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KMID : 1011320100030010023
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Journal of Pharmacoepidemiology and Risk Management
2010 Volume.3 No. 1 p.23 ~ p.31
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Analysis of Characteristics about Spontaneous Reporting - Reported in 2008
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Kim Ja-Young
Ha Ji-Hye
Kim Bo-Ra
Jang Jung-Hoon
Park Hye-Jin
Kim Young-Hoon
Kim Myung-Jung
Hwang Myung-Sil
Jin Byung-Jo
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Abstract
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Objective: To describe characteristics and reporting patterns of the spontaneous adverse event reported to Korea Food and Drug Administration (KFDA) in 2008.
Methods: First, active ingredients and adverse events were coded to Anatomical Therapeutic Chemical (ATC) code and World Health Organization-Adverse Reaction Terminology (WHO-ART) code, respectively. The number of reports and reporting rate were analyzed by report source. Patient characteristics (age, gender) numbers of reports and reporting rate were also analyzed. The number of reports and reporting rate based by ATC code and WHO-ART code was analyzed.
Results: Adverse event report document was changed by revision of regulation, and there are many cases that has more than one suspicion drug and adverse event term, so the data needs coding. The total number of AE case reports was 7,210 in 2008. The total number of adverse event number was 7,900. In the age group, 60s (60-69 years) was the most reported age in 1,181 cases (16.38%) followed by 50s (50-59 years) and 2,926 cases (40.58%) were reported from male. The most frequent reporting source was hospital 3,593 cases (49.8%) because of setting 9 regional pharmacovigilance centers in the whole country. Pharmaceutical company was now second place in 3,456 cases (48.0%). Most frequently reported drug class was antibacterials. According to the WHO-ART coding, the most frequently reported system-organ class was skin and appendages disorders system 1,715 events (21.7%) followed by Body as a whole general disorders system 1,252 events (15.8%).
Conclusion: Today’s, Government and academics are trying to increase the awareness of needs about spontaneous adverse drug reaction to be report. Also, increasing spontaneous adverse drug reaction can make Korea more safe from drug harmness. But, there are still needs to report from consumer and pharmacists and completeness of adverse event reports form to evaluate the case more thoroughly. Now it is needed more quality than quantity.
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KEYWORD
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Adverse event, Characteristic of adverse event, Pharmacovigilance, Spontaneous adverse event monitoring
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