1.Pregnancy outcome following first trimester exposure to Terbinafine Hydrochloride : A case series survey
MASAHIRO HAYASHI ; RITSUKO YAMANE ; MASA TANAKA ; KAYOKO HISHINUMA ; KAYOKO OGAWA ; IKUKO YOKOO ; HIROAKI KITAGAWA
Japanese Journal of Drug Informatics 2009;11(1):31-34
Objective: Treatment of tinea unguium with topical drugs alone is difficult, and medication with oral terbinafine hydrochloride is necessary in many cases. Since Trychophyton infects the nails in not only men but also women at a reproductive age, the influence on a fetus of the drug ingested during early pregnancy is a matter of concern of many women. The objective of this study was to investigate the influence of oral terbinafine hydrochloride on fetuses.
Methods: The outcomes were investigated in pregnant women who ingested terbinafine hydrochloride and visited the ‘Outpatient Services for Consultation on Pregnancy and Drugs (Teratology Information Services)’ of Toranomon Hospital, and cases were collected.
Results: Fifteen pregnant women ingested the drug during the organogenic period, in which the teratogenic risk is the highest. All 15 pregnant women gave birth to healthy babies.
Conclusion: This is the first survey concerning newborns delivered by women who ingested terbinafine hydrochloride during pregnancy in Japan. All investigated women gave birth to healthy babies, and the incidence of congenital abnormalities did not markedly exceed that in the general population. Since the number of cases was small, it is necessary to perform a cohort study to investigate details of the safety for fetuses.
2.Survey regarding pregnant women receiving novel antipsychotic agents
RITSUKO YAMANE ; MASAHIRO HAYASHI ; MASA TANAKA ; KAYOKO HISHINUMA ; KAYOKO OGAWA ; IKUKO YOKOO ; HIROAKI KITAGAWA
Japanese Journal of Drug Informatics 2009;11(1):35-38
Objective: Novel antipsychotic agents less frequently cause extrapyramidal side effects compared to conventional antipsychotic agents, contributing to improvement in the QOL. Recently, these agents have also been increasingly prescribed to females who may become pregnant. In Japan, no epidemiological survey regarding the application of novel antipsychotic agents in pregnant women has been published. In this study, we investigated the influence on fetuses in pregnant women receiving novel antipsychotic agents.
Methods: In pregnant women on novel antipsychotic agents who consulted the Pregnancy and Drug Consultation Outpatient Clinic of Toranomon Hospital, the outcome of pregnancy was confirmed.
Results: Twenty-nine pregnant women took novel antipsychotic agents in the organogenesis phase, in which the risk of teratogenicity is the highest. The agents consisted of olanzapine in 8 patients, risperidone in 11, quetiapine fumarate in 7, and perospirone hydrochloride hydrate in 4. The outcomes of pregnancy were full-term delivery in 24 patients, premature delivery in 1, spontaneous abortion in 2, and artificial abortion in 2. Of the 29 patients, 15 (60%) had continuously taken these agents until delivery. All 25 neonates were healthy without malformation.
Conclusion: This report describes the first prospective survey in Japan regarding infants delivered by pregnant women receiving novel antipsychotic agents. All patients delivered healthy neonates; the incidence of congenital anomalies did not exceed that in the general population. This survey included a small number of patients; cohort studies should be conducted to evaluate the safety in fetuses.
3.Design of Educational Programs for Japanese Nurses Who Transfer Nursing Knowledge and Skill in Developing Countries
Naoko HAYASHI ; Junko TASHIRO ; Michiko HISHINUMA ; Naoko ARIMORI ; Yuko HIRABAYASHI ; Kayoko HIRANO
Journal of International Health 2008;23(1):23-31
Since the 1960s, Japanese nurses have been working as international nursing collaborators with or for the people in developing countries in order to promote health through transferring nursing knowledge and skill. However a number of nurses reported that they did not have enough competencies as international nursing collaborators. The objectives of this study were: a) to describe the experiences of Japanese international nursing collaborators whose mission was transferring nursing knowledge and skill and b) to determine their learning needs as international collaborators, and to design educational programs (graduate program) based on the results of survey. The participants of this study were twenty-seven nurses who had had an international collaborative mission and stayed in a developing country for more than one year. Semi-structured group or individual interviews were used in order to describe activities process and leaning needs as international collaborators. The interview data were analyzed using content analysis from the viewpoint of competency and learning needs. Nurses reported needs in two major areas: Fundamental Competences and Knowledge, and Required Competences for Development of International Collaborative Tasks. Fundamental Competences and Knowledge consisted of nine components: (1) cross-cultural experiences, (2) acceptance of cultural differences, (3) professional experience, (4) degree and qualifications, (5) philosophy of nursing, (6) language, (7) interdisciplinary knowledge for international cooperation activities, (8) knowledge about own project, and (9) knowledge on theories of international cooperation. Required Competences for Development of International Collaborative Tasks consisted of thirty components which were divided into four phases (personal competences, preparation and planning phase, implementation phase, and after project.) Based on the result of this survey the investigators designed the international nursing graduate program. The program has started from the academic year of 2005 at the investigators' college. The progress of students' learning and outcomes of these educational programs should be monitored using formative evaluation.