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I.V. Solution Shortages Affecting Healthcare Providers Across the Nation

Shortages of IV fluids are affecting healthcare providers in all settings across the nation. Oncology offices, rural healthcare providers and acute care providers report the shortages are affecting patient care.  

The FDA Response

On April 28th, 2014 the FDA posted an update on the saline drug shortage: In response to the ongoing shortage of 0.9% sodium chloride injection (normal saline),Baxter Healthcare Corp. of Deerfield, Ill., will temporarily distribute normal saline in the United States from its Spain manufacturing facility. FDA is temporarily exercising its discretion regarding the distribution of Baxter’s saline product from Spain and Fresenius Kabi’s saline product from Norway as needed to address this critical shortage, which poses a serious threat to patients.

FDA inspected Baxter’s Spain facility where its normal saline product is made to ensure the facility meets FDA standards. FDA asks that health care professionals contact the Baxter directly to obtain the product.

In addition to these sources of normal saline, U.S.-based manufacturers – Baxter Healthcare Corp. , B.Braun Medical Inc., and Hospira Inc., – are currently producing and releasing normal saline. Baxter’s saline product from Spain will be distributed temporarily in addition to Baxter’s FDA-approved version that is currently manufactured and distributed in the United States.
While the shipments described above will help reduce current disruptions, they will not resolve the current shortage of 0.9% sodium chloride injection. Preventing drug shortages is a top priority for the FDA, and we are doing everything within our authority to improve access and alleviate this shortage. 

Reference: http://www.fda.gov/drugs/drugsafety/ucm382255.htm


The Cause of the Shortage

The FDA first addressed the issue in January of 2014 stating they were aware of the shortage of intravenous solutions, particularly 0.9% sodium chloride injection, which is used primarily for hydration as well as other conditions.  The government agency stated that the shortage had been triggered by a range of factors including increased demand by hospitals for use in treating the influenza virus.

Some remain skeptical about the flu being an explanation for the supply problems.  But only 3 manufacturers in the U.S. produce saline solutions: Baxter Healthcare Corp, B.Braun Medical Inc., and Hospira Inc. There have been several recalls of intravenous solutions due to particulate matter found in the solutions, how this has impacted the supply chain is not clear.

Solutions Offered by Pharmacists

The American Society of Health-System Pharmacist has compiled a list of intravenous solution conservation strategies that could be implemented until supplies can keep up with the demand.



Intravenous Solution Conservation Strategies

(Compiled by the American Society of Health-System Pharmacists and the University of Utah Drug Information Service, March 20, 2014) 

Introduction

This fact sheet summarizes the status of the current acute shortage of certain large-volume intravenous
solutions and provides a list of potential actions to conserve them that organizations might consider to
manage the shortage. Healthcare professionals should use their professional judgment in deciding how
to use the information in this document, taking into account the needs and resources of their individual
organizations.

Why is Conservation Necessary?

There is a national shortage of 0.9% Sodium Chloride Injection, 0.45% Sodium Chloride Injection,
Lactated Ringer’s Injection, and 5% Dextrose Injection that is not expected to resolve until May or June,
2014. Products most affected by this shortage are large-volume (i.e., 1000 mL) bags.

What can clinicians do to conserve?

Use oral hydration whenever possible.

Review the suggested clinical approaches and product conservation strategies in collaboration withthe organization’s stakeholders and the Pharmacy and Therapeutics (P&T) Committee or otherorganization-wide medication policy group for applicability to the organization.

Implement an organization-specific action plan to conserve IV fluids where possible. Allow flexibility
as the shortage status of specific products may change frequently. For example, Lactated Ringer’s
Injection may be more available than 0.9% Sodium Chloride Injection and vice-versa depending
product availability and allocation schedules.

Develop medical staff-approved policies for substitution of IV solutions based on product availability
within the organization. Example: an organization might allow substitution of Lactated Ringer’s
Injection for 0.9% Sodium Chloride Injection or vice-versa depending on what is in stock. Table 1
provides a comparison of common intravenous fluid components.

Patient Clinical Evaluation

Frequently, or at minimum once each shift, evaluate the clinical need to continue intravenous fluid
therapy. Consider identifying specific clinical personnel to actively monitor usage for each patient.
Discontinue infusions as soon as appropriate. Consider stop orders for infusions, for example 24–48
hour automatic stops, if not reordered.

Frequently, or at minimum once each shift, assess need to continue “keep vein open” (KVO) orders.
Consider locking catheters rather than infusing 0.9% sodium chloride injection at a KVO rate when
possible.

Consider flushing central venous access devices (CVADs) 1–3 times per week rather than daily.

Evaluate total fluid requirements for surgeries. The American College of Surgeons: Principles and
Practice 2014 notes that total volume replacement needs for elective surgeries are much less (500
mL to 3000 mL total) than previously thought (4500 mL to 6000 mL total).1

Product Conservation

Use small-volume bags for low infusion rates (see Table 2).

Consider reserving some products for specific clinical situations. Table 3 outlines potential
suggestions, but is not inclusive of all possible actions.

Consider deferring elective procedures and surgeries requiring 0.9% Sodium Chloride Injection or
other solutions in short supply.

Consider hang times longer than 24 hours for solutions (if infusion is spiked immediately prior to
administration). There is no nationally published guideline recommending a maximum hang time for
an infusion. If longer hang times are used, hospital leadership; medical, nursing and pharmacy staff;
infection control; risk management; and other stakeholders should weigh the risk of infection
against the need to conserve intravenous solutions. Note: hang times should not exceed
manufacturers’ instructions, if available, or beyond-use dating assigned according to USP-NF
Chapter <797>, Compounding Sterile Preparations for compounded solutions.

Evaluate the clinical practice of using flush bags for intermittent medications when no primary
solution is being administered. 0.9% Sodium Chloride flush syringes are an alternative.

Use commercially available dialysis solutions whenever possible, instead of compounding with 0.9%
sodium chloride.

Inventory Control Strategies

Evaluate IV fluid supplies on a health system-wide basis in order to redeploy solutions to areas of
greatest need.

Minimize unit stock of large-volume bags to the extent possible or stock product only in critical care
areas where fluids are an essential component of emergency supplies.

Ensure smaller volume bags are stocked in other supply areas, especially pediatric areas.

Limit quantities of bags placed in warmers.

Ensure purchasing agents have active backorders in place and are obtaining allocations as available.

Frequently communicate with distributor as allocations and shipment dates may be unpredictable.

Establish routine conference calls or meetings among stakeholders to discuss supply status before
supplies become critically low.

Avoid buying products from sources outside the traditional supply chain. Report suspected illegal
activity by nontraditional distributors to the state board of pharmacy, state attorney general, or
FDA’s Office of Criminal Investigation.

Provide regular or as needed updates on shortage status and action plan adjustments to clinicians
and other organizational stakeholders (e.g., risk management/patient safety, leadership, etc.)

The use of multiple communication methods is highly recommended.

Caveats / Safety information

Compounding sodium chloride solutions from sterile water for injection and concentrated sodium
chloride injection is error-prone, labor-intensive, and may worsen the existing shortage of
concentrated sodium chloride injection. In addition, the high-volume of product needed to meet
patient needs makes compounding impractical. Compounding should be limited to solutions needed
to meet urgent short-term needs for sodium and fluid replacement therapy, when commercial
products are unavailable.

Reflect use of smaller volumes in infusion pump libraries, pre-printed or electronic order sets, and
standard IV fluid labels as needed.

Avoid intravenous use of sodium chloride irrigation solution. Sterility requirements and limits on
particulate matter differ between these two products. 

To view the original ashp.org document click here with referenced tables click the link below.

http://www.ashp.org/doclibrary/policy/conservation-strategies-for-iv-fluids.pdf
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