J Korean Med Sci.  2015 Apr;30(4):371-377. 10.3346/jkms.2015.30.4.371.

Pediatric Medication Error Reports in Korea Adverse Event Reporting System Database, 1989-2012: Comparing with Adult Reports

• Woo Y
• Kim HE
• Chung S
• Park BJ

• KMID: 2164443
• DOI: http://doi.org/10.3346/jkms.2015.30.4.371

Abstract

Children have dynamic process of maturation and substantial changes in growth and development which eventually make the drug safety profiles different from adults. Medication errors (MEs) in pediatrics are reported to occur three times more likely than adults. The aims of this study were to identify the characteristics of pediatric MEs in Korea at national level and help raise awareness of risks from the MEs in pediatrics. We conducted a descriptive analysis with the pediatric ME reports in Korea Adverse Event Reporting System (KAERS) database from 1989 to 2012 and 208 ME reports in pediatrics were found. Based on KAERS database, the proportion of reported pediatric ME in adverse drug event (ADE) reports was 2.73 times (95% CI, 2.35-3.17) higher than that of adult ME. In 208 ME reports, we found a total of 236 ME-related terms within 19 types of MEs. The most common type of MEs was "accidental overdose" (n = 58, 24.6%), followed by "drug maladministration" (n = 50, 21.2%) and "medication error" (n = 41, 17.4%). After the narratives of ME reports were reviewed, we noticed that most of them did no harm to patients, but some cases were needed for medical treatment. Our data suggest that MEs in pediatrics are not negligible in Korea. We expect that this study would increase the awareness of the problem in pediatric MEs and induce the need for further development of an effective national ME preventing system in Korea.

Keyword

Pediatrics; Medication Errors; Korea Adverse Event Reporting System; Drug-Related Side Effects and Adverse Reactions

MeSH Terms

Adult
*Adverse Drug Reaction Reporting Systems
Child
*Databases, Factual
Humans
Medication Errors/*statistics & numerical data
Republic of Korea/epidemiology
Time Factors

Figure

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  Fig. 1 Pediatric and adult ME reports searching process in KAERS database. KAERS, Korea Adverse Event Reporting System; ADE, adverse drug event; ME, medication error.

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  Fig. 2 Study flow process of pediatric ME reports. ME, medication error.

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  Fig. 3 Number (%) of reports by ME terms coded in KAERS in pediatric ME reports. Total of 236 ME terms with 19 type of MEs was involved.

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  Fig. 4 Number (%) of reports by therapeutic groups in pediatric ME reports. Total of 237 medicines with 17 therapeutic groups was involved.

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