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Introduction The study objective was to determine factors that stimulate or hinder student pharmacist participation in research and scholarship, to determine factors faculty believe are motivators or barriers for student pharmacist participation, and to compare student and faculty responses. Methods An electronic questionnaire was developed and emailed to all students enrolled in the doctor of pharmacy program and to all program faculty. To increase response rate, students were provided class time to complete the survey. Responses were collected anonymously. Results A total of 404 students (69% response rate) and 35 faculty (78% response rate) participated. Motivational factors rated highly by both students and faculty were interest in the topic, comfort level in working with faculty, energetic quality of faculty, and becoming more competitive for post-graduate training. Students indicated that projects benefiting the profession/medical community was an important motivator, while faculty believed that pursuing a position that requires research/scholarship was a key motivational factor. The most highly rated barrier was lack of time. Conclusions Student pharmacist participation in research and scholarship with faculty is variable in our program and little was known previously about factors that led student pharmacists to engage in research and scholarship. There was general agreement among student and faculty regarding several motivating factors; however, some important differences did exist. Addressing these differences may help increase student involvement in research and scholarship in the future.

Background and purpose With a prevalence of about one million d/Deaf and Hard of Hearing (HOH) patients that utilize American Sign Language (ASL) and the strong potential for communication barriers to adversely influence patient care outcomes, strategies must be developed to support health care professionals and students in learning to better care for d/Deaf and HOH patients. The primary objective of this project was to implement and assess a co-curricular course focused on helping student pharmacists become more confident and comfortable in communicating with d/Deaf and HOH patients. Educational activity and setting The co-curricular course (ASL for the Pharmacy Professional) consisted of four 90-min classes, each covering different words/phrases and Deaf cultural competence. Students were taught basic ASL including the alphabet, numbers, vocabulary, and sentence structure. Deaf culture and d/Deaf patient interaction was also covered. Students interacted with a Deaf physician over Skype and with d/Deaf and HOH individuals from the local community. Findings Pre- and post-surveys that contained an identical set of questions were administered before and after course completion. Surveys assessed confidence and level of comfort of first- and second-professional year student pharmacists surrounding Deaf culture and interacting with d/Deaf and HOH patients. Following the course, students reported significantly improved confidence in communicating with d/Deaf patients directly and with a translator. Summary Following completion of a co-curricular ASL course, doctor of pharmacy students perceived an increase in confidence in working with d/Deaf and HOH patients. Program logistics were simplified through collaboration with an outside entity.

Introduction Standards 2016 state students must be “practice-ready” upon graduation and utilizing health information technology is one skill needed to ensure students are practice-ready. Incorporating academic electronic health records (EHRs) into the didactic pharmacy curriculum is one tool for preparing students to be practice-ready, but it is unclear if this technology is used to facilitate assessment of students' patient care skills. Methods A 35-question electronic survey was distributed to each school/college of pharmacy (S/COP) with questions focused on general use of EHRs and characterizing EHRs as a tool to assess students' patient care skills in the didactic curriculum. Aggregate, anonymous data was reported and analyzed using descriptive statistics. Results Fifty-nine survey responses were suitable for inclusion in the analysis (43.8% response rate). Of those, 37 S/COP (62.7%) used an EHR in the didactic curriculum. Frequently performed and assessed EHR functions were collecting information and documentation, and EHRs were most commonly utilized to assess students' abilities to perform the collect (96.9%) and assess (93.8%) steps of the Pharmacists' Patient Care Process. EHRs were perceived to be most effective in assessing the following Center for the Advancement of Pharmacy Education Educational Outcomes: patient-centered care (93.9%), problem solving (83.9%), and learner (80.6%). Conclusions Optimizing the use of EHRs in S/COP is critical. Determining which outcomes are best suited to be assessed utilizing this technology and the optimal method to do so is an appropriate next step.

Background Only few studies have investigated the role of probiotics in the development of obesity. We aimed to determine the efficacy and safety of an intake of Lactobacillus plantarum K50 (LPK) on body fat and lipid profiles in people with obesity. Methods This randomized, double-blind, placebo-controlled, clinical trial involved 81 adults with a body mass index of 25–30 kg/m2 who were assigned randomly to a diet including 4 × 109 colony-forming unit of LPK or a placebo. Changes in body fat, anthropometric parameters, and biomarkers of obesity were compared using a linear mixed-effect model. Results After 12 weeks of treatment, body weight, fat mass, and abdominal fat area did not change significantly in the two groups. However, total cholesterol levels decreased from 209.4 ± 34.4 mg/dL to 203.5 ± 30.9 mg/dL in the LPK group, but increased from 194.7 ± 37.5 mg/dL to 199.9 ± 30.7 mg/dL in the placebo group (P = 0.037). Similarly, triglyceride levels decreased from 135.4 ± 115.8 mg/dL to 114.5 ± 65.9 mg/dL in the LPK group, with a significant difference between groups. LPK supplementation also tended to decrease leptin levels compared with placebo. It also changed the distribution of gut microbiota significantly, with an increase in L. plantarum and a decrease in Actinobacteria, both of whose changes in abundance were correlated with changes in visceral adiposity, with borderline significance. Conclusion A 12-week consumption of LPK reduced the total cholesterol and triglyceride levels significantly with favorable alterations in microbiota, suggesting potential benefits for controlling blood lipid profiles.

Purpose To describe opioid prescribing practice patterns and trends in emergency department visits (EDs) by provider type: physicians and advanced practice providers (APPs), which include nurse practitioners (NPs) and physician assistants (PAs). Methods The data source was the ED visit files of the 2005–2015 National Hospital Ambulatory Care Survey. The study sample was opioid prescription-related ED visits. Descriptive and multinomial logistic regression analyses were conducted to assess the proportion of opioid prescription-related visits by provider type over time in total and by patient age group. We then characterized opioid prescribing practices of NPs, PAs, and physicians according to type of opioid and pain-related diagnosis. Results From 2005 to 2015, there was a 116.7% increase in the proportion of the opioid prescription-related visits seen by NPs and a 61.2% increase seen by both APPs and physicians. In contrast, the proportion of the physician-only visits decreased (−8.3%). When stratified by age group, the growth was particularly notable among the visits with patients aged 65 and older seen by both APPs and physicians (AOR = 2.35, 95% CI = 1.69, 3.25). Proportionally less hydromorphone and morphine was prescribed by APPs than by physicians. Opioids were prescribed more often by APPs in visits involving dental and injury-related pain, whereas physicians prescribed opioids more in abdominal and chest pain-related visits. Conclusions From 2005 to 2015, APPs, particularly NPs played an increasing role in opioid prescribing in EDs. Opioid prescribing practices of APPs and physicians varied by patient condition as well as by opioid type.

The rheological and physiological properties of red blood cells (RBCs) are affected by many factors in the vascular environment. Among them, membrane fluctuations (MFs), particularly dynamic fluctuations in RBC cell membrane thickness (RBC-MFs), are likely to be altered by the level of glycation of haemoglobin in patients with diabetes mellitus (DM). We investigated the associations of RBC-MFs with physiological variables associated with DM and cardiovascular diseases (CVDs). Forty-one healthy control subjects and 59 patients with DM were enrolled. Five-microliter samples of blood were collected and diluted 400 times. To measure the RBC-MFs, holotomography was used, which non-invasively and precisely analyses the optical characteristics of RBCs. Associations between the RBC-MFs and biochemical parameters related to glucose homeostasis and lipid profiles were investigated. Independent associations of the RBC-MFs with the presence of CVDs were also analysed. RBC-MFs were lower in patients with DM than in healthy participants (61.64 ± 7.49 nm vs 70.65 ± 6.65 nm, P = 1.4 × 10

BACKGROUND: Practice guidelines recommend urine drug monitoring (UDM) at least annually in the setting of chronic opioid therapy as an objective assessment of substance use. However, empirical evidence on who gets tested and how often testing occurs is lacking. OBJECTIVES: This study investigates 10-year UDM trends in the United States based on 2 factors: (1) the duration of prescription opioid treatment, and (2) having an opioid use disorder (OUD) diagnosis and medications for opioid use disorder (MOUD) prescriptions. STUDY DESIGN: Observational cross-sectional study. SETTING: Research was conducted using administrative claims data from Optum’s deidentified Clinformatics Data Mart Database for the period 2007 to 2016. The dataset contained information on the plan enrollment and health care claims from 50 states and the District of Columbia. METHODS: To examine trends in UDM based on the duration of prescription opioid treatment, persons receiving prescription opioid analgesics were categorized into 4 groups based on the number of days covered: (a) less than 90 days, (b) 90 to 179 days, (c) 180 to 269 days, and (d) at least 270 days. To examine trends based on an OUD diagnosis and MOUD prescriptions, persons diagnosed with OUD were identified and categorized based on the presence of MOUD prescriptions as follows: (a) OUD with buprenorphine (BPN) and naltrexone (NTX) in the same year; (b) OUD with BPN only; (c) OUD with NTX only; (d) OUD with chronic prescription opioid analgesics (≥ 90 days); (e) OUD without prescription opioid analgesics, BPN, or NTX; and (f) chronic prescription opioid analgesics (≥ 90 days) without an OUD diagnosis. For analysis, the percent receiving UDM was estimated per group per year. Then the data were restricted to those receiving at least one UDM to estimate the average number of UDM per person. RESULTS: Data included an average of 364,485 persons per year receiving prescription opioid analgesics for chronic use, and 10,277 per year receiving an OUD diagnosis. Among those receiving prescription opioid analgesics, less than 50% received UDM. For those receiving at least one UDM, one additional UDM was performed per person as the duration of opioids increased by 90 days. Among persons with OUD, the percent receiving UDM was the highest for those receiving both BPN and NTX (87%), followed by those receiving BPN only (80%), chronic opioids (79%), NTX only (72%), and those not receiving any MOUD/opioids (54%). LIMITATIONS: Methadone dispensing for OUD treatments was not captured in administrative claims data. CONCLUSIONS: Although recommended for patients with chronic pain, UDM is provided less than half of the time for these patients. However, once patients received at least one UDM, they would continue to receive it on a fairly regular basis. Compared with those with chronic pain, persons diagnosed with OUD are more likely to receive UDM at a more frequent interval.

Objective. To evaluate faculty and student perceptions of and performance on virtual skills-based assessments focused on communication compared to in-person assessments. Methods. In spring 2020, virtual skills-based assessments were conducted. After all assessments were completed, two 12-item questionnaires, one for students and one for the faculty members who conducted the assessment, were designed to assess perceptions of virtual skills-based assessments. The surveys were distributed via an online platform to second- and third-year (P2 and P3) pharmacy students and to faculty who had participated in a virtual skills-based assessment. Scores from the spring 2020 virtual skills-based assessment were compared to scores on the in-person skills-based assessment that took place in spring 2019. Results. Of the 19 faculty and 279 students invited to participate, 18 (94.7%) faculty and 241 (86.4%) students responded. The majority of faculty (88.9%) and students (63.5%) perceived the virtual skills-based assessments to be effective at simulating an interaction. However, only 33.3% of faculty and 28.6% of students preferred the virtual environment. There was not a significant difference in student performance between in-person and virtual assessments for patient consultation and SOAP note skills. Conclusion. Providing sufficient formative and summative feedback to pharmacy students is a challenge, particularly in the context of skills-based assessments. Students and faculty reported that the virtual assessment provided an opportunity for an appropriate assessment of student communication skills. However, a strong preference for using virtual skills-based assessments in the future was not observed.

The opioid epidemic has had a devastating impact on our country, with wide-ranging effects on healthcare, corrections, employment, and social systems. Programs have been put in place for monitoring prescriptions, initiating and expanding medications for opioid use disorder, and harm reduction (i.e., naloxone distribution, needle exchanges). However, opportunities for personalization of opioid therapy based on addiction risk have been limited. The goal of the present study was to develop an objective risk assessment algorithm based on genetic markers that are correlated with opioid use disorder (OUD). A total of 180 single-nucleotide polymorphisms (SNPs) were tested in patients with and without OUD. SNPs selected for testing were associated with opioid metabolism and drug reward pathways based on previous studies. Of the 394 patients recruited, 200 had OUD and 194 served as controls without OUD but with prior opioid exposure. Logistic regression analyses stratified by sex identified ten unique SNPs in females and nine unique SNPs in males that were significantly associated with OUD. A Genetics Opioid Risk Score (GenORs) was calculated by counting the number of OUD risk-associated SNPs/genotypes for each patient. To evaluate the discrimination of the GenORs, a receiver operating characteristic (ROC) curve for each sex was generated and determined to be sensitive and specific. This represents the first published example of a sex-based genetic risk score with potential to predict OUD, and the first OUD algorithm to include opioid-associated pharmacokinetic genes.

Objectives The objective of the study was to estimate the national rates of naloxone coprescribing with opioids in office-based practice and emergency department (ED) settings in the United States (US). Study design This study is a cross-sectional study. Methods We used the National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) datasets to estimate the national rates of naloxone coprescribing with opioids for the period 2014–2016. The analysis was stratified into office-based practice and ED settings. In ED settings, opioid and naloxone could be given to patients while they were in ED or as a prescription at discharge. Patients of all ages were considered for the analysis and sampling weights were applied to estimate national rates. Results In office-based settings, 7918 sample visits included one or more opioid prescriptions (10.67 per 100 office visits). Of those, one included naloxone as a coprescription. In ED settings, the opioid prescription was given at discharge in 6124 sample visits (9.68 per 100 ED visits). Of those, two included naloxone as a coprescription. On the other hand, opioid was given to patients in the ED in 8811 sample visits (13.57 per 100 ED visits). Of those, 30 included naloxone as a coprescription. Conclusions The rates of naloxone coprescribing with opioids were extremely low in office-based and ED settings in the US. Expanding access to naloxone is a key component of the public health response to the opioid crisis. Based on our study findings, promoting the coprescription of naloxone with opioids may provide greater access to naloxone for those who are at risk of opioid overdose.

Objective As uncontrolled hyperuricemia has been associated with an increased risk of cardiovascular disease and the progression of chronic kidney disease (CKD), management of serum uric acid levels is important. The aim of this study was to evaluate the effectiveness of febuxostat in regulating uncontrolled hyperuricemia in patients with renal dysfunction. Materials and methods We included patients with CKD and persistent uncontrolled hyperuricemia despite treatment with allopurinol. The primary outcome of the study, which was the overall response rate of febuxostat, was defined as the proportion of patients that achieved a serum uric acid level l 7.0 mg/dL. The secondary outcomes included the change in renal function and factors that might influence treatment outcomes. The safety outcome was evaluated based on the incidence of adverse reactions. Results A total of 111 patients who switched medication to febuxostat were included. Febuxostat treatment significantly lowered serum uric acid level and the response rates were above 70% at all the time points for 1 year. Febuxostat-treated patients demonstrated no significant change in renal function during the study period. A history of gout attack decreased the response rate of febuxostat (odds ratio (OR): 3.13, 95% confidence interval (CI): 1.08 - 9.06), whereas low-dose aspirin use significantly increased response rate (OR: 0.29, 95% CI: 0.09 - 0.92) in the first month. No patients experienced any severe adverse events. Conclusions Febuxostat effectively lowered serum uric acid levels and was well tolerated in patients with CKD and allopurinol-refractory hyperuricemia. .

s Background Clinical trial globalization is a major trend for industry-sponsored clinical trials. There has been a shift in clinical trial sites towards emerging regions of Eastern Europe, Latin America, Asia, the Middle East, and Africa. Our study objectives were to evaluate the current characteristics of clinical trials and to find out the associated multiple factors which could explain clinical trial globalization and its implications for clinical trial globalization in 2011–2013. Methods The data elements of “phase,” “recruitment status,” “type of sponsor,” “age groups,” and “design of trial” from 30 countries were extracted from the ClinicalTrials.gov website. Ten continental representative countries including the USA were selected and the design elements were compared to those of the USA. Factors associated with trial site distribution were chosen for a multilinear regression analysis. Results The USA, Germany, France, Canada, and United Kingdom were the “top five” countries which frequently held clinical trials. The design elements from nine continental representative countries were quite different from those of the USA; phase 1 trials were more prevalent in India (OR 1.517, p

BACKGROUND AND OBJECTIVES: Attention-deficit/hyperactivity disorder (ADHD) medication use and psychotherapeutic polypharmacy is increasing. This study was designed to assess annual rates of ADHD medication prescribing and psychotherapeutic polypharmacy among patients 2 to 24 years old in the United States, identify commonly prescribed ADHD medications and concomitant psychotropic agents, and assess if specific characteristics are associated with polypharmacy. METHODS: In this cross-sectional study, we used publicly available ambulatory health care data sets to evaluate ADHD and psychotropic polypharmacy use in patients 2 to 24 years old from 2006 to 2015. National rates were estimated by using sampling weights, and common ADHD and psychotropic drugs prescribed were identified. Multivariate logistic regression models were developed to assess the strength of association between polypharmacy and patient or provider characteristics. RESULTS: Between 2006 and 2015, ADHD medication prescribing increased from 4.8% to 8.4%. ADHD polypharmacy increased from 16.8% to 20.5%, whereas psychotropic polypharmacy increased from 26.0% to 40.7%. The most common ADHD combinations were stimulants and α-2 agonists (67.1%), whereas the most common concomitant psychotropic agents were selective serotonin reuptake inhibitors (14.4%) and second-generation antipsychotics (11.8%). Factors associated with polypharmacy were age, female sex (psychotropic), nonprivate insurance, northeast and south regions (ADHD), receipt of mental health counseling or psychotherapy, and calendar year. CONCLUSIONS: ADHD and psychotropic polypharmacy use is increasing and associated with specific patient characteristics. These patterns should spark further inquiry about the appropriateness, efficacy, and safety of psychotherapeutic polypharmacy in children and young adults, particularly within subgroups in which the use is high.

Objectives The objectives of this study were (1) to determine the rate of antibiotic prescribing at ambulatory clinics, and (2) to assess the concordance of antibiotic prescriptions with published guidelines and Food and Drug Administration–approved indications in terms of drug choices and dosing regimen. Design Cross-sectional study. Setting and participants Patients of all ages receiving at least 1 prescription during ambulatory visits in 2016 to 2017 were observed. Outcome measures For each of the 3 clinic systems included in this study, oral antibiotic prescribing rates were estimated per patient and per ambulatory visit. Then, the concordance of oral antibiotic prescribing was assessed with respect to (1) choice of agent and (2) the dosing regimen by comparing it to the recommended therapeutic regimen (RTR). Results A total of 284,348 patients receiving at least 1 prescription were included in the analysis. Between clinics, 17.4 to 43.7 per 100 patients received antibiotics. Of the antibiotics prescribed, 48.9% in Clinic A, 48.0% in Clinic B, and 60.7% in Clinic C were considered to be discordant in terms of drug choice. When the dosing regimen was taken into account in addition to the choice of agent, 72.6% in Clinic A, 76.7% in Clinic B, and 81.6% in Clinic C were discordant based on drug choice or dosing regimen. Of the prescriptions written with a discordant dosing regimen, 91.2% in Clinic A, 79.6% in Clinic B, and 91.0% in Clinic C were at a higher dosage than RTR. Conclusion Antibiotic prescribing rates vary by clinics, whereas discordant prescribing is consistently prevalent across clinics. More efforts should be put into ambulatory care to address antibiotic misuse problems, and our method could improve ambulatory antimicrobial stewardship programs.

OBJECTIVE: To test whether Medicaid expansion is associated with (a) a greater number of naloxone prescriptions dispensed and (b) a higher proportion of naloxone prescriptions paid by Medicaid. DATA SOURCES/STUDY SETTING: We used the IQVIA National Prescription Audit to obtain data on per state per quarter naloxone prescription dispensing for the period 2011‐16. STUDY DESIGN: In this quasi‐experimental design study, the impact of Medicaid expansion on naloxone prescription dispensing was examined using difference‐in‐difference estimation models. State‐level covariates including pharmacy‐based naloxone laws (standing/protocol orders and direct authority to dispense naloxone), third‐party prescribing laws, opioid analgesic prescribing rates, opioid‐involved overdose death rates, and population size were controlled for in the analysis. PRINCIPAL FINDINGS: Medicaid expansion was associated with 38 additional naloxone prescriptions dispensed per state per quarter compared to nonexpansion controls, on average (P = .030). Also, Medicaid expansion resulted in an average increase of 9.86 percent in the share of naloxone prescriptions paid by Medicaid per state per quarter (P

Background and purpose In this article, we developed and implemented an escape room activity for first-year pharmacy student orientation. The purpose of the activity was to engage students in socialization with their classmates, to familiarize students with the key personnel of the program, to acquaint students with co-curricular programming in the academic calendar, and to peruse key policies in the student handbook. Educational activity and setting An escape room was developed for first professional year student orientation in a large classroom setting. The escape room featured several gameplay elements, including a personnel bingo game, a computerized student calendar scavenger hunt, and group assessments designed to acquaint students with policies within the student handbook. One hundred nineteen students participated simultaneously in the orientation escape room activity in break-out groups to accomplish the objectives of the escape room as measured by embedded assessments. Findings All students successfully escaped the encounter. Students demonstrated proficiency in orientation learning objectives on group assessments. Students were queried about their attitudes towards the instructional design via a post-survey. The proof-of-concept for this work was evaluated via a log of estimated faculty time and monetary costs for implementation. Summary A student orientation escape room was successfully designed and implemented. Students were assessed to evaluate the retention of knowledge obtained during orientation. Despite not having previously met their classmates, survey responses indicated that students were positively inclined toward the educational activity. This is the first report of a co-curricular escape room developed for pharmacy student orientation.

Key Points Question Are legal mandates for naloxone coprescription associated with increases in naloxone prescription dispensing? Findings In this population-based, state-level cohort study using data from retail pharmacies in all 50 states and the District of Columbia, having a legal mandate for naloxone coprescription was associated with approximately 7.75 times more dispensed naloxone prescriptions compared with not having the requirements. This equates to an estimated 214 additional naloxone prescriptions dispensed per month in the period following the mandates, holding all other variables constant. Meaning State legal interventions that mandate naloxone coprescription for potentially at-risk patients may be associated with increases in naloxone prescription dispensing in retail pharmacies, and this strategy may be useful to improve naloxone availability and reduce opioid-related harm., Importance To mitigate the opioid overdose crisis, states have implemented a variety of legal interventions aimed at increasing access to the opioid antagonist naloxone. Recently, Virginia and Vermont mandated the coprescription of naloxone for potentially at-risk patients. Objective To assess the association between naloxone coprescription legal mandates and naloxone dispensing in retail pharmacies. Design, Setting, and Participants This was a population-based, state-level cohort study. The sample included all prescriptions dispensed for naloxone in the retail pharmacy setting contained in IQVIA’s national prescription audit, which represents 90% of all retail pharmacies in the United States. The unit of observation was state-month and the study period was January 1, 2011, to December 31, 2017. Exposures State legal intervention mandating naloxone coprescription. Main Outcomes and Measures Number of naloxone prescriptions dispensed. State rates of naloxone prescriptions dispensed per month per 100 000 standard population were calculated. Results The rate of naloxone dispensing increased after implementation of legal mandates for naloxone coprescription. An estimated 88 naloxone prescriptions per 100 000 were dispensed in Virginia and 111 prescriptions per 100 000 were dispensed in Vermont during the first full month the legal requirement was effective. In comparison, 16 naloxone prescriptions per 100 000 were dispensed in the 10 states (including the District of Columbia) with the highest opioid overdose death rates and 6 prescriptions per 100 000 were dispensed in the 39 remaining states. The number of naloxone prescriptions dispensed was associated with the legal mandate for naloxone coprescription (incidence rate ratio [IRR], 7.75; 95% CI, 1.22-49.35). Implementation of the naloxone coprescription mandate was associated with an estimated 214 additional naloxone prescriptions dispensed per month in the period following the mandates, holding all other variables constant. Among covariates, naloxone access laws (IRR, 1.37; 1.05-1.78), opioid overdose death rates (IRR, 1.06; 95% CI, 1.04-1.08), the percentage of naloxone prescriptions paid by third-party payers (IRR 1.009; 1.008-1.010), and time (IRR, 1.06; 95% CI, 1.05-1.07) were significantly associated with naloxone prescription dispensing. Conclusions and Relevance These study findings suggest that legally mandated naloxone prescription for those at risk for opioid overdose may be associated with substantial increases in naloxone dispensing and further reduction in opioid-related harm., This population-based cohort study examines the rates of naloxone coprescription since implementation of state laws mandating coprescription for persons at risk for opioid overdose.

Objectives To construct a database of published clinical drug trials suitable for use 1) as a research tool in accessing clinical trial information and 2) in evidence-based decision-making by regulatory professionals, clinical research investigators, and medical practitioners. Materials Comprehensive information obtained from a search of design elements and results of clinical trials in peer reviewed journals using PubMed (http://www.ncbi.nlm.ih.gov/pubmed). Method The methodology to develop a structured database was devised by a panel composed of experts in medical, pharmaceutical, information technology, and members of Ministry of Food and Drug Safety (MFDS) using a step by step approach. A double-sided system consisting of user mode and manager mode served as the framework for the database; elements of interest from each trial were entered via secure manager mode enabling the input information to be accessed in a user-friendly manner (user mode). Information regarding methodology used and results of drug treatment were extracted as detail elements of each data set and then inputted into the web-based database system. Results Comprehensive information comprising 2,326 clinical trial records, 90 disease states, and 939 drugs entities and concerning study objectives, background, methods used, results, and conclusion could be extracted from published information on phase II/III drug intervention clinical trials appearing in SCI journals within the last 10 years. The extracted data was successfully assembled into a clinical drug trial database with easy access suitable for use as a research tool. The clinically most important therapeutic categories, i.e., cancer, cardiovascular, respiratory, neurological, metabolic, urogenital, gastrointestinal, psychological, and infectious diseases were covered by the database. Names of test and control drugs, details on primary and secondary outcomes and indexed keywords could also be retrieved and built into the database. The construction used in the database enables the user to sort and download targeted information as a Microsoft Excel spreadsheet. Conclusion Because of the comprehensive and standardized nature of the clinical drug trial database and its ease of access it should serve as valuable information repository and research tool for accessing clinical trial information and making evidence-based decisions by regulatory professionals, clinical research investigators, and medical practitioners.

The purpose of this study was to identify genotypes associated with dose-adjusted tacrolimus trough concentrations (C0/D) in kidney transplant recipients using whole-exome sequencing (WES). This study included 147 patients administered tacrolimus, including seventy-five patients in the discovery set and seventy-two patients in the replication set. The patient genomes in the discovery set were sequenced using WES. Also, known tacrolimus pharmacokinetics-related intron variants were genotyped. Tacrolimus C0/D was log-transformed. Sixteen variants were identified including novel CYP3A7 rs12360 and rs10211 by ANOVA. CYP3A7 rs2257401 was found to be the most significant variant among the periods by ANOVA. Seven variants including CYP3A7 rs2257401, rs12360, and rs10211 were analyzed by SNaPshot in the replication set and the effects on tacrolimus C0/D were verified. A linear mixed model (LMM) was further performed to account for the effects of the variants and clinical factors. The combined set LMM showed that only CYP3A7 rs2257401 was associated with tacrolimus C0/D after adjusting for patient age, albumin, and creatinine. The CYP3A7 rs2257401 genotype variant showed a significant difference on the tacrolimus C0/D in those expressing CYP3A5, showing its own effect. The results suggest that CYP3A7 rs2257401 may serve as a significant genetic marker for tacrolimus pharmacokinetics in kidney transplantation.

Objective. To determine how pharmacy students’ perceptions of electronic nicotine delivery systems (ENDS) differ from those of other health care students. Methods. A 33-item questionnaire was sent to health professional students at a Midwestern university to assess their tobacco use, insights regarding ENDS, cessation education, and perceptions. Health professions included were pharmacy, nursing, public health, optometry, dental hygiene, and others. Results. The overall response rate to the questionnaire was 41% (1152/2799). The study population reported high ENDS use. Almost half (47%) of the respondents had ever used ENDS and 14% were current users (6% pharmacy students vs 19% other health care students). A lower percentage of pharmacy students than other health care students agreed that using ENDS is healthier than using tobacco (18% vs 26%). Overall, pharmacy students more strongly agreed that they had received enough education to counsel patients regarding tobacco cessation (rated 4.7 by pharmacy students vs 3.6 by other health care students on a seven-point Likert scale) and ENDS cessation (rated 3.3 by pharmacy students vs 2.9 by other health care students). Finally, pharmacy students were less likely than other health care students to recommend the use of ENDS to aid patients in quitting traditional cigarette use (2.9 vs 3.2, respectively). Conclusion. The rapid rise in use of ENDS and the continued use of cigarettes in the United States makes it imperative for health care professionals to be knowledgeable about these products and prepared to counsel patients regarding them. We found that pharmacy students tended to have more negative perceptions about ENDS and a lower percentage of pharmacy students than other health care students agreed that ENDS should be used as a cessation tool for quitting traditional cigarettes.

Gene maturation differs between paediatric and adult populations, and the extrapolation of adult pharmacogenomic information to paediatrics is not always appropriate. We sought to determine the extent of paediatric pharmacogenomic trial translation into US FDA-approved labels and to evaluate needs for biomarker studies. Using FDA's Table of Genomic Biomarkers and Drugs@FDA website, 38 pharmacogenomic biomarkers in 56 drug labels were identified with possible application in paediatrics. Of these 56 drugs, biomarker comparison against 'Very Important Pharmacogenes (VIPs)' defined in PharmGKB's database revealed a total of eight VIPs labelled among 41 drugs. One hundred and thirty-nine product reviews posted on the FDA website under the Best Pharmaceuticals for Children Act and Paediatric Research Equity Act between October 2007 and July 2014 were examined. Review screening identified 43 drugs with 'pharmacogenomic' content, of which only three were true genotyping study reviews for proton pump inhibitors, all evaluating CYP2C19 polymorphisms. Pantoprazole was the sole drug labelled with pharmacogenomic information obtained specifically from paediatric trials. Clinicaltrials.gov was searched to further evaluate the current availability of pharmacogenomic studies in the paediatric population. Of the 33,132 trials registered on Clinicaltrials.gov, 137 were labelled as paediatric pharmacogenetic and pharmacogenomic studies. Pharmacogenomic studies directly conducted in paediatric patients are lacking, and thus, pharmacogenomic biomarker information based on adult studies is commonly presented in FDA-approved labels for use in paediatric patients. Considering differences in gene expression and physiological maturation between paediatric and adult populations, studies investigating pharmacogenomic effects specifically in paediatric patients should be conducted whenever significant biomarkers are available.

The objectives of this study are: (1) to estimate the expected health outcomes of atypical antipsychotics (AAPs) and other non-stimulant attention-deficit/hyperactivity disorder (ADHD) medications and (2) to evaluate the cost-effectiveness of AAPs compared to other non-stimulant ADHD medications. We used decision analysis to compare three alternatives for treating children and adolescents with ADHD who failed initial stimulant treatment: (1) AAPs, (2) a selective norepinephrine reuptake inhibitor (atomoxetine), and (3) selective α2-adrenergic agonists (clonidine and guanfacine). Probability estimates and quality-adjusted life year (QALY) weights were derived from a literature review. Cost-effectiveness was estimated using the expected health outcomes derived from the decision analysis and expected costs from the literature. The study was conducted from the third-party payer perspective, and the study period was 1 year. One-way deterministic sensitivity analysis and a Monte Carlo simulation were performed. Over the course of 1 year of ADHD pharmacotherapy, the highest QALY was for clonidine/guanfacine (expected QALY = 0.95) followed by atomoxetine (expected QALY = 0.94). Atypical antipsychotics yielded the lowest health outcome with an expected QALY of 0.84. In the cost-effectiveness analysis, the AAP strategy was dominated as it was less effective and more costly than other two strategies. Compared to clonidine/guanfacine, AAPs provided lower QALYs (0.11 QALY lost) at an additional cost of $2186 on average. Compared to atomoxetine, AAPs resulted in 0.10 QALYs lost at an additional cost of $2186. In this decision analysis model, AAPs provide lower expected health outcomes than other ADHD medications in children and adolescents who failed prior stimulant therapy. Furthermore, AAPs were not a cost-effective option.

Kentucky Department for Behavioral Health Developmental and Intellectual Disabilities conducted a survey to evaluate consumers’ satisfaction with services delivered at the Community Mental Health Centers (CMHCs) in Kentucky. The survey was administered at outpatient clinics operated by fourteen CMHCs in 2010. The purpose of this study was to identify factors that predict whether clients will respond that they were “generally satisfied” with services received from CMHCs. A logistic regression model was developed using respondents’ characteristics and their responses to survey questions. Survey questions were grouped into seven core domains: general satisfaction, access, quality, participation in treatment planning, outcomes, functioning, and social connectedness. In result, responses to domains of access, quality and participation in treatment planning significantly affected clients’ perception of general satisfaction. Respondents who positively assessed those domains of services were more likely to answer that they were generally satisfied with services. Based on the analysis in this report, improvement in certain domains of services, especially access, quality and participation in treatment planning could increase the level of positive responses in general satisfaction.