Valinciute-Jankauskiene Agne, Loreta Kubiliene
Department of Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Sukileliu Ave. 13, LT-50166 Kaunas, Lithuania.
Healthcare (Basel). 2021 Mar 9;9(3):303. doi: 10.3390/healthcare9030303.
Direct patient reporting of adverse drug reactions (ADRs) is available in many countries, as patients are often knowledgeable about their health conditions and medicines. This study aimed to assess whether patients can recognize ADRs and whether they know how to proceed with ADR reporting. The study also assesses ADR information sources and the main barriers to reporting. Through the purposive and snowball sampling techniques, 42 consumers participated in focus group discussions. All discussions were audio recorded, transcribed verbatim, and analyzed for thematic content analysis. The thematic content analysis yielded four major themes: knowledge about medication safety, ADRs, and pharmacovigilance; information sources about medicines and ADRs; knowledge about ADR reporting; attitudes towards ADR reporting; benefits of ADR reporting; barriers to ADR reporting. Participants were able to identify ADRs and used different information sources about medicines and ADRs to confirm their beliefs. However, the poor communication between consumers, pharmacists, and physicians is the main barrier to ADR reporting. This study identified the challenges in relation to pharmacovigilance in Lithuania from patients' perspectives. Our study indicated a lack of clearly set standards and communication guidelines between patients, physicians, and pharmacists. Active pharmacovigilance might help develop consumer habits regarding the reporting of ADRs in the presence of spontaneous pharmacovigilance.
在许多国家，患者可直接报告药物不良反应（ADR），因为患者通常了解自身健康状况和所服用的药物。本研究旨在评估患者是否能够识别药物不良反应，以及他们是否知道如何进行药物不良反应报告。该研究还评估了药物不良反应的信息来源以及报告的主要障碍。通过目的抽样和滚雪球抽样技术，42名消费者参与了焦点小组讨论。所有讨论均进行了录音，逐字转录，并进行了主题内容分析。主题内容分析产生了四个主要主题：药物安全性、药物不良反应和药物警戒知识；药物和药物不良反应的信息来源；药物不良反应报告知识；对药物不良反应报告的态度；药物不良反应报告的益处；药物不良反应报告的障碍。参与者能够识别药物不良反应，并使用关于药物和药物不良反应的不同信息来源来证实他们的看法。然而，消费者、药剂师和医生之间沟通不畅是药物不良反应报告的主要障碍。本研究从患者角度确定了立陶宛在药物警戒方面的挑战。我们的研究表明，患者、医生和药剂师之间缺乏明确制定的标准和沟通指南。在自发药物警戒的情况下，积极的药物警戒可能有助于培养消费者报告药物不良反应的习惯。
