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의약품 유통 선진화를 위한 유통체계 개선방안 연구

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Type
Research report
Author(s)
김동숙송인명최상은임은아박은자이주연허규남신주영이혜성김상현이새롬정상준박정연
Issued Date
2024-02
Publisher
건강보험심사평가원
URI
https://repository.hira.or.kr/handle/2019.oak/3251
Table Of Contents
제1장 서론 ····························································· 3
1. 연구 배경 및 필요성 ············································································· 3
가. 의약품 공급망 관리 필요성 ········································································ 3
나. 국내 환경 변화와 의약품 유통업 혁신 필요성 ·············································· 6
다. 의약품 수급불안정 문제 대응 필요성 ························································ 10
2. 연구의 목적 ······················································································· 11
3. 연구내용 및 추진체계 ·········································································· 11

제2장 국내 의약품 유통제도 현황 ····························································· 17
1. 의약품 공급망과 유통업체의 역할 ························································· 17
가. 의약품 시장의 특징 ················································································· 17
나. 일반적 산업과 의약품 유통 모형 ······························································ 20
2. 국내 의약품 유통제도 조사 ·································································· 23
가. 의약품 공급자 분류 ················································································· 23
나. 의약품 유통제도 변화 ·············································································· 26
다. 의약품 유통정보시스템 ············································································· 32
라. 기타 유통정보시스템 ··············································································· 46
마. 국내 의약품 유통 관련 법규 ···································································· 59
3. 국내 선행연구 고찰 ············································································· 82
가. 국내 의약품 유통 이슈 및 문제점 ····························································· 82
나. 의약품 유통 선진화 방안 ········································································· 88

제3장 외국의 의약품 유통 선진화 제도 조사 ····························································· 105
1. 개요 ·································································································· 105
가. 의약품 공급망 보안(Supply chain security) ··········································· 105
나. 외국의 전략 ·························································································· 110
2. 우수의약품 유통기준(GDP) ································································ 112
가. GDP(Good Distribution Practices) 배경 ·············································· 112
나. WHO ·································································································· 114
다. 유럽 ···································································································· 114
라. 미국 ···································································································· 120
마. 일본 ···································································································· 121
바. 외국의 GDP와 국내 KGSP 비교 ···························································· 122
3. 의약품 공급망 매핑 ··········································································· 127
가. 공급망 가시성(SCV)과 매핑(SCM) ·························································· 127
나. 미국의 의약품공급망안전법 ····································································· 132
다. 유럽 ICMRA 보고서 ············································································· 137
라. 튀르키예 ······························································································ 138
4. 의약품 도매업체 구조 개선 ································································ 152
가. 미국, 유럽 ··························································································· 152
나. 일본 ···································································································· 154

제4장 국내 의약품 유통 문제점 진단 ····························································· 163
1. 연구내용 및 방법 ·············································································· 163
가. 의약품 유통현황 분석 ············································································ 163
나. 의약품 유통 문제점에 대한 이해관계자 의견수렴 ······································ 165
2. 의약품 유통 전체구조 및 규모 ··························································· 169
가. 의약품 유통업체수 ················································································· 169
나. 의약품 표준코드 현황 ·············································································· 173
다. 의약품 유통시장 전체 규모 ···································································· 174
라. 일련번호 보고율 현황 ············································································ 178
3. 코로나 전후 인슐린 제제 등 유통현황 ················································· 181
가. 연도별 공급현황 ····················································································· 181
나. 인슐린 제제 공급 및 반품 ····································································· 188
다. DPP4 저해제 공급추이 검토 ································································ 192
라. 소결 ·································································································· 195
4. 국내 의약품 유통의 문제점 진단을 위한 인터뷰 ··································· 197
가. 의약품 유통의 현황 및 문제점 진단 ························································ 197
나. 의약품 유통 개선방안 ············································································ 210
다. 차세대 의약품정보시스템에 대한 의견 ····················································· 226
라. 의약품 수급 불안정 원인진단 및 개선방안 ··············································· 232

제5장 의약품 유통체계 개선방안 제언 ····························································· 259
1. 의약품 유통 환경 분석 및 진단 ·························································· 259
가. 보건의료 환경 변화 분석 ······································································· 259
나. 외국의 의약품 유통선진화 흐름 ······························································ 261
다. 의약품 유통현황 진단 ············································································ 262
2. 의약품 유통 선진화를 위한 유통체계 개선방안 ····································· 265
가. 전략과 과제 ·························································································· 265
나. 중장기 로드맵개선방안 제언 ··································································· 267

제6장 국내외 의약품 수급불안정 관리제도 고찰 ····························································· 279
1. 의약품 수급불안정 정의 및 발생원인 ·················································· 279
가. 수급불안정 의약품 정의 ········································································· 279
나. 의약품 수급불안정 현황 ········································································· 285
다. 의약품 수급불안정 발생원인 ··································································· 289
라. 의약품 수급불안정이 환자에게 미치는 영향 ·············································· 299
마. 의약품 수급불안정 감지 관련 선행연구 ···················································· 302
2. 외국의 수급불안정 의약품 관리체계 ···················································· 309
가. 개요 ···································································································· 309
나. 미국 ···································································································· 326
다. 유럽 ···································································································· 334
라. 캐나다 ································································································· 342
마. 대만 ···································································································· 350
바. 일본 ···································································································· 351
3. 국내 의약품 수급불안정 현황 및 관리제도 ··········································· 359
가. 국내 제도 ···························································································· 359
나. 국내 의약품 수급불안정 문제 현황 ·························································· 373

제7장 의약품 수급불안정 위험 감지모형 개발 ····························································· 383
1. 연구내용 및 방법 ·············································································· 383
가. 자료수집 ······························································································ 383
나. 분석대상 의약품 ···················································································· 384
2. 인공지능 기반 의약품 수급불안정 위험 감지모형 ·································· 385
가. 연구모형 ······························································································ 385
나. 연구결과 ······························································································ 396
3. 시계열 분석 기반 의약품 수급불안정 위험 감지모형 ····························· 417
가. 연구모형 ······························································································ 417
나. 연구결과 ······························································································ 420

제8장 의약품 수급불안정 관리방안 ····························································· 447
1. 의약품 수급불안정 위험 감지모형 활용방안 ········································· 447
가. 모형개발 결과 ······················································································· 447
나. 모형 활용방안 ······················································································· 449
2. 의약품 수급불안정 관리방안 ······························································· 455
가. 의약품 수급불안정 발생 원인 ································································· 455
나. 관리방안 ······························································································ 456

◾ 참고문헌 ···················································································· 465
◾ 부록 ·························································································· 479
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건강보험심사평가원
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김동숙. (2024-02). 의약품 유통 선진화를 위한 유통체계 개선방안 연구.
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