소아 약물유해반응 보고 사례 분석
Assessment of Pediatric Adverse Drug Reaction Reports
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
Objectives : This study was conducted in order to analyze the pattern and severity of pediatric adverse drug reactions (hereafter, ADRs), suspicious medication and the reports for preventing and predicting further ADRs in order to apply for the construction of the Korean pediatric ADR database. Methods : A total of 1,011 reports, including pediatric ADRs, reported to the KFDA between January and June 2010 were analyzed. The reports, which had a higher category than ‘possible’ in the Naranjo scale, were included. Results : Oseltamivir phosphate (364 reports, 11.0%), methylphenidate (272 reports, 8.2%) and acetaminophen (109 reports, 3.3%) were the most suspicious drugs found in pediatric ADRs. The most common ADRs in pediatrics were vomiting (451 reports, 16.2%), nausea (319 reports, 11.5%) and diarrhea (183 reports, 6.5%). Most of the ADR reports were conducted with health care professionals, including doctors, pharmacists, and nurses. Conclusion: Drug monitoring for pediatric patients should be intensively conducted with health professionals and public health care programs for the education of ADR reports should also be offered.
Abstract
Objectives : This study was conducted in order to analyze the pattern and severity of pediatric adverse drug reactions (hereafter, ADRs), suspicious medication and the reports for preventing and predicting further ADRs in order to apply for the construction of the Korean pediatric ADR database. Methods : A total of 1,011 reports, including pediatric ADRs, reported to the KFDA between January and June 2010 were analyzed. The reports, which had a higher category than ‘possible’ in the Naranjo scale, were included. Results : Oseltamivir phosphate (364 reports, 11.0%), methylphenidate (272 reports, 8.2%) and acetaminophen (109 reports, 3.3%) were the most suspicious drugs found in pediatric ADRs. The most common ADRs in pediatrics were vomiting (451 reports, 16.2%), nausea (319 reports, 11.5%) and diarrhea (183 reports, 6.5%). Most of the ADR reports were conducted with health care professionals, including doctors, pharmacists, and nurses. Conclusion: Drug monitoring for pediatric patients should be intensively conducted with health professionals and public health care programs for the education of ADR reports should also be offered.
참고문헌 (28)
- "Recent trends in infant mortality in the US. National Center for Health Statistics"[URL]
- 윤병준, "한미간 건강수준 및 건강행태에 관한 비교", 대한보건연구, 37(1), pp.149~158 (2011), 사단법인 대한보건협회
- 이경희, "국가필수예방접종 전액지원사업 후 예방접종현황의 변화 및 이용자 만족도 : 서울시 강남구 사례를 중심으로", 대한보건연구, 37(1), pp.15~27 (2011), 사단법인 대한보건협회
- Jick H., "Adverse drug reactions : the magnitude of the problem", J Allergy Clin Immunol, 74(4), pp.555~557 (1984)
- Lazarou J., "Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies", JAMA, 279(5), pp.1200~1205 (1998)
- Silverman J.B., "Multifaceted approach to reducing preventable adverse drug events", Am J Health Syst Pharm, 60(6), pp.582~586 (2003)
- Perrone J., "Pharmacy and therapeutics committees: leadership opportunities in medication safety for medical toxicologists", J Med Toxicol, 7(2), pp.99~102 (2011)
- Wu W.K., "Evaluation of outpatient adverse drug reactions leading to hospitalization", Am J Health-Syst Pharm, 60(3), pp.253~259 (2003)
- Huang N.N,, "Comparison of serum levels following the administration of oral and parenteral preparations of penicillin to infants and children of various age groups", J Pediatr, 42(6), pp.657~668 (1953)
- Silverio J., "Serum concentrations of ampicillin in newborn infants after oral administration", Pediatrics, 51(3), pp.578~580 (1973)
- Jalling B., "Plasma concentrations of phenobarbital in the treatment of seizures in newborns", Acta Paediatr Scand, 64(3), pp.514~524 (1975)
- Weiss C.F., "Chloramphenicol in the newborn infant: A physiologic explanation of its toxicity when given in excessive doses", N Engl J Med, 262, pp.787~794 (1960)
- Nahata M.C., "Comparative bioavailability and pharmacokinetics of chloramphenicol after intravenous chloramphenicol succinate in premature infants and older patients", Dev Pharmacol Ther, 6(1), pp.23~32 (1983)
- Andersen D.H., "A difference in mortality rate and incidence of kernicterus among premature infants allotted to two prophylactic antibacterial regimens", Pediatrics, 18(4), pp.614~624 (1956)
- Kramer M.S., "Adverse drug reactions in general pediatric outpatients", The Journal of Pediatrics, 106(2), pp.305~310 (1985)
- Bruce C., "Active surveillance systems for pediatric adverse drug reactions: an idea whose time has come", Current Therapeutic Research, 62(10), pp.738~742 (2001)
- Menniti I.G., "Active monitoring of adverse drug reactions in children", Lancet, 355(9215), pp.1613~1614 (2000)
- 금민정, "원내 소아 환자에서 보고된 약물 부작용 사례 분석", 병원약사회지, 28(3), pp.253~261 (2011), 한국병원약사회
- 임혜리, "원내 약물부작용 보고 유형별 분석", 병원약사회지, 28(2), pp.1~9 (2011), 한국병원약사회
- 김승란, "소아 약물처방 스크린프로그램과 임상약사 활동이 drug safety 향상에 미치는 효과", 병원약사회지, 24(3), pp.1~9 (2007), 한국병원약사회
- Naranjo C.A., "A method for estimating the probability of adverse drug reaction", Clin Pharmac Ther, 30(2), pp.239~245 (1981)
- Hartwig S.C., "Preventability and severity assessment in reporting adverse drug reactions", Am J Hosp Pharm, 49(9), pp.2229~2232 (1992)
- Launes C., "2009 Influenza A H1N1 infections: delays in starting treatment with oseltamivir were associated with a more severe disease", Pediatr Infect Dis J, 30(7), pp.622~625 (2011)
- Zopf Y., "Gender-based differences in drug prescription: relation to adverse drug reactions", Pharmacology, 84(6), pp.333~339 (2009)
- Jha N., "Adverse drug reaction reporting in a pharmacovigilance centre of Nepal", Australas Med J, 5(5), pp.268~271 (2012)
- Lieber N.S., "Adverse drug reactions leading children to the emergency department", Rev Bras Epidemiol, 15(2), pp.265~274 (2012)
- Rieder M., "New ways to detect adverse drug reactions in pediatrics", Pediatr Clin North Am, 59(5), pp.1071~1092 (2012)
- Hunsel F., "Experiences with adverse drug reaction reporting by patients : an 11-country survey", Drug Saf, 35, pp.45~60 (2012)