Even Sterile Water for Injection Becomes Hard for Hospitals to Obtain

Problems in the supply of pharmaceuticals for the U.S. market have reached the point where hospitals nationwide cannot readily obtain sterile water for injection — the essential ingredient to preparing many drug products for IV use.

On January 22, FDA added sterile water for injection to the agency’s Drug Shortages Database.

No vials of the medically necessary product have been received by Pender Community Hospital since early December 2017, estimated Megan Schlaebitz, clinical pharmacist for the 21-bed critical access hospital in northeast Nebraska.

With 12 20-mL vials in stock, Schlaebitz recently said five of those vials will be needed for an upcoming infliximab dose that the facility obtained through a patient assistance program for a man who has lost his medical insurance.

The drug’s labeling declares sterile water for injection as the only option for reconstituting the lyophilized powder.

Allegheny Health Network recently became unable to obtain 10-mL vials of sterile water for injection, said Laura K. Mark, vice president for pharmacy at the seven-hospital healthcare system in western Pennsylvania.

Usage of the vials more than doubled after the network converted IV drug infusions to “push” whenever possible, owing to the ongoing shortage of small-volume parenteral solutions, she said.

That shortage, according to the results of an informal survey ;conducted by ASHP in November 2017, has affected patient care in the nation’s hospitals and health systems.

“The biggest question right now is, What do we do with our IV push antibiotics?” Mark said a few hours before a January 25 strategy-planning meeting between the pharmacy and all the network’s distribution and pharmacy suppliers.

Vicky Vega, interim IV room supervisor at 677-bed Mobile Infirmary in Alabama, said her hospital had not been "dramatically" affected until last week.

During the 2017 Atlantic hurricane season, the pharmacy entered “strategy mode” upon learning that Puerto Rico had been hit, Vega said.

“We knew that that’s where our Mini-Bag Pluses were coming from,” she said.

Mini-Bag Plus, by Baxter Healthcare Corporation, is a line of small-volume parenteral solutions whose container features a vial adapter for making IV admixtures directly from drug vials.

Vega said pharmacy personnel repeatedly asked and answered the following question: If I can’t get this, what will I do?

As a result, she said, the pharmacy “ordered up a lot of different stocks of different nature so we would have different alternatives.” Another action was to change many of the IV drug deliveries from infusion to push, making use of the additional sterile water for injection that would be on hand.

“As of last week, there is none to be had,” Vega said. “We can’t get any.”

ASHP staffers have made sure that FDA knows of members’ struggles to deal with the shortage of sterile water for injection, said Michael Ganio, director of pharmacy practice and quality at ASHP.

Ganio said he and Deborah Pasko, director of medication safety and quality at ASHP, have also been in contact with the University of Utah Drug Information Service regarding the shortage of sterile water for injection, including to work on an FAQ.

“We’ve also been hearing from our members on ASHP Connect,” Ganio said, referring to the member-only online discussion service. “The Section leaders have been passing that feedback on to Deb Pasko and to myself.”

To cope with the shortage, Mark said Allegheny Health Network is “essentially reshuffling the new deck we’ve been dealt,” adopting the following strategies:

• Evaluate a return to IV infusion via minibag for drugs whose mode of delivery, because of the shortage of small-volume parenteral solutions, had become IV push via syringe
• Convert the mode of drug reconstitution for IV products from sterile water for injection to 0.9% sodium chloride injection, when possible
• Conserve the 10-mL sterile water vials for drugs that can only be reconstituted with sterile water and cannot be reconstituted with 0.9% sodium chloride injection

Schlaebitz said Pender Community Hospital is having the nurses use vial adapters, whenever possible, for mixing antimicrobials and certain other medications when the dose is the same as the full vial.

With this on-demand method of compounding sterile preparations, she explained, the nurses directly connect the medication vial to the minibag, turn the powder to liquid without using sterile water, and then immediately administer the dose.

For doses that require less than a full vial, Schlaebitz said she tries to have the pharmacy, which is not open 24 hours a day, mix any IV drug that is compatible with 0.9% sodium chloride injection or another sterile solution other than water. This leaves the remaining sterile water vials available for instances when no other option is available.

Vega said Mobile Infirmary’s pharmacy, which already pulled in all sterile water vials from the automated dispensing cabinets, counts its supply of sterile water every day and calls its distributors and wholesalers every day.

Her essential tool is the whiteboard in her office. Updated every other day, this whiteboard shows the inventory of IV-related products on hand and how much of each item is on allocation from the manufacturer, Vega said. Using that information, she decides how the pharmacy will provide IV drug therapies for the next couple of days.

Ganio suggested that ASHP members monitor Connect discussions to see how other members are dealing with the shortage.

A week after Schlaebitz posted a message about the situation at her hospital, including an upcoming infliximab dose, Georganne Vandyke at Denver Health and Hospital Authority shared a letter she received from Janssen Scientific Affairs, LLC. That company is related to the one that markets infliximab.

The letter states that the results of a study conducted by the developer of infliximab suggest the drug, when reconstituted with 0.9% sodium chloride injection, “remains stable for 24 hours at room temperature.”