Analysis of Spontaneously Reported Adverse Drug Events: Towards Developing Systems for Preventability.

IF 2.6 3区 生物学 Q3 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
BioMed Research International Pub Date : 2024-08-30 eCollection Date: 2024-01-01 DOI:10.1155/2024/1906797
Courage Edem Ketor, Charles Kwaku Benneh, Emmanuel Sarkodie, Juliet Ama Anaglo, Adelaide Mensah, Samuel Owusu Somuah, Selorm Akakpo, Eric Woode
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引用次数: 0

Abstract

Background: Analysing data on adverse drug reactions (ADRs) in health facilities is an essential step to help develop effective strategies to reduce their incidence. The objective was to analyse spontaneous ADR reports sent to the Ghanaian Food and Drugs Authority (FDA) by two reporting health facilities over 5 years. Methods: Data from duplicate spontaneous ADR reports sent to the FDA (Ghana) from 2014 to 2018 were extracted. The relationship between independent variables such as age, sex, and source of drugs and ADR outcomes was assessed with either chi-square or a Cramer's V test for association where appropriate. Results: Type A reactions (65.2%) were the most prevalent of the ADRs, followed by Type B (34.1%), with the majority (80%) of patients affected recovering fully. The majority of Type A reactions (54.1%) occurred in the clinic, while the majority of Type B reactions (43.5%) occurred in the hospital. The skin and central nervous system (CNS) were the most affected (70.8%) organs. A higher incidence of CNS and skin-related ADRs was recorded in patients older than 30 (RR = 1.28 (1.07-1.53)). Also, females were more likely to experience a CNS-related ADR. The seriousness of the ADR was found to be significantly associated with the (1) type of prescriber, (2) whether the drug was prescribed, or (3) whether the drug regimen prescribed was appropriate. Even though, in 86% of cases, the offending drug was withdrawn within the first 5 days, it exceeded 20 days in about 6% of cases. The record of allergy status in a patient's folder and the source of the drug were significantly associated with the chance that the offending drug was withdrawn. However, recording ADRs did not influence whether the offending drug was stopped. Conclusion: Most of the ADRs experienced by patients could be avoided if the current systems are improved to prevent the rechallenge of offending drugs. Efforts to improve and update patient medication records and steps to ensure continuity of care are essential in preventing these adverse drug events.

分析自发报告的药品不良事件:开发可预防性系统。
背景:分析医疗机构的药物不良反应(ADRs)数据是帮助制定有效策略降低不良反应发生率的必要步骤。本研究旨在分析两家医疗机构在 5 年内自发向加纳食品药品管理局(FDA)提交的 ADR 报告。方法:从 2014 年至 2018 年期间发送至 FDA(加纳)的重复自发 ADR 报告中提取数据。年龄、性别、药物来源等自变量与ADR结果之间的关系酌情用秩方或克拉默V检验进行评估。结果A型反应(65.2%)是最常见的不良反应,其次是B型反应(34.1%),大多数(80%)患者完全康复。大多数 A 类不良反应(54.1%)发生在诊所,而大多数 B 类不良反应(43.5%)发生在医院。皮肤和中枢神经系统(CNS)是受影响最大的器官(70.8%)。据记录,30 岁以上的患者发生中枢神经系统和皮肤相关不良反应的几率更高(RR = 1.28 (1.07-1.53))。此外,女性更容易出现中枢神经系统相关不良反应。研究发现,ADR 的严重程度与(1)处方者的类型、(2)是否处方了药物或(3)处方的药物疗程是否适当有显著关联。尽管在 86% 的病例中,违规药物在最初 5 天内被停用,但仍有约 6% 的病例超过了 20 天。病人文件夹中的过敏状态记录和药物来源与违规药物被撤消的几率有很大关系。然而,记录 ADR 并不影响违规药物是否被停用。结论如果能改进现有系统,防止违规药物再次出现,那么患者遇到的大部分不良反应都是可以避免的。努力改进和更新患者用药记录,并采取措施确保护理的连续性,对于预防这些药物不良反应事件至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BioMed Research International
BioMed Research International BIOTECHNOLOGY & APPLIED MICROBIOLOGY-MEDICINE, RESEARCH & EXPERIMENTAL
CiteScore
6.70
自引率
0.00%
发文量
1942
审稿时长
19 weeks
期刊介绍: BioMed Research International is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies covering a wide range of subjects in life sciences and medicine. The journal is divided into 55 subject areas.
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