의약품 허가관리 전산시스템 모형 개발과 이에따른 경제성 분석

Abstract

[한글]

국민들의 건강수준 향상으로 의약품의 역할이 커짐에 따라 복잡 다양해지는 약무행정 업무의 능률을 제고하기 위하여 의약품 허가관리 전산화는 필수적이다. 이 연구는 양적증대와 고도의 전문성이 요구되는 의약품 허가관리 업무를 새로운 전산시스템을 이용하여

보다 체계적이고 효율적으로 수행할 수 있도록 하기 위하여 현재의 허가관리 전산시스템을 분석하고 문제점을 도출하였으며 이에 따른 새로운 시스템의 모형을 개발하였다. 그리고 새로운 시스템 도입시의 경제성등 타당성 여부를 평가한 결과 다음과 같은 결론을 얻었다.

첫째, 현재 운영되는 의약품 허가관리 전산시스템은 단순통계등의 자료활용과 허가사항의 확인에 치중되어 있고, 수작업에 의한 허가처리와 전산입력의 이중작업으로 효율적인 전산관리가 어려우며, 각종 정보의 수집, 분석능력이 결여되어 허가정보원으로서의 기능이 미약한 실정이다.

둘째, 이러한 문제점을 보완하기 위하여 허가(변경) 사항등록 시스템, 사후관리 시스템, 전산망 구성등 새로운 전산시스템 모형을 제시하였다. 이것이 개발될 경우 전문인력의 효율적인 활용과 반복되는 의약품 허가서류 검토시에 발생하는 오류와 누락을 방지할 수 있고, 부정·불량의 약품에 대한 신속한 정보의 제공으로 의약품의 오남용과 부작용 위해를 예방하며, 연구기관, 단체등과 의약품 관련정보의 공유화를 통해 각종 현황자료의 입수, 분석과 향후 전략구상에 많은 도움을 줄 수 있을 것이다.

셋째, 새로운 전산시스템 모형 개발에 따른 비용-편익등 경제성을 분석한 결과 개발비용(3억 2천만원)보다 5년간의 누적가치로서 6배정도 (19억 3천 8백만원)의 가치가 나타나며, 년평균 투자회수율(ROI)이 121.1%로 증가되었다. 그밖에 조직의 기능향상, 파급효과등 현금으로 계산될 수 없는 무형의 이익이 커지기 때문에 경제성 측면에서 층분히 타당성이 인정된다.

따라서 의약품 허가관리 전산시스템의 개발은 조속한 시일내에 추진될 필요성이 있으며 이 업무의 성공적인 발전을 위해 첫째, 의약품 허가관리 담당부서 요원들에 대한 기본 전산교육과 의약품 허가관리 전산화의 필요성 교육등을 실시하여 전산화 업무의 인식을

새롭게 하고, 둘째, 자신의 업무를 보다 효율적으로 추진할 수 있는 시스템 개발에 적극적으로 참여하고 예산확보등 전산화 업무추진 여건조성에 능동적인 자세를 가지도륵 하여야 할 것이며 셋째, 연구기관, 단체등에서는 과거의 한정된 의식 구조에서 탈피하여 의약

품 정보의 체계화와 종합화 목적에 부응하는 효용가치 제고방안등 다양한 대응책을 강구하는데 주력하여야 할 것이다.

A STUDY OF DEVELOPMENT FOR NEW MODEL OF COMPUTER SYSTEM IN THE PHARMACEUTICALS

APPROVAL MANAGEMENT AND IT'S EVALUATION FOR ECONOMIC VALUE.

Soon Wook Hong

Graduate School of Health Science and Management, Yonsel University

(Directed By Prof. Young Moon Chae, Ph.D.)

As the pharmaceutical products play an increasingly great role in improving the

national standard of health, it is essentially required to computerize the

pharmaceuticals approval process in order to enhance the efficiency of

pharmaceutical administrative work which gets diversed and complicated.

The purpose of this study is to analyze the current computer system of approval

management and to develop a new model of computer system which improves the

pharmaceuticals approval management which requires increasing work load and higher

speciality. As a result of evaluating soundness of introducing a new computer

system in terms of economy, etc., the following conclusion has been obtained.

1) The pharmaceutical approval management system in current operation is centered

upon employment of statistics and ascertainment of approval-related points. The

dual work of manual approval management and computer inputting makes it difficult

to carry out efficient management. The system lacks in capability of collecting and

analyzing various information, and is weak in its function as a source of

approval-related information.

2) In order to solve such problems, a new computer system model, comprising a

system for registering approval-related(approval change-related) points, a

post-approval management system, a format of a computer network, etc., has been

suggested. When this model is developed, it will be possible to make efficient use

of special manpower: to prevent errors and omissions form being repeated at the

time of reviewing pharmaceutical approval-related documents: to prevent drug misuse

and overuse and harm from drug side effects by providing information about illegal

and low-quality drugs swiftyly.

3) The eveluation for economic value in the new computer system model shows that

the 5-year accumulated value of 1,938 million Won will be 6 times as high as the

development cost of 320 million Won and that the annual average

return-on-investment (ROI) will increase by 121.1%. Besides, stance such invisible

value as improvement of organizational functions pervasive effects, etc., which can

not be calculated in cash increases, there is enough soundness recognized of

developing the new computer system in terms of economy.

Therefore. there is need for proceeding with the development of a pharmaceutical

approval management computer system as early as possible. In order to ensure

successful evolution of this project. It is required:

1) to educate the personnel concerned of the pharmaceutical approval-related

department(s) upon basic computer operation and need for computerizing

pharmaceutical approval management and thus let them have better understanding of

the computerization work.

2) to have them actively participate in developing a system which will enable

them to carry out their works more efficiently and take an active posture toward

forming am environment for proceeding with the computerization project including

securing a budget.

[영문]

As the pharmaceutical products play an increasingly great role in improving the national standard of health, it is essentially required to computerize the pharmaceuticals approval process in order to enhance the efficiency of pharmaceutical administrative work which gets diversed and complicated.

The purpose of this study is to analyze the current computer system of approval management and to develop a new model of computer system which improves the pharmaceuticals approval management which requires increasing work load and higher

speciality. As a result of evaluating soundness of introducing a new computer system in terms of economy, etc., the following conclusion has been obtained.

1) The pharmaceutical approval management system in current operation is centered upon employment of statistics and ascertainment of approval-related points. The dual work of manual approval management and computer inputting makes it difficult

to carry out efficient management. The system lacks in capability of collecting and analyzing various information, and is weak in its function as a source of approval-related information.

2) In order to solve such problems, a new computer system model, comprising a system for registering approval-related(approval change-related) points, a post-approval management system, a format of a computer network, etc., has been

suggested. When this model is developed, it will be possible to make efficient use of special manpower: to prevent errors and omissions form being repeated at the time of reviewing pharmaceutical approval-related documents: to prevent drug misuse

and overuse and harm from drug side effects by providing information about illegal and low-quality drugs swiftyly.

3) The eveluation for economic value in the new computer system model shows that the 5-year accumulated value of 1,938 million Won will be 6 times as high as the development cost of 320 million Won and that the annual average return-on-investment (ROI) will increase by 121.1%. Besides, stance such invisible

value as improvement of organizational functions pervasive effects, etc., which can not be calculated in cash increases, there is enough soundness recognized of developing the new computer system in terms of economy.

Therefore. there is need for proceeding with the development of a pharmaceutical approval management computer system as early as possible. In order to ensure successful evolution of this project. It is required:

1) to educate the personnel concerned of the pharmaceutical approval-related department(s) upon basic computer operation and need for computerizing pharmaceutical approval management and thus let them have better understanding of the computerization work.

2) to have them actively participate in developing a system which will enable them to carry out their works more efficiently and take an active posture toward forming am environment for proceeding with the computerization project including

securing a budget.