A cross-sectional survey of knowledge, attitude, and willingness to engage in spontaneous reporting of adverse drug reactions by Korean consumers

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.

Evaluation of Prescription Medication Sharing Among Adults in South Korea: A Cross-Sectional Survey

“…To improve the external validity and to minimize selection bias, stratification method was used during the recruitment process reflecting the national census statistics by age, gender, and region. In addition, the biggest consumer panel available in South Korea was employed (Kim et al, 2020;Panel Marketing Interactive, 2021). Second, our study included people younger than 70 year old as the study utilized an internet-based survey.…”

“…A cross-sectional study was conducted using an online selfadministered survey to evaluate the experience of medication sharing among adults aged 19 years or above, excluding healthcare professionals. Participants were recruited using a commercially available consumer panel of a nationwide convenience sample operated by the Panel Marketing Interactive company, which included 1.59 million people, one of the biggest consumer panels in South Korea in 2020 (Panel Marketing Interactive, Seoul, South Korea; Kim et al, 2020). A more detailed description of the panel has been published elsewhere (Panel Marketing Interactive, 2021).…”

Estimation of adverse drug reaction reporting in Iran: Correction for underreporting

“…69 The SR is affected by factors such as the reporters' skill and experience to detect the ADR, their level of knowledge on how and where to report the ADRs, workload, lack of time, the unavailability of reporting forms, personal thoughts on the SR system, difficulty detecting the ADRs, and ADRs considered not serious enough. [69][70][71][72][73] Moreover, the main causes related to underreporting in resource-limited countries were indifference, insecurity, complacency, ignorance, lack of training, lack of interest, a fear of legal liability, and poor communication between physicians and other healthcare professionals. 20,74,75 Meanwhile, the main cause of underreporting in Iran is unawareness about the existence of a national pharmacovigilance center, 76,77 inadequate knowledge regarding reporting, 78,79 and fear of punishment and criticism.…”

“…The SR system is a passive surveillance method that solely relies on healthcare professionals to detect and take the initiative to report an ADR 69 . The SR is affected by factors such as the reporters' skill and experience to detect the ADR, their level of knowledge on how and where to report the ADRs, workload, lack of time, the unavailability of reporting forms, personal thoughts on the SR system, difficulty detecting the ADRs, and ADRs considered not serious enough 69‐73 . Moreover, the main causes related to underreporting in resource‐limited countries were indifference, insecurity, complacency, ignorance, lack of training, lack of interest, a fear of legal liability, and poor communication between physicians and other healthcare professionals 20,74,75 .…”

Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan

“…Compared to the number of reports filed in the EU (European Union) as an example, this is far behind that of the EU (Table 1 ), even if we take into account the difference in the population sizes (the EU has approximately 4 times as many citizens as Japan) [ 9 ]. In South Korea, of the approximately 1.6 million total ADR reports made from 1989 to 2018, only about 8% were filed by consumers [ 10 ]. In Malaysia and the Philippines, although the receipt of direct reports from patients began in the 2000s [ 11 ], detailed statistics regarding these reporting systems are unknown.…”