A questionnaire survey of risk management systems for medical products was conducted with the cooperation of domestic and foreign pharmaceutical companies. As for the foreign companies, it was revealed that specialized safety management teams and data-management committees are established to formulate risk management plans in order to create systems that assure consistent risk management for each company. In addition, it was revealed that toxicologists are incorporated in the central decision making organization. As for domestic companies, it turned out that no less than half of the respondents pay attention to consistent risk management from the development stage through the post marketing stage. From now on, it will be essential to consolidate safety data, improve the accessibility of centralized safety data from the relevant departments, and establish systems to provide consistent risk management from the development stage to the post marketing stage.

Purpose: Many types of antihistamines used for the treatment of allergic rhinitis induce drowsiness as a side effect. Whether or not patients taking the internal drugs know of this untoward effect is a matter of importance. Recently we conducted a questionnaire survey to know how many patients are aware of this.Method: The subjects were 257 patients who visited our hospital for treatment of alergic rhinitis and took the prescription from February through March this year. The patients filled in a questionnaire given at the window of the dispensary. All the participants in this survey gave their informed consent.Results: Effective replies (90.3%) were obtained from 232 patients (mean age: 53.5±17.5; sex: 85 males and 147 females). Of those respondents, 45 individuals (19.9%) said they did not know that the antihistamines produce drowsiness. Furthermore, the survey found that 24 out of the 45 individuals were actually taking the type of antihistamine that caused drowsiness and 21 individuals were not given any explanation of the side effect by their doctors. The patients said that if they knew of the side effect they would not have taken the medicine. Moreover, it was found that 10 out of the 21 patients drove their cars while they felt drowsy.Conclusions: The survey revealed the hard fact that the drowsiness as side reaction the patients might have after taking antihistamines was made light of. The findings brought home to us the importance of giving clear directions to the patients about the medicine and the precaution against the side effects.
Drowsiness ; Surveys ; Antihistamines ; adverse effects ; Effective

High-quality terminal care cannot be given without good communication and understanding among patients, their family members and health as well as medical professionals.Recently, we have taken a questionnaire survey on new inpatients in our hospital to sound them out on their thinkings about hospital care, and examined the findings along with the validity of survey.Many respondents including those contracting either benign or malignant diseases wished to be keptposted on what they are really up against and to partake in the decision-making process before treatment plans are put into practice. The recent questionnaire survey has proved to be worthwhile as a tool to know the wishes of hospitalized patients and suggested an effective way to promote the practice of obtaining informed consent before specific test and therapautic procedure.

Background: The demand for palliative care in Japan has risen over recent years, and training of palliative care physicians is an important problem. However, little is known about unmet needs for education and training systems as well as career development among young physicians who wish to specialize in palliative care. Purpose: To explore unmet needs among palliative care physicians in training. Method: We held group discussions in a forum for physicians of postgraduate year≦15, and analyzed their opinion on topics such as "what are unmet needs?" using theme analysis. Results: Forty physicians participated. Theme analysis revealed the following unmet needs among young physicians; "securing of manpower", "securing of quality of training programs/education", "improvement of network", "removal of many barriers to keeping on a palliative care physician", and "establishment of career models for a specialist". Conclusions: We should discuss solutions for the unmet needs to secure more palliative care physicians.