CDC Restates Position on Single-dos​e/Single-U​se Vials || Reports > A Review of FDA's Approach to Medical Product Shortages

In an effort to ensure clinicians are clear about CDC guidelines, the Agency is restating its position on the use of single-dose/single-use vials and also seeks to dispel inaccuracies being disseminated to healthcare providers.
Reports > A Review of FDA's Approach to Medical Product Shortages



CDC’s Position: Protect Patients Against Preventable Harm from
Improper Use of Single-dose/Single-use Vials

The Centers for Disease Control and Prevention’s guidelines call for medications labeled as “single dose” or “single use” to be used for only one patient. This practice protects patients from life-threatening infections that occur when medications get contaminated from unsafe use. Concerns have been raised about whether these guidelines and related policies contribute to drug shortages and increased medical costs to healthcare providers. CDC recognizes the problem of drug shortages; however, such shortages are a result of manufacturing, shipping, and other issues unrelated to the above guidelines (http://www.fda.gov/DrugShortageReport). CDC ’s priority is protecting patients from harm. 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 healthcare 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.

Read more at http://www.cdc.gov/injectionsafety/CDCposition-SingleUseVial.html and www.cdc.gov/injectionsafety.