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Celebrating Over 75 Years Of Service

The American Academy of Otolaryngic Allergy (AAOA) represents over 2,700 Board-certified otolaryngologists and health care providers. Otolaryngology, frequently referred to as Ear, Nose, and Throat (ENT), uniquely combines medical and surgical expertise to care for patients with a variety of conditions affecting the ears, nose, and throat, as well as commonly related conditions. AAOA members devote part of their practice to the diagnosis and treatment of allergic disease. The AAOA actively supports its membership through education, research, and advocacy in the care of allergic patients.

"Dedicated to enhancing knowledge and skill in the care of the allergic patient."

ADVOCACY UPDATES

Breaking News on USP Chapter 797

An updated draft of USP Chapter 797 was released today. Updated Chapter 797 Posted for Public Comment: Separate Requirements…

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Congress Makes Changes to MACRA

The second year of the Quality Payment Program (QPP) authorized by the Medicare Access and…

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CMS Extends the MIPS 2017 Data Submission Deadline from March 31 to April 3 at 8 PM EDT

If you’re an eligible clinician participating in the Quality Payment Program, you now have until Tuesday, April 3,…

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Changes in MACRA

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Before the close of 2017, all physicians must take action to avoid the 4 percent cut that will be assessed in 2019 for not participating in the new Quality Payment Program (QPP) authorized by the Medicare Access and CHIP Reauthorization Act (MACRA).  Read More

CMS Announces Changes in MACRA Implementation Timeline. The Centers for Medicare and Medicaid Services (CMS) announced major changes to the implementation of the Medicare Access and CHIP Re-authorization (MACRA).
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Upcoming Dates

06/01/2018: Research Grant Cycle

12/01/2018: Research Grant Cycle
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06/15/18: Membership Application Deadline to be eligible for AAOA Member rate for the 2018 Basic Course

07/31/18: Membership Application Deadline to be voted in at the 2018 Annual Meeting and to be eligible for AAOA Member Rate (FREE) for the 2018 Annual Meeting
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04/01/2019: 2019 Fellow Exam Application Deadline
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EDUCATION

Why attend the 2018 AAOA Annual Meeting in Philadelphia from September 14-16? Learn some of the reasons to attend from the AAOA Leadership and staff. Register

Different Advanced Course

What is it in today’s otolaryngology practice that is resonating as a hot topic? Where are the novel treatment strategies? What is today’s typical otolaryngology practice or more specifically the typical AAOA member’s practice?  These are the questions we try to address when building out our Advanced Course in Allergy & Immunology. Read More

Codes/Guidelines

CMS Announces Changes in MACRA Implementation Timeline. The Centers for Medicare and Medicaid Services (CMS) announced major changes to the implementation of the Medicare Access and CHIP Re-authorization (MACRA).
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IFAR

Editor in Chief Search
The ARS-AAOA IFAR LLC is pleased to announce its search for Editor in Chief, term beginning April 2020. Read More

IFAR Impact Factor: 2.135

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Now Available

Changes in Managing Practices

Mission

Working together with AAOA staff, volunteer leadership and members will enable us to have a positive impact on our members’ practices.

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Live and Online CME

2018 AAOA Annual Meeting
September 14-16 | Philadelphia, PA
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2018 Advanced Course in Allergy & Immunology
December 6-8 | Atlanta, GA
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AAOA Clinical Insights
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PATIENT CORNER

Avoidance

The first most basic treatment step, once an allergen has been identified, is to eliminate or avoid contact with it, if possible. Unfortunately, avoiding some allergens (such as dust, molds, and animals) is often difficult and thus allergen avoidance alone may not be effective.

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News and Updates

Social and Networking Events at the 2018 AAOA Annual Meeting

This year’s Annual Meeting assures to be not only educational, interactive, and practice-centered, but also…

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2018 AAOA Annual Meeting – Important Dates

August 14 - Hotel Discounted Rate Deadline Room Rate Room rate is $219 (plus 15.5% tax) single/double…

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Burnout: A Real Problem, Not Just a Trendy Talk Show Topic

When you really look at hot topics in medicine, physician burnout seems to really skyrocket…

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Vials Of Allergens

Allergenic Extracts

In late November 2013, Congress passed the Compounding Bill. This legislation enforces regulation of compounding pharmacies, as a result of injections of contaminated compounded drugs – which caused 64 deaths and many more nonfatal injuries.

PLEASE NOTE: The preparation of allergenic extract vials is considered compounding. The AAOA is pleased that the new legislation does not restrict or limit the ability of Allergists to compound allergy vaccines. AAOA members may have to adopt additional measures to ensure sterility, based on USP guidelines, but fortunately the ability to continue compounding extracts remains.

The statute contains two provisions that may impact allergy immunotherapy. Since the law is effective, it is recommend that you implement these changes as soon as possible. The AAOA expects practices will be subject to inspections to monitor compliance.

The first requirement is that all compounded sterile preparations have a prescription. This should not cause much of a problem since most AAOA members already have an order sheet of some sort, which is used to instruct staff to make a new or renewal vial for a patient. These order sheets can be labeled at the top as a prescription for a specific patient, and they can have a line at the bottom for the physician’s (or other appropriately licensed provider’s) signature. Again, you are already signing off on this process, as well as the shots, so this should not be a huge practice change.

In addition, it appears that physicians will be required to comply with all of the USP 797 sterile compounding rules. Fortunately, because of work by the AAOA in conjunction with JCAAI back in 2006, USP 797 contains specific rules for allergy vaccine compounding that are much less stringent than the rules applicable to other compounded sterile products. While the USP rules are not draconian (no filtered air or laminar flow hoods required), they do increase the standard for sterility.You can read the relevant Allergy Section of USP 797 by clicking here or read the rules below.

“Allergen extracts, as compounded sterile preparations (CSPs), are single-dose and multiple dose intradermal or subcutaneous injections that are prepared by specially trained physicians and personnel under their direct supervision. Allergen extract, as CSPs, is not subject to the personnel environmental and storage requirements for all CSP microbial contamination risk levels in this chapter, BUT only if all of the following criteria are met:

  1. The compounding process involves simple transfer via sterile needles and syringes of commercial sterile allergen products and appropriate sterile added substances (e.g., Glycerin, phenol in sodium chloride injection).
  2. All allergen extract as CSPs shall contain appropriate substances in effective concentrations to prevent the growth of microorganisms. Non-preserved allergen extracts shall comply with the appropriate CSP risk level requirements in the chapter.
  3. Before beginning compounding activities, personnel perform a thorough hand cleansing procedure by removing debris from under fingernails using a nail cleaner under running warm water followed by vigorous hand and arm washing to the elbows for at least 30 seconds – with either non-antimicrobial or antimicrobial soap and water.
  4. Compounding personnel don hair covers, facial hair covers, gowns and face masks.
  5. Compounding personnel perform antiseptic hand cleansing with an alcohol – based surgical hand scrub with persistent activity.
  6. Compounding personnel don powder – free sterile gloves that are compatible with sterile 70% isopropyl alcohol (IPA) before beginning compounding manipulations.
  7. Compounding personnel disinfect their gloves intermittently with sterile 70% IPA when preparing multiple allergen extracts as CSPs.
  8. Ampule necks and vial stoppers on packages of manufactured sterile ingredients are disinfected by careful wiping with sterile 70% IPA swabs to ensure that the critical sites are wet for at least 10 seconds and allowed to dry before they are used to compound allergen extracts as CSPs.
  9. The aseptic compounding manipulations minimize direct contact contamination (e.g., from glove, fingertips, blood, nasal and oral secretions, shed skin and cosmetics, other non-sterile materials) of critical sites (e.g., needles, open ampules, vial stoppers).
  10. The label of each multiple-dose vial (MDV) of allergen extracts (as CSPs) lists the name of one specific patient, a “by use date” (BUD) and storage temperature range that is assigned based on manufacturers recommendations or peer-reviewed publications.
  11. Single-dose allergen extracts as CSPs shall not be stored for subsequent additional use.

Personnel who compound allergen extracts as CSPs, must be aware of greater potential risk of microbial and foreign material contamination when allergen extracts are compounded in compliance with the foregoing criteria instead of the more rigorous standards in the USP chapter for CSP microbial contamination risk levels. Although contaminated allergen extracts as CSPs can pose health risks to patients when they are injected intradermally or subcutaneously, these risks are substantially greater if the extract is inadvertently injected intravenously.”

References

1. Lay PC, Bass R, Lin SY. Allergen vial mixing and immunotherapy:  risks of infection and vial contamination.  Otolaryngol Head Neck Surg. 2007 Aug;137(2):243-5

2. Lin SY, Lay PC, Hughes LF, Bass R. The safety of multi-dose vials in allergy immunotherapy.  Otolaryngol Head Neck Surg. 2008 Aug;139(2):195-7

3. Lay PC, Bass R, Hughes LF, Lin SY. Risks of allergy vial contamination: Comparison of mixing in-office versus under ventilation hood. Otolaryngol Head Neck Surg. 2008 Sep;139(3):364-6.

4. Gilbert KC, Sundareshan V, Bass RM, Lin SY.  Antibacterial Properties of Additives Used in Injection Immunotherapy. Int Forum Allergy Rhinol.  2011 Dec 7. doi: 10.1002/alr.20105. [Epub ahead of print].

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