244 - Acid Blocker Dispensing to Children Following the Recall of Ranitidine

Poster Number: 244
Publication Number: 244.1713

Background: Although drug recalls are common, few studies have assessed their effects on drug dispensing to children. In late September 2019, several manufacturers recalled ranitidine, an H2 receptor antagonist (H2RA), due to contamination with a carcinogen. Ranitidine was completely withdrawn in April 2020. These events provide a valuable opportunity to understand how recalls affects drug dispensing to children, given the frequency with which children are prescribed H2RAs as well as other acid blockers, such as proton pump inhibitors (PPIs). As acid blockers are often used unnecessarily in infants with physiologic reflux, the ranitidine recall also provides a unique opportunity to assess how recalls affect use of a commonly overprescribed drug.

Objective: To assess the effect of the ranitidine recall on acid blocker dispensing to children.

Design/Methods: We analyzed the 2016-2022 IQVIA Longitudinal Prescription Database, an all-payer database reporting dispensing from 92% of U.S. pharmacies. The outcome was monthly dispensing of any acid blocker (H2RA or PPI). Using an interrupted time series design, we assessed for level and slope changes in this outcome in October 2019. We added another break point in April 2020 to account for any changes associated with the COVID-19 outbreak and the withdrawal of ranitidine. We conducted analyses separately among infants aged 0-1 years and older children aged 2-18 years.

Results: In both age groups, ranitidine dispensing decreased sharply in October 2019 (Fig 1a-1b). While famotidine and PPI dispensing increased in this month, there was still a large level decrease in overall dispensing of acid blockers to infants (-36,801 prescriptions, 95% CI: -47,507, -26,094) and older children (-21,263 prescriptions, 95% CI: -48,103, 5,576). There was no level or slope change in acid blocker dispensing to infants in April 2020, but there was a slope increase in older children (8,828 prescriptions/month, 95% CI: 531, 17,125). In December 2022, acid blocker dispensing to infants was 32.7% lower than predicted had pre-October 2019 trends continued, compared with 3.1% lower in older children (Fig 2).

Conclusion(s): Acid blocker dispensing to infants fell after the initial ranitidine recalls and remained well below expected levels in December 2022. In contrast, declines in acid blocker dispensing to older children were only transient. Findings suggest recalls may affect drug dispensing to a greater degree for infants than for older children. Future studies should investigate whether the reduction in acid blocker dispensing to infants represented declines in appropriate versus inappropriate use.