title: Adherence with allergen immunotherapy labeling guidelines.
abstract: BACKGROUND
  Little is known about the adherence rate to allergen immunotherapy (AIT) labeling guidelines.
  
  
  OBJECTIVE
  To assess adherence to labeling guidelines of AIT Practice Parameter 2011 at University of Michigan Health Service.
  
  
  METHODS
  AIT vials of 320 patients who received their care at the University of Michigan Health Service were reviewed. Data collected looked at patient identifiers (PI), concentrations in volume/volume (v/v) format, color coding, allergen content, expiration date and instructions about AIT dosing, and systemic reaction treatment. Data were analyzed by using χ(2) test and the Fisher exact test and logistic regression.
  
  
  RESULTS
  Of 238 non-university formulated labels, 65% had 2 PIs, 62% had a v/v concentration, 41% had color coding, 71% had the content listed, and 100% had a recorded expiration date. Only 21% had all 5 recommended components. All 82 University vials had 5 components. Labels with 2 PIs were more likely to have a v/v concentration with its corresponding color coding (odds ratio [OR] 3.84 [95% CI, 1.9-7.7]; P < .001). Labels that specified the extract's content were more likely to be color coded or to have a v/v concentration listed (OR 6.3 [95% CI, 3.4-11.8]; P < .001). For all AIT vials, complete labels were significantly more likely to have a clear buildup schedule (OR 9.6 [95% CI, 4.2-23.2]; P < .001), dosing adjustment after a missed dose (OR 8.2 [95% CI, 3.4-19.8]; P < .001) or after a reaction (OR 13.7 [95% CI, 7.8-2.1]; P < .001), and clear systemic reaction treatment instructions (OR 9.7 [95% CI, 7.8-24.1]; P < .001).
  
  
  CONCLUSIONS
  Fewer than 25% of the nonuniversity prescribers adhered to AIT practice parameters 5 years after publication. Recording 2 PIs, the v/v concentration, or the color coding increased the likelihood of having a complete label. Complete label contents were associated with clear instructions about AIT dosing and reaction treatment and/or dose adjustments.
authors.affiliation: Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Mich.
authors.forename: Marilyn
authors.initials: M
authors.lastname: Karam
authors.affiliation: Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Mich; University of Michigan School of Pharmacy, Ann Arbor, Mich.
authors.forename: Kiela
authors.initials: K
authors.lastname: Samuels
authors.affiliation: Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Mich.
authors.forename: Christine
authors.initials: C
authors.lastname: Holland
authors.affiliation: University Health Services, University of Michigan, Ann Arbor, Mich.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Hernandez
authors.affiliation: Division of Allergy and Clinical Immunology, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Mich; Child Health Evaluation and Research Unit, Division of General Pediatrics, Department of Pediatrics, University of Michigan Medical School, Ann Arbor, Mich. Electronic address: mgreenha@med.umich.edu.
authors.forename: Matthew
authors.initials: M
authors.lastname: Greenhawt
mesh_terms: D003888:Desensitization, Immunologic / Q000592:standards*; D004348:Drug Labeling; D006801:Humans; D006967:Hypersensitivity / Q000628:therapy; D008824:Michigan; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000592:standards*; D013333:Student Health Services / Q000592:standards
keywords: Adherence; Allergen extracts; Allergen immunotherapy; Health services research; Immunotherapy labeling; Practice guidelines; Practice parameters; Student health services