SGO Clinical Practice Advisory: Intravenous Solutions Shortage Guidelines

The following practice advisory has been endorsed by the Society of Gynecologic Surgeons (SGS).

In the wake of Hurricanes Helene and Milton, many U.S. medical facilities nationwide are experiencing significant disruptions in the supply chain for IV solutions. Information about affected IV solution suppliers, the federal response, and anticipated resolution of this critical problem has been previously reported^1,2.

Some healthcare systems have sufficient IV supply for treatment, surgery, and emergencies, while others face significant shortages. The SGO is addressing this by informing relevant authorities, including the White House and Food and Drug Administration, about the impact on patients and advocating for prioritizing IV solution production. To conserve IV solutions and promote excellent stewardship of these products in a resource-constrained environment, SGO recommends consideration of the guidelines below. These principles aim to ensure responsible use of IV products and maintain high standards of patient care.

General Principles

On October 7, 2024, the American Society of Health-System Pharmacists (ASHP) and the University of Utah released updated recommendations for managing IV fluid shortages and conserving supply after Hurricane Helene forced the closure of Baxter International, a critical manufacturing plant in North Carolina³. This resource, created in 2022, was updated to reflect the current supply status of small- and large-volume IV solutions. The document provides operational steps that organizations may consider in conserving inventory and managing fluid shortages.

All guidelines should be evaluated within the context of specific resources and IV solutions inventory available within each healthcare system.

Preoperative Principles

• Educate perioperative and healthcare staff about the shortage and the importance of conserving IV fluids. Encourage them to adhere to best practices in fluid management.
• Review all order sets for unnecessary utilization of IV fluids (i.e., consider changing order set defaults from starting with 100 cubic centimeters (cc) to 42 cc to help prompt clinicians to choose lower rate).
• Consider oral clear liquids instead of IV fluids up to two hours before the scheduled procedure time for patients under nothing by mouth (NPO) orders. When placing an NPO order, clinicians should specify in the comments that oral fluids may be administered up until two hours before the procedure.
• Do not initiate IV fluids in the preoperative setting; initiate fluids in the operating room (OR).
• When antibiotics are indicated for surgery, consider administering orally (PO) medications in the pre-operative setting within 30-60 minutes of surgery.

Intraoperative Principles

• Formally discuss intraoperative and postoperative IV fluid needs with the perioperative team during pre-anesthesia or pre-procedure surgical time-outs.
• Utilize enhanced recovery after surgery (ERAS) principles in all procedures.
• Use saline flushes to remove blood in IV lines after blood transfusion.
• Due to expiration date concerns, consider storing fewer IV fluid bags in the OR warmer.
• Consider judicious use of solutions for irrigation in the OR.
• When using the suction irrigator in the OR, do not spike the bag of fluid unless clinically indicated.
• Consider using hemodynamic monitoring systems to guide resuscitation in moderate- to high-risk surgeries.
• Consider distilled water for irrigation/flushing of chronic wounds in immuno-proficient patients.
• In select, clinically-appropriate cases with high anticipated blood loss, cell-saver technology may be considered.

Case Specific Principles

• When performing hysteroscopy, use smaller bags of fluid (e.g., one liter (L) instead of three L) or IV fluid pushes and up-titrate as clinically needed. Use hysteroscopic fluid management systems judiciously in straightforward cases.
• Minimize the use of IV solutions in straightforward, minor procedures.
• When performing abdominopelvic washings during a minimally invasive surgery, instill small volumes of fluid through a laparoscopic port and avoid utilizing a large IV fluid bag.
• For cystoscopy, consider backfilling the bladder with smaller quantities of fluid or utilizing an already open, sterile bag of fluid (i.e., one used with the suction irrigator).
• Hyperthermic intraperitoneal chemotherapy (HIPEC) considerations: If a healthcare institution is severely impacted by the IV solution shortages, HIPEC procedures should be considered carefully to ensure adequate fluid supply can be available to prevent serious kidney injury.
• Irrigate surgical sites at the end of procedures with the minimum amount of fluid.

Postoperative Principles

• Consider same-day surgery discharge for patients whenever safe and feasible.
• For patients undergoing minor surgeries, same day procedures, or laparoscopic/robotic procedures, finish administering any OR IV fluid bags in the postoperative anesthesia or inpatient units, and hold additional IV fluids unless clinically indicated.
• Avoid “keep vein open” (KVO) orders.
• Minimize the use of IV maintenance fluids.
• Consider early PO hydration/feeding per institutional ERAS guidelines.
• When clinically appropriate and antibiotics are needed postoperatively, consider PO instead of IV antibiotics.
• Use distilled water to flush nasogastric tubes.

Chemotherapy Administration Principles

• Every effort should be made to prioritize keeping patients on schedule with chemotherapy treatments.
• All pre-medications prior to chemotherapy should be administered as IV push or switched to oral medications (i.e., IV push ondansetron, IV push famotidine, oral dexamethasone, IV push aprepitant)⁴.
• Many immunotherapeutic agents and bevacizumab can be concentrated in 50 milliliter (mL) bags to conserve fluid usage^5,6.
• All carrier fluids for chemotherapy should be removed if possible. Exceptions may include the first dose of a new regimen and regimens with risk of significant hypersensitivity.
• Caution: Concentrating chemotherapy to conserve fluids can be employed on a dose-by-dose basis. To ensure proper concentration is maintained to avoid precipitation, some institutions utilize bag sizes to help communicate with nursing what infusion rate is necessary. For example, institutions utilize 500 mL bags of paclitaxel to ensure an infusion time of three hours is maintained. Smaller bags denote an administration time of 60 minutes. If you choose to concentrate chemotherapy to preserve fluids as a last resort, proper nursing education from nursing leadership needs to be clear and repeated frequently. Chemotherapy bags should be clearly labeled.
• Cisplatin considerations: Reduction of fluids from 1L of NS with potassium and magnesium pre- and post-cisplatin can be reduced to administering pre-cisplatin only. Oral hydration may also be used⁷.
• If using etoposide, consideration of switching to etopophos can be made as higher bag concentrations can be utilized compared to etoposide⁸.
• If using fluorouracil (5-FU), consider switching all patients to capecitabine. IV bolus of 5-FU should be held.
• If using leucovorin for high-dose methotrexate, use oral leucovorin instead of IV dosing with careful monitoring for methotrexate toxicity (max oral dose of 25 milligrams (mg); if higher dosing needed, use IV)⁹. Reduce bicarbonate IV infusion rates to 50-100 mL/hour for the first 48-96 hours if adequately supplied or can switch to high doses of bicarbonate orally (bicarbonate 1300 mg by mouth every 4-6 hours)¹⁰. Oral intake of fluids should be documented by nursing every six hours to maintain goal oral intake of 2000 mL/24 hours for the first 72 hours of chemotherapy initiation. Discontinue bolus IV bicarbonate – can utilize acetazolamide or oral bicarbonate to maintain urine pH of 8-9.
• All anthracyclines can be administered as IV push.
• Switch to subcutaneous (SQ) denosumab from IV zoledronic acid if needed.
• Switch to atezolizumab SQ injection from IV dosing if needed.

Clinical Trial Principles

1. Although the IV solutions shortage may lead to a clinical trial protocol deviation and may impact data interpretation, patient safety and outcomes must be prioritized¹¹. While every effort should be made to adhere to the clinical trial protocol, it is reasonable to consider modifications to clinical trials in the setting of IV solutions shortages¹² and the general chemotherapy principles (link above) may also apply. Patients receiving therapy as part of standard-of-care therapy or a clinical trial should be given equal prioritization during the IV solutions shortage.
2. For investigator-initiated trials or cooperative group studies in which referral to another institution is not feasible, avoid enrollment of new study participants until confirmation of an adequate and sustainable institutional IV solution supply. Investigators should communicate with their local institutional review board (IRB) and with the study chairs/principal investigators if a pause in enrollment is anticipated.
3. In settings in which an institutional IV solution shortage impacts patients already enrolled on a clinical trial, the respective study chairs/principal investigators should be contacted to discuss each situation on a case-by-case basis.
4. The Department of Health and Human Services regulations 45 CFR 46.103(b)(4)(iii), provide robust protections for human research study subjects and offer guidance for protocol modifications¹². Modifications to consider for patients enrolled on such trials include:
   1. Utilizing the lowest permissible volume of IV fluid to dilute the study drugs and supportive medications.
   2. Substituting IV formulations for oral formulations.
   3. Delaying the next treatment cycle briefly or non-emergent interventions if an IV fluid supply is anticipated soon.
   4. Omitting the drug requiring IV fluid but continuing with other study treatment if receiving a multi-drug regimen, if medically appropriate.
5. When an IV solutions shortage exists, impacted patients enrolled in clinical trials must be informed of any treatment delays or modifications, as well as potential associated risks¹². Any treatment modifications and associated patient counseling should also be documented in the patient’s medical record and reported to the IRB

References 

1. Lovelace B. and Fattah M. Hospitals take steps to conserve IV fluid supply after Helene strikes critical factory. NBC News. October 3, 2024. Accessed on October 14, 2024, at https://www.nbcnews.com/health/health-news/hospitals-take-steps-conserve-iv-fluid-supply-helene-strikes-critical-rcna173861 
2. American Hospital Association. UPDATE: Baxter to Increase Allocations for IV Solution Supplies to Hospitals Effective Today, Oct. 9. October 9, 2024. Accessed on Octobert 14, 2024, at https://www.aha.org/special-bulletin/2024-10-09-update-baxter-increase-allocations-iv-solution-supplies-hospitals-effective-today-oct-9 
3. ASHP News Center. ASHP Offers New Guidance for Managing IV Fluid Shortages. October 4, 2024. Accessed on October 14, 2024, at https://news.ashp.org/News/ashp-news/2024/10/04/ashp-offers-new-guidance-for-managing-iv-fluid-shortages 
4. PR Newswire. October 10, 2024. Heron Therapeutics Reaffirms Availability and Ample Supply of CINVANTI®, SUSTOL®, and APONVIE® as Alternatives During the Potential Shortage of Intravenous Fluids. Accessed on October 14, 2024, at https://finance.yahoo.com/news/heron-therapeutics-reaffirms-availability-ample-200000749.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAABvP19zxS5VwWaKJbSHH4nhYOI2JJC5IsrZhLqcMBC3NWJqc20oAsE0hXTqIWqt4431fzbYYtpFpL-6 
5. Keytruda®. Package insert. Merck Sharp & Dohme Corp.; 2021. 
6. Avastin®. Package insert. Genentech, Inc.; 2022.
7. Horinouchi H, Kubota K, Miyanaga A, Nakamichi S, Seike M, Gemma A, Yamane Y, Kurimoto F, Sakai H, Kanda S, Fujiwara Y, Nokihara H, Yamamoto N, Tamura T, Ohe Y. Oral rehydration solution (OS-1) as a substitute of intravenous hydration after cisplatin administration in patients with lung cancer: a prospective multicenter trial. ESMO Open. 2018 Jan 29;3(1):e000288. doi: 10.1136/esmoopen-2017-000288. PMID: 29503734; PMCID: PMC5812393.
8. Etopophos®. Package insert. Baxter Healthcare Corporation; 2010.  
9. Leucovorin Calcium Tablets USP. Package insert. American Health Packaging; 2022. 
10. Heisler RD, Kelly JJ, Abedinzadegan Abdi S, Hawker JL, Fong LG, Quon JL, Rioux JZ, Jupp JC. Evaluation of an oral sodium bicarbonate protocol for high-dose methotrexate urine alkalinization. Support Care Cancer. 2022 Feb;30(2):1273-1281. doi: 10.1007/s00520-021-06503-3. Epub 2021 Sep 1. PMID: 34471970. 
11. Goozner M. Drug shortages delay cancer clinical trials. Journal of the National Cancer Institute. 2012; 104(12):891–892.
12. U.S. Department of Health and Human Services. Office for Human Research Protections. Regulation 45CFR46. March 10, 2021. Accessed on October 14, 2024, at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html