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Bacteriostatic Sodium Chloride

Why Is There A Shortage of Bacteriostatic Sodium Chloride?

Bacteriostatic Sodium Chloride injection is a sterile isotonic solution of Sodium Chloride and a bacteriostatic agent in water for injection. It is intended for intravenous administration. It is also used to reconstitute injections, dilute or dissolve drugs for IV, and flush catheters or an IV line.

Bacteriostatic Normal Saline (BNS) contains one or more bacteriostatic agents listed on the label. Isotonicity is achieved by adding 0.9% sodium chloride to the solution.

The solution is not packaged in vials larger than 30 mL. BNS is thus available in multi-dose plastic flip-top vials of 10ml, 20ml, and 30ml. There are varying causes behind the shortage of Bacteriostatic Normal Saline, such as increased demand, production, and storage costs.

How to use BNS?

BNS is used to flush IV catheters and for the reconstitution of drugs.

Flushing IV catheter

It is used to flush IV lines or catheters to maintain patency. Here are the steps involved in flushing:

Step 01: Prepare supplies and clean the hand with soap or an alcohol-based hand sanitiser.

Step 02: Flush the catheter:

  • Clean the injection cap and do not touch it after cleaning.
  • Hold the catheter carefully and uncap the syringe.
  • Remove the air bubbles.
  • Flush with BNS and then with heparin.

Reconstitution

When used as a vehicle, care must be taken to ensure that the specified antimicrobial agent on the label does not interact with any drug constituent. The reconstitution volume varies with different drug products.

Caution for use

When only a small quantity is used to flush IV lines or reconstitution, the antimicrobial agent benzyl alcohol is safe. However, it can damage the liver in neonates with premature birth and low body weight.

Causes of shortage

It is nothing new that Bacteriostatic Normal Saline is in short supply. It began following the devastation of Hurricane Maria in Puerto Rico in 2017, which halted the production of Pharmaceuticals. It continues to haunt the supply chains to date.

Demand and supply gaps

The two biggest producers of Bacteriostatic Normal Saline are Fresenius Kabi and Pfizer. Data from both companies suggest that the leading factor contributing to the bacteriostatic saline shortage is a rise in demand and a decline in supply.

Production and storage expense

Another reason is that Bacteriostatic normal saline (BNS) costs extra to manufacturers and suppliers due to production and storage expenses. Therefore they cut down its production, halting the smoothness in supply chains and leading to shortage.

COVID-19 and Bacteriostatic normal saline shortage

COVID-19 has affected the supply chains badly; due to the massive demand for COVID-19 vaccines. Normal Saline is used several times daily, even in the smallest clinical setting.

Any delay in the manufacturing process leads to a considerable supply and demand gap. Currently, according to FDA, all sizes of normal saline bags and vials are in shortage across the US.

Products Affected

According to ASHP following are the bacteriostatic saline products that are affected due to the above-mentioned reasons:

  1. 0.9% Sodium Chloride injection, bacteriostatic 30 mL vial manufactured by Fresenius Kabi
  2. 0.9% Sodium Chloride injection, bacteriostatic 30 mL vial, manufactured by Pfizer
  3. 0.9% Sodium Chloride injection, bacteriostatic 10 mL vial, manufactured by Fresenius Kabi
  4. 0.9% Sodium Chloride injection, bacteriostatic 10 mL vial, manufactured by Pfizer
  5. 0.9% Sodium Chloride injection, bacteriostatic 20 mL vial, manufactured by Pfizer

Effects of BNS shortage

Normal bacteriostatic saline is used for injection reconstitution, i.e., dilution and dissolution of various IV drugs. Shortages have impacted patient care, making it more difficult for HCPs to provide quality health care as they continue searching for substitutes while reconstituting various drugs.

One of the most common uses of BNS is to flush catheters on the IV line. HCPs frequently struggle to know what to do about it in its absence. Switching to an oral rather than an IV route is frequently advised, but what if an IV is required?

Stable Alternatives in the absence of BNS

There are suggested alternative methods in the absence of BNS when a catheter flushing is required.

For reconstitution, sterile water for injection is typically provided along with injection powder. After that, the medication can be diluted with any acceptable diluent. Drug compatibility and patient compatibility for diluents vary.

For instance, Ceftriaxone cannot be diluted with ringer lactate, so compatibility varies depending on the patient. Diabetic patients cannot be administered any medication diluted in dextrose water.

IV line can be flushed with sterile water for injection that is available on the market in 5ml and 10ml ampoules. Depending on the drug administered after, any diluent can be used for flushing.

For example, flushing an IV line with ringer lactate is not recommended if ceftriaxone is administered after it because they both have an incompatibility of the IV site.

Flushing an IV line with heparin and sterile water for injection is usually practised in the absence of BNS.

Any diluent can be used depending upon compatibility with the drug. Following is a list of alternative diluents that can be used:

  • 0.45% saline
  • 5% Dextrose water
  • 5% Dextrose Saline
  • 5% Dextrose + Half saline

The National Home Infusion Association NHIA has released a list of alternatives that can be used in the absence of BNS for reconstitution. It should be consulted along with other authentic sources while reconstituting any drug.

In absence of a suitable diluent, alternative methods can be used. HCPS can shift to any method that does not require an IV catheter without affecting the quality of patient care.

For instance, use IV push instead of infusion, change medications to the oral route, use syringe pumps, and use other solvents for reconstitution. In shortage of BNS, HCPs should avoid preparing IV lines beforehand to avoid waste.

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