Navigating IV Fluid Shortages Post-Hurricane Helene: Insights From USP on Compounding and Conservation Strategies

Pharmacy Times interviewed Farah Towfic, PharmD, MBA, RPh, senior director of the Healthcare Quality and Safety Center of Excellence at US Pharmacopeia (USP), on the significant IV fluid shortages caused by damage to a Baxter manufacturing plant in the aftermath of Hurricane Helene. The plant, which produces over 60% of large-volume IV fluids in the US, plays a critical role in supplying essential fluids such as dextrose. Towfic explains how these shortages have disrupted health systems, leading to increased reliance on compounding practices to manage fluid availability.

Damage was done to buildings and structures throughout the region affected by Hurricane Helene, such as a bridge in Fries, Virginia that was destroyed by the hurricane. Image Credit: © Timothy - stock.adobe.com

Towfic emphasizes the importance of operational considerations in response to the shortages. USP, in collaboration with organizations such as American Society of Health-System Pharmacists (ASHP), Institute for Safe Medication Practices (ISMP), and End Drug Shortages Alliance (EDSA), have provided resources to mitigate the impact, including an operational considerations document. This document offers guidelines on conserving available IV fluids, compounding alternatives, and strategies to reduce errors that may arise from process changes. For instance, guidance is given on switching from injectable to oral medications where possible, avoiding anticipatory compounding, and managing storage conditions during power outages.

Towfic also highlights the importance of proper training for compounding personnel, especially when roles shift during shortages, and maintaining clear communication around labeling and dosage changes to avoid medication errors. She underscores the need for collaboration with regulatory bodies and invites pharmacy professionals to provide feedback on the operational document to ensure it continues to address their needs.

Pharmacy Times: How can medication compounding help mitigate shortages resulting from natural disasters, such as Hurricane Helene?

Farah Towfic, PharmD, MBA, RPh: In the aftermath of Hurricane Helene, a Baxter manufacturing plant was impacted, and as we saw, this is a manufacturing plant that provided more than 60% of large IV fluids across the United States. And I think particularly of note with this shortage, is that these are large volume IV fluids, they are the lifeblood of many health systems. So, as a result, there's catastrophic impact upon these health systems that are looking to ensure the continued availability of these fluids so that they can continue to take care of their patients. Now during a time of a drug shortage, that's when compounding becomes an even more important solution in order to be able to help mitigate the impact of those shortages, because—as I mentioned—these are large IV fluids, the compounding implications upon them are quite significant. They're lengthier in duration, and during times of a shortage, that's when health systems might have changes within their procedures to try and incorporate in compounding as a solution, and that can potentially cause an error in patient care due to the fact that the change in process takes place at the health system level. So, when you have a change in any process that you've done on a regular basis, and suddenly you have a shortage and you're going to have to change your procedures that can make it more prone in order to have potential errors. And that's why organizations like ASHP, ISMP, EDSA, [and] others have really shared significant clinical resources to help support [health care professionals] in order to be able to help mitigate those situations.

What we created with USP is an operational consideration document that, as you're going to be using compounding as a way to mitigate that large lifeblood of the health system [and] large IV fluid shortages, these are considerations that can be incorporated into the policies and procedures during the shortage to ensure that we get proper quality for those products and ensure patient safety.

Pharmacy Times: What are current strategies available to address these shortages, and what resources has USP made available to aid in this endeavor?

Towfic: One of the resources that that I mentioned have been clinical intervention. So, what do you do in order to preserve these large IV fluids that are in shortage right now? It's a matter of…can a patient take an oral medicine and they were scheduled to get an injectable medicine? If that's the case, and they can take an oral medicine, you want to switch them to oral. So again, these are organizations like ASHP, ISMP, and EDSA that have issued guidance around that.

These are interventions on fluid conservation strategies for compounded sterile preparations, so that includes guidance around when you use certain fluids, these large volume fluids, or alternative considerations in order to be able to take care of the patient and preserve the fluids that you already have within the health system. So, an example would be those mitigative strategies so you can conserve what you currently have. There [are] practices that you would avoid that's included in this operational consideration document, so those include practices like anticipatory compounding, trying to prep larger volume products, and that's something that you don't want to do in this situation because, again, patient care needs can change, a patient can get discharged, [and so on]. Again, these are all intended to help preserve what the health system already has, so that you don't run into a situation of running out of these critical IV fluids.

I think it's also important to note, again, in times of a drug shortage, when a health system and other health care practices have to change a process that they've done deliberately [and] consistently over a time period, that's when things can be prone to errors. So, for example, one of the considerations especially around sterile water shortages during this time period. Well, [at] USP, we've shared as part of this operational consideration document an infographic around water considerations that are used within formulation. So, purified water, drinking water…there are significant differences in what you can utilize in order to be able to create sterile water, essentially. So, it's important to note that in order to prevent any potential settings from utilizing the wrong type of water, in order to try and mitigate the shortage during this time period. So again, these operational consideration documents are intended to support the health system as part of their policies and procedures to mitigate the impact of this shortage.

One other important component as an example in the operation consideration document, is around excursions for products. During the hurricane, many locations may have lost power. So, how long was a product in a refrigerator with the door closed, what temperature was it exposed to during that time period? We've shared considerations around temperature and storage definitions our general chapter <659> as well as mean kinetic temperature monitoring general chapter that can help settings determine if those products should be quarantined, or if those products could still be used. So again, those are tools that health systems and other settings can utilize in being able to ensure that no product is wasted. Again, we're really trying to conserve the supply of these essential preparations.

Pharmacy Times: What are some operational considerations for sterile compounding for pharmacists following Hurricane Helene and for future public health emergencies and natural disasters generally?

Towfic: The operational consideration document that USP created, we do intend it to be utilized…to help mitigate the impact of this particular shortage driven by Hurricane Helene, and also for other natural disasters in the future. These are considerations that will constantly come up when a natural disaster happens. We know during those time periods, a health system, a community pharmacy, [or] other entities could lose power, and in that case, what do you do with the often very expensive products that you have under refrigeration? So, that's why these temperature and excursion guidance that we included as part of the operational consideration document is going to be helpful for these entities in order to ensure that they're not wasting product when they have appropriate data that shows the temperature that the product was exposed to and whether it could be quarantined, or whether…it could be utilized in order to care for patients.

Beyond that…sterile water is one of the shortages that has been prompted by the impact on the Baxter manufacturing plant. So, it's important to note the differences in the different types of water that are available to health systems, drinking water, sterile water for irrigation versus sterile water for injection versus purified water, so, that's why this whole consideration around water is important to note, especially as entities are trying to compound and potentially mitigate the shortage for sterile water formulations.

Other considerations are more about working with your state or federal entities that are the ones that are working closely with you to create maximum flexibility in order for these health systems to continue to be able to care for patients. So, work with your regulator, stay apprised of any interventions that are that they are sharing, as far as guidance to help mitigate the impact of this shortage.

Pharmacy Times: Any closing thoughts?

Towfic: During times of a significant drug shortage, especially in this particular case where we know the Baxter manufacturing plant produces more than 60% of the these IV fluids in the United States, it's important to understand that entities are going to be significantly impacted. So, during this time period, the policies and procedures that we all follow—I'm a pharmacist by training as well—these are very deliberately shared across the health system and utilized in training individuals in order to ensure appropriate patient care and quality of prepared medicines continues to take place.

Now, when you have a change in process due to the shortage that would occur, it's important to understand, especially—for example—if you're bringing in a technician that's going to be exclusively compounding these large volume preparations, and that's not something that they do in their typical day-to-day, perhaps they compound other formulations. What additional training considerations does this person have to have? So, that might not be something that's in the existing policy and procedure, but that's something that's part of the operational consideration document that we call attention to so that as you're bringing in this individual to potentially help mitigate this shortage, you have a thorough view on other training considerations that they would have and any other labeling changes that might need to take place, for example, if you have different strengths of a medicine than what you're normally carrying just due to the shortage. What other considerations do you have to have to alert your practitioners and those who are particularly administering medicine, so that they're more alert to changes in labeling that would take place, changes in the usual dosages that you have for the medicines. These are built into the operational consideration document so that they can help mitigate any potential patient safety impact and help ensure the quality of those medicines.

And finally, and most importantly, do reach out to us as part of that operational consideration document, we provide our compoundingsl@usb.org email account. If there's other resources or information that you believe would help you during this time of a shortage, in order to help mitigate the impact, ensure that you can continue to take care of patients, reach out to us as we continue to evolve this document to ensure that it meets your needs. Your feedback helps to inform that work. So, thank you so much for everything that you're doing.