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Multidose vials: Follow the 28-day rule

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Patient safety

Multidose vials: Follow the 28-day rule

Multidose vials run the risk for infections and citations if they aren’t used appropriately

After reading this article, you will be able to: 

  • Define the 28-day rule for multidose vials
  • Demonstrate ways to document compliance

On one hand, multidose vials are a great way to get more for your money with expensive medications. On the other hand, they can cause multiple complications if staff members are not following very precise procedures.

One of the primary concerns of multidose vials is the fact that multiple staff members enter the vial with a syringe, creating multiple opportunities to spread infection, says Peggy Prinz-Luebbert, MS, MT(ASCP), CIC, CHSP, owner and consultant for Healthcare Interventions, Inc., in Omaha, NE. In fact, the best solution for multidose vial complications is not to use them.

“A lot of the risk occurs when you go in and out of that vial,” Luebbert says.

But healthcare facilities don’t always have that option, and as a result they may have multiple multidose vials available for clinicians. This brings up the second problem: expiration dates. 

Multidose vials have a limit on how long they can be stored after being opened or punctured; typically that limit is around 28 days. Your multidose vial may have an expiration date on the label, but that does not take  into consideration the date the vial is first used, which is when the 28-day rule takes effect. 

In addition, not all medications are alike—some must be used soon after being opened, which requires the manufacturer’s specific recommendations.

“The issues are that the preservatives in them may be a short-acting preservative, and so it might not be maintaining sterility for a longer period of time because if the preservation breaks down, then the bugs or the chemicals in there could be starting to take over,” Luebbert says. “So you need to worry about the shelf life based upon the sterility and stability of the agent in the vial.”

Current guidelines

There are a few current guidelines that address expiration dates for multidose vials. The US Pharmacopeia (USP 2008), A General Chapter <797> Pharmaceutical Compounding? Sterile Preparations, requires multidose vials to be discarded 28 days after initial stopper penetration unless the manufacturer specifies otherwise. The vial should be labeled to reflect the penetration date or the beyond-use date.

However, the CDC indicates that multidose vials can be used until the expiration date, unless there are concerns with sterility. 

The Association for Professionals in Infection Control (APIC) takes a stance between the two. In its document APIC Position Paper: Safe Injection, Infusion, and Medication Vial Practices in Health Care, it recommends that facilities develop policies based on one guideline or the other, then follow through with those policies. 

“There are varying recommendations on when the used multidose vials should be discarded, which is why our position paper noted it as an unresolved issue,” says Susan A. Dolan, RN, MS, CIC, director of the Department of Epidemiology at Children’s Hospital in Aurora, CO, and lead author of APIC’s position paper. “Everyone would agree that it should be discarded if the sterility of the vial is in question. Prior to discarding it, though, contact your infection preventionist, as they may want the vial to culture it for microorganisms. It would be helpful to have one evidence-based recommendation for discarding used multidose vials that healthcare personnel and surveyors can both utilize.”

The regulatory perspective

On June 9, Joint Commission Online published a clarification on multidose vials, reinforcing the 28-day rule.

MM.03.01.01, element of performance 7, requires facilities to store all medications labeled with an expiration date, which is defined as the last date the product can be used, the clarification says. Therefore, facilities need to relabel the expiration date once the vial is punctured in order to reflect the 28-day rule. 

CMS has also announced that inspectors will look at the 28-day window for multidose vials, and that requirement has been reflected in the “Surveyor Tool for Infection Control in Ambulatory Surgery Centers.”

Dolan notes that although APIC’s position paper straddles the line on the 28-day issue, it seems more surveyors are using that time period as a barometer. 

“When we wrote our position paper, our communication indicated that staff was to follow their own hospital policy,” Dolan says. “However, that may not be the case today given conversations I had with colleagues at our recent APIC national conference. Therefore, we are currently having conversations with various organizations to help develop one consistent message for the [healthcare professional]. It appears that the 28-day recommendation will prevail along with ensuring vials are accessed, stored, and utilized properly.”

Use the smallest vial possible

Luebbert’s first recommendation is to use multidose vials as little as possible to minimize risks and complication. However, some drugs may only be provided in multidose vials by manufacturers, so there may be some cases where their use cannot be avoided. In this scenario, she recommends purchasing the smallest bottle possible to avoid any complications involving entering the vial multiple times and adhering to the 28-day rule. 

Many facilities, particularly those with tight budgets, find they can get better prices on medicine by purchasing large quantities in multidose vials. 

“Then the other issue is going in and out so many times,” Luebbert says. “If you’re only using half a milliliter and you have a half-a-liter vial, you could go in that forever and ever, and so every time you go in you put yourself more at risk.”

Talk to the manufacturer 

The best way to avoid complications is to contact the manufacturer for each multidose vial and get the exact recommendations for the beyond-use date, Luebbert says. This will ensure that you are following the intended specifications. 

“Typically, most people will do the 28 days just because they don’t want to hassle with it, but I’ve run into some that were 10 days,” she says. “Sometimes it depends on refrigeration, so you need to talk to the manufacturer and get it in writing.”

Keep a log

When Luebbert consults with facilities on how to handle multidose vials, she recommends developing a log, similar to sharps safety evaluations, so that you can track each medication and provide documentation to a surveyor to prove compliance. 

The log should include the following information:

  • Name of the manufacturer
  • What procedures the product is used for
  • Size of the vial
  • Why a multidose vial is required
  • Storage considerations

Luebbert says this log should be evaluated annually by your infection control committee. This documentation will provide a strict policy and appease surveyors.

“[The surveyors] won’t look any further because they know you’ve made an attempt to do due diligence,” says Luebbert.  

Providing education

The last step is to be sure staff members are aware of the requirements for multidose vials. Luebbert has added a slide on safe injection practices to her orientation training. In it, she reveals newspaper headlines from cases where multidose vials were used inappropriately—headlines including the names of healthcare workers. “I might say, ‘You’re the nurse who just went into this multidose vial, you’re probably the 20th person that went in, and you are the one now giving it to the patient. You are the one whose name is going to be in the [newspaper] if this patient gets an infection. Do you trust everyone who went into that before you? How do you know they changed syringes? How do you know they changed needles?”

Luebbert also includes the pharmacy department on all educational efforts because pharmacy is often responsible for purchasing medication. “It’s a constant struggle because what the manufacturers do is to increase the price by only a few cents for the next size up,” she says.


Briefings on Infection Control, September 2010, HCPro, Inc.