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CDC restates position on single-dose/single-use vials amid controversy

April 30, 2012

Premier Safety Institute - Safety Share Newsletter

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CDC restates position on single-dose/single-use vials amid controversy

Recently, there
have been suggestions by some clinicians that restricting single-dose/single-use medication vials
to only one patient is contributing to drug shortages and increasing medical costs to healthcare providers.

CDC issue position statement

In response CDC issued a
position statement restating its long-standing position that vials labeled by manufacturers as
"single-dose" or "single-use" should only be used for a single patient to protect
against life-threatening infections. These single-dose/single use medication vials typically lack antimicrobial preservatives and can become contaminated and serve as a source of infection.

Ongoing outbreaks – evidence of harm

In the past five years alone, CDC is aware of at least 26 outbreaks due to unsafe injection practices and the majority (19) involved the use of single-dose/single-use medications for more than one patient. Even if a single-dose or single-use vial appears to contain multiple doses or contains more medication than is needed for a single patient, that vial should not be used for more than one patient nor stored for future use on the same patient.

USP 797 does allow repackaging/split doses under strict sterile conditions

CDC explains that in times of critical need, contents from unopened single-dose/single-use vials can be repackaged for multiple patients. However, this should only be performed by qualified healthcare personnel in accordance with meticulously applied practice and quality standards in
United States Pharmacopeia – Chapter 797- Pharmaceutical Compounding
– Sterile Preparations
. Healthcare facilities can proactively arrange for these doses to be split, in accordance with USP standards, when necessary.

Safe Injections Practices Focus of Recent Premier-SIPC Meeting

The Premier healthcare alliance and the
Safe Injection Practices Coalition
(SIPC) last year convened a stakeholder meeting on
injection safety that focused on one-time use of
needles and syringes and single-dose/single use
medication vials. Presentations by Joint Commission, CDC, FDA, CMS and others are included in the proceedings
and can be downloaded at

Safety Institute



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