A cross-sectional survey of knowledge, attitude, and willingness to engage in spontaneous reporting of adverse drug reac
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RESEARCH ARTICLE
Open Access
A cross-sectional survey of knowledge, attitude, and willingness to engage in spontaneous reporting of adverse drug reactions by Korean consumers Seungyeon Kim1, Yun Mi Yu2,3*, Myoungsoon You4, Kyeong Hye Jeong5 and Euni Lee1*
Abstract Background: Spontaneous reporting (SR) of adverse drug reactions (ADRs) from patients can be considered as a valuable activity providing both objective and subjective data. However, improving the rate of under-reporting has been a major challenge to ensure successful operation of the SR system. This study aimed to assess knowledge, attitude, and intent to report ADRs and explore the factors contributing to consumers’ reporting intent in South Korea. Methods: Self-administered questionnaire was collected from a sex-, age-, and regionally stratified nationwide convenience sample of consumers using a commercial panel in December 2018. Univariate and multivariate logistic regression analyses were used to explore the factors contributing to the intent to report ADRs by consumers. Results: A total of 1000 respondents were enrolled in the survey; 50.9% were males and the mean age was 44.4 (standard deviation, 13.3) years. While less than 15% of the respondents were aware of the SR system and even fewer (3.4%) had actual experience of SR, however, 59.2% expressed their intent to report ADRs. The positive attitude (adjusted odds ratio [aOR] 3.972, p < 0.001), awareness of the SR system (aOR 2.102, p < 0.01), self-efficacy for SR (aOR 1.956, p < 0.001), and experiences related to ADR counselling with healthcare professionals (OR 2.318, p < 0.001) are the significant factors contributing to reporting intent. Conclusions: Findings of this study highlight the need for increasing the awareness of the SR system among consumers and empowering them to report ADRs by themselves, which would ultimately improve the drug-safety environment. Keywords: Pharmacovigilance, Adverse drug reaction, Consumer, Spontaneous reporting, Attitude, Awareness, Selfefficacy
Background Spontaneous reporting (SR) of adverse drug reactions (ADRs) is one of the fundamental activities by which * Correspondence: [email protected]; [email protected] 2 Department of Pharmacy and Yonsei Institute of Pharmaceutical Sciences, College of Pharmacy, Yonsei University, Incheon 21983, Republic of Korea 1 College of Pharmacy & Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul 08826, Republic of Korea Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated
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