Critical Intravenous Solution Shortages

The View From the FDA

Laurie Scudder, DNP, NP; Valerie Jensen, RPh

|Disclosures|February 20, 2014
 

Editor's Note:
A recent shortage of intravenous (IV) solutions, most acutely affecting normal saline solutions, has prompted concerns across the nation. This most recent incident adds to a growing list of products that have experienced shortages, including chemotherapeutic agents. The shortage of saline solutions has coincided with cold and flu season, a time of the year when demand for IV fluids typically increases. Additionally, saline solutions are critical in the treatment of the most vulnerable patients, including cancer, dialysis, surgical, septic, and other critically ill patients. The US Food and Drug Administration (FDA) has been working with hospitals and healthcare professionals to examine factors that led to the IV solution shortage. The FDA is also working with the manufacturers to develop an effective response. Medscape spoke with Capt. Valerie Jensen, RPh, Associate Director of the Drug Shortages Program in FDA's Center for Drug Evaluation and Research and a US Public Health Service officer, about FDA's response.

Medscape: Can you begin by describing the current concerns regarding shortages of IV solutions? When was this issue first identified? Are all regions of the country affected? Besides normal saline solution, are there other products that are of concern?

Capt. Jensen: The FDA became aware that there were short-supply issues with IV solutions late in 2013. There were some delays at some of the manufacturers, which was reported to us, but the delays were not expected to result in a shortage. The companies felt that they would be able to continue to meet demand but were just letting us know that there were some delays. Unfortunately, in mid-January we started to hear from the companies that they were experiencing a very large increase in demand that was really unprecedented. Although they were trying to meet that demand and all 3 major manufacturers were in full production, they were not able to do so. They let us know that they would do everything possible to increase supply, but they have not been able to keep up with demand. This situation is affecting all regions of the country, and manufacturers are trying to get products as evenly distributed as possible.

Medscape: What do you think is the reason behind the demand? Flu, obviously, is an issue, and we typically see an increase of 10% or 15% in demand in the winter, so that is somewhat predictable. Are there other factors ongoing that appear to be driving this demand?

Capt. Jensen: From the information provided by the manufacturers, increased demand is what has been driving this situation. The companies did report some delays in late 2013, but again, that was not anticipated to be a shortage situation by the manufacturers. What we are dealing with is an increase in demand complicated by a capacity issue, where the companies didn't have the ability to suddenly increase production. All of the companies are definitely working to get additional supplies out. Influenza is possibly one of those factors behind the demand, but there could be other triggers as well, such as increased hospital needs for other reasons. Hospital demand in general has just been high this year, as we are hearing from the manufacturers.

Medscape: Does the fact that this shortfall is occurring now, in a cyclically high period of utilization, make it harder to correct?

Capt. Jensen: We have heard from hospitals and other facilities, and we know that some of them have to make decisions on how best to manage this situation. In some cases, hospitals are instituting guidelines for conserving the use of the solutions for patients who absolutely need them. FDA can't make a recommendation as to how a hospital should manage its own supply and how to make those decisions. However, we know that hospitals are evaluating their use of the solutions and making changes in how they use the solutions until supplies are able to meet all demand.

Medscape: Can you speak to what specific products are in shortfall and the alternative agents that can be used? What are some of the strategies that clinicians can adopt in response? Is compounding by hospital pharmacies suggested?

Capt. Jensen: Normal saline or 0.9% sodium chloride solution is the IV hydration solution that is very commonly used for many different types of patients and is the product that is most affected -- specifically 1-liter bags. There are other IV solutions. Lactated Ringer's and dextrose 5% in water are two that are also commonly used. But not all patients can use the same types of solutions, so it depends on the patient being treated and what is best in that case. Normal saline is very widely used and is absolutely needed for patient care. These bags are used for mixing drugs as well; there are very specific instructions, so some drugs can only be mixed in normal saline and not in other IV fluids. An alternative agent for that use does not exist in many cases, but hospitals may have to substitute other sizes of normal saline for this purpose. Some hospitals have reported the use of compounded solutions to augment supplies.

Medscape: What has been the response of manufacturers? Does the FDA have the authority to mandate changes in production? How is the FDA helping manufacturers respond to the shortage?

Capt. Jensen: We cannot require a company to make any amount of the product, and we cannot require a company to increase production. However, we have been working very closely with all of the firms making IV fluids and they are responding well. They don't want this to happen again next year, and, of course, we don't either. We are all working together on ways that we can help avoid this in the future, which means additional capacity by the current manufacturers and additional buffer that would be available to meet a spike in demand. It's important to note that companies are required to notify the FDA once they become aware of a potential supply disruption. And the companies did notify us in this case. However, it was at a point where they were already experiencing an increase in demand, so it was very difficult for them to quickly increase supply, which we are working with them on now.

Medscape: And by buffer, do you mean additional production in lower peak times so that it is available to roll out when needed?

Capt. Jensen: That is what we are encouraging, but again we cannot require that. However, we are talking to the companies about ways in which we can all avoid this situation in the future.

Medscape: Can you place this shortage, and the FDA's response, in the context of the ongoing issue of shortages? Is this a unique situation or does it fit the bigger picture?

Capt. Jensen: This is the type of situation that does happen periodically, especially with drugs that are given by injection. There is limited capacity in manufacturing, so it is difficult when there are increases in demand or some issue occurring at a manufacturing facility. It is very difficult for companies to increase production quickly, and commonly there are not large inventories kept of these types of drugs. So it is something that we continue to deal with, especially for critical drugs, such as saline, that are very widely used. Millions of these bags are used every week, so it is one of these shortages that we are extremely concerned about. We are doing everything we can do to work with the companies on this, and we believe they are responding.

 
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Authors and Disclosures

Interviewer

Laurie Scudder, DNP, NP

Executive Editor, Medscape

Interviewee

Valerie Jensen, RPh

Associate Director, Drug Shortages Program, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland

Disclosure: Valerie Jensen, RPh, has disclosed no relevant financial relationships.

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