undue waste, we have and will continue to implement changes that will allow us to use the resources available in the most efficient manner.”
ROi/Mercy
Mercy has been minimally impacted by the current IV shortage, says Jon Lakamp, vice president of pharmacy. “Due to the implementation of conservation strategies as well as a direct relationship with our IV solution vendor, the impact has been significantly minimized.” That’s an accomplishment, considering the healthcare system serves millions annually in 33 acute care hospitals, four heart hospitals, two children’s hospitals, three rehab hospitals, one orthopedic hospital and nearly 700 clinic and outpatient facilities in Arkansas, Kansas, Missouri and Oklahoma.
In the last five to 10 years, the IDN has experienced sporadic supply issues with a single product in the IV solution category, but nothing to match the scope and length of the current shortage from a national perspective, he says. “Nationally, the current shortage of IV solutions is unprecedented in recent memory.
“With this new reality, health-system pharmacists have become very skilled at minimizing the impact of shortages to patients and clinicians. This particular shortage is no different. At Mercy, our team of pharmacists and supply chain experts developed a strategy to conserve existing supply as well as strengthen our existing relationship with manufacturers to continue direct access to IV solution supply as released by the manufacturers.”
In 2002, Mercy founded a supply chain company – ROi (Resource Optimization & Innovation) – to internalize medical distribution capabilities, including warehouse and logistics, explains Lakamp. Through ROi, Mercy is able to source and deliver supplies and pharmaceuticals directly from manufacturers. “This strategy has helped us to minimize the impact of this shortage in particular.”
In addition, Mercy’s conservation strategies for IV solutions focus around three areas:
- Using oral rehydration when possible.
- Using smaller IV solution bag sizes for patients requiring lower volume.
- Evaluating on an ongoing basis the need for IV solutions in patients.
“Be proactive,” says Lakamp, when asked about lessons learned from current shortage. “Early conservation of products in short supply can pay off dramatically when those shortages become chronic problems.”
Editor’s note: The public can view current drug shortages on the FDA website. Go to http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
Manufacturers step it up
Baxter International, B. Braun Medical and Hospira Inc. reported working diligently to step up production and ease the shortage. And in March, the FDA announced that it was “temporarily exercising enforcement discretion” and allowing Fresenius Kabi USA to distribute normal saline in the United States while needed.
Baxter International
“Baxter continues to help support the increased market need by continuing to produce at maximum capacity, working with customers to meet patients’ medical needs, and exploring alternative solutions with all stakeholders,” said Baxter spokesman John O’Malley. In fact, Baxter increased its production of IV solutions by 3 percent in 2013, and is making investments to increase production by an additional 9 percent in 2014, said O’Malley. The Food and Drug Administration has allowed the company to temporarily distribute its 0.9% sodium chloride injection from its Spain facility, while normal saline remains in short supply.
B. Braun Medical
In a Jan. 31, 2014, letter to customers, B. Braun Medical Vice President of Pharmaceutical Marketing Rick Williamson cited an “unprecedented increase in customer demand” for intermittent backorders of 0.9% sodium chloride injection, USP, 1000mL, 500mL, 250mL; and 5% Dextrose Injection USP, 1000 mL and 250mL.
“We are addressing this industrywide shortfall within our current manufacturing processes and with our investment in a next-generation IV container, E3TM,” he wrote. “With this investment, B. Braun will significantly increase its IV container production capacity over the next three years.” (The E3 containers are free of natural rubber latex, DEHP and PVC.)
Hospira
“Hospira understands the criticality of saline products to patients and healthcare providers,” said Hospira spokesman Dan Rosenberg. “Today, Hospira is producing product at full capacity, working 24/7 on product releases and expediting shipments to mitigate local and regional disruptions.”
Fresenius Kabi USA
In March, the FDA announced that it was allowing Lake Zurich, Ill.-based Fresenius Kabi USA to distribute its 0.9% sodium chloride injection while needed. “FDA inspected Fresenius Kabi’s Norway facility, where its normal saline product is made, to ensure the facility meets FDA standards,” the agency reported. Shipments began arriving from Norway in April.
It is not the first time Fresenius Kabi has worked with the FDA to help with product shortages, said Matt Kuhn, senior director, communications and government affairs. In the recent past the company imported sodium phosphate (Glycophos®) and trace elements for adult (Addamel®) and pediatric (Peditrace®) patients under regulatory discretion. Fresenius Kabi has also imported Propoven, a European version of propofol.