Catholic University Our Lady of Good Counsel, Department of Chemical-Toxicological and Pharmacological Evaluation of Drugs, Tirana, Albania.
Spahiu Dental Clinic, Rruga Him Kolli, Tirana, Albania.
Int Dent J. 2024 Apr;74(2):242-245. doi: 10.1016/j.identj.2023.08.005. Epub 2023 Sep 19.
Procedures on reporting adverse drug reactions (ADRs) in Albania are not yet standardised with the European Union despite continuous legislative changes. The aim of this study was to assess for the first time in Albania the reporting of ADRs by dentists and dental patients and to evaluate the frequency and timing of ADRs.
We conducted a questionnaire-based survey for dentists and dental patients in Albania on their knowledge on ADR signalling. Dentists and their patients were randomly reached in private dental clinics. Ninety-five dentists and 640 dental patients from 5 different cities in Albania agreed to participate in the study. Only dentists who were actively working on their dental clinics and who volunteered to participate in the study were considered eligible.
The response rates were 95.0% and 91.4% for dentists and dental patients, respectively. In addition, 7.36% of dentists reported to have been informed on the national ADR signalling through conferences, but when asked about the procedures only 28.6% of them reported to have knowledge on the concrete process. None of the dental patients knew how to report ADRs.
The findings demonstrate the complete lack of information on ADR signalling in a randomly selected group of 640 dental patients and 95 dentists surveyed. The results of the study are concerning and show that knowledge on ADR signalling should massively increase through public and social media.
尽管立法不断变化,但阿尔巴尼亚报告药物不良反应 (ADR) 的程序仍未与欧盟标准化。本研究的目的是首次在阿尔巴尼亚评估牙医和牙科患者报告 ADR 的情况,并评估 ADR 的频率和时间。
我们在阿尔巴尼亚的私人牙科诊所对牙医和牙科患者进行了一项基于问卷调查的 ADR 信号知识调查。共有 95 名牙医和来自阿尔巴尼亚 5 个不同城市的 640 名牙科患者同意参与这项研究。只有积极在其牙科诊所工作并自愿参与研究的牙医才有资格参加。
牙医和牙科患者的回复率分别为 95.0%和 91.4%。此外,7.36%的牙医表示通过会议了解了国家 ADR 信号,但当被问及具体程序时,只有 28.6%的牙医表示了解具体流程。没有一名牙科患者知道如何报告 ADR。
研究结果表明,在随机选择的 640 名牙科患者和 95 名牙医中,完全缺乏关于 ADR 信号的信息。研究结果令人担忧,表明应通过公共和社交媒体大量增加对 ADR 信号的了解。