Single-Use Vials -- The Debate Continues

Laura A. Stokowski, RN, MS


December 11, 2012

In This Article

Cutting Into the Bottom Line

Cost goes hand-in-hand with waste, and for many providers, cost is the real issue. As one pain management specialist said, "Contrast is expensive and should be used until it is gone unless manufacturers produce smaller vials. This won't happen because it will cut into their bottom line. In the investigation of the pain clinic, other sources of infection should be considered. Contrast itself is bacteriostatic."

A pediatrician stated, "I give palivizumab to multiple patients from single-dose vials and will continue to do so. Each vial costs more than $1000, and it make no sense to throw away unused medication worth hundreds of dollars unless there is a real risk... Using an alcohol swab before re-entering a single use vial to withdraw medication does not pose any risk."

One nurse wrote, "I'm too cynical of the drug companies in that they don't want to make multiple-use vials for profit reasons. I understand the logic of not reusing a vial on multiple patients, but the same patient? Please!"

Even if providers are able to justify the risk to patients and the potential costs of treating preventable infections and settling malpractice claims stemming from patient injury, facilities should realize that failure to follow safe injection practices can also endanger a healthcare facility's "bottom line." The Centers for Medicare & Medicaid Services (CMS) recently issued a memo[3] to its state agency directors indicating that healthcare facilities that do not adhere to USP<797> standards, but reuse single-dose/single-use vials for multiple patients, must be cited for noncompliance.

CMS cites examples of what is not permissible:

• Preparation on a patient/resident care unit of multiple doses from 1 single-dose vial (even in a patient treatment room or medication room);

• A syringe with a single dose from a single-dose vial that will be administered more than 1 hour after preparation;

• Using a single-dose vial in the same manner as a multidose vial; and

• Using a single-dose vial to administer anesthesia, moderate sedation, or other medication to more than 1 patient.

CMS has received requests to relax its policies on the use of single-dose vials for multiple patients. Shortages of critically needed drugs have prompted healthcare facilities to seek ways to make efficient use of the available drug supply. Requestors maintain that wastage of vial contents that exceed the single-patient dose aggravates drug shortages. They question the CMS policy on deficiency citations when medications packaged in single-dose vials are reused for multiple patients. However, CMS has declined to change its policy.

CMS shares healthcare provider concerns about shortages but is equally concerned about healthcare-associated infections caused by unsafe medication preparation and injection practices, including using single-dose vials for multiple patients in the same manner as multidose vials. Such reuse of single-dose vials is not compliant with infection-control requirements and must be cited as a deficiency. "Remember," cautions a pharmacist, "your practice is held to the same USP standards even if you are ignorant of the standards."