Department of Health Services Research, Carl von Ossietzky University Oldenburg, Oldenburg, Germany.
University Department of Anesthesiology, Critical Care, Emergency and Pain Medicine, Klinikum Oldenburg, Oldenburg, Germany.
Pharmacol Res Perspect. 2023 Apr;11(2):e01077. doi: 10.1002/prp2.1077.
Spontaneous reporting is based on the experience of all healthcare professionals (HCPs) but also consumers/non-HCPs and therefore reveals a broad picture of a drug's adverse reactions. Recent studies found substantial differences between reports from these varying sources including the reports' completeness. Using the example of opioid-associated abuse, dependence, or withdrawal, this study analyzed the completeness and characteristics of spontaneous reports from Germany focusing on the reporter. Based on EudraVigilance data, we included all cases of abuse, dependence, or withdrawal associated with opioids indicated for pain therapy and filed from Germany until 2018. Completeness and characteristics were analyzed by a reporter (physician, pharmacist, other HCPs, consumers/non-HCPs) and also by time period to account for other influencing factors. In total, 1721 cases were included, mainly filed by physicians (38.5%) and pharmacists (30.7%). Completeness of demographics varied from 74.5% (other HCPs) to 42.7% (consumers/non-HCPs). Consumers/non-HCPs most often provided any indication/comorbidity (75.2%), whereas this was the case for only 20.2% of pharmacists. Large differences between the reporters were found for almost all characteristics. Other HCPs far more often coded a history of drug abuse, dependence, or withdrawal than other reporters (46.9% vs. 11.6%-24.2%, respectively), and fatal outcomes were also mainly filed by other HCPs (68.1% vs. 14.8%-20.4% by all other reporters). Differences in completeness and characteristics were also observed over time. Studies analyzing spontaneous data should consider potential differences between the various reporting groups in terms of completeness and characteristics. Further, the impact of other influencing factors has to be assessed.
自发报告基于所有医疗保健专业人员（HCPs）的经验，但也包括消费者/非 HCPs，因此揭示了药物不良反应的广泛情况。最近的研究发现，来自这些不同来源的报告之间存在实质性差异，包括报告的完整性。本研究以阿片类药物相关滥用、依赖或戒断为例，分析了德国自发报告的完整性和特征，重点关注报告人。基于 EudraVigilance 数据，我们纳入了所有与疼痛治疗相关的阿片类药物相关滥用、依赖或戒断的病例，并从德国报告至 2018 年。通过报告人（医生、药剂师、其他 HCPs、消费者/非 HCPs）和时间段分析完整性和特征，以考虑其他影响因素。共纳入 1721 例病例，主要由医生（38.5%）和药剂师（30.7%）报告。人口统计学信息的完整性从其他 HCPs 的 74.5%到消费者/非 HCPs 的 42.7%不等。消费者/非 HCPs 最常提供任何适应症/合并症（75.2%），而药剂师只有 20.2%的情况如此。几乎所有特征的报告人之间都存在很大差异。其他 HCPs 比其他报告人更常编码药物滥用、依赖或戒断的病史（46.9%比其他报告人分别为 11.6%-24.2%），并且致命结局也主要由其他 HCPs 报告（68.1%比所有其他报告人分别为 14.8%-20.4%）。随着时间的推移，在完整性和特征方面也观察到不同的差异。分析自发数据的研究应考虑到不同报告人群在完整性和特征方面的潜在差异。此外，还必须评估其他影响因素的影响。
