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Background <p>To limit health care expenditures and alleviate the burden on consumers, maintaining a stable supply of generic pharmaceuticals has become a major health care challenge. Recently, suspensions in the distribution of generic drugs and supply restrictions for pharmaceuticals with the same active ingredients have occurred owing to quality test alterations by pharmaceutical companies and shortages of drug ingredients during the coronavirus disease 2019 (COVID-19) pandemic. This study investigated changes in the generic dispensing ratio and medication costs for quetiapine tablets before and after supply restrictions to evaluate their influence on pharmaceutical supply.</p> Methods <p>This retrospective observational study used routinely collected dispensing data from nine community pharmacies operated by Minaminihon Pharmaceutical Center. We used a non-probability sampling approach and included all eligible prescriptions containing quetiapine tablets dispensed at the participating pharmacies from May to December 2021. The daily generic dispensing ratio and medication costs for quetiapine tablets were compared between the periods before and after the supply restrictions. September 1, 2021, was defined as the intervention point, and changes in these outcomes associated with the supply restrictions were assessed using interrupted time-series (ITS) analysis.</p> Results <p>The generic dispensing ratio was significantly lower after the supply restrictions than before the restrictions (before: 95.53%; after: 67.19%; <i>p</i> &lt; 0.0001). The median medication cost per patient per day increased significantly from 14.4 Japanese yen (JPY; approximately 0.13 US dollars [USD]/0.11 euros [EUR]) before the supply restrictions to 20.2 JPY (approximately 0.18 USD/0.16 EUR) afterward (<i>p</i> &lt; 0.01). In the ITS analysis using a generalized linear model, the slope changes after the supply restrictions were − 0.0077 for the generic dispensing ratio (95% confidence interval [CI]: −0.0120 to − 0.0034; <i>p</i> = 0.0004) and 0.0043 for daily medication costs per prescription (95% CI: 0.0035 to 0.0051; <i>p</i> &lt; 0.0001), respectively.</p> Conclusions <p>Generic drug supply restrictions for quetiapine tablets were associated with a decrease in the generic dispensing ratio and an increase in medication costs. The ITS analysis suggested that these effects became more pronounced over time after the start of supply restrictions.</p>

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Influence of generic drug supply restrictions on quetiapine tablet dispensing ratio and medication costs in community pharmacies in Japan

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月29日

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  • Erisa Mukai,
  • Yuki Kondo,
  • Tomoko Kondo,
  • Naoto Okada,
  • Azusa Miura,
  • Kayoko Kubota,
  • Hirokazu Azuma,
  • Shinichiro Yamakado,
  • Yoichi Ishitsuka

摘要

Background

To limit health care expenditures and alleviate the burden on consumers, maintaining a stable supply of generic pharmaceuticals has become a major health care challenge. Recently, suspensions in the distribution of generic drugs and supply restrictions for pharmaceuticals with the same active ingredients have occurred owing to quality test alterations by pharmaceutical companies and shortages of drug ingredients during the coronavirus disease 2019 (COVID-19) pandemic. This study investigated changes in the generic dispensing ratio and medication costs for quetiapine tablets before and after supply restrictions to evaluate their influence on pharmaceutical supply.

Methods

This retrospective observational study used routinely collected dispensing data from nine community pharmacies operated by Minaminihon Pharmaceutical Center. We used a non-probability sampling approach and included all eligible prescriptions containing quetiapine tablets dispensed at the participating pharmacies from May to December 2021. The daily generic dispensing ratio and medication costs for quetiapine tablets were compared between the periods before and after the supply restrictions. September 1, 2021, was defined as the intervention point, and changes in these outcomes associated with the supply restrictions were assessed using interrupted time-series (ITS) analysis.

Results

The generic dispensing ratio was significantly lower after the supply restrictions than before the restrictions (before: 95.53%; after: 67.19%; p < 0.0001). The median medication cost per patient per day increased significantly from 14.4 Japanese yen (JPY; approximately 0.13 US dollars [USD]/0.11 euros [EUR]) before the supply restrictions to 20.2 JPY (approximately 0.18 USD/0.16 EUR) afterward (p < 0.01). In the ITS analysis using a generalized linear model, the slope changes after the supply restrictions were − 0.0077 for the generic dispensing ratio (95% confidence interval [CI]: −0.0120 to − 0.0034; p = 0.0004) and 0.0043 for daily medication costs per prescription (95% CI: 0.0035 to 0.0051; p < 0.0001), respectively.

Conclusions

Generic drug supply restrictions for quetiapine tablets were associated with a decrease in the generic dispensing ratio and an increase in medication costs. The ITS analysis suggested that these effects became more pronounced over time after the start of supply restrictions.