본문 바로가기
KERD
논문KCI 등재

단일 상급 종합병원에서 소아 입원환자의 주사제 사용현황 분석을 통한 저함량 단위 주사제의 필요성 제언

Analysis of Injectable Drug Use in Pediatric Inpatients and the Necessity for Low-dose Formulations: A Single Center Study

0

조회

0

다운로드

0

인용

0

참고문헌

키워드

초록

Background : Currently, most clinical trials are conducted on adults. Also, dose formulations are developed based on adult standard doses, resulting in problems with pediatric administration. Firstly, the excess drugs become medical waste. Secondly, patients may be overcharged even when they only use a small portion of the drugs. Lastly, medical errors may arise while preparing and administering pediatric doses with comparatively large dose formulations. Therefore, this study aimed to analyze the status of injectable drug use in pediatric inpatients and estimate the discarded drug amounts and the proportion of the actual dose used, thus evaluating the marketability of lower dose formulations. Methods : The data of injectable drugs prescribed from June 1, 2018, to May 31, 2019, were collected and retrospectively analyzed using the Order Communication System program. Results : The average daily injectable drug prescriptions for children were 1,738.1, and 40.1% of them were for less than the dose formulations. The number of injections discarded daily was 435.7, accounting for 1,692,217 Korean won. The injectable drugs frequently prescribed in small proportions were dexamethasone 5 mg/ampoule (A), ranitidine 50 mg/A, cimetidine 200 mg/A, and furosemide 20 mg/A. Among the top 20 products, only seven had lower dose formulations available in Korea, of which three were unavailable due to low demand, never produced though granted permission, and one was due to non reimbursement by insurance. Moneywise, the biggest loss was from caspofungin 50 mg/vial (V), whose daily drug disposal accounted for 256,352 Korean won, followed by smoflipid 20%® 100 ml/bottle, ganciclovir 500 mg/V, and teicoplanin 200 mg/V. Conclusion : This study showed that utilizing injectable drugs with adult dose formulations for children could result in biohazardous medical waste and economic losses. However, there are only a few alternatives currently available. Therefore, the government, instead of individual medical institutions or pharmaceutical companies, should authorize the investigation and development of lower dose formulations for children.

Abstract

Background : Currently, most clinical trials are conducted on adults. Also, dose formulations are developed based on adult standard doses, resulting in problems with pediatric administration. Firstly, the excess drugs become medical waste. Secondly, patients may be overcharged even when they only use a small portion of the drugs. Lastly, medical errors may arise while preparing and administering pediatric doses with comparatively large dose formulations. Therefore, this study aimed to analyze the status of injectable drug use in pediatric inpatients and estimate the discarded drug amounts and the proportion of the actual dose used, thus evaluating the marketability of lower dose formulations. Methods : The data of injectable drugs prescribed from June 1, 2018, to May 31, 2019, were collected and retrospectively analyzed using the Order Communication System program. Results : The average daily injectable drug prescriptions for children were 1,738.1, and 40.1% of them were for less than the dose formulations. The number of injections discarded daily was 435.7, accounting for 1,692,217 Korean won. The injectable drugs frequently prescribed in small proportions were dexamethasone 5 mg/ampoule (A), ranitidine 50 mg/A, cimetidine 200 mg/A, and furosemide 20 mg/A. Among the top 20 products, only seven had lower dose formulations available in Korea, of which three were unavailable due to low demand, never produced though granted permission, and one was due to non reimbursement by insurance. Moneywise, the biggest loss was from caspofungin 50 mg/vial (V), whose daily drug disposal accounted for 256,352 Korean won, followed by smoflipid 20%® 100 ml/bottle, ganciclovir 500 mg/V, and teicoplanin 200 mg/V. Conclusion : This study showed that utilizing injectable drugs with adult dose formulations for children could result in biohazardous medical waste and economic losses. However, there are only a few alternatives currently available. Therefore, the government, instead of individual medical institutions or pharmaceutical companies, should authorize the investigation and development of lower dose formulations for children.

참고문헌 (17)

  1. Ivanovska V, "Pediatric drug formulations: a review of challenges and progress", Pediatrics, 134(2), pp.361~372 (2014)
  2. MA Turner MC, "Paediatric drug development: The impact of evolving regulations", Advanced Drug Delivery Reviews, 73, pp.2~13 (2014)
  3. Richey RH, "A systematic review of the use of dosage form manipulation to obtain required doses to inform use of manipulation in paediatric practice", Int J Pharm, 518(1-2), pp.155~166 (2017)
  4. 질병관리본부 의료감염관리과, "의료관련감염 표준예방지침" (2018), 질병관리본부
  5. Semba CP, "Alteplase:stability and bioactivity after dilution in normal saline solution", J Vasc Interv Radiol, 14(1), pp.99~102 (2003)
  6. Longfield R, "Multidose medication vial sterility : an in-use study and a review of the literature", Infect Control, 5(4), pp.165~169 (1984)
  7. Almeida MA, "Evaluating pharmaceutical waste disposal in pediatric units", Rev Esc Enferm USP, 50(6), pp.922~928 (2016)
  8. Parezanović GŠ, "Environmental Transformation of Pharmaceutical Formulations : A Scientific Review", Arch Environ Contam Toxicol, 77(2), pp.155~161 (2019)
  9. 환경부 자연환경정책실 환경경제정책관 환경연구개발과, "환경통계연감 2018" (2019), 환경부
  10. 박광준, "소아약학 특수연구회 실태조사", 병원약사회지, 18(3), pp.317~328 (2001)
  11. Cherif A, "Evaluation of administration errors of injectable drugs in neonatology", Ann Pharm Fr, 73(6), pp.461~470 (2015)
  12. 신은정, "소아입원환자에서의 약물사용 평가", 한국임상약학회지, 15(1), pp.27~33 (2005), 한국임상약학회
  13. Clinical Investigation of Medicinal Products in the Paediatric Population, , European Medicines Agency, ~ (2001)
  14. "의약품안전나라 의약품통합정보시스템" (2020), 식품의약품안전처[URL]
  15. "UpToDate" (2020)[URL]
  16. Kwon HY, "Drug pricing in south Korea", Applied Health Economics and Health Policy, 15(4), pp.447~453 (2017)
  17. Cho M, "Considerations for pediatric trial designs and analyses", Journal of Biopharmaceutical Statistics, 28(3), pp.413~436 (2018)

관련 논문AI추천

이 간행물의 다른 논문 (6건)