The implications of regulatory guidelines on allergen vial mixing for the practicing otolaryngologist.
OBJECTIVE
To introduce otolaryngologists to proposed standards regarding allergen vial mixing, to identify clinical implications, and to recommend efforts to address the issue of vial mixing standards.


METHODS
A policy review.


RESULTS
The Institute of Medicine report on medical errors increased awareness of medication errors, spurring efforts to improve patient safety. One example is the United States Pharmacopoeia's (USP) Chapter 797, a standard for sterile medication compounding. This standard requires the use of a dedicated clean room, ventilation hood, air sampling, surface sampling, and formal testing of mixing personnel. Regulatory agencies may include allergy vial mixing under USP 797. Formal allergy vial mixing guidelines are presented as a standard created by the American Academy of Otolaryngic Allergy taskforce on allergen vial mixing.


CONCLUSIONS
Otolaryngologists must be involved the discussion regarding vial mixing standards to ensure that the standards developed are reasonable, safe, preserve patient access, and are based on evidence based medicine.
Lin
Sandra Y
SY
Department of Otolaryngology, Johns Hopkins School of Medicine, Baltimore, MD, USA. Slin30@jhmi.edu
Houser
Steven M
SM
Rodriguez
Hector P
HP
D000485:Allergens; D004339:Drug Compounding / Q000592:standards; D010036:Otolaryngology; D017410:Practice Guidelines as Topic
D000485:Allergens