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Objectives <p>Dentists frequently encounter adverse drug reactions (ADRs) in their day-to-day work. Despite the legal obligation in Germany to report ADRs, systematic evaluations of dental pharmacovigilance data remain scarce. This study aimed to analyze ADR reports submitted by dentists to the Drug Commission of the German Dental Association.</p> Materials and methods <p>All ADR reports submitted between 2010 and 2024 were analyzed according to year, medication class, and affected organ system. Incidence rates per dentist were calculated and trends over time were assessed using Poisson regression analysis.</p> Results <p>A total of 983 ADR reports were included. Antibiotics accounted for the majority of reports (59.4%), followed by local anesthetics (15.7%). The most frequently affected organ systems were the skin (39.8%) and the gastrointestinal tract (21.7%). On average, 65.5 reports were submitted annually. The overall incidence rate was 91.7 reports per 100,000 dentist years, declining by 9.5% annually over the study period. Clindamycin had the highest incidence of ADR reports (26.7 per 100,000 dentist years) but also the steepest annual decrease (–17.1% per year).</p> Conclusion <p>The proportion of ADRs reported by dentists is low compared with the expected number of ADRs, indicating substantial underreporting. A significant decline in reporting was observed over time. Consistent with previous studies, antibiotics and cutaneous reactions predominated. The reduction in clindamycin-related ADR reports reflects a substantial decrease in clindamycin prescriptions in Germany.</p> Clinical relevance <p>Mandatory spontaneous reporting remains essential for dental pharmacovigilance. However, implementing digital tools and low-threshold reporting systems could improve the quantity and quality of future ADR reports.</p>

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Trends in adverse drug reaction reporting by dentists: a 15-year analysis of German pharmacovigilance data

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月27日

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  • Frank Halling,
  • Rainer Lutz,
  • Axel Meisgeier

摘要

Objectives

Dentists frequently encounter adverse drug reactions (ADRs) in their day-to-day work. Despite the legal obligation in Germany to report ADRs, systematic evaluations of dental pharmacovigilance data remain scarce. This study aimed to analyze ADR reports submitted by dentists to the Drug Commission of the German Dental Association.

Materials and methods

All ADR reports submitted between 2010 and 2024 were analyzed according to year, medication class, and affected organ system. Incidence rates per dentist were calculated and trends over time were assessed using Poisson regression analysis.

Results

A total of 983 ADR reports were included. Antibiotics accounted for the majority of reports (59.4%), followed by local anesthetics (15.7%). The most frequently affected organ systems were the skin (39.8%) and the gastrointestinal tract (21.7%). On average, 65.5 reports were submitted annually. The overall incidence rate was 91.7 reports per 100,000 dentist years, declining by 9.5% annually over the study period. Clindamycin had the highest incidence of ADR reports (26.7 per 100,000 dentist years) but also the steepest annual decrease (–17.1% per year).

Conclusion

The proportion of ADRs reported by dentists is low compared with the expected number of ADRs, indicating substantial underreporting. A significant decline in reporting was observed over time. Consistent with previous studies, antibiotics and cutaneous reactions predominated. The reduction in clindamycin-related ADR reports reflects a substantial decrease in clindamycin prescriptions in Germany.

Clinical relevance

Mandatory spontaneous reporting remains essential for dental pharmacovigilance. However, implementing digital tools and low-threshold reporting systems could improve the quantity and quality of future ADR reports.