Assessment of Medication Regimen Complexity of COPD Regimens in Individuals Visiting Community Pharmacies.

Purpose: Non-adherence is common and linked to poor COPD outcomes. Medication Regimen Complexity Index (MRCI) scores affect other disease outcomes. Little is known about the implications of MRCI scores in COPD. Secondary analysis was done to calculate MRCI scores assessing relationship to symptoms, COPD severity and health literacy (HL) to identify potential interventions to optimize adherence. Patients and Methods: Secondary analysis was conducted of cross-sectional, non-randomized survey data. Participants with self-reported COPD completed a survey of demographics, exacerbations, symptoms (COPD Assessment Test (CAT)), and self-reported COPD regimens. COPD severity was classified into Global Initiative for Chronic Obstructive Lung Disease (GOLD) ABCD categories using exacerbation history and CAT. CAT scores were categorized as low (<10), high (>10) and very high (>20). A 1-year proportion of days covered (PDC) was calculated. A MRCI calculator scored regimens (primary endpoint). Published cut-off points were used to categorize MRCIs as low (≤4), medium (5-8) and high (>8) and inhaled device polypharmacy (IDP) as ≥3 devices. Risk for low HL was assessed using a Single Item Literacy Screener. Descriptive and Chi-squared statistics were used. Results: Participants' (N = 709) PDC for 1 maintenance medicine averaged 0.43 ± 0.37; 28.7% were adherent (PDC ≥ 80%). CAT scores were very high in 54.6% and high in 35.8%. Distribution of GOLD categories were A (6%), B (35%), C (4%) and D (55%). High, medium and low MRCI were 85%, 14% and 9%, respectively. Mean devices per regimen was 2.05 ± 0.8; IDP was 28%. MRCI and IDP increased with worsening CAT scores and COPD severity per GOLD category (p<0.05), but not low HL. Conclusion: MRCI scores for COPD regimens increased with COPD severity and symptoms. Overall adherence was low despite high symptom scores; high MRCI scores could contribute. All COPD medication classes are available in multiple devices, combinations, and daily formulations; there is potential to simplify regimens. Prospective studies are needed to evaluate if interventions minimizing MRCI scores improve adherence and COPD outcomes.

Concordance between reported medication taking behavior and prescription instructions for patients with chronic obstructive pulmonary disease visiting community pharmacies.

BACKGROUND: Understanding types and frequency of medication taking discrepancies could help design pharmacist interventions to improve adherence, outcomes, and prescribing. OBJECTIVE: This study aimed to assess concordance between participants' descriptions of chronic obstructive pulmonary disease (COPD) medication taking behaviors and prescription instructions. METHODS: Continued analysis of previously collected data. Dispensing data from 35 community pharmacies identified participants at the age of ≥ 40 years, with ≥ 1 COPD maintenance medication in the past year and self-reported COPD. Participants completed a survey of demographics, corticosteroid/antibiotic drug use, and symptom scores. Participants listed each medication and described medication taking behavior. COPD severity was classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) ABCD categories from exacerbation history and symptoms. Aggregate proportion days covered (PDC) for any 1 maintenance medicine was calculated using 12-month dispensing data. Discrepancies between medication taking and instructions were classified: (1) overuse, (2) underuse, or (3) discontinued by participant (without prescriber knowledge). Descriptive statistics summarized survey results. Chi-square compared discrepancies among long-acting bronchodilators (LABDs), inhaled corticosteroids (ICS), and short-acting bronchodilators (SABDs). RESULTS: Most participants (N = 709; 27.6% urban, 70.5% rural) were highly symptomatic (GOLD groups B/D = 89.9%) and high risk (groups C/D = 59.2%). Median medication number was 4. Concordance of ICS and LABD taking behavior with prescriber instructions was 80.6% and 81.8%, respectively (P > 0.05). PDC averaged 0.46 ± 0.37; only 28.7% were adherent (i.e., PDC ≥ 0.80). ICS underuse (11.8%) exceeded LABD (5.5%). LABD discontinuation (7.4%) exceeded ICS (2.7%) or SABD (0.6%). SABD overuse (9.3%) exceeded ICS (3.4%) or LABD (4.3%) (P < 0.5 all comparisons). CONCLUSION: Although most were highly symptomatic, high risk, and frequently described correct medication taking behavior, overall adherence was very low. Discrepancies included overuse, underuse, and self-discontinuation. Nonadherence and medication taking discrepancies may increase symptoms, exacerbations, and additional medication prescribing. Potential pharmacist strategies include regularly assessing adherence and differentiating intentional versus nonintentional nonadherence to identify and implement patient-specific interventions to encourage medication taking as prescribed.

Consistency of chronic obstructive pulmonary disease regimens for patients visiting community pharmacies with the Global Initiative for Chronic Obstructive Lung Disease recommendations.

OBJECTIVE: Despite evidence-based Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations, outcomes are poor. GOLD uses chronic obstructive pulmonary disease (COPD) assessment test (CAT) scores with exacerbation history to categorize COPD severity into A, B, C, and D severity groups. Therapy is group-specific; monotherapy/dual long-acting bronchodilators (LABDs) therapy is preferred to inhaled corticosteroids (ICS). Pharmacist-accessible data could be used to identify evidence-based interventions to improve outcomes. The primary objective was to analyze previously collected data to compare the consistency of patient-described COPD regimens with GOLD therapeutic recommendations to identify potential pharmacist interventions. METHODS: Cross-sectional, nonrandomized design using a written questionnaire and CAT scores. Dispensing data from 35 Missouri community pharmacies initially identified participants aged 40 years or older with 1 or more COPD medications dispensed in the past year. Those self-reporting COPD, emphysema, or chronic bronchitis completed a demographic survey with medication history, including oral corticosteroid and antibiotic use, and CAT scores. Proportion of days covered (PDC) was calculated for any COPD maintenance medication dispensed over 1 year. The participants' COPD was categorized into A, B, C, and D severity groups. The reported medication regimens were categorized into consistent with, escalated from, or less than initial first-line/alternative recommended therapy for the A, B, C, and D severity groups. RESULTS: The participants totaled 709 (group A: 6%; group B: 35%; group C: 4%; group D: 55%). Of the regimens, 41% were consistent with, 34% were escalated from, and 24% were less than initial first-line/alternative GOLD recommendations. Most (96%) of the participants were highly symptomatic. Regimens containing ICS: (67.5%); ICS plus LABD (37.2%) exceeded dual LABD (4.2%). The average PDC was 0.43 ± 0.37; only 28.7% were adherent (PDC ≥ 0.80). CONCLUSIONS: Participants with self-reported COPD were highly symptomatic and nonadherent; undertreatment was noted. Community pharmacists could provide therapeutic interventions consistent with GOLD A, B, C, and D severity groups, promote dual LABD versus ICS therapies, and optimize adherence.

Assessment of symptom burden and adherence to respiratory medications in individuals self-reporting a diagnosis of COPD within a community pharmacy setting.

OBJECTIVES: Data on symptom burden or medication adherence in patients with chronic obstructive pulmonary disease (COPD) within a community pharmacy setting are limited. This study assessed symptom burden and adherence to respiratory medications in individuals reporting COPD, chronic bronchitis, or emphysema diagnoses visiting community pharmacies. DESIGN: This cross-sectional study enrolled participants visiting 35 community pharmacies in Missouri (October 2016 to April 2017). PARTICIPANTS: Eligible participants (aged 40 years or more with a self-reported history of COPD, prescription for at least 1 COPD maintenance medication during the previous 12 months, and able to complete an English questionnaire) were identified from pharmacy dispensing records. MAIN OUTCOME MEASURES: Participants completed a questionnaire assessing demographics, clinical characteristics, health literacy, COPD Assessment Test (CAT) modified Medical Research Council (mMRC) dyspnea scale scores, and exacerbation history. Recent spirometry data were obtained, if available, from participants' physicians. COPD was classified according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2016 criteria. Medication adherence was assessed as proportion of days covered (PDC) from dispensing records. RESULTS: Of 682 participants (mean age 63.0 years; 57% female) with available pharmacy data, 251 (36.8%) had available spirometry data. Most participants had mMRC scores ≥ 2 (60.9%) and CAT scores ≥ 10 (90.2%); 57.2% reported at least 2 moderate or 1 or more severe exacerbations within the previous 12 months. GOLD classifications varied depending on the scale used (mMRC vs. CAT); more participants were classified as group C/D than group A/B, with the highest proportion classified as group D (higher symptom burden and exacerbation risk). Mean PDC was 0.46 ± 0.37; only 28.7% of participants were adherent (PDC ≥ 80%) to at least 1 COPD maintenance medication. CONCLUSION: Individuals self-reporting a COPD diagnosis receiving respiratory medications from community pharmacies in Missouri have a high symptom burden and low medication adherence. Further research should determine reasons for low adherence and ways to reduce COPD symptoms.

A structured mentoring program to develop junior faculty into successful co-coordinators of a large multi-instructor pathophysiology course.

BACKGROUND AND PURPOSE: To develop and implement a system for junior clinical faculty to become successful course coordinators with the use of a mentoring program and ensure that student performance and satisfaction are maintained at a high level. EDUCATIONAL ACTIVITY AND SETTING: For five years, first-time faculty discussion group leaders in a required large (>225 students) multi-instructor pathophysiology course opted into a structured mentoring program for course coordination in the subsequent year. Program categories included course material development, exam and quiz management, discussion group management, and communication among students, faculty, and staff. FINDINGS: Mentors' previous coordination experience ranged from a few years to over a decade. Faculty participants included three second-year faculty. Each participant successfully undertook a full co-coordinator role the following year. Subsequently, each then became a lead mentor the following year for new participants. Exam quality/reliability statistics were sustained at a high level, course evaluations and student performance improved throughout the program, and all mentor/mentee reflections demonstrated a positive and impactful experience. DISCUSSION AND SUMMARY: Course coordination can be a small percentage of clinical faculty workload, yet is a significant time commitment. Pharmacy resident certificate or new faculty academy programs often do not include course coordination, which is a vital, higher level function/role. Structured mentoring early in professional career of junior faculty aids in the assumption of pedagogical leadership roles, while also developing mentoring skills of mid-level faculty.

Design and Validation of Patient-Centered Communication Tools (PaCT) to Measure Students' Communication Skills.

Objective. To develop a comprehensive instrument specific to student pharmacist-patient communication skills, and to determine face, content, construct, concurrent, and predictive validity and reliability of the instrument. Methods. A multi-step approach was used to create and validate an instrument, including the use of external experts for face and content validity, students for construct validity, comparisons to other rubrics for concurrent validity, comparisons to other coursework for predictive validity, and extensive reliability and inter-rater reliability testing with trained faculty assessors. Results. Patient-centered Communication Tools (PaCT) achieved face and content validity and performed well with multiple correlation tests with significant findings for reliability testing and when compared to an alternate rubric. Conclusion. PaCT is a useful instrument for assessing student pharmacist communication skills with patients.

Patient perspectives on fluticasone-vilanterol versus other corticosteroid combination products for the treatment of asthma.

OBJECTIVE: Fluticasone furoate (FF), an inhaled corticosteroid (ICS), and vilanterol (VI), a long-acting beta2 receptor agonist (LABA), is a new combination used in an Ellipta(®) device. This article compares FF-VI to other ICS-LABA combinations available, particularly emphasizing product selection from the patient perspective. DATA SOURCES: A PubMED and EMBASE search completed in October 2015 identified trials using the MeSH terms "fluticasone", "vilanterol", and "asthma". Additional information was gathered from references cited in the identified publications, the manufacturer, package insert, and ClinicalTrials.gov registry. STUDY SELECTION/DATA EXTRACTION: Preference was given to randomized controlled clinical trials. Animal trials, trials for COPD, and non-English sources were excluded. DATA SYNTHESIS: Seven efficacy trials of FF-VI in asthma were identified. Only one (24 weeks) trial compared FF-VI to another ICS-LABA combination (fluticasone propionate-salmeterol). Primary outcomes (usually lung function) and secondary outcomes (eg, quality of life and symptom scores) were comparable. In three FF-VI safety trials, the type and frequency of common adverse reactions (ie, thrush and dysphonia) were similar to those in clinical trials. Over 90% of subjects rated the Ellipta(®) device as "easy to use" and demonstrated correct device technique initially and at 4 weeks. CONCLUSION: Individuals may have drug- and device-specific preferences that should be incorporated into therapeutic decision making. Limited data indicate that clinical and patient-oriented efficacy/safety outcomes of FF-VI are likely comparable to other available combinations for adults with asthma. Patient-friendly features include once-daily dosing, flexibility of dose timing, and design/ease of the use of the device. Additional larger and long-term comparative studies are needed to determine whether these features translate into greater efficacy, safety, patient preference, or adherence versus other ICS-LABA combinations. In the next few years, the availability of less expensive generic ICS-LABA products may strongly influence patient preference.

Fluticasone-formoterol: a systematic review of its potential role in the treatment of asthma.

BACKGROUND: The purpose of this systematic review is to summarize and evaluate the available published data regarding the efficacy and safety of a combination product containing fluticasone propionate/formoterol (FP-F) in order to establish its potential role compared with other inhaled combination corticosteroid/long-acting beta2 receptor agonists for the maintenance treatment of asthma. METHODS: A PubMed and EMBASE search was conducted using the terms "fluticasone propionate", "formoterol fumarate", "Flutiform(®)", and "asthma" in July 2014 to identify trials using this combination specifically for the treatment of asthma. Additional information was gathered from references cited in the identified publications, the package insert, and the ClinicalTrials. gov registry. All randomized controlled clinical trials for humans in asthma were evaluated for inclusion. Data from animal trials, clinical trials for chronic obstructive pulmonary disease, and non-English sources were excluded. RESULTS: Seven short-term safety and efficacy trials of FP-F compared with its individual components and two comparison trials of FP-F versus other combination products were identified. Generally, the incidence of drug-related adverse events was low and consistent with previously reported drug class-related adverse events (ie, pharyngitis, dysphonia, and headache). The combination of FP-F was shown to be noninferior to fluticasone propionate/salmeterol for improving predose forced expiratory volume at one second (FEV1) and 2 hours post dose FEV1. FP-F was also noninferior to budesonide/formoterol in improving predose FEV1. Other clinical endpoints, including various symptom scores, asthma control, quality of life, and subjects' assessment of the medications were not significantly different. CONCLUSION: Poor asthma control is common. The data from short-term studies indicate that this inhaled corticosteroid and long-acting beta2 receptor agonist combination product is non-inferior to similar combination products available. As FP-F is available in different strengths, the corticosteroid dose can be titrated without changing devices. A potential advantage is that those with good technique, the same type of device could be used for both their controller and rapid relief inhaler medicines. The choice of this combination versus other similar products may be based primarily on cost.

Student use of health literacy tools to improve patient understanding and medication adherence.

OBJECTIVE: Evaluate curricular changes related to health literacy and determine impact on independent-living senior residents as part of an introductory pharmacy practice experience for third-year student pharmacists. DESIGN: Students were randomly assigned a resident whom they visited multiple times to conduct assessments and provide various services using three methods: Ask Me 3™ Four Habits Model, and Teach-back. SETTING: The study was conducted at independent-living apartments within a 24-mile radius from the St. Louis College of Pharmacy, St. Louis, Missouri. PATIENTS, PARTICIPANTS: Participants (n = 147 to 173, across all three years) were volunteer, elderly residents, living at a facility that collaborated with the research. INTERVENTIONS: Within one academic year, students collected medical and medication histories, conducted household safety checks, performed screening assessments, assessed adherence, and provided general recommendations to a resident. MAIN OUTCOME MEASURE(S): Outcomes included resident satisfaction, student satisfaction, and correlations between student use of health literacy tools and resident satisfaction. RESULTS: Exit surveys indicated resident overall satisfaction with the program, increased understanding of health-related information, increased confidence in asking health care professionals questions about their health, and greater commitment to medication adherence as a result of the experience. Students were highly satisfied with the program. Analyses reveal some correlations between a previously determined performance level of student communication and resident satisfaction. CONCLUSIONS: Students' use of health literacy communication tools during encounters with independent-living senior residents can result in greater patient understanding and empowerment, which may in turn help improve medication adherence.

Combination of fluticasone furoate and vilanterol for the treatment of chronic obstructive pulmonary disease.

OBJECTIVE: To evaluate the efficacy and safety of the combination of fluticasone furoate/vilanterol (FF/VI) and compare it with other inhaled combination corticosteroid/long-acting ß2-receptor agonists for maintenance treatment of chronic obstructive pulmonary disease (COPD). DATA SOURCES: A PubMed and EMBASE search in June 2013 using the MeSH terms fluticasone and vilanterol identified trials using this combination for COPD. Additional information was gathered from references cited in the identified publications, the manufacturer, and package insert as well as the ClinicalTrials.gov registry. STUDY SELECTION/DATA EXTRACTION: Preference was given to randomized controlled clinical trials. Data from animal trials, clinical trials for asthma, and non-English sources were excluded. DATA SYNTHESIS: Given once daily, FF/VI improves trough forced expiratory volume at 1 s by about 230 mL in a 28-day trial versus placebo. However, a more modest increase (100-130 mL) was seen in 2 longer 28-week trials. In the longest trial of 1 year, a slight but significant decrease in the yearly rate of moderate plus severe exacerbations, the time to first moderate or severe exacerbation, and the frequency of exacerbations requiring systemic corticosteroids was seen. There was no difference in the rate of exacerbations requiring hospitalization. The product appears to have the adverse effect profile typical of its class. CONCLUSIONS: Of the inhaled corticosteroid/long-acting ß2 receptor agonist combinations, VI/FF is the first allowing once-daily dosing. Similar to the other combination products, it may slightly decrease the incidence of COPD exacerbations in the patient subset with Global Initiative for Chronic Obstructive Lung Disease risk category C or D. There are no direct safety or efficacy data comparing this with other available inhaled combination products. The once-daily dosing might improve adherence in select patients. The Ellipta delivery device may assist some who are unable to use other devices correctly.

Health literacy: use of the Four Habits Model to improve student pharmacists' communication.

OBJECTIVE: To assess whether student pharmacists' communication skills improved using the Four Habits Model (FHM) at the St. Louis College of Pharmacy. METHODS: During the Fall of 2009 and 2010, student pharmacists in the third professional year learned and practiced the FHM. They were given feedback by faculty on three of the four Habits, used the FHM for self and peer assessment, and were formally evaluated on all four Habits during a standardized patient encounter. RESULTS: Student pharmacist performance significantly improved from baseline during both Fall 2009 and Fall 2010 in the majority of the Habits assessed. CONCLUSION: Use of the FHM in pharmacy education can improve a student pharmacists' ability to display the four Habits of communicating and developing relationships with patients. Tailoring of the FHM to pharmacy encounters will further enhance the utility of this communication framework. PRACTICE IMPLICATIONS: Use of the FHM enhances the measurement and assessment of the relational aspects of student pharmacist-patient communication skills. Consistent use of the FHM over time is likely necessary to fully develop and retain communication skills. The overall goal is to improve patient's health literacy and appropriate medication use by improving communication and the pharmacist-patient relationship.

Psychoeducational characteristics of children with hypohidrotic ectodermal dysplasia.

OBJECTIVE: Hypohidrotic ectodermal dysplasia (HED) is an X-linked hereditary disorder characterized by hypohidrosis, hypotrichosis, and anomalous dentition. Estimates of up to 50% of affected children having intellectual disability are controversial. METHOD: In a cross-sectional study, 45 youth with HED (77% males, mean age 9.75 years) and 59 matched unaffected controls (70% males, mean age 9.79 years) were administered the Kaufman Brief Intelligence Test and the Kaufman Test of Educational Achievement, and their parents completed standardized neurodevelopmental and behavioral measures, educational, and health-related information regarding their child, as well as standardized and nonstandardized data regarding socioeconomic information for their family. RESULTS: There were no statistically significant differences between the two groups in intelligence quotient composite and educational achievement scores, suggesting absence of learning disability in either group. No gender differences within or between groups were found on any performance measures. Among affected youth, parental education level correlated positively with (1) cognitive vocabulary scores and cognitive composite scores; (2) educational achievement for mathematics, reading, and composite scores. CONCLUSION: Youth affected with HED and unaffected matched peers have similar profiles on standardized measures of cognition, educational achievement, and adaptive functioning although children with HED may be at increased risk for ADHD.

Asthma friendly pharmacies: a model to improve communication and collaboration among pharmacists, patients, and healthcare providers.

Pharmacists, with expertise in optimizing drug therapy outcomes, are valuable components of the healthcare team and are becoming increasingly involved in public health efforts. Pharmacists and pharmacy technicians in diverse community pharmacy settings can implement a variety of asthma interventions when they are brief, supported by appropriate tools, and integrated into the workflow. The Asthma Friendly Pharmacy (AFP) model addresses the challenges of providing patient-focused care in a community pharmacy setting by offering education to pharmacists and pharmacy technicians on asthma-related pharmaceutical care services, such as identifying or resolving medication-related problems; educating patients about asthma and medication-related concepts; improving communication and strengthening relationships between pharmacists, patients, and other healthcare providers; and establishing higher expectations for the pharmacist's role in patient care and public health efforts. This article describes the feasibility of the model in an urban community pharmacy setting and documents the interventions and communication activities promoted through the AFP model.