Influence of Helicobacter pylori eradication blister-pack handling on outpatient AWaRe access share: a Japanese community pharmacy-based sensitivity analysis.

Abstract

Background: Helicobacter pylori (H. pylori) eradication regimens may influence outpatient AWaRe Access share when routine surveillance is based on oral antibacterials classified under the Anatomical Therapeutic Chemical (ATC) code J01. This study evaluated how commercially identifiable H. pylori eradication blister-pack handling affects the reported AWaRe Access share using community pharmacy dispensing data.

Methods: We analyzed monthly outpatient dispensing data for oral antibacterials in ATC J01 from community pharmacies in Nayoro, Japan, from July 2022 to March 2025. AWaRe Access share was primarily compared between an unadjusted series and a pack-adjusted series in which commercially identifiable eradication blister packs were handled using a predefined pack-derived offset. An exploratory extended adjustment also considered probable non-pack eradication regimens. Blister packs were identified by product name. In the pack-adjusted series, pack days of therapy were conservatively converted into a DDD-equivalent offset and subtracted from both the numerator and denominator. The primary outcome was the monthly difference in Access share between the unadjusted and pack-adjusted series (ΔAccess).

Results: Among 20,129 oral J01 records, commercially identifiable eradication blister packs accounted for a median of 1.13% of monthly records and 0.55% of monthly DOT. The difference between the unadjusted and pack-adjusted series (ΔAccess) was positive in all 33 months, with a median of 0.59% points (pp) (IQR, 0.47-0.83; range, 0.26-1.43). These findings indicate that the handling of commercially identifiable eradication blister packs had a consistent but modest influence on the reported Access share.

Conclusions: The handling of commercially identifiable H. pylori eradication blister packs had a consistent but modest influence on outpatient AWaRe Access share derived from dispensing data. Although the observed difference was modest in this low-Access-share setting, explicit reporting of blister-pack handling may improve transparency, particularly in benchmark-based or close comparative evaluations. Routine AWaRe surveillance should therefore define how commercially identifiable eradication packs are handled, ideally using standardized adjustment or dual reporting.