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Multi-dose vial management
The Centers for Disease Control and Prevention
(CDC) and the World Health Organization (WHO)
have developed recommendations and guidelines
administration rather than multi-dose vials due to the
risk of cross contamination and the potential to
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.

Use single-dose, preservative-free medications for a
studies reviewed by these two organizations reported
that multi-dose vials were identified as a potential
source of infection, despite the presence of
preservatives to reduce bacterial survival.1,2 The
single patient only.

contents have been drawn up into a syringe and
studies also found that multi-dose vial handling and
poor technique by healthcare workers were
contributing factors to the incidence of hospital
Discard single-use vials and ampules after the
discard the syringe after use on a single patient.

If multi-dose vials must be used, aseptic technique
must be strictly adhered to:
acquired infections.1,2
The Joint Commission has established National Patient
-
Avoid touch contamination.
-
Cleanse the vial diaphragm or septum with 70%
alcohol before inserting an access device (needle
Safety Goals (NPSGs) in conjunction with the Standards
or other).
for Hospital Accreditation Program. There are two 2012
-
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.”
Consider a syringe or needle/cannula
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
or administration set.
promote safe patient care.
The American Society of Anesthesiologists (ASA)
Recommendations for Infection Control for the Practice
of Anesthesiology has identified that there is potential
risk of infection with the use of multi-dose vials,
-
higher volume of critically ill patients, there are more
opportunities for breaks in aseptic technique. Therefore,
Documentation on the multi-dose vial label should
include the revised expiration date (or “beyond use”
date, which is 28 days after opening) and the initials
of the person who opened the vial.

Refrigerate any opened and properly labeled
medication as recommended by the manufacturer.

Discard opened multi-dose vials 28 days after
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
Discard multi-dose vials if there is any suspected
visible contamination.

maintained or opened vials are not properly managed
areas such as the operating room (OR), where there is a
Do not leave access device in diaphragm or
septum.

especially when aseptic technique has not been
and labeled.3 The recommendations suggest that in
Use only sterile, single-use syringes and access
then the shorter date must be used.

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
guidelines.
Setup for multi-dose vials
Due to medication supply shortages pharmacies may
have to supply medications in the multi-dose or multiuse form to meet patient care needs.
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
inaccuracies.
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 multidose vial. Once the setup for both is complete, thorough
testing of the process from dispensing via the Pyxis®
Examples of formulary setup
Generic
Brand
Strength
Strength unit
Volume
Volume unit
Dosage form
Generic
Brand
Strength
Strength unit
Volume
Volume unit
Dosage form
neostigmine 1:1000 (10 mL vial)
Prostigmin 1:1000 (10 mL vial)
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10
mL
mL
etomidate 2 mg/1 mL (20 mL vial)
Amidate 2 mg/1 mL
40
mg
20
mL
mg
Generic
Brand
Strength
Strength unit
Volume
Volume unit
Dosage form
labetalol HCL 5 mg/1 mL (20 mL vial)
Trandate 5 mg/1 mL
100
mg
20
mL
mg
Anesthesia System or Pyxis MedStation® system to the
usage messages sent to and received by the hospital
billing system must occur to validate consistently
accurate patient charges.
Loading
In the examples listed, the dosage form is the key
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
maximum par level is 600mg.
Example: Labetalol 5mg/mL, 20 mL vial (100 mg/vial)
Desired Min = 4 vials Desired Max = 6 vials
Refilling
For the Labetalol example, refilling is done in
amounts of 100 mg rounded down to the nearest
whole unit or vial. For example, if the refill report
indicated that 425 mg of Labetalol was needed to
refill the device, then 400 mg or 4 vials should be
refilled.
(mg/mL) in the generic medication description are
helpful in facilitating accurate picking and refilling for
the Pyxis system.
Dispensing
When dispensing for a patient, the user should enter
the total amount of milligrams or milliliters needed for
the dose. In the Labetalol example, if a dose of 20mg
is needed, the quantity of 20 will need to be accounted
for because the dosage form is 1mg.
Testing
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
activated.
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
applicable.
.
Sources
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
IV.H. Safe Injection Practices.
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.
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