Japanese Drug Research Articles

Toward a unified understanding of drug-drug interactions: mapping Japanese drug codes to RxNorm concepts.

Linking information on Japanese pharmaceutical products to global knowledge bases (KBs) would enhance international collaborative research and yield valuable insights. However, public access to mappings of Japanese pharmaceutical products that use international controlled vocabularies remains limited. This study mapped YJ codes to RxNorm ingredient classes, providing new insights by comparing Japanese and international drug-drug interaction (DDI) information using a case study methodology. Tables linking YJ codes to RxNorm concepts were created using the application programming interfaces of the Kyoto Encyclopedia of Genes and Genomes and the National Library of Medicine. A comparative analysis of Japanese and international DDI information was thus performed by linking to an international DDI KB. There was limited agreement between the Japanese and international DDI severity classifications. Cross-tabulation of Japanese and international DDIs by severity showed that 213 combinations classified as serious DDIs by an international KB were missing from the Japanese DDI information. It is desirable that efforts be undertaken to standardize international criteria for DDIs to ensure consistency in the classification of their severity. The classification of DDI severity remains highly variable. It is imperative to augment the repository of critical DDI information, which would revalidate the utility of fostering collaborations with global KBs.

α-Pyrrolidinohexanophenone (α-PHP) and α-Pyrrolidinoisohexanophenone (α-PiHP): A Review.

New Psychoactive Substances are currently a serious and growing problem affecting public health worldwide. By 2022, 1184 of these substances had been identified over a period of 16 years. Within these, α-pyrrolidinohexanophenone (α-PHP) and α-pyrrolidinoisohexanophenone (α-PiHP) have emerged, two synthetic cathinones from the pyrovalerone derivates subgroup that are positional isomers of each other. Alpha-PHP appeared on the Japanese illicit drug market in 2014 and, two years later, α-PiHP was identified for the first time in China. They were placed in schedule II on the list of Psychotropic Substances under International Control in 2020 and in March 2023, respectively. Both cathinones have no therapeutic potential for medical use and therefore are abused for recreational habits, which can lead to fatalities. The most frequent adverse effects reported are cardiac, psychiatric, and neurologic, and fatal intoxications have already been described. In Portugal, their consumption and consequent seizures are more prevalent on the archipelagos, which has been aggravating the health situation. In conclusion, these types of substances are a challenge for forensic toxicology since they are easily synthesized, modified, and placed on the market. Therefore, more studies to develop analytical methods to detect them and more comprehensive legislation should be applied. Thus, this review aimed to address the legislative, physicochemical, toxicological, and analytical aspects of both substances.

Streamlining Considerations for Safety Measures: A Predictive Model for Addition of Clinically Significant Adverse Reactions to Japanese Drug Package Inserts.

The addition of clinically significant adverse reactions (CSARs) to Japanese package inserts (PIs) is an important safety measure that can be used to inform medical personnel of potential health risks; however, determining the necessity of their addition can be lengthy and complex. Therefore, we aimed to construct a machine learning-based model that can predict the addition of CSARs at an early stage due to the accumulation of both Japanese and overseas adverse drug reaction (ADR) cases. The target comprised CSARs added to PIs from August 2011 to March 2022. The control group consisted of drugs without the same CSARs in their PIs by March 2022. Features were generated using ADR case accumulation data obtained from the Japanese Adverse Drug Event Report and the U.S. Food and Drug Administration Adverse Event Reporting System databases. The model was constructed using DataRobot, and its performance evaluated using the Matthews correlation coefficient. The target for the addition of CSARs included 414 cases, comprising 302 due to domestic case accumulation, 22 due to both domestic and overseas case accumulation, 12 due to overseas case accumulation, and 78 due to revisions of the company core data sheet. The best model was a generalized linear model with informative features, achieving a cross-validation of 0.8754 and a holdout of 0.8995. In conclusion, the proposed model effectively predicted CSAR additions to PIs resulting from the accumulation of ADR cases using data from both Japan and the United States.

Current Advances in Japanese Encephalitis Virus Drug Development.

Japanese encephalitis virus (JEV) belongs to the Flaviviridae family and is a representative mosquito-borne flavivirus responsible for acute encephalitis and meningitis in humans. Despite the availability of vaccines, JEV remains a major public health threat with the potential to spread globally. According to the World Health Organization (WHO), there are an estimated 69,000 cases of JE each year, and this figure is probably an underestimate. The majority of JE victims are children in endemic areas, and almost half of the surviving patients have motor or cognitive sequelae. Thus, the absence of a clinically approved drug for the treatment of JE defines an urgent medical need. Recently, several promising and potential drug candidates were reported through drug repurposing studies, high-throughput drug library screening, and de novo design. This review focuses on the historical aspects of JEV, the biology of JEV replication, targets for therapeutic strategies, a target product profile, and drug development initiatives.

Lack of information on gender differences in the package inserts of prescription drugs in Japan.

The package inserts of prescription drugs provide essential information for the proper administration of pharmacotherapy. The incidence of adverse reactions for several drugs is known to be higher in women than in men. However, no studies have examined whether information on gender differences is included in Japanese package inserts. Therefore, this study investigated information on gender differences in the package inserts of Japanese prescription drugs, using the drug information database JAMES provided by the Medical Information System Development Center and the Japan Pharmaceutical Information Center. Non-proprietary names of prescription drugs were yielded 1,679 in Japan. Of the 1,679 ingredients in package inserts of prescription drugs, 76 (4.5%) included information on gender differences. The number of inserts that contained information on gender differences in the "DOSAGE AND ADMINISTRATION," "ADVERSE REACTIONS," and "PHARMACOKINETICS" sections was 3, 16, and 62, respectively. Furthermore, in the "ADVERSE REACTIONS" section, 15 of the 16 inserts mentioned a higher frequency of adverse reactions in women compared with men. Importantly, most of the inserts with information on gender differences in the "PHARMACOKINETICS" section mentioned a higher area under the curve for women than for men. Most of the package inserts of prescription drugs with information on gender differences provide useful information aimed at preventing risks in women. However, there is an extreme lack of information on gender differences in the package inserts of prescription drugs in Japan, and we consider enhancing information on gender difference as an urgent issue.

Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model

PurposeTo develop a machine learning (ML)-based model for predicting the addition of clinically significant adverse reaction (CSAR)-associated information to drug package inserts (PIs) based on information of adverse drug reaction (ADR) cases during the post-marketing stage in Japan.MethodsWe collected data on CSARs added to PIs from August 2011 to March 2020. ADR cases that led to CSARs resulting in PI revisions were considered as a positive case, and ML was used to construct a binary classification model to predict the PI revisions. We selected 34 features based on the ADR aggregate data collected 6 months before PI revisions. Prediction performance was evaluated using the Matthews correlation coefficient (MCC).ResultsWe found CSAR information added to PIs in 617 cases, 334 of which were due to the accumulation of domestic cases, and used only domestic case data for the prediction model. Among prediction models developed using several kinds of algorithms, the support vector machine with the radial basis function kernel with feature selection showed the highest predictive performance, having an MCC of 0.938 for the cross-validation and 0.922 for the test dataset. The feature with the highest importance in the model was the “average number of patients reported per quarter.”ConclusionOur model accurately predicted PI revisions using information on ADR cases that occurred 6 months before. This is the first ML model that can predict the necessary safety measures and is an efficient method for guiding the decision to adopt additional safety measures early.

Assessment of satisfaction with antiretroviral drugs and the need for long-acting injectable medicines among people living with HIV in Japan and its associated factors: a prospective multicenter cross-sectional observational study

BackgroundLong-acting injectable formulations for HIV infection have been approved and are now available in Japan. Although not currently recommended as first-line drugs in Japanese or overseas guidelines, use of such formulations may increase, in accordance with patient conditions and preference. We determine the level of satisfaction with current anti-HIV drugs and analyzed the preferences of patients who favor long-acting injectable drugs based on their satisfaction level with the present anti-HIV drugs.MethodsPeople living with HIV (PLWH) who had received antiretroviral therapy (ART) for at least one month and consented to the study between 1 April and 31 December 2021 were included in a survey conducted using a self-administered questionnaire. The content of the survey included satisfaction with seven items (tablet size, ease and feeling when taking the medicine, color, taste, portability, daily oral therapy, and co-payment) related to the anti-HIV drugs they were taking and their need for future drugs (dosage form, frequency of dosing, long-acting injectable, etc.). In addition, factors related to the need for long-acting injectable medications were analyzed with regard to the relationship with satisfaction with anti-HIV drugs.ResultsOverall, 667 patients available for analysis were included in this study. Satisfaction with anti-HIV drugs was highest with regard to “co-payment” and lowest with “daily oral therapy”. Regarding the need for long-acting injectable medications, logistic regression analysis indicated that tablet size and daily oral therapy were significant predictors of patient preference for a once-every-eight-weeks intramuscular formulation in terms of their requirement for long-acting injectable medications (tablet size, OR = 2.14, 95%CI 1.030–4.430, p = 0.042; and daily oral therapy, OR = 1.75, 95%CI 1.010–3.030, p = 0.044).ConclusionsPatients currently receiving anti-HIV drugs who express dissatisfaction with tablet size and daily oral therapy may prefer a long-acting injectable formulation, taking into consideration patient age, employment status, ART history, frequency of daily dosage and concomitant medications other than ART.

Comparison of safety outcomes of anticancer drugs in Japanese and non-Japanese patients in multi-regional clinical trials: meta-analysis of safety profiles.

No report has assessed the differences in adverse event (AE) profiles of anticancer drugs for all types of cancers in clinical trials involving Japanese patients. This study aimed to compare the safety outcomes of anticancer drugs in Japanese and non-Japanese patients in multi-regional clinical trials (MRCTs), regardless of the type of cancer or drug. All new approvals of oncology drugs in Japan from January 2009 to December 2018 were searched through the Pharmaceuticals and Medical Devices Agency website. The odds ratio (OR) for comparing the incidence of AEs between Japanese and non-Japanese patients was estimated using the Mantel-Haenszel method with a random effect model. Sixty-six multi-regional phase 3 trials were identified involving 43,712 patients. Severe AE, AE leading to dose reduction, and AE leading to dose interruption were significantly more frequent in Japanese patients than in non-Japanese (odds ratios [ORs] were 1.32 (95% confidence interval (CI): 1.13-1.53), 1.97 (95% CI: 1.66-2.31), and 1.63 (95% CI: 1.43-1.86), respectively). Serious AEs (SAEs) and AEs leading to death were significantly less frequent in Japanese patients (OR: 0.70 (95% CI: 0.62-0.77) vs. 0.56 (95% CI: 0.44-0.67), respectively). There were no differences in AEs leading to study withdrawal. The incidence of most AEs was significantly higher in Japanese patients. In Japanese patients, the incidence of SAEs and AEs leading to death was low, but severe AEs, AEs leading to dose reductions, AEs leading to dose interruption, and individual adverse events were high.

Regional disparity in first-in-class anticancer drug development in the US, EU, and Japan.

A cancer diagnosis is devastating for both patients and their caregivers. With high morbidity and mortality, cancer is a serious disease area with unmet medical needs. Thus, innovative anticancer drugs are in high demand worldwide but are unequally available. Our study focused on first-in-class (FIC) anticancer drugs and investigated their actual development situation in the United States (US), European Union (EU), and Japan over the last two decades to obtain fundamental information for understanding how the aforementioned demands are met, especially to eliminate drug lags among regions. We identified FIC anticancer drugs using pharmacological classes for the Japanese drug pricing system. Most FIC anticancer drugs were first approved in the US. The median approval time for anticancer drugs in new pharmacological classes during the last two decades in Japan (5072 days) was significantly different (p=0.043) from that in the US (4253 days), though it was not significantly different from that in the EU (4655 days). Submission and approval lags between the US and Japan were more than 2.1 years, and those between the EU and Japan were more than 1.2 years. However, those between the US and the EU were less than 0.8 years. The development rate of FIC anticancer drugs in Japan is slower than in other regions. Even among developed countries, FIC anticancer drug lags exist. Considering the high impact of FIC anticancer drugs on society worldwide, we should work together to reduce drug lag among regions using an improved international cooperative framework.

Association of demographics, HCV co-infection, HIV-1 subtypes and genetic clustering with late HIV diagnosis: a retrospective analysis from the Japanese Drug Resistance HIV-1 Surveillance Network.

Late diagnosis of the human immunodeficiency virus (HIV) is a major concern epidemiologically, socially and for national healthcare systems. Although the association of certain demographics with late HIV diagnosis has been reported in several studies, the association of other factors, including clinical and phylogenetic factors, remains unclear. In the present study, we conducted a nationwide analysis to explore the association of demographics, clinical factors, HIV-1 subtypes/circulating recombinant form (CRFs) and genetic clustering with late HIV diagnosis in Japan, where new infections mainly occur among young men who have sex with men (MSM) in urban areas. Anonymized data on demographics, clinical factors and HIV genetic sequences from 39.8% of people newly diagnosed with HIV in Japan were collected by the Japanese Drug Resistance HIV-1 Surveillance Network from 2003 to 2019. Factors associated with late HIV diagnosis (defined as HIV diagnosis with a CD4 count <350 cells/μl) were identified using logistic regression. Clusters were identified by HIV-TRACE with a genetic distance threshold of 1.5%. Of the 9422 people newly diagnosed with HIV enrolled in the surveillance network between 2003 and 2019, 7752 individuals with available CD4 count at diagnosis were included. Late HIV diagnosis was observed in 5522 (71.2%) participants. The overall median CD4 count at diagnosis was 221 (IQR: 62-373) cells/μl. Variables independently associated with late HIV diagnosis included age (adjusted odds ratio [aOR] 2.21, 95% CI 1.88-2.59, ≥45 vs. ≤29 years), heterosexual transmission (aOR 1.34, 95% CI 1.11-1.62, vs. MSM), living outside of Tokyo (aOR 1.18, 95% CI 1.05-1.32), hepatitis C virus (HCV) co-infection (aOR 1.42, 95% CI 1.01-1.98) and not belonging to a cluster (aOR 1.30, 95% CI 1.12-1.51). CRF07_BC (aOR 0.34, 95% CI 0.18-0.65, vs. subtype B) was negatively associated with late HIV diagnosis. In addition to demographic factors, HCV co-infection, HIV-1 subtypes/CRFs and not belonging to a cluster were independently associated with late HIV diagnosis in Japan. These results imply the need for public health programmes aimed at the general population, including but not limited to key populations, to encourage HIV testing.

Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan.

Background: The Japanese drug use system allowed the once-daily use of inhaled corticosteroid fluticasone furoate (FF) combined with a long-acting beta-2 agonist vilanterol (VI) and a long-acting muscarinic antagonist umeclidinium (UMEC) against asthma on 18 February 2021. We investigated the real-world effects of these drugs (FF/UMEC/VI) mainly on lung function tests. Methods: This was an open-label, uncontrolled, within-group time-series (before-after) study. Prior asthma treatment (inhaled corticosteroid with/without a long-acting beta-2 agonist with/without a long-acting muscarinic antagonist) was switched to FF/UMEC/VI 200/62.5/25μg. Subjects were evaluated by lung function tests prior to, and 1-2months after, initiation of FF/UMEC/VI 200/62.5/25μg. Patients were asked questions regarding the asthma control test and preference for drugs. Results: Overall, 114 asthma outpatients (97% Japanese) were enrolled from February 2021 to April 2022: 104 subjects completed the study. Forced expiratory volume in 1s, peak flow, and asthma control test score of FF/UMEC/VI 200/62.5/25μg-treated subjects were significantly increased (p < 0.001, p < 0.001, and p < 0.01, respectively). In contrast with FF/VI 200/25μg, instantaneous flow at 25% of the forced vital capacity and expiratory reserve volume were significantly increased by FF/UMEC/VI 200/62.5/25μg (p < 0.01, p < 0.05, respectively). Sixty-six percent of subjects declared they wanted to continue FF/UMEC/VI 200/62.5/25μg in the future. Adverse effects, mainly local, were seen in 30% of patients, but no serious adverse effects were seen. Conclusion: Once-daily FF/UMEC/VI 200/62.5/25μg was effective against asthma without serious adverse events. This is the first report that demonstrated FF/UMEC/VI dilated peripheral airways using lung function tests. This evidence on drug effects may improve our understanding of pulmonary physiology and the pathophysiology of asthma.

Carrying out the demercurization of heavy metals (mercury) using the Denite immobilizer and its effect on the soil

On the territory of the Northern industrial zone of Pavlodar in the area of the industrial wastewater reservoir «Bylkyldak» in some areas of the earth there is soil contamination with mercury, exceeding the MPC for mercury (2.1 mg/kg) by 500 times. The total mass of mercury dispersed in the surface layer of soils is 2.8 tons. The mass of contaminated soil is approximately 208,000 tons. Pollution of the territory is historical. The purpose of the article is to determine the efficiency of chemical binding (immobilization) of mercury in the soil with the Japanese drug Denite® in real field conditions of the territory of mercury contamination in the Northern industrial zone of Pavlodar using an experimental study; to determine the stability of insoluble mercury compounds formed by the preparation at extreme winter and summer temperatures and seasonal fluctuations in open ground. Soil samples were taken for the study at 11 points in the centers of mercury pollution. Laboratory studies were carried out in an accredited analytical laboratory of the Testing Center of JSC Caustic. Soil samples were treated with Denite®, the preparations obtained were stabilized, and water extracts were prepared. The content of mercury in soils, extracts from them, and plants was determined by the atomic absorption method on a RA-915+ spectrometer equipped with RP-91 and RP-91S attachments. As a result of research, the effectiveness of Denite® in the chemical binding of mercury in the soil has been proven and its optimal dosages have been determined. As a result of the positive tests of the technology of chemical immobilization of mercury, the prospect of a practical solution to the issue of demercurization of mercury-contaminated soil on the territory of the Northern industrial zone appeared.

Risk Factors in Japanese Drug Overdose Patients: Identifying Their Associations With Suicide Risk.

Several suicide attempts presented at the emergency department are due to drug overdose associated with psychiatric disorders. We examined and identified the major risk factors among Japanese drug overdose patients and several close associations of suicide risk. We enrolled 101 patients who attempted suicide by drug overdose between January 2015 and April 2018, assessed their background using the SAD PERSONS scale, and performed association rule analysis to characterize the major risk factors and their associations. We identified three main nodes-depressive state, social support lacking, and no spouse-as considerable risk factors. Furthermore, we identified several close associations of suicide risk and their intensity; in cases with previous suicide attempts and ethanol abuse or substance use, a simultaneous social support lacking is likely. These findings align with previous studies that used conventional statistical analysis on suicide and suicide attempt risk and highlight its importance.

Effects of a web-based relapse prevention program on abstinence: Secondary subgroup analysis of a pilot randomized controlled trial.

AimThe effect of a web‐based relapse prevention program might vary depending on a specific population if the study participants included drug users with various characteristics. This secondary analysis explored subgroups among Japanese drug users that may benefit from a web‐based relapse prevention program.MethodsOutpatients with drug use disorder (n = 48) were randomly assigned to an 8‐week, six‐session web‐based relapse prevention program (intervention group) or web‐based self‐monitoring only (control group). We tested the effects of the intervention on abstinence in different subgroups divided by a primary abused drug (methamphetamine vs other drugs), previous face‐to‐face relapse prevention (received vs not received), and outpatient treatment term (long‐term: ≥3 years vs short‐term: <3 years). Consecutive abstinence duration from the primary abused drug was compared in the subgroups, and the interaction between the intervention condition and the subgroup condition was assessed.ResultsIn the subgroup with short‐term outpatient treatment, the intervention group maintained better abstinence than the control group. For those who used methamphetamine or those who had previously received a face‐to‐face relapse prevention program, the intervention group showed larger effect sizes than the results from all the participants. However, the interaction between the intervention condition and the subgroup condition was not significant for any subgroup.ConclusionsThis study suggests that patients with short‐term treatment may benefit from a web‐based relapse prevention program as an alternative treatment. We need to recruit and allocate patients considering their treatment term in a future definitive trial.

Application of Traditional Japanese Drug Jidabokuippo in a Modern Society.

Background: Jidabokuippo (JDI) (治打撲一方) has been used in Japan to alleviate contusion-induced swelling and pain since medieval times. Method: This review investigated the effects of JDI on various symptoms in patients with trauma or static blood[TM1]. The PubMed and Igaku Chuo Zasshi databases were searched until 24 December 2021. We summarize the benefits of applying JDI to inflammatory conditions, including bruises. Results: JDI has been used to resolve blood [TM1] stasis, regulate qi in trauma patients, and treat inflammatory swelling and pain caused by rheumatoid arthritis and cellulitis. As the adverse event rate associated with JDI is low (1.3%), JDI is considered a safe drug. Conclusion: JDI can be used to resolve blood[TM1] stasis in trauma patients without adverse events associated with nonsteroidal anti-inflammatory drugs.

Effect of the Japanese herbal drug rikkunshito for the treatment of malnutrition in patients with chronic heart failure

AbstractAimAlthough malnutrition is an important prognostic factor in patients with chronic heart failure (CHF), no effective treatment for malnutrition has been established. Rikkunshito (RKT) is a Japanese herbal drug that has been used in daily practice for patients with loss of appetite. However, no data have demonstrated whether or not RKT can improve the body composition in patients with CHF. The aim of this study was to elucidate the effect of RKT on the nutritional status of patients with CHF.MethodsThis single‐center retrospective observational study included 14 patients with CHF and loss of appetite who were treated with RKT. Body mass index (BMI) and body composition including fat‐free mass index (FFMI), skeletal muscle mass index (SMI) and fat mass index (FMI) were measured by the bioimpedance method. Body composition was measured at baseline and 12 weeks later. The primary endpoint was the change of BMI and body composition.ResultsBMI was significantly improved from 23.7 (20.0–26.1) kg/m2 to 24.2 (20.3–27.3) kg/m2 (p = 0.0494). FFMI was significantly improved from 13.7 (11.3–14.9) kg/m2 to 14.2 (12.0–15.7) kg/m2 (p = 0.0002). SMI was also improved from 5.0 (3.0–6.2) kg/m2 to 5.3 (3.3–6.8) kg/m2 (p = 0.0085). On the other hand, FMI was not significantly changed (9.4 (7.2–12.0) kg/m2 to 10.3 (7.9–12.0) kg/m2, p = 0.8552).ConclusionThe Japanese herbal drug RKT was effective in improving the nutritional status of patients with CHF.

Polymorphism analysis of TCP gene region to intraspecific analysis of Paeonia lactiflora, and application for authentication of Paeoniae Radix.

We attempted to conduct an intraspecific analysis of 30 peony cultivars in Japan and to authenticate five herbal medicine samples derived from Paeoniae Radix by polymorphism analysis of the TEOSINTE BRANCHED1, CYCLOIDEA, and PCF (TCP) gene region. We focused on cultivar-dependent differences in leaf margin undulation and analyzed the sequence of the related TCP gene region. As a result, we found that the nucleotide sequences of 29 cultivars of Paeonia lactiflora except 'America' exhibit interspecific variations compared with the nucleotide sequences of Paeonia suffruticosa and Paeonia tenuifolia. Therefore, in the dendrogram constructed on the basis of the sequence similarity in the TCP gene region, the 29 cultivars of P. lactiflora were separated from P. suffruticosa, P. tenuifolia, and 'America', and clustered into three subgroups. There were 16 variations containing heterogenous DNA sequences within P. lactiflora species, and two characteristic variations in subgroup I. Some P. lactiflora cultivars showed the same nucleotide sequence in the TCP gene region, whereas the five herbal medicine samples showed different sequences, although all of them could be authenticated. The results suggest that Paeoniae Radix in the Japanese crude drug market can be authenticated by analysis of the TCP gene region.

Gender Differences in the Relationship between Methamphetamine Use and High-risk Sexual Behavior among Prisoners: A Nationwide, Cross-sectional Survey in Japan

ABSTRACT This study aimed to examine the relationship between methamphetamine (MA) use and high-risk sexual behavior among newly incarcerated prisoners in Japan. We conducted a secondary analysis using cross-sectional survey data, which constituted a nationwide prison sample surveyed between July and November 2017. In total, 699 participants (462 male and 237 female prisoners), who completed the self-administered questionnaire during imprisonment were recruited for the study. The prevalence of high-risk sexual behaviors was as follows: inconsistent condom use (78.4% male, 81.7% female), multiple sexual partners (61.3% male, 41.3% female), history of sexually transmitted diseases (14.1% male, 23.6% female), and trading sex for drugs (15.6% male, 17.7% female). A logistic regression analysis showed that MA use during sex increased the likelihood of high-risk sexual behavior in both male (adjusted odds ratio [AOR] = 5.86; 95% confidence interval [CI] = 3.41–10.07) and female prisoners (AOR = 2.58; 95% CI = 1.33–5.00). Additionally, in female prisoners, a history of sharing MA injection (AOR = 1.60; 95% CI = 1.06–2.42) increased high-risk sexual behavior. Our results indicate that harm reduction programs tailored according to the specific necessities of each gender to reduce high-risk sexual behaviors among MA users should be included in Japanese drug policies.

Communication for Open Innovation in Japanese Drug Discovery Ventures

Drug discovery ventures find candidate substances likely to develop into new drugs by selecting and concentrating management resources that specialize in basic and exploratory research and license them to pharmaceutical companies. They conduct RD however, the number of their licensing cases is small. Therefore, in this study, we conducted a questionnaire survey to find variables that affect the performance of open innovation. Questionnaires were mailed to 349 drug discovery venture companies in Japan (41 addresses unknown), and valid responses were collected from 42 companies (response rate: 13.6%). Using a SEM analysis, we found the importance of communication in open innovation. Communication has direct impact on open innovation and has been found to enhance open innovation through customer orientation. Drug discovery ventures are the ultimate technology-oriented companies, and, while they tend to lower their communication awareness in business negotiations, they must raise their communication awareness to improve the performance of open innovation.

A Mixed-Methods Evaluation of Usability and Acceptability of Web-Based Relapse Prevention and Self-Monitoring Program: Secondary Analysis of a Pilot Randomized Controlled Trial.

This secondary analysis of a pilot randomized controlled trial assessed the usability and acceptability of a web-based relapse prevention and self-monitoring program, which was newly developed for Japanese drug users. We analyzed quantitative and qualitative data using a mixed-method approach among 43 study participants. We assessed the usability of the programs using the Web Usability Scale (WUS) and satisfaction and acceptance using the Client Satisfaction Questionnaire 8-item version (CSQ-8). We also collected qualitative feedback using semi-structured open-ended questions. The results of WUS indicated that the usability of the programs was sufficient. According to the CSQ-8 results, the self-monitoring program had less satisfaction, while the web-based relapse prevention program met satisfaction. Some possible improvements for a future version of the web-based programs were suggested based on participants' feedback.