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KMID : 1011320120050020068
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Journal of Pharmacoepidemiology and Risk Management
2012 Volume.5 No. 2 p.68 ~ p.77
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Public Awareness of Adverse Drug Reactions and Pharmacovigilance System in Korea
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Lee Jin
Lee Eun-Hee
Jung Jae-Woo
Kang Hye-Ryun
Cho Sang-Heon
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Abstract
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Objective: As more medications we used, the more frequent adverse drug reactions (ADRs) we encounter. To use drugs safely, we have to establish ADR reporting system and let the public be aware of it. The purpose of this study was to evaluate the attitude and knowledge of the public on ADRs and pharmacovigilance system.
Methods: A survey was performed using a structured questionnaire on 338 townspeople who participated in a health fair in Seoul and 202 subjects visiting the outpatient clinic in Seoul National University Hospital between 1st September and 30th September 2010. The results were statistically analyzed by using the SPSS Program. Chi-square test was performed.
Results: Among 540 respondents, 79.6% have ever used drugs in recent three years. Among subjects who ever took medicine in recent years, 14.5% of publics and 34.7% of outpatients experienced ADRs. A majority of the respondents (93.1%) recognized ADRs as preventable partly or completely. Responsibilities of compensation for ADRs were mainly attributed to physicians (62.2%) and pharmaceutical companies (32.4%). Although 91.1% of the respondents agreed that a national ADR reporting system should be established, only 23.3% were aware of the currently existing spontaneous ADR reporting system in Korea. More than half (53.5%) of the study subjects responded simplification of reporting process is needed to activate spontaneous reporting system in Korea in the future.
Conclusion: The majority of respondents ever took medicine and a fourth of them experienced ADRs. The great majority of respondents agreed on the necessity of ADR reporting but did not recognize the existing pharmacovigilance system. Therefore the education and campaign for the public should be reinforced in order to improve public awareness.
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KEYWORD
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Pharmacovigilance, Adverse drug reaction report, Spontaneous reporting system, Attitude
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