In a recent memo, the Centers for Medicare and Medicaid Services denied requests to relax its policy on the safe use of single does/single use medications.
Many facilities have pleaded with CMS that its single-dose vial (SDV) policy coupled with recent drug shortages is causing them to waste critical medication.
Despite such efforts by providers, CMS remains steadfast on its position, noting that while it sympathizes with hospitals’ concerns about meeting patients needs, it cannot relax a policy that could result in an increase in hospital-acquired infections (HAIs).
CMS underscored that SDVs cannot be “reused” on multiple patients; however, they can be “repackaged” into smaller doses, as long as the repackaging process meets the standards below.
- The medications are repackaged under specified conditions, using qualified, trained personnel under International Organization for Standardization (ISO) Class 5 conditions utilizing a primary engineering control (PEC), located within an ISO Class 7 buffer area (the area where the PEC is physically located and which is used for preparing supplies used for drug repackaging under the hood).
- SDVs exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture.
- All repackaged doses prepared in accordance with these standards must be assigned a “beyond use date” (BUD) based on determination by the licensed healthcare professional supervising the repackaging process of an appropriate contamination risk level for compounded sterile preparations (CSPs) and direct testing or extrapolation from reliable literature sources and other documentation (see Stability Criteria and Beyond-Use Dating under Pharmaceutical Compounding—Nonsterile Preparations, United States Pharmacopeia General Chapter 795).
- The BUD and storage conditions for safe use of the repackaged medication are to be identified on a label, in addition to the correct name, concentration and volume of the drug, and route of administration.
To further clarify the distinction between “reuse” and “repackaging,” CMS delineated several examples of what constitutes inappropriate reuse:
- Preparation on a patient/resident care unit of multiple doses for multiple patients from one SDV would be evidence that the medication in the SDV has not been repackaged appropriately.
- A syringe with a single dose from an SDV prepared on a patient/resident care unit that will be administered more than one hour after preparation is evidence that the SDV has not been repackaged appropriately.
- If a nurse, physician or other healthcare professional authorized to administer drugs and biologicals uses a SDV in the same manner as a multi-dose vial, i.e., to administer injections to more than one resident or patient, that would be evidence that the medication in the SDV has not been repackaged appropriately.
- If an anesthetist uses one SDV to administer anesthesia, moderate sedation, or other medication to more than one patient, that would be evidence that the medication in the SDV has not been repackaged appropriately.
Finally, CMS’s policy notes that facilities that have outsourced repackaging of SDVs must be able to provide documentation that the vendor or centralized sterile compounding facility adheres to current USP 797 requirements. (The ASHP Foundation provides a free tool for assessing pharmaceutical compounding partners, which is available here.)
Facilities that do not follow the above practices regarding appropriate repackaging will receive deficiency citations from CMS.
For more information on Pharmaceutical Compounding – Sterile Preparation, see USP General Chapter 797.
The Center for Disease Control and Prevention also reiterated the position, including a list of recent outbreaks associated with the reuse of SDVs and other unsafe injection practices.
Get PSO News Via Email
Read Our Free PSO WhitepaperLearn how PSOs can help you build a safer, smarter organization without the fear of legal liability. Read our FREE whitepaper, "Patient Safety Organizations: Gaining Better Insight Without the Fear of Legal Discovery," authored in conjunction with Lynda M. Johnson, partner at Friday Eldredge & Clark, LLP.