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과제정보

과제정보
과제명 의약품정보의 효율적 지속적인 수집관리 및 제공방안마련
기관명 식품의약품안전처 담당부서 식품의약품안전평가원 연구기획조정과
전화번호 연구기간 2004-06-18 ~ 2004-12-20
연구분야 의약품안전
개요 의약품정보의 효율적 지속적인 수집관리 및 제공방안마련

계약정보

과제정보
수행기관 한국보건사회연구원 [기타]
수행연구원 정영철 계약일자 2004-06-18
계약방식 일반경쟁입찰에 의한 계약 계약금액 40,000,000원

연구결과 정보

과제정보
제목 의약품정보의 효율적 지속적인 수집관리 및 제공방안마련
연구보고서
목차
요 약 ··························································································································· 11 제1장 서론 ················································································································· 33 제1절 연구배경 및 필요성 ································································································ 33 제2절 연구목적 ···················································································································· 35 제3절 연구내용 및 방법 ···································································································· 35 제2장 국내 의약품안전관리업무 및 정보관리현황 ··········································· 37 제1절 허가심사업무 ············································································································ 38 제2절 신약등의 재심사업무 ······························································································ 39 제3절 의약품재평가업무 ···································································································· 41 제4절 의약품등 안전성정보 모니터링업무 ···································································· 43 제5절 기타 ···························································································································· 46 제6절 의약품안전정보 관리업무 ······················································································ 47 제3장 국내 의약품안전정보 관련기관 및 정보관리 분석 ······························· 54 제1절 한국병원약사회 ········································································································ 54 제2절 대한약학정보화재단 ································································································ 58 제3절 숙명여자대학교 의약정보연구소 및 의약품연구정보센터 ······························ 61 제4절 BIT 컴퓨터의 BIT DrugInfo ·················································································· 66 제5절 홈케어센터 ················································································································ 68 제6절 KIMS OnLine ············································································································ 70 제4장 해외 의약품안전정보 관리분석 ································································· 74 제1절 일본 ···························································································································· 74 제2절 미국 ···························································································································· 82 제3절 영국 ···························································································································· 85 제4절 유럽연합 ···················································································································· 91 제5절 세계보건기구 ············································································································ 93 제5장 국내 타부처 관련정보센터 분석 ································································· 97 제1절 한국과학기술정보연구원 ························································································ 97 제2절 한국농립수산정보센터 ···························································································· 99 제3절 한국교육학술정보원 ······························································································ 101 제4절 국가환경기술정보센터 ·························································································· 104 제5절 한국유통물류진흥원 ······························································································ 105 제6절 중앙고용정보원 ······································································································ 107 제7절 한국특허정보원 ······································································································ 108 제8절 한국희귀의약품센터 ······························································································ 110 제6장 의약품안전정보 관리방안 ··········································································· 115 제1절 의약품안전정보관리 비전 및 목표 ···································································· 116 제2절 대상 정보별 관리방안 ·························································································· 117 제7장 의약품정보원(가칭) 설립방안 ····································································· 125 제1절 의약품정보원의 설립 필요성 ·············································································· 125 제2절 의약품정보원의 목적 및 역할 ············································································ 126 제3절 의약품정보원의 설립유형 및 재원확보방안 ···················································· 127 제4절 의약품정보원의 조직 및 업무 ············································································ 128 제5절 의약품정보원의 예산 ···························································································· 131 제6절 의약품정보원 근거법률 ························································································ 133 제7절 본 연구의 제한점 및 고려사항 ·········································································· 138 제8장 연구개발목표 달성도 및 대외기여도 ······················································· 140 제9장 연구개발결과의 활용성 및 계획 ······························································· 141 제10장 기타 중요변경사항 ····················································································· 142 제11장 참고문헌 ······································································································· 143 부 록 ························································································································· 145 연구과제 요약서 ······································································································· 165
 

요 약 ··························································································································· 11
제1장 서론 ················································································································· 33
제1절 연구배경 및 필요성 ································································································ 33
제2절 연구목적 ···················································································································· 35
제3절 연구내용 및 방법 ···································································································· 35
제2장 국내 의약품안전관리업무 및 정보관리현황 ··········································· 37
제1절 허가심사업무 ············································································································ 38
제2절 신약등의 재심사업무 ······························································································ 39
제3절 의약품재평가업무 ···································································································· 41
제4절 의약품등 안전성정보 모니터링업무 ···································································· 43
제5절 기타 ···························································································································· 46
제6절 의약품안전정보 관리업무 ······················································································ 47
제3장 국내 의약품안전정보 관련기관 및 정보관리 분석 ······························· 54
제1절 한국병원약사회 ········································································································ 54
제2절 대한약학정보화재단 ································································································ 58
제3절 숙명여자대학교 의약정보연구소 및 의약품연구정보센터 ······························ 61
제4절 BIT 컴퓨터의 BIT DrugInfo ·················································································· 66
제5절 홈케어센터 ················································································································ 68
제6절 KIMS OnLine ············································································································ 70
제4장 해외 의약품안전정보 관리분석 ································································· 74
제1절 일본 ···························································································································· 74
제2절 미국 ···························································································································· 82
제3절 영국 ···························································································································· 85
제4절 유럽연합 ···················································································································· 91
제5절 세계보건기구 ············································································································ 93
제5장 국내 타부처 관련정보센터 분석 ································································· 97
제1절 한국과학기술정보연구원 ························································································ 97
제2절 한국농립수산정보센터 ···························································································· 99
제3절 한국교육학술정보원 ······························································································ 101
제4절 국가환경기술정보센터 ·························································································· 104
제5절 한국유통물류진흥원 ······························································································ 105
제6절 중앙고용정보원 ······································································································ 107
제7절 한국특허정보원 ······································································································ 108
제8절 한국희귀의약품센터 ······························································································ 110
제6장 의약품안전정보 관리방안 ··········································································· 115
제1절 의약품안전정보관리 비전 및 목표 ···································································· 116
제2절 대상 정보별 관리방안 ·························································································· 117
제7장 의약품정보원(가칭) 설립방안 ····································································· 125
제1절 의약품정보원의 설립 필요성 ·············································································· 125
제2절 의약품정보원의 목적 및 역할 ············································································ 126
제3절 의약품정보원의 설립유형 및 재원확보방안 ···················································· 127
제4절 의약품정보원의 조직 및 업무 ············································································ 128
제5절 의약품정보원의 예산 ···························································································· 131
제6절 의약품정보원 근거법률 ························································································ 133
제7절 본 연구의 제한점 및 고려사항 ·········································································· 138
제8장 연구개발목표 달성도 및 대외기여도 ······················································· 140
제9장 연구개발결과의 활용성 및 계획 ······························································· 141
제10장 기타 중요변경사항 ····················································································· 142
제11장 참고문헌 ······································································································· 143
부 록 ························································································································· 145
연구과제 요약서 ······································································································· 165
초록
□ 의약품안전정보를 종합적이고 체계적으로 수집, 처리하여 최신의 정확하고 과학적이며 신뢰 성있는 의약품정보를 신속하고 손쉽게 제공하기 위한 관리체계를 마련하고자 함. - 의약품의 안전한 사용을 위해 체계적으로 관리가 필요한 정보는 다음과 같음. ? 국내의약품허가정보, 재심사?재평가 및 각종 행정조치결과에 의한 허가변경정보, 각국 의 약품집 및 전문학술지 등에 실린 전문의약정보 혹은 최신의약정보, 첨부문서정보, 국내 이상반응 보고정보, 안전성에 문제가 있다고 판단되어 규제조치가 취해진 각국 의 안전성정보, 희귀의약품정보, 그리고 복지부, 식약청 등 관계부처의 관련고시, 공고 및 관련지침, 학회?관련 세미나 등의 각종 행사정보, 업계동향 등 - 정보수집: 정보제공처(정보발생처)에서 온라인을 통해 전자적으로 직접 자료를 입력하거나 혹은 정보제공자가 제공한 오프라인상의 정보를 전담기관에서 받아 데이터베이스에 입력함. - 정보축적 및 정보처리: 관련 홈페이지 및 관련문헌 등에서 정보를 발췌, 신속하고 지속 적으로 데이터베이스에 축적, 데이터웨어하우스 등을 구축하며, 데이터마이닝기법을 통 해 혹은 각종 통계SW, 질의어 등을 활용하여 사용자의 정보욕구충족 - 정보제공: 의약품안전정보 전용홈페이지 해당코너 이용, 새소식 혹은 팝업 창 이용, 이 메일리스트, 식약청, 심평원, 보건복지부 등 관계부처 및 관련기관 홈페이지에 링크 □ 이러한 의약품안전정보 관리를 전담할 주체로써 제안하고자 하는 ‘의약품정보원(가칭)’은 다음과 같음. - 의약품정보원은 안전정보관리 기본계획수립, 안전성정보 모니터링업무 수행, 관련정보 수집?분석?평가 및 제공, 관련 데이터베이스 구축 및 관리?운영, 의약품안전정보시스템 및 전용 홈페이지 구축?운영, 소비자 피해신고센터 운영 및 피해상담, 각종 대중매체의 의약품정보 모니터링, 관련교육 실시, 국제협력업무 수행 등의 역할을 수행함. - 비영리법입으로써, 공익 재단법인의 성격을 띔. - 정부(식약청)와의 관계는 의약품정보원은 정부의 의약품안전관리제도(시판후측면) 수행을 위한 지원기관으로서 관련자료를 수집, 분석, 평가하여 근거에 기반한 과학적인 의사결정 지원 정보를 제공하며, 정부는 이에 따른 최종의사결정을 수행하여 행정을 집행하는 역 할을 설정하고자 함. - 민간 관련기관과의 관계는 의약품정보원은 철저한 공공성을 답보하여 정부가 생산하는 1차적 관련정보와 해외정보 수집 및 전파를 위주로 하며, 민간 관련기관은 이러한 정보 를 밑거름으로 한 2차적 가공정보 개발 및 보급으로 역할을 구분하고자 함. - 의약품정보원의 재원확보는 정부의 지원금, 정부외의 자의 출연금, 기타 수익금 등으로 함. - 조직구조는 2개 실(의약품정보관리실, 의약품정보지원실), 9개 팀(전략기획팀, 신약재심사 팀, 의약품재평가팀, 부작용모니터링팀, 식별표시팀, 홈페이지운영팀, 상담 및 매체모니터 링팀, 국제협력팀, 행정서비스팀) 총 88명으로 구성할 것을 제안함. - 초기 설립예산은 시스템구축비(하드웨어, 소프트웨어, 네트워크, 관련정보시스템개발비), 집기/비품비, 사무실 임대비등으로 나누어 볼 수 있으며, 약 64억+사무실임대비로 산정할 수 있고 설립이후부터의 운영비에는 시스템유지비(개발비포함), 사무실임대비, 인건비, 사 업비 등으로 약 39억 +사무실임대비로 산정할 수 있음. - 의약품정보원의 근거법률에는 기존 법률(약사법)의 한 ‘장’이나 ‘절’을 신설하는 방안과 별개의 독립된 ‘의약품정보원법’을 신설하는 방안이 있음. - 근거법률에 있어 유의할 사항으로는 기존의 법률?조직과의 관계 설정, 재원?조직구성에 관한 구체적 규정, 민간기관에 대한 의무부과 규정, 정보보호 등이 있음. - 예산상의 효율성, 새로운 조직에 대한 초기정착의 어려움, 유사한 업무의 통합, 기존 자원의 활용 등 측면에서 보았을 때 공공성을 띠고 운영하고 있는 기존조직 등을 업무 및 기능확 장, 업무 통합 등의 형태로 하여 의약품정보원으로 활용하는 것도 고려해볼 여지가 있음.
 

□ 의약품안전정보를 종합적이고 체계적으로 수집, 처리하여 최신의 정확하고 과학적이며 신뢰
성있는 의약품정보를 신속하고 손쉽게 제공하기 위한 관리체계를 마련하고자 함.
- 의약품의 안전한 사용을 위해 체계적으로 관리가 필요한 정보는 다음과 같음.
? 국내의약품허가정보, 재심사?재평가 및 각종 행정조치결과에 의한 허가변경정보, 각국
의 약품집 및 전문학술지 등에 실린 전문의약정보 혹은 최신의약정보, 첨부문서정보,
국내 이상반응 보고정보, 안전성에 문제가 있다고 판단되어 규제조치가 취해진 각국
의 안전성정보, 희귀의약품정보, 그리고 복지부, 식약청 등 관계부처의 관련고시, 공고
및 관련지침, 학회?관련 세미나 등의 각종 행사정보, 업계동향 등
- 정보수집: 정보제공처(정보발생처)에서 온라인을 통해 전자적으로 직접 자료를 입력하거나
혹은 정보제공자가 제공한 오프라인상의 정보를 전담기관에서 받아 데이터베이스에 입력함.
- 정보축적 및 정보처리: 관련 홈페이지 및 관련문헌 등에서 정보를 발췌, 신속하고 지속
적으로 데이터베이스에 축적, 데이터웨어하우스 등을 구축하며, 데이터마이닝기법을 통
해 혹은 각종 통계SW, 질의어 등을 활용하여 사용자의 정보욕구충족
- 정보제공: 의약품안전정보 전용홈페이지 해당코너 이용, 새소식 혹은 팝업 창 이용, 이
메일리스트, 식약청, 심평원, 보건복지부 등 관계부처 및 관련기관 홈페이지에 링크
□ 이러한 의약품안전정보 관리를 전담할 주체로써 제안하고자 하는 ‘의약품정보원(가칭)’은
다음과 같음.
- 의약품정보원은 안전정보관리 기본계획수립, 안전성정보 모니터링업무 수행, 관련정보
수집?분석?평가 및 제공, 관련 데이터베이스 구축 및 관리?운영, 의약품안전정보시스템
및 전용 홈페이지 구축?운영, 소비자 피해신고센터 운영 및 피해상담, 각종 대중매체의
의약품정보 모니터링, 관련교육 실시, 국제협력업무 수행 등의 역할을 수행함.
- 비영리법입으로써, 공익 재단법인의 성격을 띔.
- 정부(식약청)와의 관계는 의약품정보원은 정부의 의약품안전관리제도(시판후측면) 수행을
위한 지원기관으로서 관련자료를 수집, 분석, 평가하여 근거에 기반한 과학적인 의사결정
지원 정보를 제공하며, 정부는 이에 따른 최종의사결정을 수행하여 행정을 집행하는 역
할을 설정하고자 함.
- 민간 관련기관과의 관계는 의약품정보원은 철저한 공공성을 답보하여 정부가 생산하는
1차적 관련정보와 해외정보 수집 및 전파를 위주로 하며, 민간 관련기관은 이러한 정보
를 밑거름으로 한 2차적 가공정보 개발 및 보급으로 역할을 구분하고자 함.
- 의약품정보원의 재원확보는 정부의 지원금, 정부외의 자의 출연금, 기타 수익금 등으로 함.
- 조직구조는 2개 실(의약품정보관리실, 의약품정보지원실), 9개 팀(전략기획팀, 신약재심사
팀, 의약품재평가팀, 부작용모니터링팀, 식별표시팀, 홈페이지운영팀, 상담 및 매체모니터
링팀, 국제협력팀, 행정서비스팀) 총 88명으로 구성할 것을 제안함.
- 초기 설립예산은 시스템구축비(하드웨어, 소프트웨어, 네트워크, 관련정보시스템개발비),
집기/비품비, 사무실 임대비등으로 나누어 볼 수 있으며, 약 64억+사무실임대비로 산정할
수 있고 설립이후부터의 운영비에는 시스템유지비(개발비포함), 사무실임대비, 인건비, 사
업비 등으로 약 39억 +사무실임대비로 산정할 수 있음.
- 의약품정보원의 근거법률에는 기존 법률(약사법)의 한 ‘장’이나 ‘절’을 신설하는 방안과
별개의 독립된 ‘의약품정보원법’을 신설하는 방안이 있음.
- 근거법률에 있어 유의할 사항으로는 기존의 법률?조직과의 관계 설정, 재원?조직구성에
관한 구체적 규정, 민간기관에 대한 의무부과 규정, 정보보호 등이 있음.
- 예산상의 효율성, 새로운 조직에 대한 초기정착의 어려움, 유사한 업무의 통합, 기존 자원의
활용 등 측면에서 보았을 때 공공성을 띠고 운영하고 있는 기존조직 등을 업무 및 기능확
장, 업무 통합 등의 형태로 하여 의약품정보원으로 활용하는 것도 고려해볼 여지가 있음.
제작일 2004-12-20
발행년도 2004년

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