Adherence with allergen immunotherapy labeling guidelines.

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).

CONCLUSION

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.