No results found.
Tamara Grubb, DVM, PhD, DACVAA, Washington State University
Sign in to Print/View PDF
This is a filled error message
To access full articles on www.cliniciansbrief.com, please sign in below.
Create an account for free
Want free access to the #1 publication for diagnostic and treatment information? Create a free account to read full articles and access web-exclusive content on cliniciansbrief.com.
Passwords do not match
Where are you from?
AG|Antigua and Barbuda
BA|Bosnia and Herzegovina
IO|British Indian Ocean Territory
CF|Central African Republic
CC|Cocos (Keeling) Islands
CD|Congo, the Democratic Republic of the
FK|Falkland Islands (Malvinas)
TF|French Southern Territories
HM|Heard Island and McDonald Islands
VA|Holy See (Vatican City State)
KR|Korea, Republic of
LY|Libyan Arab Jamahiriya
MK|Macedonia, the former Yugoslav Republic
FM|Micronesia, Federated States of
MD|Moldova, Republic of
MP|Northern Mariana Islands
PG|Papua New Guinea
KN|Saint Kitts and Nevis
VC|Saint Vincent and the Grenadines
ST|Sao Tome and Principe
GS|South Georgia and the South Sandwich Islands
PM|Saint Pierre and Miquelon
SJ|Svalbard and Jan Mayen
SY|Syrian Arab Republic
TW|Taiwan, Province of China
TZ|Tanzania, United Republic of
TT|Trinidad and Tobago
TC|Turks and Caicos Islands
AE|United Arab Emirates
UM|United States Minor Outlying Islands
VG|Virgin Islands, British
VI|Virgin Islands, U.S.
WF|Wallis and Futuna
DC|District of Columbia
Micronesia (Federated States Of)
US Minor Outlying Islands
Armed Forces Africa
Armed Forces Americas Aa (except Canada)
Armed Forces Canada
Armed Forces Europe Ae
Armed Forces Middle East Ae
Armed Forces Pacific Ap
PE|Prince Edward Island
Tell us about yourself
Choose the category that describes your business/professional activity
What best describes your position? (question 1 of 2)
Veterinarian Role: (question 2 of 2)
Non-Veterinarian Role: (question 2 of 2)
Yes, I would like to receive updates about products & services, promotions, special offers, news & events from Brief Media.
Already have an account? Sign in here.
Acceptance to the GDPR regulations is required.
The United States Food and Drug Administration (FDA) mandates that preservative-free alfaxalone be discarded within 6 hours of vial puncture. Preservatives are commonly added to drugs to prevent bacterial contamination, which can occur when a needle punctures the vial stopper. Microbial contamination of drug vials has been identified in human cases of nosocomial morbidity and mortality.1 The FDA mandate is designed to preserve drug integrity and support patient safety, as the greatest risk for contamination occurs in multidose vials without preservatives, but failure to use the entire vial within the allotted time can result in drug wastage and increased costs.
Content continues after advertisement
Because alfaxalone is approved for use until 7 days after vial puncture in Australia,2 this study* evaluated the integrity of preservative-free alfaxalone in a multiuse system. Vials were refrigerated (at 39.2°F [4°C]) or stored at room temperature (71.6°F [22°C]). Samples were drawn by daily needle puncture through the rubber stopper of the vial or by 1 of 2 drug withdrawal systems that allowed a single puncture of the rubber stopper. Samples were incubated in soy broth ± subcultured on blood agar.
Although incidence of bacterial contamination was low, 6 of the 22 samples had bacterial growth. One isolate was identified on day 3 in a vial stored at room temperature from the repeated puncture group. The other 5 bacterial isolates were identified on day 7 or later in both refrigerated and room temperature samples. Four of the 6 isolates were from the repeated puncture group.
Key pearls to put into practice:
It is possible to use preservative-free alfaxalone for up to 7 days, with the precaution of using specialized withdrawal equipment that allows only one puncture of the vial’s rubber stopper.
Use of an open vial for more than 7 days is not recommended, especially if the vial has multiple punctures. Although the study authors recommended drug refrigeration, the results do not support refrigeration as a means to decrease contamination.
Use of preservative-free alfaxalone more than 6 hours after vial puncture should be weighed against patient safety and standard of care. Appropriate patient care could be questioned if nosocomial infection is suspected following alfaxalone administration and the FDA’s 6-hour discard requirement has not been followed. Thus, the safest and most defensible option for clinicians is to use alfaxalone with a preservative, which was approved by the FDA in June 2018 and can be used up to 28 days after vial puncture.3
*This study was supported by Jurox Pty Ltd.
Material from Clinician’s Brief may not be reproduced, distributed, or used in whole or in part without prior permission of Educational Concepts, LLC. For questions or inquiries please contact us.
Clinician's Brief provides relevant diagnostic and treatment information for small animal practitioners. It has been ranked the #1 most essential publication by small animal veterinarians for 9 years.*
*2007-2017 PERQ and Essential Media Studies
It's Free & Simple
Delivered to Your Inbox
Join the Conversation
Follow us @CliniciansBrief
© 2018 Educational Concepts, L.L.C. dba Brief Media ™ All Rights Reserved.