pass on the additional costs to patients and insurers. “We are especially concerned about
the impact of higher costs and resul- tant lack of access this would have on vulnerable populations, especially in underserved inner cities and rural America, where access and coverage of allergen immunotherapy for indi- viduals with asthma and allergic rhi- nitis already presents a challenge,” the letter states. AAAAI says safety considerations,
such as the possibility of life-threat- ening allergic reactions, make it a bad idea to move allergen extract prepa- ration to large compounding labo- ratories or pharmacies. In a letter to members, AAAAI says there were only two known facilities in the country equipped to take on allergen extract compounding. “It would give them a virtual mo-
nopoly,” Dr. Alvarez said. “They could not handle the volume, so patients’ ac- cess is going to be limited.” More frequent refills also expose
the patient to potential allergic reac- tion, allergists say, because of the sub- tle differences between extracts with different lot numbers, which can vary in content and potency. In their comment letter, AAAAI
and ACAAI cite several studies back- ing up the sterility of allergen extract preparation using aseptic technique. (See “Studies Say In-Office Mixing Is Safe,” page 65.) For USP’s part, Ms. Becker says the expert committee will see what stakeholders have to say about the proposed revisions. “I don’t think it’s the intention of
the committee to make it an undue burden on anyone,” she said. “But what they look at is patient safety, and if a product is supposed to be sterile and has to be sterile under certain conditions, that’s what they’re look- ing at.”
Then-TMA President Tom Garcia,
MD, says while TMA respects the abil- ity and professionalism of compound- ing and hospitalist pharmacists, “there are certain areas that require the doc-
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May 2016 TEXAS MEDICINE 67
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