#SAVE ALLERGY SHOTS

#SaveAllergyShots

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The American Academy of Allergy, Asthma & Immunology (AAAAI), a professional membership organization of more than 6,800 allergist/immunologists, is spreading the word that newly proposed regulations from the United States Pharmacopeia (USP) could dramatically limit patient access to allergen immunotherapy (allergy shots).

Help the AAAAI save patient access to allergy shots. Sign this petition to let USP know they should keep the existing requirements in place—and not move forward with these new proposed regulations.
What are allergy shots and who is proposing these new regulations?
Allergy shots, also known as allergen immunotherapy, are an important treatment for allergic diseases that has substantially improved patient care, reduced emergency room visits, decreased medication costs and decreased hospitalization.
As mentioned above, the new regulations are being introduced by the United States Pharmacopeia (USP). There is no data in the peer-reviewed medical literature that allergy shots have ever caused infections in patients, but this is the concern driving USP to propose these new guidelines.
If these new regulations go into effect, how will it impact patients?
The more extensive procedures for mixing under the new regulations would make it highly unlikely that allergists would be able to continue to mix allergen extracts for their patients in the office setting.
Non-healthcare system employed physicians will have very limited options to secure allergy immunotherapy prescriptions for their patients. There are only two facilities that have been identified as resources for this service in the United States. Having to use outside facilities may limit the timelines of allergy shot treatment, among other consequences. Also Medicare currently does not cover allergen immunotherapy manufactured by a third party vendor. Thus, Medicare recipients, and potentially commercially insured patients, would no longer have allergen immunotherapy as a covered service. USP’s proposed requirements would directly transfer the cost of a previously covered benefit to the beneficiary.
What can I do to prevent these regulations from going into effect?
Again, sign this petition to let USP know: 1) you are concerned about how these proposed changes will impact patient access to allergen immunotherapy and 2) they should keep the existing requirements in place.
USP is also accepting public comments about the proposed changes until January 31. AAAAI encourages patients to provide personal comments to USP describing: 1) the benefits you have received from being treated with allergen immunotherapy, and 2) requesting that USP keep the existing guidelines that maintain the allergy shot preparation requirements currently in place.
Visit the USP website here.

Once there, you will need to scroll down to the second to last paragraph and click on the link to the submission template you must use. Download the template, write your comments under the general comments section, and email it to CompoundingSL@usp.org.

LETTER TO
United States Pharmacopeia
Allergy shots, also known as allergen immunotherapy, are an important treatment for allergic diseases that has substantially improved patient care, reduced emergency room visits, decreased medication costs and decreased hospitalization.

We are concerned about how these proposed changes to “General Chapter 797: Pharmaceutical Compounding—Sterile Preparations” will impact patient access to allergen immunotherapy.

Please save patient access to allergy shots by keeping the existing requirements in place.

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