의약품 유통 선진화를 위한 유통체계 개선방안 연구
- Type
- Research report
- Issued Date
- 2024-02
- Publisher
- 건강보험심사평가원
- 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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- 김동숙. (2024-02). 의약품 유통 선진화를 위한 유통체계 개선방안 연구.
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