Identification and International Comparison of Drugs Contraindicated for Pregnant Women in the Package Inserts / 医薬品情報学

Objective: The package inserts are official clinical decision-making documents that provide pharmacological treatment information. However, it has been noted that package inserts on perinatal drug usage differ greatly from expert opinions. This study identified Japanese package insert drugs that are contraindicated for pregnant women and compared them to foreign risk categories.Methods: The survey included 19,022 drugs on the drug pricing list as of April 2022, with package inserts available on the Pharmaceuticals and Medical Devices Agency website. We retrieved the package inserts with the word “pregnant” in the “Contraindications” section and reviewed the descriptions to exclude those that satisfied the exclusion criteria. We also checked the foreign risk categories of contraindicated ingredients for pregnant women. This study used the Australian Therapeutic Goods Administration’s categorization for prescribing medicines in pregnancy (the TGA classification).Results: Of the 19,022 medicines studied, 4,111 (21.6%) were contraindicated for pregnant women. Conversely, 19 (5.1%) ingredients categorized under the relatively safe TGA classifications A, B1, and B2 were also contraindicated for pregnant Japanese women.Conclusion: This study revealed that Japanese package inserts contraindicate over 20% of drugs for pregnant women. On the other hand, some forbidden ingredients did not match the foreign risk categories. Therefore, healthcare professionals should be aware of the limitations of Japanese package inserts concerning pregnant women and make careful decisions based on both package inserts and additional drug information.

Epidemiological survey to establish thresholds for influenza among children in satellite cities of Tokyo, Japan, 2014–2018

@#Objective: We described the characteristics of children reported as having influenza across five consecutive influenza seasons and investigated the usefulness of setting influenza thresholds in two satellite cities of Tokyo, Japan. Methods: An annual survey was conducted among parents of children at preschools (kindergartens and nursery schools), elementary schools and junior high schools in Toda and Warabi cities, Saitama prefecture, at the end of the 2014–2018 influenza seasons. Using the World Health Organization method, we established seasonal, high and alert thresholds. Results: There were 64 586 children included in the analysis. Over the five seasons, between 19.1% and 22% of children annually were reported as having tested positive for influenza. Influenza type A was reported as the dominant type, although type B was also reported in more than 40% of cases in the 2015 and 2017 seasons. The median period of the seasonal peak was 3 weeks in mid-January, regardless of school level. Of the five surveyed seasons, the high threshold was reached in 2014 and 2018, with no season exceeding the alert threshold. Discussion: This study provides insights into the circulation of influenza in children in the study areas of Toda and Warabi, Japan, from 2014 to 2018. Although we were able to utilize these annual surveys to calculate influenza thresholds from five consecutive seasons, the prospective usefulness of these thresholds is limited as the survey is conducted at the end of the influenza season.

Associations of education and income with hazardous drinking among postpartum women in Japan: results from the TMM BirThree Cohort Study

BACKGROUND@#Although the postpartum period is suggested to provide an ideal opportunity for interventions to prevent hazardous drinking, evidence on the associations of education and income with hazardous drinking during this period is limited, including in Japan.@*METHODS@#We analyzed data from 11,031 women who participated in the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study in Japan. Hazardous drinking was defined as ethanol intake of ≥20 g/day 1 year after delivery. We conducted multiple logistic regression analyses to examine whether educational attainment or equivalent household income was associated with hazardous drinking, adjusting for age, parity, drinking status during pregnancy, work status, postpartum depression, breastfeeding, and income/education. We also conducted stratified analyses by income and education groups.@*RESULTS@#The prevalence of hazardous drinking 1 year after delivery was 3.6%. Lower education was associated with hazardous drinking; the odds ratio (95% confidence interval) of high school education or lower compared with university education or higher was 2.17 (1.59-2.98). Lower income was also associated with hazardous drinking, but this association disappeared after further adjustments for education; the odds ratios (95% confidence intervals) of the lowest compared with highest level of income were 1.42 (1.04-1.94) and 1.12 (0.81-1.54), respectively. A significant interaction was detected; lower education and lower income were associated with increased risks of hazardous drinking only in a lower income group and lower education group, respectively.@*CONCLUSIONS@#Postpartum women with lower education and lower income had higher risks of hazardous drinking in Japan.

The prevalence of psychological distress during pregnancy in Miyagi Prefecture for 3 years after the Great Eas t Japan Earthquake

BACKGROUND@#To examine changes in psychological distress prevalence among pregnant women in Miyagi Prefecture, which was directly affected by the Great East Japan Earthquake and tsunami, and compare it with the other, less damaged areas of Japan.@*METHODS@#This study was conducted in conjunction with the Japan Environment and Children`s Study. We examined 76,152 pregnant women including 8270 in Miyagi Regional Center and 67,882 in 13 other regional centers from the all-birth fixed data of the Japan Environment and Children's Study. We then compared the prevalence and risk of distress in women in Miyagi Regional Center and women in the 13 regional centers for 3 years after the disaster.@*RESULTS@#Women in the Miyagi Regional Center suffered more psychological distress than those in the 13 regional centers: OR 1.38 (95% CI, 1.03-1.87) to 1.92 (95% CI, 1.42-2.60). Additionally, women in the inland area had a consistently higher prevalence of psychological distress compared to those from the 13 regional centers: OR 1.67 (95% CI, 1.18-2.38) to 2.19 (95% CI, 1.60-2.99).@*CONCLUSIONS@#The lack of pre-disaster data in the Japan Environment and Children's Study made it impossible to compare the incidence of psychological distress before and after the March 2011 Great East Japan Earthquake. However, 3 years after the Great East Japan Earthquake, the prevalence of pregnant women with psychological distress did not improve in Miyagi Regional Center. Further, the prevalence of mental illness in inland areas was consistently higher than that in the 13 regional centers after the disaster.

The Usage of Acetylsalicylic Acid for Lenalidomide Medication in Patients with Multiple Myeloma / 医薬品情報学

Lenalidomide (LD) was reported to increase the risk of thromboembolism when it was used along with dexamethasone (DEX). Prophylactic administration of antithrombotic drugs against thromboembolism has been recommended for proper use of LD, but none of the recommendation is stated in the package insert. The purpose of this study was to elucidate the usage of acetylsalicylic acid (ASA) for lenalidomide medication in patients withmultiple myeloma. We used the MDV analyzer to investigate clinical data retrospectively. The investigation period was from October 1, 2016 to September 30, 2017. Subjects were outpatients aged 20 years or older who were recorded in clinical data as multiple myeloma. There were 7,590 outpatients with multiple myeloma. They were divided into 4 groups by the combined use situation of LD and DEX: LD/DEX non-use group (n＝5,462), DEX alone group (n＝632),LD alone group (n＝203), and LD/DEX together group (n＝1,293), respectively. The prevalence rate of thromboembolism was 7.3% in the DEX alone group and 16.9% in the LD/DEX together group (p＜0.0001). Among the LD/DEX together group, ASA was prescribed at 63.6% in the group without thromboembolism (n＝1,074). The prevalence rate of thromboembolism was higher in the LD/DEX combined group than in the DEX alone group. Considering these findings, risk management for thromboembolism caused by administration of antithrombotic drugs should be considered. It is necessary to create more evidence concerning the necessity of administration of antithrombotic drug in combination with LD/DEX medication.

Awareness of Nursing Students about the Importance of Folic Acid Intake for the Prevention of Neural Tube Defects / 日本補完代替医療学会誌

Objective: Adequate periconceptional intake of folic acid decreases the risk of neural tube defects of infant. The present study aimed to investigate the awareness of nursing students about the importance of folic acid intake for the prevention of neural tube defects.Design: Questionnaire survey.Methods: A self-administered questionnaire regarding the importance of folic acid intake for the prevention of neural tube defects was distributed to 423 nursing students of Tohoku University and Tohoku Fukushi University.Results: Among the 408 respondents (response rate; 96.5%), 129 (31.6%) nursing students were aware that folic acid intake decreases the risk of neural tube defects. In the multivariate logistic regression analysis, grade 3-4 (odds ratio = 11.779, 95% confident interval = 5.739-24.177) were associated with the awareness of the importance of folic acid intake among nursing students. Of 129 nursing students who recognized the importance of folic acid intake, 52 (40.3%) and 11 (8.5%) recognized that women should begin folic acid intake before conception and should take about 400μg of folic acid per day during pregnancy respectively.Conclusion: About 30% of nursing students recognized that folic acid intake decreases the risk of neural tube defects and many did not know the details of the effective intake for the prevention of neural tube defects. Therefore, more aggressive promotion of the awareness of the importance of folic acid intake among nursing students is warranted.

Awareness of Pharmacy Students regarding the Importance of Folic Acid Intake for the Prevention of Neural Tube Defects / 医薬品情報学

<b>Objective: </b>Adequate periconceptional folic acid intake decreases the risk of neural tube defects in infants.  The present study aimed to investigate the awareness of pharmacy students regarding the importance of folic acid intake for the prevention of neural tube defects.<br><b>Design: </b>Questionnaire survey.<br><b>Methods: </b>A self-administered questionnaire regarding the importance of folic acid intake for the prevention of neural tube defects was distributed to 750 pharmacy students at Tohoku and Ohu Universities.<br><b>Results: </b>Among the 685 respondents (response rate; 91.3%), 74 (10.8%) were aware that folic acid intake decreases the risk of neural tube defects.  In multivariate logistic regression analysis, awareness of the importance of folic acid intake was evident among 5th- and 6th-year pharmacy students (odds ratio=3.352, 95% confidence interval=1.797-6.253) and among those who used dietary supplements (2.275, 1.306-3.966).  Among the 74 pharmacy students who recognized the importance of folic acid intake, 17 (23.0%) and 3 (4.1%) were aware that women should begin taking a folic acid supplement before conception and should take about 400 μg per day during pregnancy, respectively.<br><b>Conclusion: </b>Only about 10% of the pharmacy students in this study recognized that folic acid intake decreases the risk of neural tube defects, and many were unaware of the recommended intake amount.  Therefore, awareness of the importance of folic acid intake must be more aggressively promoted among pharmacy students.

Pharmacists’ Awareness of the Importance of Folic Acid Intake for the Prevention of Neural Tube Defects / 医薬品情報学

<b>Objective: </b>Adequate periconceptional intake of folic acid decreases the risk of neural tube defects.  The present study aimed to investigate pharmacists’ awareness of the importance of folic acid intake for the prevention of neural tube defects and to identify factors associated with pharmacists’ awareness.<br><b>Design: </b>Questionnaire survey.<br><b>Methods: </b>A self-administered questionnaire regarding the importance of folic acid intake for the prevention of neural tube defects was distributed to pharmacists who attended educational seminars offered by the Sendai City Pharmaceutical Association in December 2010.<br><b>Results: </b>Among the 166 respondents, 104 (62.7%) pharmacists were aware that folic acid intake decreases neural tube defects.  After stratification for age and sex including history of delivery, female gender and history of delivery were significantly associated with the awareness of the importance of folic acid intake only among pharmacists younger than 40 years old. Of 104 pharmacists who recognized the importance of folic acid intake for the prevention of neural tube defects, 51.0% and 27.9% recognized that women should begin intake of folic acid before conception and should take about 400 μg of folic acid per day during pregnancy, respectively.<br><b>Conclusion: </b>Although about 60% of pharmacists recognized that folic acid intake decreases the risk of neural tube defects, many did not know the intake level required to effectively prevent neural tube defects.  Therefore, more aggressive promotion of the awareness of the importance of folic acid intake among pharmacists is warranted.