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醫藥品品質向上을 爲한 保健行政學的 調査硏究

A Study for Improvement of Pharmaceutical Control -with Emphasis on Public Health Administration-

공중보건잡지 1967년 4권 2호 p.87 ~ 100
정춘영 (  ) - 서울대학교 보건대학원

Abstract


The following conclusion has been derived from the documentary study of the annual Statistical Reports of the Ministry of Health and Social Affairs, the Statistical Abstract of the United States, the Sanitation Laboratory Report of Japan, the Current Status Report of the National Institute of Health, and the activities reports of the Hygienic Laboratory of the Special City of Seoul and provincial hygienic laboratories, plus case studies conducted on the sex, age, salary, longivity of service and research record status of 397 managerial pharmaceutists of 170 pharmaceutical companies from Aug. I to 31, 1967
1) Current Production Status of Pharmaceutical Firms
The operating status of Pharmaceutical firms shows irregular yearly fluctuations. To break down the national product of pharmaceuticals by kind, medicines for digestive organs constitute 17.2 per cent of a total of 1,811 kinds of pharmaceuticals produced in this country, those for the central nervous system (including antifebriles) 17.0 per cent and nutrient preparations 15.1 per cent, thereby showing rather unbalanced proportions.
Raw pharmaceuticals constitute only 0.02 per cent. The small percent age occupied by raw pharmaceuticals, it is feared, may aggravate the unstable growth of pharmaceutical firms and the spread of quasi-pharmaceuticals. It may also hinder their stable business operation and supply of quality products. It may also give rise to an excessive competition among the firms.
To solve this problem, their managerial system should be switched to a system suitable for small and medium enterprises, and new pharmaceuticals should be developed through introduction of new ideas, thus to rationalize the pharmaceutical business.
2) Export and Import
The nation´s imports of pharmaceuticals are roughly equivalent in amount to six times their exports. Moreover, as 82 per cent of the exports is constituted by herb medicines, while only 18 per cent accouts for ordinary pharmacreuticals.
In order to improve the balance of export, the pharmaceutical industry should be modernized to produce high quality medicines and to seek to exploit overseas makets.
3) Comparison of Marketing Status of Pharmaceuticals in Various Nations
in the U. S. and Britain, initiative is held by pharmacies and ratail stores in marketing pharmaceuticals be cause means of transportation are relatively developed in those countries, their peoples have high degrees of understanding about science, and their formation of capital is balanced. In Japan however, the maketing is still under the influence of wholesalers. In Korea, different considerations is required in different areas in the course of selecting appropriate marketing processes due to the financial weakness of wholesalers, the low standards of popular understanding about pharmacenticals or medicines, and the unconvenient means of transportation.
4) Indequate Quality Control
It is almost impossible to set standards for pharmaceuticals as long as numerous kinds of pharmaceuticals are produced in small quantity. The quality control is very inadequate at present inasmuch as it is conducted for the sole purpose of passing the quality inspection. Little zeal was noted of pharmaceutical manufacturers for quality improvement.
5) Inadequate Number of Managerial Pharmacists
Each firm has an average of two of three pharmacists controlling production and/or quality of pharmaceuticals. This is from adequate. The greatest proportion of 25.7 per cent of them was constituted by those with duration of employment for one year to three years and the second greatest percentage of 22.4 per cent by those with duration of one less. This indicates their unstable employment as well as the short number of qualified pharmacists employed by pharmaceutical firms. Such a status of their employment it is believed, in turn makes them to dislike their work, and hinders their exercise of creativity for research work and hinders their exercise of creativity for research work and technical improvement. This is believed to bar the scentific operation of the pharmaceutical industry in this country.
As a means to improve this situation, it is suggested that an adequate number of pharmacists be employed for both management and production; and their treatment improved. so that they may have a sense of stable employment and begin to like their work. In order to help them continue research activities, it is also recommended that they be sent to schools or other research institutions for retraining under a long-range plan for securing and adequate number of pharmacists and other technical personnel.
Also nesessary is to conduct training within pharmaceutical firms by means of inviting lecturers from outside and sending employees to inspect other firms of advanced installations. The development and improvement of products should thus be sought under a plan to utilize, to the maximun extent, the academic knowledge and technical know-how acquired under the training program.
6) Gradual Switch to Local Autonomy System
It is, of course, important to strengthen the local autom mous system of pharmaceutical administration. However, a centralized administration is believed more effective in view of the currently inadequate budget, personnel and facilities. Therefore, the current system should be gradually replaced with local autonomous system simultaneously with securing adequate budget, personnel and facilities.
7) Enactment and Enforcement of Appropriate Law
In order to set up an administrative system to effectively enforce the technical administation, it is believed necessary to enact and enforce laws, which are scientific and suitable to the current situation.
8) Delegation of Authority
Being a highly specialized and technical administration, the pharmaceutical administration is believed to need the elastic delegation of authority to lower authorities as well as the discernable enforcement of legislated laws.
8) Strict Control of Substandard Pharmaceuticals
The research and inspection agencies should be strengthened, thus to more adquately guide and foster the pharmaceutical industry, and to strictly control substandard pharmaceuticals both before and after their production.

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