“They’re looking at what are rea- sonable beyond-use dates,” Ms. Becker said. “You have a sterile preparation, and you have to make sure that indeed that preparation is going to be sterile after it’s opened … that it’s going to last and be sterile and stable for whatever amount of time that has been studied for. That’s what they look for. That’s why they would’ve made the change.” USP says the Compounding Expert Committee’s roster includes com- pounding practitioners, infection con- trol specialists, industrial hygienists, and environmental engineers, among others. No physicians are on the com- mittee. The roster lists one medical doctor among its government liaisons. Ms. Becker says USP’s motiva-
tion in proposing the revised stan- dards was in part organizational. The change from three risk categories to two, she says, was something the committee saw as “a better way of capturing what was being done in compounding.” “We were told, and our committee
certainly heard, that there were some areas that needed to be revised,” she said. “The organization wasn’t what we felt was the best that it could be, so we look at things like that.” The federal Drug Quality and Se-
curity Act of 2013 reaffirms that com- pounded preparations must adhere to USP standards. In its comment letter to USP, TMA
says the guideline revisions would result in patients losing access to in- dividual therapy. “TMA recommends that the current standards applicable to allergenic extracts … be maintained and that any proposed revisions to those standards be developed in col- laboration with affected stakeholders and based on a thorough consider- ation and analysis of the impact of any proposed changes on patients.”
CONCERNS ABOUT COST, CARE AAAAI and ACAAI lay out serious misgivings in their comment let- ter about how the stricter standards would affect efficacy, patient access,
May 2016 TEXAS MEDICINE 65
STUDIES SAY IN-OFFICE MIXING IS SAFE
In objecting to USP’s proposed revisions to the standards for allergen extract mixing, the American Academy of Allergy, Asthma & Immunology and the American College of Allergy, Asthma & Immunology cited several studies demonstrating the safety of preparing allergen extracts in physicians’ ofices. One 2008 study from the journal Otolaryngology–Head and
Neck Surgery that the allergist groups cited compares the risk of bacterial contamination from in-ofice mixing to the risk of contamination from mixing under a ventilation hood. According to the abstract of the study, the research
involved preparing 537 vials over an 11-month period: 320 pre- pared in ofice and 217 prepared under a ventilation hood. “A total of two positive cultures occurred in vials prepared in-ofice and one from under-hood preparation,” the abstract said. “Follow-up cultures of these three vials were all negative. No patients receiving injections had signs or symptoms of skin or systemic infections from the injections.” The research ultimately suggests “the risk of bacterial contamination in im- munotherapy vials in both groups is rare.” A 2007 study that appeared in the same journal looked at
more than six years of retrospective data covering 272 pa- tients and nearly 26,800 immunotherapy injections. No skin or systemic infections occurred, leading to the conclusion that the research “revealed no complications of infection from the preparation and administration of immunotherapy performed in an outpatient clinic.”
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