Single-Use Vials -- The Debate Continues

Laura A. Stokowski, RN, MS

Disclosures

December 11, 2012

In This Article

Where Are the Smaller Vials?

A nurse wrote, "Single-dose vials are meant for single use; there is no preservative to maintain a shelf life once they are opened. As wasteful as it seems, discarding leftovers is the most prudent course of action. However, it is just plain wrong for drug companies to supply large vials from which most must be wasted when only a small amount is needed per patient." This opinion was echoed by many other healthcare professionals.

"Nobody wants to waste medicine. Why don't manufacturers make single-dose containers closer to recommended dosages in certain populations -- for example, NICU and pediatrics?" asked a neonatal nurse. Another nurse believes that "manufacturers need to make the single-use vials an amount that would be most commonly used on 1 patient. A vial of fentanyl 250 µg is too much for a single dose. Recently, I saw where a manufacturer was making hydromorphone 10 mg in a 1-mL vial. That is just an accident waiting to happen."

A physician offered this solution. "In most cases, the drawn-up syringes can simply be thrown in a freezer dedicated to that use and pulled and thawed on a syringe-warmer for use within an hour or so. But, of course, a practical solution like this doesn't even get considered -- all our administrators can think to do is draw up yet more regulations, put more burden on all of us in the field who actually do the work, and make everything more costly, while they cause shortages by such crazy ideas -- I mean, really crazy, as vials engineered to be accessible only once."

Some, like this orthopedic practitioner, have taken matters into their own hands. "We are having our compounding pharmacy place smaller volumes of our interventional pain drugs into sterile glass vials so we can use them as needed for each case without so much waste. We save on waste, but the cost of taking a 10 cc vial of contrast agent and splitting it into five 2 cc vials is $30. This cost is non-reimbursable and is added to our per procedure costs. It works for us until manufacturers make smaller volumes available at lower costs."

Indeed, CDC is working with federal and professional partners to remove some of the barriers to safe injection practice. This includes having vials manufactured in volumes that better match patient treatment needs. Provider groups are beginning to engage more with drug manufacturers, and some are finding that they are able to negotiate on price.

When asked why manufacturers don't make smaller single-use vials of sterile medications, Lisa Kubaska, PharmD, of the US Food and Drug Administration (FDA), responded in an email to Medscape, "Manufacturers determine the amount of drug in single-use vials. Individual patient dosage amounts can vary based on a wide range of circumstances (eg, patient weight) that are evaluated by medical professionals at the time of drug administration."

The FDA also emphasizes that "even if a single-use vial appears to contain multiple doses or contains more medication than is needed for a single patient, the vial should not be used for more than 1 patient nor stored for future use on the same patient. To prevent unnecessary waste or the temptation to use contents from single-use vials for more than 1 patient, healthcare personnel should select the smallest vial necessary for their needs when making purchasing decisions."

Clinicians also ask, "Why can't preservatives be added to all vials to inhibit growth of microorganisms?" Joseph Perz, DrPH, MA, of the CDC's Division of Healthcare Quality Promotion, responds that even if this was a common practice, it would only affect the growth of bacteria, yeasts, and fungi. Many outbreaks, including some of the largest, involved viral infections such as hepatitis B and C.[4]

Moreover, adds the FDA, preservatives (eg, antimicrobial substances) are, by their nature, potentially toxic. Preservatives can be particularly dangerous when administered by the epidural or intrathecal route because of direct access to the central nervous system. Typical pharmaceutical preservatives include benzyl alcohol, methylparaben and propylparaben, phenol, sulfites, polyethylene glycol, and thimerosal. The public is wary of the effects of, and the need for, preservatives in anything, and they have received much bad press, some of which was not justified.[5] Nevertheless, this has contributed to a trend toward preservative-free pharmaceuticals. Formulating drugs with preservatives that are stable and effective, without being toxic to human cells, is a challenge.[6] In any case, preservatives, when present, cannot substitute for safe injection practices.

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