著者
栗原 千絵子 松本 佳代子 石光 忠敬
出版者
公益社団法人 日本薬学会
雑誌
YAKUGAKU ZASSHI (ISSN:00316903)
巻号頁・発行日
vol.123, no.3, pp.91-106, 2003-03-01 (Released:2003-03-26)
参考文献数
102
被引用文献数
1 1

The Japanese Pharmaceutical Law was revised at the end of July 2002. The important features of this revision are the postmarketing safety scheme, especially for biological products, and reconstruction of the legislation for effective pharmaceutical development. This is based on the national policy to foster life sciences such as genetic research and regenerative medicine for both healthcare improvement and industrial promotion. Such research requires study participants who donate human tissue including abandoned embryos or aborted fetuses, which may touch the human dignity. In particular, fetal stem cell research appears to have unpredictable risks not only to women who undergo abortions but also to societal epistemology. The authors conducted risk-benefit assessment of fetal stem cell research, reviewing the scientific, ethical, legal, and social aspects, including a case study of critical appraisal on a report of the double-blind, sham surgery-controlled trial of implantation of fetal tissues in patients with Parkinson's disease conducted in the USA. It is concluded that risk-benefit assessment with a wide, profound perspective is necessary for advanced biotechnology. Some types of research should not be assessed based only on such utilitarian viewpoints as risk and benefit. Conscientious reflection is necessary to reach a public consensus on which types of human material can be utilized as research or pharmaceutical resources.
著者
松本 佳代子 福島 紀子 小林 静子 津谷 喜一郎
出版者
一般社団法人 日本薬剤疫学会
雑誌
薬剤疫学 (ISSN:13420445)
巻号頁・発行日
vol.4, no.1, pp.47-57, 1999-05-31 (Released:2011-02-28)
参考文献数
14
被引用文献数
1 1

Objectives : High and medium-dose combination hormone agents have long been used in their off-label use as oral contraceptives. Oral contraceptives (the low-dose pill) are expected to be approved by the standing committee of the Central Pharmaceutical Affairs Council in June 1999, and are expected to be on the market by autumn, available to anyone bearing a doctor's prescription. A survey was conducted of pharmacy students to determine their acceptance and their perceptions of oral contraceptives (the low-dose pill). The results are discussed along with ways of dealing with the scientific information on the possible soon to be approved oral contraceptives (the low-dose pill), and some proposals are made for the future.Methods : The survey was conducted by distributing questionnaire sheets to female pharmacy college students in September 1996. Of the 670 subjects, 98 responded positively to the use of oral contraceptives (the positive group), while 572 preferred not to use them (the negative group). The two groups were compared and the data was analyzed. Mantel-Haenszel test was used to evaluate demographic and background data, their views on using oral contraceptives (the low-dose pill) and ways of obtaining necessary information.Results : In the responses to the questions on how the subjects feel about oral contraceptives (the low-dose pill), the positive group gave these reasons more frequently than those in the negative group : simple to use (p<0.001), a method with a high contraceptive rate (p<0.001), a means of contraception controlled by the woman (p<0.001). On the other hand, the reasons given more frequently by the negative group : feeling concerned about adverse drug reactions (p<0.001), a method allowing sexually transmitted diseases to propagate (p=0.009), a method increasing the burden on the woman (p<0.001).In terms of the subjects' knowledge of oral contraceptives (the low-dose pill), although there has been some improvement observed during their four-year college life, they did not seen to understand accurate information.Conclusion : The surveyed subjects had not understood accurate information, and this lack of knowledge may have formed their biased views on oral contraceptives (the low-dose pill). Given such results, it is anticipated that such misconceptions may affect their own decision-making in their use of the drug, and that it would cause inefficiency in providing future users with accurate information when these students become pharmacists. In the near future, there is expected to be a deluge of information concerning the low-dose pill. It is clearly necessary in pharmaceutical education to provide proper training of pharmacy students for self-education so as to increase efficiency when considering and evaluating information.