Multi-dose vials boast advantages of reduced costs and less unused medication waste. But regulatory guidelines geared toward infection control can hinder providers from achieving such benefits.
Unfortunately, infection contamination through unsafe injection practices is still an issue. Even more unfortunate is that the issue appears to be growing.
According to the Centers for Disease Control and Prevention, there have been at least 49 infection outbreaks due to contaminated injectable medical products at the point of administration since 2001. Twenty-six of those outbreaks occurred in the past five years.
In 2008, nearly 40,000 patients at a Nevada endoscopy center were potentially exposed to Hepatitis C after a provider reused syringes and single-use medication vials on multiple patients. In 2001, an anesthesiologist in a New York endoscopy center reused syringes and contaminated a multi-dose medication vial, infecting 19 patients with Hepatitis C.
Such outbreaks are undeniably devastating for everyone involved. Sterilization is a key pillar of safe healthcare practices, and these contamination incidents demonstrate how one error can have damaging consequences.
To curb the rate of such incidences, the CDC has initiated a number of protocols, established guidelines and even launched a national initiative to help ensure sterilization, including the One & Only Campaign, a public health initiative to eliminate unsafe medical injections.
Single vs. multi-dose vials
Part of the CDC's safe injection protocols discusses the use of single- versus multi-dose vials, any liquid medication intended for parenteral administration. Per the CDC's recommendation, single-dose vials are exactly what they sound like: one dose for one use on one patient. For multi-dose vials, one might expect them to also mirror their name, but multi-dose vials are often treated as single-dose vials for a number of reasons, raising questions of waste and the purpose of such vials.
A multi-dose vial is simply packaged with more than one dose of medication. The CDC recommends multi-dose vials to be dedicated to just one patient whenever possible, but it still does recognize the possibility that a vial may need to be used on multiple patients, which becomes increasingly important as drug shortages loom in the industry.
This is where it gets tricky. Should a physician need to use a multi-dose vial on multiple patients, that vial may not enter an "immediate treatment area," including patient rooms, operating rooms or recovery rooms. "Basically anywhere a patient is likely to be," says Jeff Summers, MD, president of the International Spine Intervention Society and director of the interventional pain management division at NewSouth NeuroSpine in Flowood, Miss.
Because of the logistical challenges this creates, the use of multi-dose vials in certain settings are often rendered useless for multi-use, multi-patient despite any marketed benefits.
"The obvious advantage to a multi-use vial is reduction of costs and waste of unused medication," Dr. Summers says. However, he notes that practical application makes this challenging. "There are instances in which the use of multi-dose vials…is too difficult for this to be practical or even viable for the typical outpatient service due to the logistics involved in transporting the contents of a multi-dose vial from a non-treatment area to where they would be injected."
What's the point?
While the benefits of multi-use vials are worthy in theory, they aren't always practical, given the strict protocol surrounding their use. As they are essentially treated as single-use vials, is there a point to continue manufacturing multi-dose vials?
If a healthcare provider can adequately adhere to all the CDC guidelines and ensure patient protection, then multi-use vials are potentially highly beneficial for cost management and cutting medication waste. However, as Dr. Summers mentioned earlier, adequate adherence is difficult, though it is not entirely impossible.
"As long as the relevant CDC guidelines are followed, some facilities might decide that changing their physical layout to accommodate these policies [regarding multi-use vials] is cost-effective," Dr. Summers says, adding that adhering to the guidelines in his practice "was difficult enough that my facility decided it was not practical to re-use multi-dose vials, which we discard after a single use, just as if it were a single dose vial."
In hospital settings, Dr. Summer adds, the process often is less cumbersome as in-house pharmacies can more easily separate larger vials into smaller dosage units.
Charles Tullius, MD, a board-certified anesthesiologist in Savannah, Ga., would flatly argue no, multi-use vials are not worth continuing to manufacture. "Multi-use vials have no redeeming qualities except for the convenience of not having to check out drugs from the pharmacy as often," he says. "The only way I can see using multi-dose vials is to draw up a unit dose all at once for several patients. However, you can't have syringes with drugs in them — or empty, for that matter — sitting around for any length of time."
The real savings
Based on the CDC's guidelines and best practices, the theory surrounding multi-dose vials on multiple patients does not translate well into reality. The CDC's overarching recommendation is to stick to one vial — single- or multi-dose — per patient. If and when healthcare providers are in a situation where they want or need to use multi-dose vials on multiple patients, regulatory guidelines make such a practice difficult to properly execute.
The cost-saving and reduction of wasted medication are hard to concede, but, as the CDC puts it, infection control and proper adherence to guidelines is the top priority, and it almost always pays for itself.
"Any potential savings from stretching the contents of single-dose vials by healthcare providers can be quickly offset by the costs associated with viral hepatitis, bloodstream infections, meningitis, epidural abscesses and other infectious complications," according to the CDC website.
Adds Dr. Summers, "it's important that providers realize that these guidelines weren't just the brainchild of meddlesome government bureaucrats. They were spawned by outbreaks, which resulted in multiple preventable, yet catastrophic, illness and even deaths. Lives were injured, ruined and lost, and it is the CDC's mission to address such challenges. It is our responsibility to provide the safest possible care for our patients."
More articles on infection control:
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Patient safety tool: Qualis Health's online toolkit for engaging patients in infection control
CDC: Risk of Ebola spreading to US unlikely