Pharmacovigilance Signals of the Opioid Epidemic over 10 Years: Data Mining Methods in the Analysis of Pharmacovigilance Datasets Collecting Adverse Drug Reactions (ADRs) Reported to EudraVigilance (EV) and the FDA Adverse Event Reporting System (FAERS).
Pharmacovigilance Signals of the Opioid Epidemic over 10 Years: Data Mining Methods in the Analysis of Pharmacovigilance Datasets Collecting Adverse Drug Reactions (ADRs) Reported to EudraVigilance (EV) and the FDA Adverse Event Reporting System (FAERS).
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DOI：
10.3390/ph15060675
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发表时间：
2022-05-27
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影响因子：
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在过去二十年中，类阿片药物的消费已达到相当大的比例，导致药物误用和滥用的增加，类阿片依赖性和相关死亡增加。因此，本研究的目的是确定以下处方阿片类药物是否存在滥用、误用和依赖的药物警戒信号及其性质：可待因、双氢可待因、芬太尼、羟考酮、喷他佐辛和曲马多。分析药物警戒数据集EudraVigilance（EV）和FDA不良事件报告系统（FAERS），以识别和描述可能的误用/滥用/依赖相关问题。对选定的药物不良反应（ADR）进行了描述性分析，并对药物警戒信号指标（即，报告比值比、比例报告比、信息成分和经验贝叶斯几何平均值）计算滥用、误用、依赖和戒断的首选术语（PT），以及最终与它们相关的PT（例如，侵略）。从2003年到2018年，两个数据集中选定阿片类药物的ADR报告都有所增加。总体而言，分别向EV和FAERS提交了16，506份和130，293份选定阿片类药物的ADR。与其他阿片类药物相比，记录的滥用问题主要与芬太尼和羟考酮有关，而曲马多和羟考酮与药物依赖和戒断的相关性更强。苯二氮卓类、抗抑郁药、其他阿片类、抗组胺药、娱乐性药物（例如，可卡因和酒精）以及包括米曲宁和卡西酮在内的几种新型精神活性物质是最常报告的合并用药。药物警戒数据库中的ADR报告证实了处方类阿片滥用和依赖性数据的可用性，应将其视为监测和预防此类问题的资源。开阿片类药物处方的精神科医生和临床医生应了解其滥用和依赖性以及可能伴随其使用的影响，特别是与伴随药物一起使用。
In the past twenty years, the consumption of opioid medications has reached significant proportions, leading to a rise in drug misuse and abuse and increased opioid dependence and related fatalities. Thus, the purpose of this study was to determine whether there are pharmacovigilance signals of abuse, misuse, and dependence and their nature for the following prescription opioids: codeine, dihydrocodeine, fentanyl, oxycodone, pentazocine, and tramadol. Both the pharmacovigilance datasets EudraVigilance (EV) and the FDA Adverse Events Reporting System (FAERS) were analyzed to identify and describe possible misuse-/abuse-/dependence-related issues. A descriptive analysis of the selected Adverse Drug Reactions (ADRs) was performed, and pharmacovigilance signal measures (i.e., reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean) were computed for preferred terms (PTs) of abuse, misuse, dependence, and withdrawal, as well as PTs eventually related to them (e.g., aggression). From 2003 to 2018, there was an increase in ADR reports for the selected opioids in both datasets. Overall, 16,506 and 130,293 individual ADRs for the selected opioids were submitted to EV and FAERS, respectively. Compared with other opioids, abuse concerns were mostly recorded in relation to fentanyl and oxycodone, while tramadol and oxycodone were more strongly associated with drug dependence and withdrawal. Benzodiazepines, antidepressants, other opioids, antihistamines, recreational drugs (e.g., cocaine and alcohol), and several new psychoactive substances, including mitragynine and cathinones, were the most commonly reported concomitant drugs. ADRs reports in pharmacovigilance databases confirmed the availability of data on the abuse and dependence of prescription opioids and should be considered a resource for monitoring and preventing such issues. Psychiatrists and clinicians prescribing opioids should be aware of their misuse and dependence liability and effects that may accompany their use, especially together with concomitant drugs.
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