Single-Use Vials -- The Debate Continues

Laura A. Stokowski, RN, MS

Disclosures

December 11, 2012

In This Article

My Technique Is Decent

Many healthcare providers are aware of the potential risks but insist that their own diligent practice negates these risks. For example, a general practice provider described his or her procedure and beliefs. "What I do is draw up (using decent sterile technique, after cleaning the tops of even brand-new vials with alcohol and letting them dry) all the syringes ahead of time -- at one time. I do agree that just leaving a vial on a shelf for weeks or months, accessed by many providers -- most of us have seen this -- is not a great idea. But drawn up all at once and then stored for use...this is just not a problem, especially if it's for that day's use."

The waste of unused drug is often cited as rationale for allowing practitioners to do what might otherwise be accomplished by pharmacists.

"If a pharmacist can take a multidose vial and distribute it to sterile syringes and sell it as 'compounded product' at 10-20 times the cost (remember that this is what the Florida pharmacies did during the recent midazolam shortage), then why can't physicians in charge of surgical centers do the same in their facilities? Doing this in a correct way is not rocket science for trained physicians," maintained a gastroenterologist.

A surgical nurse weighed in with this comment: "Plenty of competent practitioners could be registered in a hospital or clinic facility to draw up single-dose syringes from a vial. Properly labeled and dated medications could be utilized rather than wasted."

Apparently, many practitioners believe that what is commonly referred to as "sterile technique" is sufficient to protect patients. So, why not rely on competent practitioners to draw up several single-dose syringes from a single-use vial? The problem, according to CDC, is that sterile technique at the bedside or in a standard medication or treatment room is not possible.

Standards set forth in United States Pharmacopeia General Chapter 797 (USP<797>), Pharmaceutical Compounding -- Sterile Preparations, require controlled conditions, which means International Standardization for Organization (ISO) class 5 air-quality conditions within an ISO class 7 buffer area. Essentially, this includes a laminar airflow hood and other protections to ensure aseptic handling of medication. Without these protections, the needle and syringe can be contaminated through direct contact with microorganisms or via airborne particles without a clinician realizing that a problem has occurred. Strict quality control of "beyond use" times and dates, and appropriate storage of compounded sterile products, are mandatory.

That being said, CDC emphasizes that practices with a significant need for minimizing waste during the extenuating circumstances of drug shortages might choose to have the in-house capability (physical space, equipment, and training necessary to meet USP<797> standards) for meticulously subdividing the sterile contents of unopened single-use vials (medium risk compounding) to meet their own patient care needs.

Interested clinicians can review the USP<797> standards. These standards have been made temporarily available free of charge as a resource for healthcare professionals. However, "If you split a single-use vial yourself under a laminar flow hood with appropriate personal protective equipment, it is still not as safe as a sterile unopened vial from the manufacturer," warns the CDC. The Association of Health Systems Pharmacists sells a manual, Compounding Sterile Preparations, 3rd Edition , available through their Sterile Compounding Resource Center.

CDC emphasizes that practices that use compounding pharmacies, or establish their own facility for splitting doses, must perform due diligence to ensure that procedures are compliant with USP<797> standards. State laws can differ on requirements for pharmaceutical compounding. More than ever, state pharmacy boards are looking carefully at the compounding of sterile products, and we may expect to see changes in compounding pharmacy regulations over the next year.

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