Investigating the effect of prescribing status and patient characteristics on the therapeutic outcomes in patients with diabetes using a leftover drug adjustment protocol.

Treatment for diabetes includes anti-diabetic medication in addition to lifestyle improvements through diet and exercise. In Japan, protocol-based pharmacotherapy management allows drug treatment to be provided through cooperation between physicians and pharmacists, based on a protocol that is prepared and agreed upon in advance. However, there are no studies to clarify the relationship between patient characteristics and therapeutic effects after pharmacist intervention in protocol-based pharmacotherapy management for patients with diabetes. Therefore, this study aimed to use protocol-based reports from pharmacies to understand the status of outpatient diabetes medication compliance. We classified patients with diabetes on the basis of patient characteristics that can be collected in pharmacies and investigated the characteristics that impacted diabetes treatment. Patients were prescribed oral anti-diabetic drugs at outpatient clinics of Hitachinaka General Hospital, Hitachi, Ltd., from April 2016 to March 2021. Survey items included patient characteristics (sex, age, number of drugs used, observed number of years of anti-diabetic drug prescription, number of anti-diabetic drug prescription days, and presence or absence of leftover anti-diabetic drugs) and HbA1c levels. Graphical analyses indicated the relationship between each categorised patient characteristic using multiple correspondence analyses. Subsequently, the patients were clustered using K-means cluster analysis based on the coordinates obtained for each patient. Patient characteristics and HbA1c values were compared between the groups for each cluster. A total of 1,910 patients were included and classified into three clusters, with clusters 1, 2, and 3 containing 625, 703, and 582 patients, respectively. Patient characteristics strongly associated with Cluster 1 were ages between 65 and 74 years, use of three or more anti-diabetic drugs, use of 3 years or more of anti-diabetic drugs, and leftover anti-diabetic drugs. Furthermore, Cluster 1 had the highest number of patients with worsening HbA1c levels compared with other clusters. Using the leftover drug adjustment protocol, we clarified the patient characteristics that affected the treatment course. We anticipate that through targeted interventions in patients exhibiting these characteristics, we can identify those who are irresponsibly continuing with drug treatment, are not responding well to therapy, or both. This could substantially improve the efficacy of their anti-diabetic care.

Is health literacy of adolescent athletes' parents whose children belonged to sports clubs related to their children's intention to receive medications, vaccines, supplements, and energy drinks? A cross-sectional study.

BACKGROUND: Adolescent athletes' values ​regarding health behaviors, including their attitudes toward doping, are largely derived from those of their parents. Therefore, clarifying the factors that affect parents' intentions regarding their children's medicine intake and nutrition can help elucidate the process of forming values ​​of healthy behaviors in young athletes. METHODS: Between March 8 and March 9, 2021, an online questionnaire survey was conducted via an Internet research company; data from 2,000 residents in Japan were collected. Participants were male and female residents aged 30-59 years with children in elementary or high school and belonging to sports clubs. The survey items included respondent's and child's basic information, respondent's health literacy, and level of sports in which the respondent and child were (or are) engaged. Respondents were also asked if they would like their children to receive prescription drugs, over-the-counter drugs, herbal medicines, vaccines, supplements, or energy drinks. Logistic regression analysis was performed to analyze the relationship between respondents' basic information and health literacy and their intention to receive prescription and over-the-counter drugs, herbal medicines, vaccines, supplements, and energy drinks. RESULTS: Higher parental health literacy was associated with higher children's willingness to receive prescription drugs (odds ratio [OR] = 1.025, 95% confidence interval [CI]: 1.016-1.035), over-the-counter drugs (OR = 1.012, 95% CI: 1.003-1.021), prescription herbal medicines (OR = 1.021, 95% CI: 1.021-1.030), over-the-counter herbal medicines (OR = 1.012, 95% CI: 1.003-1.021), and vaccines (OR = 1.025, 95% CI: 1.016-1.035). Conversely, the children's intention to receive energy drinks (OR = 0.990, 95% CI: 0.980-1.000) decreased significantly. As the child's athletic level increased, parents' willingness for their children to receive oral prescription medicines decreased (OR = 0.886, 95% CI: 0.791-0.992) and that to receive supplements (OR = 1.492, 95% CI: 1.330-1.673) and energy drinks significantly increased (OR = 1.480, 95% CI: 1.307-1.676). CONCLUSION: Health literacy of adolescent athletes' parents is associated with their children's willingness to receive medicines. Healthcare providers should counsel parents of adolescent athletes to allow their children to receive necessary drug treatments and prevent doping violations caused by supplement intake.

A non-randomized, controlled, interventional study to investigate the effects of community pharmacists' cognitive behavioral therapy-based interventions on medication adherence and relevant indicators in patients with depression.

BACKGROUND: The prevalence of depression is increasing in Japan. Pharmacists play an important role in helping patients use medicines effectively. Several studies had investigated the impact of community pharmacists on patient adherence to antidepressant therapy, and their results indicated that further study was warranted. METHODS: This study was conducted from June 2019 to May 2020 using a cluster non-randomized, open-label, parallel-group design. Four community pharmacy stores in Osaka and Hyogo Prefectures, Japan, participated in the study, and enrolled patients with unipolar depression. In the intervention group (IG), patients received cognitive behavioral therapy (CBT)-based medication support, and their medication adherence and adverse drug reactions were monitored by telephone. In the control group (CG), the pharmacists engaged in routine interactions with the study participants. Before participating in this study, the intervention-group pharmacists attended a 5-hour training session on CBT-based medication support. The primary outcome of this study was medication adherence, assessed using the Drug Attitude Inventory (DAI)-10. Secondary outcomes included the changes from baseline at 6 months in the following variables: the Patient Health Questionnaire (PHQ)-9 total score, the EQ-5D-5 L (Euro-QOL 5 dimensions 5 levels) score, patient satisfaction, and the Pharmacists' Confidence Scale about Medication Consultation for Depressive Patients (PCMCD) score. RESULTS: Four pharmacies (two in IG and two in CG) completed the intervention period. Results were obtained from 19 patients in the IG and 12 patients in the CG. In the IG, the mean DAI-10 score increased from 4.941 at baseline to 6.105, the mean PHQ-9 score decreased from 9.263 to 8.625, and the mean patient satisfaction score increased from 39.947 to 42.211. In the CG, the mean DAI-10 score decreased from 6.333 to 4.167, the mean PHQ-9 score increased from 9.333 to 12.923, and the mean patient satisfaction score decreased from 38.929 to 38.167. CONCLUSION: CBT-based medication support provided by community pharmacists may improve patient medication adherence to antidepressant therapy and symptoms. Such support can be expected to facilitate better treatment of depressed patients and may also allow the duration of treatment to be shortened. TRIAL REGISTRATION: UMIN000037954, Date of first registration: 17/06/2019.

Association Between Inappropriate Use of Over-The-Counter Drugs for Allergic Rhinitis and Side Effects on the Central Nervous system-a Cross-Sectional Survey.

Purpose: Antihistamine over-the-counter (OTC) drugs for allergic rhinitis are widely used and cause central nervous system side effects. Most available data on anti-allergic drugs are on controlled usage. It is necessary to investigate the occurrence of side effects in the context of self-medication to avoid inappropriate use. We aimed to clarify the association between the usage of OTC anti-allergic drugs and central nervous system side effects. Patients and Methods: An online, anonymous, cross-sectional study was conducted using a structured questionnaire. People who had used OTC anti-allergic drugs in the year prior to the study were recruited. To assess the association between inappropriate drug use and the occurrence of side effects, a binary logistics regression analysis was performed according to three dosage forms (oral only, nasal only, and oral and nasal combined use). Results: Somnolence was experienced by 59.1% of the participants using the OTC drug for allergic rhinitis. Using logistic regression analysis, "drug use exceeding the upper limit" was seen to be associated with side effects in only oral (Somnolence: OR = 1.41, 95% CI = 1.17-1.70; Dull head: OR=1.41, 95% CI = 1.16-1.70; Loss of concentration: OR = 1.25, 95% CI = 1.04-1.49) and oral and nasal combined use groups (Somnolence: OR = 1.33, 95% CI = 1.04-1.71; Dull head: OR = 1.47, 95% CI = 1.15-1.89; Loss of concentration: OR = 1.51, 95% CI = 1.19-1.91). Furthermore, "expired drug use" was associated with side effects in the nasal spray-only group (Somnolence: OR = 1.31, 95% CI = 1.07-1.60; Dull head: OR =1.25, 95% CI = 1.02-1.53; Loss of concentration: OR = 1.24, 95% CI = 1.00-1.54). Conclusion: Inappropriate use was common among users of OTC allergic rhinitis drugs. Differences in side effects depending on the dosage form used were observed.

[Constructs of the Collaboration between Hospital and Community Pharmacists: Findings from Community Pharmacist Perspective Using Multivariate Analysis and Structural Equation Modeling].

Collaborations between hospital and community pharmacists play a key role in ensuring consistent continuation of pharmacotherapy within official medical care plans designed to promote community-based healthcare. A previous study conducted by the authors clarified the constructs of collaboration between the hospital and community pharmacists from the hospital pharmacist's perspective. In this study, a similar questionnaire was used to survey a group of pharmacies with 424 outlets nationwide, and 244 responses were collected. Factor analysis from the community pharmacists' perspective extracted five latent factors comprising 18 variables, and structural equation modeling yielded a model with a high goodness-of-fit. In the latter model, variables representing "Organizational climate" and "Basic policy on collaboration" formed the foundation of the collaboration between hospital and community pharmacists, while variables representing "Understanding of healthcare policy", "Resources for collaboration", and "Community support systems" represented concepts that flexibly compensated for fluctuations in medical policy. These trends were similar to those of the constructs previously indicated by hospital pharmacists. We performed multiple regression analysis and structural equation modeling to confirm the impact of the inclusion of "Need for collaboration" as a dependent variable on the proposed constructs of hospital-community pharmacist collaboration using different analytical methods. Our results indicated that "Organizational climate", "Basic policy on collaboration", and "Community support systems" affected the "Need for collaboration". Our findings indicate that future studies are needed to confirm and clarify the causal relationships demonstrated by the constructs of hospital-community pharmacist collaboration seen within the current study.

Factors Associated with Medication Non-Adherence among Patients with Lifestyle-Related Non-Communicable Diseases.

This cross-sectional study explored the association between medication non-adherence and its factors in patients with non-communicable diseases (NCDs) using an online structured questionnaire emailed to 30,000 people (aged over 20 years who lived in Japan at the time of the survey). The questions concerned respondents' characteristics, medication non-adherence, health beliefs, lifestyles, and trouble taking medication. Factors related to non-adherence were analyzed among patients with lifestyle-related NCDs categorized into two age groups: 20-59, and >60 years. Unintentional (p < 0.001) and intentional (p < 0.001) non-adherence were more common among patients aged 20-59 than in older adults. NCD patients aged 20-59 experienced significantly more trouble taking medication than older adults. Multiple regression analysis showed that for patients aged 20-59 with NCDs, unintentional non-adherence was significantly and positively associated with current smoking habits (ß = 0.280, p < 0.001), while intentional non-adherence was significantly and positively associated with alcohol consumption (ß = 0.147, p = 0.020) and current smoking habits (ß = 0.172, p = 0.007). In patients aged 20-59, unhealthy eating habits (ß = -0.136, p = 0.034) and lack of exercise (ß = -0.151, p = 0.020) were negatively associated with intentional non-adherence. In conclusion, factors affecting medication non-adherence in patients with lifestyle-related diseases are related to health awareness, lifestyle, and medication barriers.

Frequency of Clinical Monitoring of Serum Concentrations of Digoxin, Potassium, and Creatinine, and Recording of Electrocardiograms in Digoxin-Treated Patients: A Japanese Claims Database Analysis.

Guidelines for cardiovascular drug therapy recommend monitoring serum digoxin concentration (SDC) in patients receiving digoxin treatment, especially those with renal dysfunction and hypokalemia. However, only a few studies have reported the prevalence of SDC monitoring and laboratory testing in clinical practice. Therefore, the aim of this study was to describe the frequency of SDC monitoring and laboratory testing in digoxin users and to assess the association between SDC monitoring and patient characteristics. We used the Japanese insurance claims data covering approximately 1.7 million patients aged 20-74 years between January 1, 2005 and March 31, 2014. All patients who had at least one prescription for digoxin were included. The frequency of SDC and laboratory tests was calculated and the association between patient characteristics and SDC monitoring was assessed using logistic regression analysis. A total of 98867 prescriptions of digoxin were issued to 3458 patients between 2005 and 2014. The annual mean frequencies of monitoring SDC, serum potassium level and serum creatinine level and of recording electrocardiograms was 16.8, 34.8, 38.7, and 24.1%, respectively. Atrial fibrillation, chronic heart failure, renal diseases, and use of oral anticoagulants were associated with SDC monitoring. We found the frequency of SDC monitoring to be relatively low in Japanese clinical practice.

Hospital-pharmacy cooperative training and drug-taking compliance in outpatients with chronic pain: a case-control study.

Purpose: Chronic pain is a common symptom that is suffered by 20% of the overall population in Japan. Although pharmacotherapy is critical for the treatment of chronic pain, there are no reports on the pharmacies. In the present study, we examined the effect of hospital-community pharmacy cooperative training on improving drug-taking compliance, pain relief, anxiety, insomnia, and motor function in patients with chronic pain. Patients and methods: The subject sample included 87 patients with chronic pain who were examined for the first time at the outpatient services department of Nihon University Itabashi Hospital. Patients were interviewed to obtain information regarding drugs used before and after the treatment, habitually used community pharmacies, presence of cooperative training with Itabashi Hospital, drug-taking compliance, and side effects. We compared treatment outcomes before and after consultation using the Brief Pain Inventory (BPI), Hospital Anxiety and Depression Scale (HADS), EuroQol Group measure (EQ-5D) for quality of life, Athens Insomnia Scale, and Locomo 25 scale for motor function. Results: In patients who used community pharmacies that perform training, drug-taking compliance was significantly better, and a significant improvement was observed in the scores of BPI, HADS Anxiety, Athens Insomnia, and Locomo 25. Conclusion: Pharmacotherapy is essential for the treatment of chronic pain. To this end, appropriate drugs with proper drug management guidance are indispensable. In this study, the use of community pharmacies that have undergone cooperative training with hospitals improves pain and anxiety. This is achieved through proper drug management guidance, shared awareness of drug information, and achievement of better drug-taking compliance. To improve the quality of treatment for chronic pain, involvement of community pharmacies such as by providing accurate information is essential. In the future, expanding cooperative training with hospitals may further help reassure patients, facilitate drug-taking, and improve the quality of treatment for chronic pain.

Validation of a Reorganized Training Program Using a Cognitive Behavioral Therapy Approach to Enable Community Pharmacists to Provide Empathic Patient Counseling.

To enable community pharmacists to provide empathic patient counseling, we developed and validated a training program based on the cognitive behavioral therapy approach (CBT-A) in our previous study. The major focus points of the re-structured training program were "inclusion of basic communication skills", "exemplifying correspondence involving CBT-A using pre-recorded video(VTR)", and "approach methods for cases where counter-evidence is unavailable". The training program lasted for 4 h per day, for a total of 8 h. We also performed role-play scenarios on information gathering and medication guidance for simulated patients before and after training, and evaluated patient satisfaction with counseling, patient counseling alliance scores, and the degrees of the psychological distance between patients and pharmacists. Participants had high satisfaction with the discussion and role-play aspects of the training, as in our previous study. Participants also showed high satisfaction with "exemplifying correspondence involving CBT-A using VTR". Counseling time was significantly longer when using CBT-A compared to ordinary information gathering and medication guidance, but patient satisfaction and patient counseling alliance scores were both higher, and the psychological distance between patient and pharmacist was lower. Accordingly, if patients cannot solve their own problems, even when pharmacists provide polite responses and expertise, patients can be guided in their problem solving using CBT-A. It suggested that using CBT-A could solve the problem of patients with anxiety due to problems that cannot be solved only via drug-centered approach.

Development and Validation of a Training Program Using a Cognitive Behavioral Therapy Approach with the Purpose of Enabling Community Pharmacists to Provide Empathic Patient Counseling.

To enable community pharmacists to provide empathic patient counseling, we developed and validated a training program based on cognitive reframing, which is one of the cognitive behavioral therapies. We divided 24 community pharmacists into two groups, providing training to the intervention group. The duration of the training program was two hours per session, with a total of eight hours. We conducted a survey of the intervention group to evaluate their training experience. In addition, we performed two role-play scenarios on patient counseling using simulated patients, evaluating the patient counseling alliance scores and the degrees of the psychological distance between the patients and pharmacists. The degree of satisfaction correlated with four training items, including "explanation by comics". When pharmacists felt that the cognitive behavioral therapy approach was successful, no significant differences were found in the patient counseling alliance grades. However, the psychological distance between the patients and pharmacists was smaller. We were able to infer that a cognitive behavioral therapy approach could decrease the psychological distance between patients and pharmacists, thereby enabling empathic patient counseling.

Assessment of Assistance in Smoking Cessation Therapy by Pharmacies in Collaboration with Medical Institutions- Implementation of a Collaborative Drug Therapy Management Protocol Based on a Written Agreement between Physicians and Pharmacists.

This study built a protocol for drug therapy management (hereinafter "the protocol") that would enable continuous support from the decision making of smoking cessation therapy to the completion of therapy through the collaboration of physicians and community pharmacists, after which we evaluated whether the use of this protocol would be helpful to smoking cessation therapy. This study utilized the "On the Promotion of Team-Based Medical Care", a Notification by the Health Policy Bureau as one of the resources for judgment, and referred to collaborative drug therapy management (CDTM) in the United States. After the implementation of this protocol, the success rate of smoking cessation at the participating medical institutions rose to approximately 70%, approximately 28-point improvement compared to the rate before the implementation. In addition to the benefits of the standard smoking cessation program, this result may have been affected by the intervention of pharmacists, who assisted in continuing cessation by advising to reduce drug dosage as necessary approximately one week after the smoking cessation, when side effects and the urge to smoke tend to occur. Additionally, the awareness survey for the intervention group revealed that all respondents, including patients who failed to quit smoking, answered that they were satisfied to the question on general satisfaction. The question about the reason for successful cessation revealed that the support by pharmacists was as important as, or more important than, that by physicians and nurses. This infers that the pharmacists' active engagement in drug therapy for individual patients was favorably acknowledged.

Community pharmacists provided telephone treatment support for patients who received long-term prescribed medication.

PURPOSE: This study was conducted to evaluate whether a community pharmacist's assistance during the treatment of a patient with a chronic illness would help to discover and improve issues regarding the treatment. METHOD: We employed a prospective intervention study with a control group. The patients ranging in age from 60 to 74, were using one of the six selected community pharmacies in the Tokyo metropolitan area. They had been prescribed six or fewer kinds of medications, one of which was amlodipine. The medication dosages covered 1 month or longer. Patients who agreed to participate in the study were randomly assigned to the groups at each pharmacy. For the patients in the intervention group, the pharmacists provided telephone counseling between physician visits, in addition to the time they visited the pharmacies to collect their medications. For the patients in the control group, the pharmacists provided counseling only at their pharmacies. RESULTS AND DISCUSSION: The average days of medication administration were 49.2 days for the 58 patients in the intervention group, and 49.8 days for the 53 patients in the control group, with the average number of medications being 3.4 items per person for both groups. Through the telephone counseling, we were able to collect more information, eg, changes in physical condition and occurrences of side effects, from the intervention group than from the control group. The rate of incident detection in the information from the intervention group was five times that of the control group, making subsequent incident resolutions faster. CONCLUSION: This study suggested that phone counseling between physician visits could enable the identification of more issues regarding patients' conditions.

Cell contact induces multiple types of electrical excitability from ascidian two-cell embryos that are cleavage arrested and contain all cell fate determinants.

Ascidian early embryonic cells undergo cell differentiation without cell cleavage, thus enabling mixture of cell fate determinants in single cells, which will not be possible in mammalian systems. Either cell in a two-cell embryo (2C cell) has multiple fates and develops into any cell types in a tadpole. To find the condition for controlled induction of a specific cell type, cleavage-arrested cell triplets were prepared in various combinations. They were 2C cells in contact with a pair of anterior neuroectoderm cells from eight-cell embryos (2C-aa triplet), with a pair of presumptive notochordal neural cells (2C-AA triplet), with a pair of presumptive posterior epidermal cells (2C-bb triplet), and with a pair of presumptive muscle cells (2C-BB triplet). The fate of the 2C cell was electrophysiologically identified. When two-cell embryos had been fertilized 3 h later than eight-cell embryos and triplets were formed, the 2C cells became either anterior-neuronal, posterior-neuronal or muscle cells, depending on the cell type of the contacting cell pair. When two-cell embryos had been fertilized earlier than eight-cell embryos, most 2C cells became epidermal. When two- and eight-cell embryos had been simultaneously fertilized, the 2C cells became any one of three cell types described above or the epidermal cell type. Differentiation of the ascidian 2C cell into major cell types was reproducibly induced by selecting the type of contacting cell pair and the developmental time difference between the contacting cell pair and 2C cell. We discuss similarities between cleavage-arrested 2C cells and vertebrate embryonic stem cells and propose the ascidian 2C cell as a simple model for toti-potent stem cells.