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.

Direct to Consumer Telemedicine: Is Healthcare From Home Best?

Direct-to-consumer (DTC) telemedicine is increasingly popular and enables patients to obtain medical advice and treatment via electronic media (e.g., computer, telephone, or smartphone) without a prior doctor-patient relationship. Convenience, accessibility, and home delivery make DTC telemedicine attractive to patients. Concerns about DTC telemedicine include: a lack of regulation, transparency, and an established patient-provider relationship (physician and pharmacist). In future, researchers, providers, and insurers need to better understand the concerns and challenges that this new form of healthcare poses.

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.

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.

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.

Assessing the utility of pre-course assessment and voluntary pre-work in two required integrated pharmacotherapy courses.

BACKGROUND AND PURPOSE: Self-assessment and self-learning are essential skills for student pharmacists. Data demonstrating the association between these skills in pharmacy courses are limited. The aim of this study was to evaluate the impact of providing pre-course review and administering a pre-course assessment on performance in two required integrated pharmacotherapy (IP) courses - IP: Pulmonology and IP: Cardiology. EDUCATIONAL ACTIVITY AND SETTING: This study included second-year student pharmacists enrolled in fall semester IP: Pulmonology and IP: Cardiology from 2019 to 2021. Voluntary pre-course review materials and pre-course assessments were added in fall 2021. Overall course grades and examination scores between each year were analyzed. Student perceptions of the pre-course assessment were also captured. FINDINGS: Of the 454 students analyzed, there was no difference in median overall IP: Pulmonology grades (85.93%, 86.67%, 86.29%; P = .63) or IP: Cardiology grades (80.25%, 78.3%, 79.96%; P = .41) for 2019, 2020, and 2021, respectively. IP: Pulmonology Exam 1 scores were statistically higher in 2021. For IP: Cardiology, Exam 1 and Final Exam scores were statistically higher in 2020 compared to 2019 and Exam 3 scores were significantly higher in 2021 than 2019. Pre-course assessment scores had a statistically significant, positive association with overall course grade. Half of the students surveyed agreed that completing the course prep work was an effective approach to learning. SUMMARY: Although overall course grades did not differ between years, pre-course assessment scores correlated with overall course grade. Thus, voluntary pre-course assessments could provide early identification of poor performance.

Management of chronic obstructive pulmonary disease: A review focusing on exacerbations.

PURPOSE: Chronic obstructive pulmonary disease (COPD) is a significant cause of morbidity and mortality in the United States. Exacerbations- acute worsening of COPD symptoms-can be mild to severe in nature. Increased healthcare resource use is common among patients with frequent exacerbations, and exacerbations are a major cause of the high 30-day hospital readmission rates associated with COPD. SUMMARY: This review provides a concise overview of the literature regarding the impact of COPD exacerbations on both the patient and the healthcare system, the recommendations for pharmacologic management of COPD, and the strategies employed to improve patient care and reduce hospitalizations and readmissions. COPD exacerbations significantly impact patients' health-related quality of life and disease progression; healthcare costs associated with severe exacerbation-related hospitalization range from $7,000 to $39,200. Timely and appropriate maintenance pharmacotherapy, particularly dual bronchodilators for maximizing bronchodilation, can significantly reduce exacerbations in patients with COPD. Additionally, multidisciplinary disease-management programs include pulmonary rehabilitation, follow-up appointments, aftercare, inhaler training, and patient education that can reduce hospitalizations and readmissions for patients with COPD. CONCLUSION: Maximizing bronchodilation by the appropriate use of maintenance therapy, together with multidisciplinary disease-management and patient education programs, offers opportunities to reduce exacerbations, hospitalizations, and readmissions for patients with COPD.

Long-acting bronchodilator therapy for the treatment of chronic obstructive pulmonary disease.

OBJECTIVE: To review clinical data on the use of long-acting bronchodilator agents as monotherapy and in combination for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD). DATA SOURCES: A literature search was performed via MEDLINE (1966-April 2008). In addition, references from publications identified were reviewed. These searches were limited to human data published in the English language. Searches used the following terms: COPD, long-acting beta(2)-agonists, long-acting anticholinergics, combination therapy, pharmacoeconomics, safety, tiotropium, salmeterol, and formoterol. STUDY SELECTION AND DATA EXTRACTION: Relevant information on the pharmacology, safety, efficacy, pharmacoeconomics, adherence, and available agents used in the treatment of COPD was selected. Randomized clinical trials and retrospective reviews were included. DATA SYNTHESIS: The Global Initiative for Chronic Obstructive Lung Disease guidelines provide general management recommendations to guide providers regarding treatment choices for COPD; however, they lack clarity regarding which long-acting bronchodilator to use and when combining agents becomes appropriate. Prospective trials evaluating short-acting anticholinergics and long-acting beta(2)-agonists have utilized spirometric endpoints that relate most to short-term symptomatic relief. Tiotropium trials have focused more on patient-oriented outcomes, with data being reported for one year. Tiotropium significantly lowers exacerbation rates and improves health resource usage as well as health-related quality of life. Tiotropium also provides superior bronchodilation and improvement in dyspnea at all time points, although onset of bronchodilation is slower than with long-acting beta(2)-agonists. Combining these agents has been shown to decrease daytime rescue inhaler use, improve morning and evening peak expiratory flow rates, and improve bronchodilator efficacy compared with monotherapy. Pharmacoeconomic data lend support to the recommendation of tiotropium as a first-line long-acting agent. CONCLUSIONS: Tiotropium appears to be the best option as a first-line drug for patients with moderate-to-severe COPD because of its ability to sustain bronchodilator effect, improve quality of life, reduce COPD exacerbations, and reduce health resource usage. Patients who remain symptomatic may benefit from the addition of a long-acting beta(2)-agonist to tiotropium monotherapy.

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.

Impact of online lecture-capture on student outcomes in a therapeutics course.

OBJECTIVES: To examine the correlation between students accessing recorded lecture files (audio and slides) online and course grades and class attendance. METHODS: Second professional year (of 6-year program) students in a therapeutics course had access to recorded online lectures for 72 hours following live lectures. The number and duration of lecture accessions were compared to final course grades and class attendance. Course grades were compared to those of a historical control group. At the end of the semester, students completed a brief survey instrument regarding their use and perceptions of online lectures. RESULTS: No correlation was found between final course grades and the number of lecture accessions (r = 0.0014) or total number of minutes lectures were viewed (r = 0.033), nor between class attendance and minutes viewed (r = 0.2158). Students with access to recorded lectures outperformed the historical control group on the final examination (p < 0.002). Seventy-two percent of students reported no influence of online files on class attendance. CONCLUSIONS: Posting lectures online did not affect student outcomes, but students did score higher on the final examination.