Point of emphasis: CDC on single-dose vials
Drug shortages, waste concerns no excuse
In light of recurrent outbreaks linked to misuse of single-dose medication vials, the Centers for Disease Control and Prevention is emphasizing that medications labeled as "single dose" or "single use" are to be used for only one patient.
In a May 2, 2012, posting (http://ow.ly/c1KE0) the CDC said this practice protects patients from life-threatening bloodborne and bacterial infections that occur when medications get contaminated from unsafe use. The CDC is aware of at least 19 outbreaks associated with single-dose/single-use medications since 2007. Seven of the outbreaks involved bloodborne pathogen infections and 12 involved bacterial infections.
The CDC also addressed common myths about vials in an effort to resolve recurrent confusion about the issue. Regarding concerns that these guidelines and related policies contribute to drug shortages and increased medical costs to health care providers, the CDC said shortages are primarily a result of manufacturing, shipping, and other unrelated issues.
"CDC's priority is protecting patients from harm," the agency stated. "CDC routinely investigates and is apprised of infectious disease outbreaks involving single-dose/single-use vials being used for multiple patients. These outbreaks cause extensive harm to patients, and they are associated with significant health care and legal expenses. Therefore, CDC continues to strongly support its current policies regarding single-dose/single-use vials. It is imperative that drug shortages and drug waste concerns are dealt with appropriately and do not lead to unsafe medical practices that impose increased disease risk on patients. Shortages of some essential medications may warrant implementation of meticulously applied practice and quality standards to subdivide contents of single-dose/single-use vials, as stated in United States Pharmacopeia General Chapter 797 Pharmaceutical Compounding – Sterile Preparations."
Additional CDC points of interest include:
- Vials labeled by the manufacturer as "single dose" or "single use" should only be used for a single patient. These medications typically lack antimicrobial preservatives and can become contaminated and serve as a source of infection when they are used inappropriately.
- Ongoing outbreaks provide ample evidence that inappropriate use of single-dose/single-use vials causes patient harm.
- 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 health care personnel in accordance with standards in United States Pharmacopeia General Chapter 797 Pharmaceutical Compounding — Sterile Preparations. Following the USP standards is imperative, as medication contamination and patient harm can occur when repackaging (e.g. splitting doses) is not done properly.
The CDC listed the following answers to some of the most common questions about this issue.
Can single-dose or single-use vials be used for more than one patient?
No. Vials that are labeled as single-dose or single-use should be used for a single patient and single case/procedure/injection. There have been multiple outbreaks resulting from health care personnel using single-dose or single-use vials for multiple patients. 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. To prevent unnecessary waste or the temptation to use contents from single-dose or single-use vials for more than one patient, clinicians and purchasing personnel should select the smallest vial necessary for their needs when making treatment and purchasing decisions.
Is it acceptable to combine (pool) leftover medication from single-dose or single-use vials?
No. Do not combine (pool) leftover contents of single-dose or single-use vials or store single-dose or single-use vials for later use. Single-dose or single-use vials are intended for use on a single patient for a single case/procedure. There have been outbreaks resulting from pooling of contents of single-dose or single-use vials and/or storage of contents for future use.
In critical situations, is there any option for medication from a single-dose/single-use vial to be used for more than one patient?
It is optimal for the medication to be used for just one patient. Shortages of some essential medications may warrant implementation of meticulously applied practice and quality standards to subdivide contents of single-dose/single-use vials. In these cases, qualified health care personnel may repackage medication from a previously unopened single-dose/single-use vial into multiple single-use vehicles (e.g., syringes). This should only be performed under ISO Class 5 conditions in accordance with standards in United States Pharmacopeia General Chapter 797, Pharmaceutical Compounding – Sterile Preparations, as well as the manufacturer's recommendations pertaining to safe storage of that medication outside of its original container.
When should single-dose or single-use vials be discarded?
Medication vials should always be discarded whenever sterility is compromised or questionable. In addition, the following recommendations are made for handling of single-dose or single-use vials:
- If a single-dose or single-use vial has been opened or accessed (e.g., needle-punctured) the vial should be discarded according to the time the manufacturer specifies for the opened vial or at the end of the case/procedure for which it is being used, whichever comes first. It should not be stored for future use.
- If a single-dose or single-use vial has not been opened or accessed (e.g., needle-punctured), it should be discarded according to the manufacturer's expiration date.
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