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Multi-dose vial management The Centers for Disease Control and Prevention administration rather than multi-dose vials due to the (CDC) and the World Health Organization (WHO) risk of cross contamination and the potential to have developed recommendations and guidelines administer too high of a dose to patients.6 regarding best practices for infection control. These recommendations and guidelines stress the Multi-dose vial use summary recommendations
importance of single-dose or single-use vials for from CDC and WHO
parenteral administration of medications. Several Avoid or strictly limit the use of multi-dose vials. studies reviewed by these two organizations reported Use single-dose, preservative-free medications for a that multi-dose vials were identified as a potential source of infection, despite the presence of Discard single-use vials and ampules after the preservatives to reduce bacterial survival.1,2 The contents have been drawn up into a syringe and studies also found that multi-dose vial handling and discard the syringe after use on a single patient. poor technique by healthcare workers were If multi-dose vials must be used, aseptic technique contributing factors to the incidence of hospital Cleanse the vial diaphragm or septum with 70% The Joint Commission has established National Patient alcohol before inserting an access device (needle Safety Goals (NPSGs) in conjunction with the Standards for Hospital Accreditation Program. There are two 2012 Use only sterile, single-use syringes and access NPSGs that apply to multi-dose vial use. Goal 3 is “Use devices and discard them after each use. Medications Safely” and Goal 7 is “Prevent Infections.” The Joint Commission Medication Management Standard contaminated once it has been used to enter or 3.01 in combination with NPSGs 3 and 7 require connect to a patient’s intravenous infusion bag processes, policies and monitoring of practices that Do not leave access device in diaphragm or septum. The American Society of Anesthesiologists (ASA) Discard multi-dose vials if there is any suspected Recommendations for Infection Control for the Practice of Anesthesiology has identified that there is potential Documentation on the multi-dose vial label should risk of infection with the use of multi-dose vials, include the revised expiration date (or “beyond use” especially when aseptic technique has not been date, which is 28 days after opening) and the initials maintained or opened vials are not properly managed and labeled.3 The recommendations suggest that in Refrigerate any opened and properly labeled areas such as the operating room (OR), where there is a medication as recommended by the manufacturer. higher volume of critically ill patients, there are more Discard opened multi-dose vials 28 days after opportunities for breaks in aseptic technique. Therefore, opening. If the manufacturer’s original expiration the trend is to use single dose vials or to discard multi- date is shorter than the revised expiration date, dose vials after use on a single patient. The Association of periOperative Registered Nurses Currently, vaccines are exempt from this (AORN) 2012 edition of Perioperative Standards and requirement and are to be discarded per the Recommendations for medication safety now includes manufacturer’s expiration date, provided they are recommendations for collaborating with pharmacy to stored and handled according to manufacturer’s procure and store single dose vials for medication Setup for multi-dose vials
Examples of formulary setup
Due to medication supply shortages pharmacies may have to supply medications in the multi-dose or multi- The hospital charge master and patient billing system must support the multi-dose medication vial process to assure compliance with government and third-party payer regulations. Coordinating multi-dose medication practice with hospital financial systems and policies will help assure successful billing audits and avoid disputes as well as potential fines for patient billing The Pyxis® system formulary and the hospital billing system need to be setup to dispense and bill for each milligram or milliliter of medication used from a multi- dose vial. Once the setup for both is complete, thorough testing of the process from dispensing via the Pyxis® Anesthesia System or Pyxis MedStation® system to the usage messages sent to and received by the hospital In the examples listed, the dosage form is the key billing system must occur to validate consistently element in setting up the formulary correctly. The dosage form drives the dispensing, refilling and patient charging. The minimum and maximum par levels should be established in multiples of the dosage form that The vials should be loaded in the Pyxis system with a equal a whole vial to facilitate replenishment. Including quantity based on the dosage form. In the example the size of the vial and the milligrams per milliliter below, the minimum par level is 400 mg and a (mg/mL) in the generic medication description are helpful in facilitating accurate picking and refilling for Example: Labetalol 5mg/mL, 20 mL vial (100 mg/vial) Desired Min = 4 vials Desired Max = 6 vials
Dispensing
Refilling
When dispensing for a patient, the user should enter For the Labetalol example, refilling is done in the total amount of milligrams or milliliters needed for amounts of 100 mg rounded down to the nearest the dose. In the Labetalol example, if a dose of 20mg whole unit or vial. For example, if the refill report is needed, the quantity of 20 will need to be accounted indicated that 425 mg of Labetalol was needed to refill the device, then 400 mg or 4 vials should be If the Pyxis Anesthesia system My Items and/or
Transfer to Patient features are being considered for
use, thorough testing of the entire process must be completed to ensure billing accuracy. The hospital pharmacy and financial systems must be able to receive
the desired billing and credit quantities from the Pyxis
Training
product interface. The testing should include end users Include training on the handling of multi-dose vials in such as anesthesia providers and nurses working implementation training as well as ongoing new user through their processes. End users should test all of the training for the Pyxis Anesthesia System. Anesthesia process steps from dispensing to the transfer of multi- providers and other clinical end users require training dose vial quantities via the Pyxis Anesthesia system with on dispensing, wasting and returning. Pharmacy staff
the My Items and/or Transfer to Patient features
requires training on loading, refilling, unloading and supporting clinical end users on multi-dose vial process questions. Policy and procedure
Clearly outline the processes for the management of
multi-dose vials for pharmacy, anesthesia providers
and other applicable clinical end users in the Pyxis
system policy and procedure. The defined processes
for replenishment and dispensing should be part of
user training. Include all dispensing scenarios:
individual patient and transfer processes for the My
Items
and Transfer to Patient features, if
1 Bulletin of the World Health Organization 2003; 81:491-500. 2 Centers for Disease Control and Prevention (CDC): Preventing Transmission of Infectious Agents in Healthcare Settings 2007, Recommendation 3 American Society of Anesthesiologists: Recommendations for Infection Control for the Practice of Anesthesiology, second edition, 1999. 4 The Joint Commission: “Standards FAQ Details” on Multi-dose vials (July 20, 2010). 5 Centers for Disease Control and Prevention (CDC): Safe Injection Practices to Prevent Transmission of Infections to Patients, May 21, 2010. 6 ISMP Medication Safety Alert-Acute Care Newsletter January 26, 2012. 2012 CareFusion Corporation or one of its subsidiaries. All rights reserved. Pyxis, Pyxis MedStation system, and Pyxis Anesthesia system are trademarks or registered trademarks of CareFusion Corporation or one of its subsidiaries. All other trademarks are the property of their respective owners. Copyright block 5.5/6 is frutiger roman. Equi tatum eugait ex eugiam inibh erit irit, quatuerat ipsusto eugait lorpero. Cid quatus que niatus, quidus perov A o rem que ne eaque vit quam, offic tectota tentiscilias il id ea et moloratem sit quossusae. Itaquae si in prorporeprae pe re laborrore velique non corem. Tem estiorrum escienis consequ idiores mo cum inusaep erspide qui diasped quam et facias es eiusaest, nectatem cusdam harci te molorere. carefusion.com

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