INNOVATIONS in pharmacy (Iip - E-Journal)
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Another Rush to Judgement: The Imaginary Worlds of ICER and Recommendations in Duchenne Muscular Dystrophy
Get PDFPrevious commentaries in the Formulary Evaluation section of INNOVATIONS in Pharmacy have pointed to the lack of credibility in modeled claims for cost-effectiveness and associated recommendations for pricing by the Institute for Clinical and Economic Review (ICER). The principal objection to ICER reports has been that their modeled claims fail the standards of normal science: they are best seen as pseudoscience. The purpose of this latest commentary is to consider the recently released ICER report for Duchenne muscular dystrophy (DMD). As ICER has continued in the case of DMD to apply its modeled cost utility framework with consequent recommendations for pricing adjustments, these recommendations also lack credibility. This commentary emphasizes again not only why the ICER methodology fails to meet the standards of normal science but to point to the importance in rare diseases for accelerated approval, while recognizing that evidence generation will continue. While this assessment of the ICER DMD model does not imply any support for this methodology, a key point is the application of quality of life measures which fail to capture the experience of patients with DMD and, importantly, the interests of both patients and caregivers. While ICER would argue that even with a limited evidence base it is important to address issues of pricing and access for new products, their reports are used as justification for coverage and reimbursement by insurers and health system decision makers without recognition of their lack of scientific merit. This rush to judgement by ICER must raise concerns about potentially adverse formulary decisions that result in access restrictions on new products. If ICER is to make a contribution to the entry of new products in the health market place then it should consider an alternative methodology that generates claims that are empirically evaluable in a timeframe relevant to health decision makers. As it stands, ICER’s recommendation should be rejected. This is not a research program that meets accepted scientific standards but one that relies on the willingness of an audience to accept the proposition that evidence is constructed not discovered.
Article Type: Commentar
Rural Physician-Pharmacist Collaborative Practice Agreements Managing Patients in Supportive Living and Assisted Living Memory Care Facilities
Get PDFSetting: Supportive living and assisted living memory care facilities in a rural West-Central Illinois county.
Objectives: 1) Evaluate the impact of active pharmacist participation on patient care for residents living in supportive and assisted living facilities, 2) demonstrate feasibility and financial sustainability of rural community pharmacists providing disease state management services, 3) create processes for best practice to expand the clinical role of the community pharmacist
Design: Case study.
Interventions: Participating residents received disease state management services provided by a community pharmacist as outlined through collaborative practice agreements with local physicians. The disease states managed included hypertension, hyperlipidemia, diabetes mellitus, and warfarin anticoagulation therapy. The pharmacist completed an initial chart review, initial face-to-face visit, subsequent monthly chart reviews, and monthly face-to-face visits with each resident.
Results: During the 6-month period of community pharmacist management, 86 face-to-face visits were completed to deliver a median of 5 visits per resident. The pharmacist identified 23 drug therapy problems with recommended solutions communicated to the resident’s primary care provider. Providers accepted 19 of these recommendations, reflecting an 82.6% acceptance rate.
Conclusions: Community pharmacists can feasibly implement enhanced clinical services to assist with disease state management of supportive living and assisted living residents in collaboration with physicians. Pharmacists can provide clinical assessment, education and effective communication to optimize medication management and utilization.
Article Type: Case Stud
Evaluation of a Resident-led Residency Preparation Series for Fourth Year Pharmacy Students
Get PDFDescription of Problem: The increased interest in residency programs nationwide has made the application process more competitive and complex.
Statement of Innovation: In 2015, Wake Forest Baptist Health (WFBH) created a resident-led residency preparatory series (RPS) to assist advanced pharmacy practice experience (APPE) students in preparing for residency applications. This study sought to evaluate the perceived value of the resident-led RPS by fourth year APPE students.
Innovation: This single-center, survey-based, descriptive study aimed to evaluate the perceived impact of a resident-led RPS. All APPE students during the 2016-2017 and 2017-2018 academic years who completed rotations in the Triad region of North Carolina were invited to participate in the RPS. Surveys were sent to eligible students and data was captured for respondents who indicated an interest in pursuing residency and attendance to at least one RPS. Survey questions evaluated satisfaction with the RPS. Survey data was collected and analyzed using Qualtrics©.
Critical Analysis: A total of 84 students were invited to attend the RPS. Thirty-three respondents participated in the RPS and indicated an interest in applying for a residency. The resident-led RPS was consistently well received by the majority of students over the course of two years, with over two-thirds of all respondents finding every session extremely or very useful. The majority of students agreed or strongly agreed with all confidence statements.
Conclusion A resident-led RPS resulted in positive student perceptions and increased confidence in the residency application process.
Article Type: Not
Trends and Disparities in Quality of Diabetes Care in the US: The National Health and Nutrition Examination Survey, 1999-2016
Get PDFObjectives: To examine trends and disparities in the quality of diabetes care among US adults with diabetes.
Methods: Individuals aged 20 years or older with diabetes from NHANES (1999-2016) were included in the study. Quality indicators for diabetes care included Hemoglobin A1c (HbA1c) < 8%, Blood Pressure (BP) < 130/80 mm Hg, Low-Density Lipoprotein (LDL-C) < 100 mg/dL, triglycerides < 150 mg/dL, receiving eye and foot examinations in the past year, and meeting with a diabetes educator in the past year.
Results: A total of 7,521 adults with diabetes were identified. During the 18-year study period, significant improvements in diabetes care were observed in the overall study sample. Adjusted regression analyses showed that compared with their White counterparts, Blacks were more likely to have received eye (OR=1.37; P=0.01) and foot (OR=1.42;P=0.01) examinations and met a diabetes educator (OR=1.40;P<0.01) over the past year. However, Blacks were significantly less likely to achieve treatment goals for HbA1c (OR=0.77, P=0.02), BP (OR=0.75, P<0.01), LDL-C (OR=0.68, P<0.01). Hispanics in general had suboptimal healthcare utilization for diabetes but the Hispanic-white disparities in diabetes care outcomes were attenuated after controlling for patient sociodemographic, clinical and utilization characteristics. Overall, suboptimal quality of diabetes care were particularly prominent among adults without health insurance and those with lower educational attainment.
Conclusions: In the United States, despite persistent efforts, racial disparities in quality of diabetes care still persist. Lack of health insurance and lower socioeconomic status are among the strongest predictors of poor quality of diabetes care. These findings provide valuable information in developing policies and practices to promote racial equity in diabetes care.
Article Type: Original Researc
The Impact of Pharmacist-delivered Motivational Interviewing on Chronic Kidney Disease Identification and Management in Patients with Diabetes Mellitus and Low Socioeconomic Status
Get PDFPurpose: Chronic kidney disease (CKD) is a common complication among patients with diabetes mellitus; however, noncompliance with the recommended annual screening is common. Increased screening among high-risk patients is important to identify the early stages CKD, potentially resulting in earlier treatment, slower progression, fewer complications, and decreased healthcare expenditures. Motivational interviewing (MI) has previously been shown to be effective for various behaviors, such as smoking cessation and cholesterol level control. The objective of this study is to evaluate the effectiveness of pharmacist-delivered MI compared to typical education (TE) methods in increasing CKD screening and subsequent angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin II receptor blocker (ARB) initiation in high-risk patient populations.
Methods: Pharmacists screened diabetic patients within their chronic disease management clinic to identify patients that are at high-risk for CKD, indicated by a score of 4 or greater on the validated SCORED screening tool. High-risk patients were randomized to one of four groups to receive either one or two face-to-face education sessions from a pharmacist or student pharmacist using either MI or TE methods. Patients were then given the option to have their urine tested with a dipstick to detect albumin and creatinine, provided at no cost. The primary outcome was to determine the rate of urinary albumin testing, and the secondary outcome was to determine the rate of ACE-I or ARB initiation in patients found to have albuminuria.
Results: There were no significant differences in the rates of urinary albumin screening (87% in TE vs. 100% in MI, P = 0.4828) or subsequent ACE-I/ARB initiation (100% in TE and 50% in MI, P = 1.000) between education groups. Of the high-risk patients who underwent urinary albumin screening, 54% (n=15) were found to have proteinuria
Conclusions: While it appears that MI does not impact patient acceptance rates of microalbuminuria screening and ACE-I/ARB initiation, this study demonstrates the feasibility of pharmacist-delivered microalbuminuria screening in patients at high-risk for CKD in the outpatient setting.
Article Type: Practice-Based Researc
An Exploratory Survey of Incorporation of Gender- and Sex-related Differences in the PharmD Curricula
Get PDFIntroduction: Clinical presentation and treatment in many disease states vary due to sex- and gender-differences. Sex-related pharmacokinetic differences are particularly important for pharmacists. The Accreditation Council for Pharmacy Education (ACPE) currently has no standard for the inclusion of gender- and sex-related differences in the didactic PharmD curriculum, but encourages advanced pharmacy practice experiences (APPEs) to include diverse populations related to gender. The purpose of this survey is to explore faculty incorporation of gender and sex differences within the PharmD didactic curriculum in preparation for a nation-wide survey. Methods: A survey was created to determine how many clinical topics incorporated gender- and sex-related differences and to what extent this information was discussed in the classroom. The survey link was emailed to pharmacotherapeutics and pharmacokinetics faculty at Midwestern University Chicago College of Pharmacy, University of Illinois at Chicago, Roosevelt University, Rosalind Franklin University, and Chicago State University. Chi square analyses were performed to examine relationships across participant responses. Results: A total of 56 faculty members participated in the survey, resulting in a 20% response rate. Of these, 30 (54.5%) faculty indicated that they discussed gender- and sex-related differences in the subject area in which they teach. Approximately 33% of respondents found gender- and sex-related differences very clinically important. Gender- and sex- related differences were taught in a variety of subject areas, including cardiology, diabetes, and chronic obstructive pulmonary disease (COPD). Conclusion: With no current standard, faculty members independently choose to include gender- and sex-related differences in their lecture topics and the extent of the discussion. Faculty should be aware of this lack of standardization and that they are independently responsible for including gender- and sex-related differences in their particular topics. Because the surveyed faculty find gender- and sex-related differences clinically important and literature suggests differences in medications depending on gender and sex, further research is planned to provide insight on a national level.
Treatment of Human Subjects: IRB exemption granted
Type: Original Researc
Healthcare Engagement and Encounters in a Rural State: A Focus Group Study
Get PDFIntroduction: Rural populations have many barriers to quality health care including lack of access to primary care and specialty care and a greater likelihood to be underinsured or uninsured. They are also less likely to use preventive screening, or to participate in self-care and engage in their health when compared to urban residents. The purpose of this paper was to describe patients’ healthcare experiences in a rural western state focusing on their healthcare expectations and engagement.
Methods: This qualitative study was conducted using a focus group protocol to elicit rural patients’ healthcare experiences. A purposeful sample of English speaking adult residents from a single county who were willing to discuss their healthcare experiences was included. Patients and community members (21 years and older) were recruited through a local hospital as well as via flyers posted throughout the community. Each audio-recorded group took about two hours. A total of 15 focus groups were conducted to obtain sufficient text for theoretical saturation and thematic analysis. Each group had a range of 3-8 participants. A $25 visa gift card and lunch were provided for each participant as an incentive.
Results: ‘Encounters with Healthcare Professionals’ and ‘Engagement in Health’ were the two dominant dimensions with two themes each. Themes centered around what characterized the best or worst encounters. Trust and Communication - both were based on time spent with the provider and establishment of rapport with the providers. The best encounters were those with health care providers or pharmacists who had sufficient time, adequately explained a diagnosis and new medications did not dismiss patient concerns, and treated individuals with respect. Typical responses describing the worst encounters included examples of misdiagnosis, dismissing patient’s symptoms, healthcare professionals whose attention was not focused on the patient, pushing too many medications, rushed encounters, and providers with poor bedside manner. ‘Engagement in Health’ dimension included the theme of Self-management Process such as taking things one day at a time, taking medication daily, and good stress management. The second theme was Barriers to Engagement and included issues regarding inclement weather, lack of sidewalks, stress, lack of time and the financial constraints for eating healthy, going to a gym, and/or problems with payer source. Participants also described a number of technological tools they utilized to engage with their healthcare including appointment reminders, health-based websites, symptom trackers, online portal systems for health care records, and online bill pay. Many used apps on smart phones to track calories and exercise as well as online community groups to encourage fitness.
Conclusions: The results from this study highlighted some of the gaps in healthcare for rural areas. A large number of participants indicated a lack of trust of their providers and only a few had any communicative interaction with their pharmacist. Future studies could evaluate training designed to teach healthcare providers and pharmacists how to engage patients in their own care. Use of technology by healthcare providers might be another way to improve healthcare engagement.
Conflict of Interest "We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties".
Acknowledgements: This study was funded by the University of Wyoming College of Health Sciences (UW CHS) Faculty Seed Grant awarded to first author Dr. Singh in April 2015. Interim results of this study have been presented at the Health Literacy Research Conference (HARC) in November 2015.
Treatment of Human Subjects: IRB review/approval required and obtained
Type: Original Researc
Piloting an Online Module for Interprofessional Education to Introduce First-Year Students to Health Behavior Change
Get PDFObjective: To meet the needs of patients with behavioral health problems, health professional students require training in helping patients contemplate and move towards behavior change. Motivational Interviewing (MI) is one such intervention. This novel online training module was developed for groups of interprofessional education (IPE) students.
Design: Thirty-eight first-year health-professions students were trained using an online introduction to MI. This was followed by cases with questions where students were asked to provide MI consistent responses. Case participation was done through an online discussion board, where all students could respond to case questions, and to their peers. The discussion board was monitored by a faculty member skilled in the practice of MI and another skilled in interprofessional education/development.
Conclusions: Students reported the course to be valuable and an acceptable way to begin learning new communication skills, and about other health-professions. Students’ self-rating of empathy and understanding of patients who do not readily commit to behavior change improved significantly from pre-module to post-module. This online MI module for IPE appeared to be a success.
Conflict of Interest None to report
Treatment of Human Subjects: IRB review/approval required and obtained
Type: Not
Team-Based Decision-Making in an Objective Structured Clinical Examination (OSCE): Are Pre-Licensure Healthcare Students “Collaborative Practice-Ready”?
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Evaluation of pre-licensure students’ competency in team-based decision-making is lacking. The purposes of this study were to evaluate pre-licensure pharmacy students’ competency in team-based decision-making in the context of an objective structured clinical examination (OSCE), and to determine whether performance correlated with reflective assignment scores. Students’ self-assessment and conceptualization of team-based decision-making in practice was also evaluated. Twenty-three pre-licensure pharmacy students’ competency in team-based decision-making was evaluated in an OSCE station and with a reflective journal assignment; rubric scores for both evaluations were compared using Spearman’s rank order analysis. Students completed an 18-item questionnaire regarding attitudes, confidence, and perceptions related to team-based decision-making. Descriptive statistics and construct analysis with open coding were used to analyse questionnaire results. Mean OSCE station and reflective journal scores were 45% and 66.3%, respectively, and were not correlated. Students’ attitudes toward team-based decision-making were positive, and they reported performing associated behaviours during experiential education rotations. Students appropriately defined ‘team-based decision-making’ and were highly confident in performing related activities. However, students’ conceptualization of team-based decision-making did not align with the pharmacy program’s competency framework. Three key themes were identified through the study analyses: 1) student performance is dependent on assessment context when evaluating collaborator-related competencies; 2) there is a mismatch between students’ perceived competency and objectively measured competence when collaborator outcomes were assessed within an OSCE; and 3) students’ perceptions of team-based decision-making do not align with the program’s competency framework. Future research is necessary to assess competency and perceptions of team-based decision-making in students from other healthcare professions, and to further evaluate whether pre-licensure students are “collaborative practice ready”.
Article Type: Case Stud
Development of Community Pharmacy Characteristics Questionnaire: Application of Cognitive Interviewing
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Background: A questionnaire specific to community pharmacy characteristics, such as staffing models for clinical activities and business operations, does not exist. As community pharmacy practice expands, it is important to characterize how pharmacies are changing for outcomes research. The aim of this study was to conduct cognitive interviewing with community pharmacists to gain feedback on the formatting, readability, and content of items measuring community pharmacy characteristics to develop such a questionnaire.
Methods: National surveys and previously developed survey work were reviewed to identify the following question categories: business operations, human resource management, division of clinical responsibilities, technology, and enhanced services. Questions for each domain were drafted and assessed for applicability across different states and level of importance by researchers in 3 different states. Using the “think aloud” method of cognitive interviewing to evaluate clarity in instructions, question items and response entry, an iterative process was established that included 3 rounds of interviews with discussion and modifications made by the research team between each round.
Results: A total of thirteen cognitive interviews across 3 rounds were conducted via telephone and lasted between 30 and 60 minutes. Time for participant pharmacists to complete the questionnaire ranged from 12 minutes to 30 minutes. The interviews revealed areas of ambiguity, and missing response options for the variety of business structures. The question categories with the most problematic items were business operations, human resource management, and division of clinical responsibilities.
Conclusion: Using cognitive interviewing, a community pharmacy questionnaire focusing on operational characteristics was developed. Future research is warranted to test the organizational characteristics defined in this paper with a larger sample size representing multiple states.
Article Type: Original Researc