Development of a Remote Health Support Program by Pharmacists and Elucidation of Its Effectiveness: A Randomized Controlled Study.

No progress has been made in using remote communication tools for less urgent but equally important health support services, such as preventive medicine and health education. In this study, we developed a remote health support program by pharmacists for community residents and conducted a randomized controlled study on its effectiveness in proper self-medication through pharmacists. People over the age of 20 years who lived in the vicinity of Gifu City, Japan were eligible to participate in this study. Participants were recruited using posters and brochures. This program comprised a lecture, based on the health belief model and behavioral economics, and access to remote health support. The participants were randomly assigned to two groups: the medicine/health class only (control) and the medicine/health class along with the program (intervention) groups. The participants were administered questionnaire surveys immediately before (the first survey) and 2 months after (the second survey) the medicine/health class, which allowed us to compare the changes in the two groups' behavior regarding performing proper self-medication through pharmacists. The percentage of individuals who started consulting pharmacists about self-medication in the intervention group (63.9%, 23/36) was significantly higher than that in the control group (15.2%, 5/33; p < 0.001). The percentage of individuals who started recording information about their self-medication in their medication notebooks in the intervention group (16.7%, 6/36) was significantly higher than that in the control group (0%, 0/33; p = 0.026). We clarified the effectiveness of this program for behavioral changes toward proper self-medication using support from pharmacists.

Impact of Polypharmacy and Risk Factors for Exacerbation of Lower Urinary Tract Symptoms in Patients with Urological Conditions: A Retrospective Study in a Japanese Municipal Hospital.

Polypharmacy exacerbates lower urinary tract symptoms (LUTS). Japan exhibits a higher prevalence of concomitant medication use in drug therapy than other countries. Previous age- and sex-specific reports exist; however, none include patients of all ages. Therefore, this retrospective study determined the impact of polypharmacy and its associated risk factors on LUTS exacerbation in outpatients with urological conditions. We included patients receiving medication who visited the Department of Urology at the Gifu Municipal Hospital (Gifu, Japan) between January, 2018 and December, 2018. The association between LUTS and polypharmacy and the risk factors for LUTS exacerbation were investigated. Patients were categorized into two groups according to their polypharmacy status. We performed propensity score matching and compared the International Prostate Symptom Score (IPSS) between the groups using the unpaired t-test. Multiple logistic regression analysis was performed to examine the risk factors, including "polypharmacy" and "taking multiple anticholinergic medications" for LUTS exacerbation. When comparing the IPSS between the groups, the polypharmacy group was found to have significantly higher scores than the non-polypharmacy group in six items, including "total score" and "storage score." Multiple logistic regression analysis results showed high significance in three items, including "polypharmacy" (odds ratio (OR) = 1.67, 95% confidence interval (CI): 1.03-2.71) and "taking multiple anticholinergic medications" (OR = 8.68, 95% CI: 1.05-71.7). In conclusion, this study revealed that "polypharmacy" and "taking multiple anticholinergic medications" were risk factors for LUTS. Particularly, "polypharmacy" is associated with storage symptom exacerbation. Therefore, eliminating "polypharmacy" and "taking multiple anticholinergic medications" is expected to improve LUTS.

Probable effects of polypharmacy and equivalent doses of psychotropic drugs on prevalence of adverse drug events among psychiatric inpatients in a general hospital in Japan.

OBJECTIVE: In psychiatry, polypharmacy or high psychotropic drug doses increase adverse drug event (ADE) prevalence. However, the full relationship between polypharmacy and ADEs is unclear, and few studies have evaluated dose equivalents for psychotropic drugs for ADEs. Thus, we conducted a retrospective analysis to clarify the effects of polypharmacy and chlorpromazine (CP)-, diazepam (DAP)-, and imipramine- equivalent doses on all ADEs in inpatients. METHODS: Psychiatric inpatients in a Japanese hospital from April 1, 2016 to March 31, 2018, were enrolled. ADE severity and causality were assessed. Multiple logistic regression analyses were performed to evaluate ADE risk factors. RESULTS: Among 462 patients analyzed, out of 471 patients enrolled, 145 (31.4%) experienced ADEs. The causality assessment determined that "possible" was 96.5%. The most common ADEs were nervous system disorders (35%). Multiple logistic regression analyses indicated an increase in ADE prevalence with the number of drugs used (≥5; p = 0.026); CP-equivalent dose (p = 0.048); and endocrine, nutritional, and metabolic disorders (p = 0.045). DAP-equivalent dose; infectious and parasitic diseases; and injury, poisoning, and consequences of other external causes decreased ADE prevalence (p = 0.047, 0.022, and 0.021, respectively). CONCLUSIONS: Avoiding polypharmacy in psychiatric inpatients and adjusting drug regimens to safe equivalent doses could reduce ADEs during hospitalization.

Detection algorithms and attentive points of safety signal using spontaneous reporting systems as a clinical data source.

Continuous evaluation of drug safety is needed following approval to determine adverse events (AEs) in patient populations with diverse backgrounds. Spontaneous reporting systems are an important source of information for the detection of AEs not identified in clinical trials and for safety assessments that reflect the real-world use of drugs in specific populations and clinical settings. The use of spontaneous reporting systems is expected to detect drug-related AEs early after the launch of a new drug. Spontaneous reporting systems do not contain data on the total number of patients that use a drug; therefore, signal detection by disproportionality analysis, focusing on differences in the ratio of AE reports, is frequently used. In recent years, new analyses have been devised, including signal detection methods focused on the difference in the time to onset of an AE, methods that consider the patient background and those that identify drug-drug interactions. However, unlike commonly used statistics, the results of these analyses are open to misinterpretation if the method and the characteristics of the spontaneous reporting system cannot be evaluated properly. Therefore, this review describes signal detection using data mining, considering traditional methods and the latest knowledge, and their limitations.

Analysis of adverse events leading to dose reduction/interruption of lenvatinib treatment in patients with Child-Pugh B unresectable hepatocellular carcinoma.

INTRODUCTION: We aimed to compare the safety of lenvatinib as first-line treatment for unresectable hepatocellular carcinoma (HCC) in patients with Child-Pugh A (CP-A) and Child-Pugh B (CP-B) and to determine the adverse events (AEs) that cause dose reduction/interruption of treatment in patients with CP-B. METHODS: Sixty-six patients with lenvatinib as a first-line treatment for HCC at Ogaki Municipal Hospital (Ogaki, Japan) between April 2018 and January 2022 were retrospectively evaluated. We analyzed the treatment duration, AEs, and reasons for dose reduction/interruption associated with lenvatinib treatment in patients with CP-A and CP-B HCC. RESULTS: The CP-B group had significantly more cases of grade ≥ 2 fatigue and anorexia than the CP-A group (p = 0.045 and p = 0.042, respectively). Regarding AEs that caused dose reduction/interruption of treatment, the CP-A group had significantly more cases of proteinuria than the CP-B group (p = 0.015), whereas the CP-B group had significantly more cases of hand-foot syndrome (HFS) than the CP-A group (p = 0.013). CONCLUSION: Patients with CP-B have greater difficulty than patients with CP-A in continuing treatment with repeated dose reductions/interruption of treatment due to intolerable grade ≥ 2 AEs (fatigue and anorexia). HFS is more likely to cause dose reduction/interruption of treatment in CP-B than in CP-A unresectable HCC.

Melphalan Febrile Neutropenia Risk Factors.

This study aimed to identify the risk factors of febrile neutropenia(FN)onset associated with melphalan(L-PAM)therapy. Thirty-nine patients(21 men, 18 women)were administered L-PAM intravenously for multiple myeloma(MM)from April 2011 to February 2022 at the Department of Hematology of Gifu Municipal Hospital. Patients were classified into those with and without FN(Grade 3 or higher), complete blood count and liver function tests were performed immediately before starting therapy. Univariate analysis with Fisher's exact probability test was performed. Factors with p<0.2 were considered as independent variables for multivariate analysis in the multiple logistic regression analysis. A multivariate analysis with 2 independent variables, lactate dehydrogenase(LD)level>222 U/L(upper limit of the facility reference value)and white <3.3×103/µL(lower limit of the facility reference value)from the univariate analysis, and FN onset(Grade 3 or higher)as the dependent variable showed that LD level>222 U/L(odds ratio: 6.33, 95% confidence interval: 1.12-35.8, p=0.037)was a significant factor. In conclusion, patients with LD levels >222 U/L immediately before starting therapy require adequate monitoring for FN onset following L-PAM administration.

Cost-effectiveness analysis of pegfilgrastim in patients with non-small cell lung cancer receiving ramucirumab plus docetaxel in Japan.

PURPOSE: The dose-limiting factor of ramucirumab plus docetaxel (RAM + DTX) in patients with non-small cell lung cancer (NSCLC) is febrile neutropenia (FN), which has a high incidence in Asians. This study aimed to evaluate the cost-effectiveness of pegfilgrastim (Peg-G) in patients with NSCLC receiving RAM + DTX in Japan. METHODS: We simulated model patients treated with RAM + DTX in Japan and developed a decision-analytical model for patients receiving Peg-G prophylaxis or no primary prophylaxis. The expected cost, quality-adjusted life-year (QALY), and incremental cost-effectiveness ratio (ICER) of each treatment were calculated from the perspective of a Japanese healthcare payer. The willingness-to-pay (WTP) threshold was set at 45,867 United States dollars (USD) (5 million Japanese yen) per QALY gained. The probabilities, utility values, and other costs were obtained from published sources. Deterministic sensitivity analysis (DSA) and probabilistic analysis were conducted to evaluate the effect of each parameter and robustness of the base-case results. RESULTS: The expected cost and QALYs were 20,275 USD and 0.701 for Peg-G prophylaxis and 17,493 USD and 0.672 for no primary prophylaxis, respectively. The ICER was calculated to be 97,519 USD per QALY gained. The results were most sensitive to FN risk with Peg-G. When FN risk with no primary prophylaxis exceeded 51% or the cost of Peg-G was less than 649 USD per injection, the ICER was below the WTP threshold. The probabilistic analysis revealed a 9.1% probability that the ICER was below the WTP threshold. CONCLUSION: Peg-G is not cost-effective in patients with NSCLC receiving RAM + DTX in Japan.

[Research on the Ratio of Anti-Cancer Drug Purchase Costs at Municipal Hospitals in the Aichi Prefecture].

We performed a study on the ratio of anti-cancer drug purchase costs at municipal hospitals in Aichi using meeting materials from the 2020 Aichi Prefectural Public Hospital Pharmacy Directors' Association. The ratio of anti-cancer drug purchase costs to all drug purchase costs at 17 hospitals was 41.5%(average)and 37.1%(median). In addition, we confirmed a positive correlation between all drug purchase costs and the ratio of anti-cancer drug purchase costs for each hospital(r= 0.537, 95%CI: 0.076-0.809, p=0.026). Furthermore, we conducted a univariate analysis on the background of hospitals where the ratio of anti-cancer drug purchase costs is ≥40%. As a result, we confirmed a significant difference(p<0.05)in the cases where there are more than 500 beds, with the approval of designated cancer hospitals, and with the department of hematology. This study clarified that hospitals with active anti-cancer drug treatment tended to increase drug purchase costs.

Differences in detected safety signals between benzodiazepines and non-benzodiazepine hypnotics: pharmacovigilance study using a spontaneous reporting system.

Introduction: In recent years, there has been an increasing number of people who feel sleep-deprived owing to sudden changes in the social environment. Patients prescribed benzodiazepine-based hypnotics (BZ drugs) also develop movement disorder action and memory disorders as adverse events (AEs), and they have further problems such as dependency and tolerance because of long-term use. Therefore, the use of non-benzodiazepine-based hypnotics (Z-drugs) is recommended for patients with insomnia. However, as AEs have also been reported for Z-drugs, it is important to identify these when switching hypnotics. Methods: To understand AEs to be noted when switching from BZ drugs to Z-drugs, we evaluated the differences in AEs developed by both these drugs using volcano plots and safety signals. For this, data registered in the Japanese Adverse Drug Event Report database were used. Results: The volcano plot and safety signals revealed six characteristic Z-drug-induced AEs. Parasomnias (ln odds ratio [OR]: 3.28, -log P: 4.34, proportional reporting ratio [PRR]: 23.47, χ 2: 309.27), Cortical dysfunction NEC (ln OR: 2.76, -log P: 4.34, PRR: 3.62, χ 2: 16.14), and Psychiatric symptoms NEC (ln OR: 2.66, -log P: 2.18, PRR: 2.51, χ 2: 6.63) were detected only in Z-drugs, and safety signals of Suicidal and self-injurious behaviour, Deliria, and Overdoses NEC were also detected with BZ drugs. However, the strength of safety signals was much higher with the Z-drugs. Conclusion: AEs related to falls and bone fractures are expected to be more strongly onset in BZ drugs than in Z-drugs, which are said to have less muscle relaxant action. However, there was no particularly significant difference in this parameter between the two drug classes. Understanding the difference between these AEs of Z-drugs and BZ drugs is important for the proper use of hypnotics.

Monitoring antimicrobial cross-resistance with cross-resistance rate correlation diagrams: Changes in antibiotic susceptibility of Pseudomonas aeruginosa due to hospital relocation.

WHAT IS KNOWN AND OBJECTIVE: Though most medical institutions calculate antimicrobial susceptibility and resistance rates of microbes isolated at their own facility as part of their efforts to promote the proper use of antibiotics, very few, if any, regularly monitor cross-resistance rates between antimicrobial agents. The authors have devised a tool in the form of a cross-resistance rate correlation diagram (CRR diagram) that allows easy identification of increases or decreases in, or changes in the pattern of, antimicrobial cross-resistance. The objective was to perform an analysis by CRR diagrams of the effect of relocation to a newly built facility on antimicrobial resistance and cross-resistance rates at a medical facility. METHODS: The Sakai City Medical Center relocated in July 2015 to a newly built facility located in a different primary medical care zone 3.5 km away. Based on the drug susceptibility test data compiled at the Sakai City Medical Center, resistance and cross-resistance rates of Pseudomonas aeruginosa before and after the relocation of the hospital facility were calculated, and the rates were assessed using CRR diagrams. RESULTS AND DISCUSSION: It was possible to confirm the effect of hospital relocation on antibiotic susceptibility of P aeruginosa in terms of changes in resistance and cross-resistance rates. The effect of the facility's relocation on cross-resistance rates was particularly notable with respect to ß-lactam antibiotics: cross-resistance rates among ß-lactams decreased substantially, represented as a large wedge-shaped change towards the origin on the CRR diagram. Rates of cross-resistance between classes of antibiotics with a different mechanism of antibiotic action changed little. WHAT IS NEW AND CONCLUSION: Including cross-resistance rates in the routine monitoring of resistance and susceptibility rates practiced by a medical institution can provide a comprehensive insight into the dynamics of bacterial flora in the facility. CRR diagrams, which allow visualization of the status and changes in cross-resistance, not only provide a new perspective for clinicians, but they also contribute to the proper use of antibiotics and serve as a tool in the education of healthcare professionals and students about antibiotic resistance.

The association between polypharmacy and the efficiency of the functional independence measure in an acute-stage hospital: a retrospective cohort study.

BACKGROUND: The Functional Independence Measure (FIM) evaluates the activities of daily living (ADL), and FIM efficiency represents daily improvement in FIM. Polypharmacy affects both ADL and FIM; however, few studies have evaluated its relationship with FIM efficiency. AIM: This retrospective study investigated the effect of polypharmacy on FIM efficiency in patients undergoing rehabilitation at our acute care hospital in 2014. METHODS: We collected data on the patients' age, sex, diagnosis, length of hospital stay, type and duration of rehabilitation, indications for rehabilitation, FIM score before and after rehabilitation, and number of pharmaceuticals being used. Polypharmacy was defined as the administration of five or more pharmaceuticals. Using propensity score matching, we compared the FIM efficiency between the polypharmacy and non-polypharmacy groups (sub-scales and totals). RESULTS: A total of 2455 patients were included. The analytical population included 2168 patients. The analytical population used for propensity score matching included 727 patients in each group (total: 1454 patients). The following FIM sub-scale items were found to be associated with significantly low FIM efficiency in the polypharmacy group: self-care (polypharmacy group FIM efficiency: 0.43 points/day, non-polypharmacy group FIM efficiency: 0.54 points/day) and sphincter control (0.11 points/day and 0.18 points/day, respectively). No significant differences in the FIM efficiency were observed either for any other sub-scales or for totals. DISCUSSION: In the polypharmacy group, self-care and sphincter control, in particular, were associated with inhibited improvement in ADL and FIM. CONCLUSIONS: Reducing polypharmacy among acute-phase patients would allow an earlier return to their normal daily lives.

What activities of daily living at discharge affect the discharge destination of patients in an acute-care hospital in Japan: A retrospective factor analysis.

It is important to clarify the influence of activities of daily living (ADL) at discharge on the discharge destination of hospitalised patients. The Functional Independence Measure (FIM) is a widely used ADL assessment scale. In this retrospective study, we aimed to identify what ADL based on FIM at discharge affect the discharge destination of hospitalised patients in an acute-care hospital, in addition to how nutritional status and the number of drugs used, as well as types of disease, affect discharge-to-home. We surveyed age, sex, disease type, length of hospital stay, discharge destination, FIM score at discharge, serum albumin level, and the number of continued drugs in hospitalised patients who underwent rehabilitation in Gifu Municipal Hospital (Gifu, Japan) between January 2014 and December 2014. Multiple logistic regression analysis was performed with discharge to home as a dependent variable and age, sex, disease, FIM score and polypharmacy as independent variables. Multiple logistic regression analysis indicated that a significantly high percentage of discharged-to-home patients were associated with 'self-care' (≥33 points; OR: 2.03), 'sphincter control' (≥14 points; OR: 1.49), 'transfers' (≥13 points; OR: 1.94), and 'locomotion' (≥7 points; OR: 3.55), among others. High FIM sub-scale scores at discharge for self-care, sphincter control, transfers, and locomotion were clarified as factors associated with discharge-to-home. These findings of the association of ADL based on FIM and discharge destination would be useful in deciding discharge destinations for patients in an acute-phase hospital.

Antiepileptic combination therapy with Stevens-Johnson syndrome and toxic epidermal necrolysis: Analysis of a Japanese pharmacovigilance database.

OBJECTIVE: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are immune-mediated diseases characterized by an extensive loss of the epidermal skin layer, often resulting in death. SJS and TEN are often triggered by certain drugs, including antiepileptic drugs (AEDs). Epilepsy is very difficult to treat and often involves the combination of two or more AEDs. In this study, we quantified not only the risk of SJS or TEN associated with single-AED therapy but also the risk related to concomitant AED treatment using reporting-derived signals. METHODS: An analysis of the Japanese Adverse Drug Event Report (JADER) database was performed from the first quarter of 2004 to the fourth quarter of 2018. The single-AED signals were evaluated using the proportional reporting ratio (PRR), and the combination therapy signals were evaluated using Ω shrinkage measure and combination risk ratio (CRR). RESULTS: SJS signals were associated with 11 AEDs, and TEN signals were related to 12 AEDs. Moreover, the following AED combinations were associated with SJS signals: carbamazepine-lorazepam (Ω025 : 0.33, CRR: 2.18) and fosphenytoin-lorazepam (Ω025 : 0.99, CRR: 39.20). The TEN signals were related to the following combinations: clobazam-gabapentin (Ω025 : 0.35, CRR: 3.14), phenytoin-gabapentin (Ω025 : 0.03, CRR: 2.18), valproic acid-gabapentin (Ω025 : 0.15, CRR: 2.25), clobazam-clonazepam (Ω025 : 0.03, CRR: 2.93), clobazam-valproic acid (Ω025 : 0.29, CRR: 1.55), fosphenytoin-lamotrigine (Ω025 : 0.05, CRR: 7.37), and lacosamide-levetiracetam (Ω025 : 0.74, CRR: 1.85). SIGNIFICANCE: This study identified two AED combinations that increased the SJS signals and seven combinations that increased the TEN signals. Although AED monotherapies require attention for SJS and TEN, some AED combinations require extra caution.

Comparison of Signal Detection Algorithms Based on Frequency Statistical Model for Drug-Drug Interaction Using Spontaneous Reporting Systems.

PURPOSE: Adverse events (AEs) caused by polypharmacy have recently become a clinical problem, and it is important to monitor the safety profile of drug-drug interactions (DDIs). Mining signals using the spontaneous reporting systems is a very effective method for single drug-induced AE monitoring as well as early detection of DDIs. The objective of this study was to compare signal detection algorithms for DDIs based on frequency statistical models. METHODS: Five frequency statistical models: the Ω shrinkage measure, additive (risk difference), multiplicative (risk ratio), combination risk ratio, and chi-square statistics models were compared using the Japanese Adverse Drug Event Report (JADER) database as the spontaneous reporting system in Japan. The drugs targeted for the survey are all registered and classified as "suspect drugs" in JADER, and the AEs targeted for this study were the same as those in a previous study on Stevens-Johnson syndrome (SJS). RESULTS: Of 3924 pairs that reported SJS, the number of signals detected by the Ω shrinkage measure, additive, multiplicative, combination risk ratio, and chi-square statistics models was 712, 3298, 2252, 739, and 1289 pairs, respectively. Among the five models, the Ω shrinkage measure model showed the most conservative signal detection tendency. CONCLUSION: Specifically, caution should be exercised when the number of reports is low because results differ depending on the statistical models. This study will contribute to the selection of appropriate statistical models to detect signals of potential DDIs.

Association between dipeptidyl peptidase-4 inhibitor and aspiration pneumonia: disproportionality analysis using the spontaneous reporting system in Japan.

PURPOSE: Dipeptidyl peptidase-4 inhibitor (DPP-4-Is), a kind of drug used for the treatment of diabetes, is considered to prevent the degradation of substance P that suppresses the occurrence of dysphagia. On the other hand, DPP-4 inhibitors are also known to act on the immune system. In this study, we used a spontaneous reporting system to evaluate the signals for dysphagia and aspiration pneumonia with DPP-4-Is. METHODS: We calculated reporting odds ratio (ROR) and information coefficients (IC) as disproportionality analysis to evaluate DPP-4-Is induced dysphagia and aspiration pneumonia using the Japanese Adverse Drug Event Report (JADER) database. RESULTS: For DPP-4-Is as a class, no signals were detected for dysphagia, but the signal for aspiration pneumonia was detected at ROR 1.67 (95% confidence interval [95% CI]: 1.20 to 2.34) and IC 0.70 (95% CI: 0.21 to 1.19). For aspiration pneumonia, trelagliptin was the only drug among the DPP-4-Is for which both ROR and IC signals were detected (ROR 9.99, 95% CI: 4.10 to 24.36; IC: 1.98, 95% CI: 0.78 to 3.18). ROR signals, but not IC signals, were detected for linagliptin (ROR 2.66, 95% CI: 1.19 to 5.94; IC: 1.09, 95% CI: - 0.004 to 2.19) and sitagliptin (ROR 1.84, 95% CI: 1.04 to 3.25; IC: 0.78, 95% CI: - 0.03 to 1.58). CONCLUSION: Since DPP-4 inhibitors prevent the degradation of substance P involved in swallowing reflex, DPP-4 inhibitors were expected to prevent dysphagia and aspiration pneumonia. However, this study revealed that DPP-4 inhibitors strongly were associated with onset rather than preventing aspiration pneumonia. This result suggests that DPP-4 inhibitors may affect the immune function associated with the development of aspiration pneumonia. Furthermore, there is a possibility that the amount of DPP-4-Is used clinically cannot increase the amount of substance P in sufficient quantity to prevent aspiration pneumonia.

Developing and Verifying the Efficacy of "Educational Program for Promoting Appropriate Self-medication via Pharmacies and Pharmacists": A Randomized Controlled Trial.

Utilization of community pharmacies/pharmacists is important for promoting appropriate self-medication; however, appropriate self-medication via pharmacies/pharmacists has not been well-implemented in Japan. Based on the transtheoretical model of health behavior change, we constructed an Educational Program for Promoting Appropriate Self-medication via Pharmacies and Pharmacists to inform the public about the assistive services of pharmacies/pharmacists regarding self-medication and the use of medication notebooks for self-medications. We then tested the efficacy of the program through a randomized controlled trial. The subjects were residents living around Gifu City, aged 20 years and above, and recruited through posters and pamphlets. The subjects were randomly allocated to a group that received only a medication/health class (control group) or one that received the medication/health class, as well as the educational program (intervention group). A questionnaire was administered immediately before the medication/health class (T1) and 2 months afterwards (T2), which allowed us to evaluate and compare the changes in the two groups' behavior regarding performing appropriate self-medication via pharmacies/pharmacists. The percentage of people who began consulting with pharmacists concerning self-medication was significantly higher among the intervention group (38.2%, 13/34) than the control group (14.3%, 4/28) (p = 0.047). The percentage of people who began recording details of self-medication in their medication notebooks was significantly higher among the intervention group (38.2%, 13/34) than the control group (10.7%, 3/28) (p = 0.019). The educational program effectively encouraged the public to adopt appropriate self-medication practices to avail the services provided by pharmacies/pharmacists.

Impact of infection control measures on the related costs and the amount of broad-spectrum antimicrobial agents used in a hospital: A time-series analysis.

Health care-associated infections (HAIs) worsen patient prognoses and increase medical costs. Antimicrobial stewardship (AMS), which involves appropriate use of antimicrobial agents and antiseptics, may be beneficial for addressing the issue of HAIs. In hospitals, an infection control team (ICT) plays an important role on the appropriate use of antimicrobial agents and antiseptics based on AMS. We aimed to conduct a time-series analysis of the efficacies of infection control measures in terms of related costs, amount of broad-spectrum antimicrobial agents used (carbapenems and quinolones), and methicillin-resistant Staphylococcus aureus (MRSA) detection rates. This retrospective cross-sectional study included in-hospital patients treated at a single institute between January 2012 and December 2015. The intervention start point (initiation of infection control measures) was January 2014. All survey items were subjected to segmented regression analysis using an autoregressive integrated moving average (ARIMA) model. Differences between pre-intervention and postintervention levels and their trends were assessed, using a statistical significance cutoff of P < .05. The infection control costs demonstrated a significantly increasing trend, despite significant decreases in the amount of carbapenems used. Accordingly, the implementation of infection control measures was associated with increased costs, whereas carbapenem use decreased immediately after intervention. Postintervention levels, trends of quinolone use, or MRSA detection rates did not reveal significant changes. Although implementation of infection control measures induced gradual increases in related costs, these measures led to immediate reductions in carbapenem use. Our study findings will support the establishment of more effective and economical infection control measures.

Analysis of Adverse Reactions Caused by Potentially Inappropriate Prescriptions and Related Medical Costs That Are Avoidable Using the Beers Criteria: The Japanese Version and Guidelines for Medical Treatment and Its Safety in the Elderly 2015.

We conducted a retrospective study to investigate adverse drug reactions and associated medical costs among elderly individuals that could be avoided if pharmacotherapy was performed in accordance with the Beers Criteria: the Japanese Version (BCJV) and Guidelines for Medical Treatment and Its Safety in the Elderly 2015 (GL2015). Patients aged at least 65 years who were either hospitalized at Gifu Municipal Hospital between October 1 and November 30, 2014 (n = 1236) or had outpatient examinations at Gifu Municipal Hospital on October 1-2, 2014 (n = 980) were included in the study. The outcomes measured were usage rates of drugs listed in the BCJV and GL2015, incidence rates of adverse drug reactions, and additional costs incurred per patient due to adverse reactions. Among the inpatients, usage rates of drugs listed in the BCJV and GL2015 were 24.0 and 72.4%, respectively, and adverse reactions to these drugs occurred at rates of 3.0 and 8.2%, respectively. Among the outpatients, while the usage rates were 26.2% (BCJV) and 59.9% (GL2015), the incidence rates of adverse reactions were 4.7% (BCJV) and 3.9% (GL2015). The additional costs incurred due to adverse drug reactions ranged from 12713-163925 yen per patient. Our results demonstrate that appropriate use of drugs based on the BCJV and GL2015 can help prevent adverse reactions; this would reduce the overall medical costs.

Effects of semi-solidification of enteral nutrients on the pharmacokinetic behavior of orally administered carbamazepine in rats.

The use of semi-solid enteral nutrients plays an extremely important role in accurate nutrition management. In the present study, we compared the pharmacokinetic profile of orally administered carbamazepine (CBZ) in rats treated with liquid RACOL®, semi-solid RACOL®, and HINE E-gel®, which are enteral nutrients marketed in Japan. Since liquid and semi-solid formulations are both marketed in Japan for RACOL®, liquid RACOL® was orally administered to control rats. The serum concentration of CBZ at each sampling point was lower in the semi-solid RACOL®-treated group than in the liquid RACOL®-treated group. No significant differences were observed in the pharmacokinetic behavior of CBZ between the semi-solid RACOL®-treated and HINE E-gel®-treated groups. Regarding pharmacokinetic parameters, the impact of the area under the curve (AUC0→5h) was the liquid RACOL® group > the semi-solid RACOL® group ≈ the HINE E-gel® group. Therefore, we concluded that serum concentrations of CBZ were lower when concurrently treating with semi-solid enteral nutrients than when simultaneously processing liquid enteral nutrients.

Cost-effectiveness analysis and effectiveness of pharmacist-managed outpatient clinics in Helicobacter pylori eradication therapy.

BACKGROUND: Helicobacter pylori is involved in many upper gastrointestinal diseases such as peptic ulcers and gastric cancers. In this study, we compared the cost-effectiveness of lansoprazole and vonoprazan in H. pylori eradication therapy and examined the effectiveness of pharmacist-managed outpatient clinics. METHODS: We investigated the efficacy and cost-effectiveness of pharmacist-managed outpatient clinics in H. pylori eradication therapy at our hospital from January 2015 to December 2017. The subjects were classified into three groups: lansoprazole group; vonoprazan group; and the medication instruction group, which received instructions at the pharmacist-managed outpatient clinics (intervention group). We examined the eradication rate and cost-effectiveness ratio of each group. RESULTS: The eradication rate of primary eradication therapy was 75.2% in the lansoprazole group, 87.8% in the vonoprazan group and 91.4% in the intervention group. When mental component summary was used as quality of life score, cost-effectiveness ratio was 224.7 yen in lansoprazole group, 223.9 yen in vonoprazan group and 222.2 yen in intervention group. Setting up pharmacist-managed outpatient clinics increases the pharmacist labour cost necessary for eradication therapy. However, if the medication instructions provided by the pharmacist can lead to improved disinfection efficiency, improvement in cost efficiency can be expected. CONCLUSION: Although medication instructions provided at the pharmacist-managed outpatient clinics incur additional labour costs, they improve patient quality of life as well as disinfection rate in H. pylori eradication therapy. Therefore, pharmacist-managed outpatient clinics are useful from the viewpoint of pharmacoeconomics.