의약품 부작용 보고에 대한 의사 및 약사의 인식도와 관련된 요인 연구

Abstract

[영문]

[한글]

A STUDY ON THE PERCEPTION OF REPORTING OF ADVERSE DRUG REACTI0N FOR DOCTORS AND

PHARMACISTS AND ITS

Shin Sil Kim

Dept. of Public Health

Graduate School of health, Sc i once and Management, Yonsei University

(Directed by Professor Young Moon Chae, Ph. D.)

Since the implementation of "The Regulation on the management of Pharmaceutical

Safety Information", lower perception of Adverse Drug Reaction(ADR ) for doctors

and pharmacists has been recognized as a main cause of under-reporting of ADR.

Thus, there is a need for study on the perception of ADR reporting for doctors

and pharmacists and its influencing factors in order to improve its reporting

system.

In this study. 176 subjects were selected using multistage stratified randomized

sampling from the nationwide population of doctors and pharmacists in April.1993.

Three types of analysis were performed :

(1) general characteristics, knowledge level, credibility ,their attitude and

perception were analyzed by t-test and oneway-ANOVA test :

(2) influenting factors were identified from the correlation and

multiple-regression analysis : and

(3) Ways to improve reporting system were identified by chi-square test and

percentage.

The results were as fort clews:

1. Perception level of ADR reporting of most repondents were relatively high :

whereas their knowledge and credibility to ADR reporting system was very low.

However, as knowledge revel and credibility in administrative activities of

regulatory authority for countermeasurement on drug safety management increase, the

level of perception of ADR reporting system also increases.

2. 70.9% of repondents has received complaints of ADRs from patients during a

period of one year : and 43.4? of ADRs had serious ones which required

discontinuation of therapy.

3. Determinant factors affecting AOR reporting system were a positive attitude on

safety fund for ADR and the previous experience of reporting to the company. This

shows that such practical safety measured were significant main variable affecting

ADR reporting system.

4. Of 176 respondents, 56.8% didn't know whether their hospitals have been

designated as mom toping institute or not. Those institute which aware of being

designated had higher level of perception on ADR reporting system than those which

d? not aware or mien-designated. Pharmacists, female, dermatologic and pediatric

specialists had significantly statistically higher perception level than doctors,

male. and other specialties.

5. With retard to the ways to improve the System, 91.5% suggested active

promotion by regulatory authority: whereas only 52.8% suggested incentive system

for reporting.

With regard to the possible foreign ADR monitoring system to be introduced in

Korea, regulatory monitoring was most preferred measure with 80.7% : whereas

compulsory monitoring and reward system were shown lower reponse rate with 44.3%

and 36.9%, respectively.