Economics of compliance for mixing allergy immunotherapy

TL;DR

The paper examines the financial impact of new USP standards on allergy clinics and finds that building an AECA is the most cost-effective long-term solution.

Contribution

The study provides a comparative financial analysis of compliance options for new allergy immunotherapy standards.

Findings

Prescription sets were found to be the most costly compliance option.

Costs for PEC Hood and AECA were recouped within three weeks of operation.

AECA is deemed most feasible for small outpatient clinics in terms of cost and revenue.

Abstract

United States Pharmacopeia (USP), a nonprofit organization that sets safety standards for food, medicine and supplements updated its Chapter 797 standards for the preparation of allergy immunotherapy vials in November 2023. These guidelines impacted facility and personnel qualifications, workflow, and laboratory documentation. We hypothesized adhering to regulations may be financially difficult for allergy practices. To comply, offices must either use mail order prescription facilities or allocate financial resources to purchase a Primary Engineering Control (PEC) Hood, a device used to protect against airborne contaminants, or build-out an Allergenic Extract Compounding Area (AECA), a room specialized for compounding allergens. We performed a comparative analysis to determine financial feasibility of these three scenarios with the support of a Public Service Enterprise Group (PSEG) grant. Of these three options prescription sets were most costly, followed by PEC Hood and AECA. For both PEC Hood and AECA, costs were recouped by the third week of operation. In conclusion, for long term operation, the AECA would be most feasible for small private practice outpatient clinics in regard to overall cost and estimated revenue.

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