Premier Safety Institute is reporting that on June 15, 2012, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum maintaining its existing policy that a citation would be issued if single dose vials (SDVs) are re-entered and used for multiple patients except in cases of repackaging of a SDV that is in compliance with USP Chapter <797> Pharmaceutical Compounding.
In clarifying its existing policy, CMS notes that the risk of infection transmission associated with using SDVs for multiple patients is well documented, with evidence accumulated from the investigation of multiple outbreaks and this practice of reuse is in conflict with nationally recognized standards, such as those issued by the Centers for Disease Control and Prevention www.cdc.gov/injectionsafety. CMS also noted that it shares the concern of providers and suppliers about patient access to critical medications that are in short supply as a reason for reuse of SDVs, but because the practice is not in compliance with infection control requirements, the agency is not changing its policy on reuse.
Examples from CMS of inappropriate reuse of SDVs:
- Preparation on a patient/resident care unit of multiple doses for multiple patients from one SDV
- 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
- Use of a SDV in the same manner as a multi-dose vial, i.e., to administer injections to more than one resident or patient
- If an anesthetist uses one SDV to administer anesthesia, moderate sedation, or other medication to more than one patient
Included among USPs standards are those related to practice and quality standards for compounded sterile preparations, USP 797: General Chapter 797, Pharmaceutical Compounding - Sterile Preparations (USP <797>), that include supervised and trained personnel; use of a controlled environment, hood, and air quality meeting ISO standards; and labeling with beyond use date, storage conditions, drug name, concentration, volume and route of administration.