The implications of regulatory guidelines on allergen vial mixing for the practicing otolaryngologist

Abstract

Objectives: 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.

Study design and 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.

Conclusion/significance: 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.