INNOVATIONS in pharmacy (Iip - E-Journal)
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More Unnecessary Imaginary Worlds – Part 2: The ICER Evidence Report on Modeling Oral Semaglutide for Type 2 Diabetes
Get PDFOn 9 December 2019, the Institute for Clinical and Economic Review (ICER) released its final evidence report to establish the value of oral semaglutide (Novo Nordisk) for Type 2 diabetes (T2DM). A key element in this report was the development of a lifetime cost effectiveness microsimulation model based on a small sample of NHANES diabetes respondents. The model contrasted oral semaglutide added to current antihyperglycemic treatment for T2DM. The purpose of the model was to estimate outcomes that included life years (LYs) gained, an estimate of equal value life years gained (evLYGs), QALYs gained, clinical events, cost per major adverse cardiovascular events (MACE) avoided and total costs for each intervention over a lifetime time horizon. Previous commentaries in INNOVATTIONS in Pharmacy have provided detailed critiques of the ICER modeling framework. While this model differs from previous ICER models, the result is still a framework that constructs a so-called evidence base that fails the demarcation test. It is best described as pseudoscience. The model creates, by assumption, an imaginary world. The claims made for oral semaglutide by ICER should not be taken seriously by health care decision makers. The purpose of this commentary is to point to the limitations of the model with particular reference to the utility metrics employed, the resulting claims for quality adjusted life years (QALYs) and consequent recommendations for price discounting and affordability.
Article Type: Commentar
Applying the Model for Improvement to a Student-run Quality Improvement Project in a Refugee Center: A Pilot Study
Get PDFDue to insufficient communication strategies between healthcare providers and refugees in the United States, this quality improvement project aimed to improve disparity in refugee healthcare. We chose to focus on community pharmacist counseling sessions with refugees in the city of Rochester, New York. The two refugee populations we focused on were the Burmese and Nepali. Due to illiteracy in their native language, the refugees were not receptive to a pamphlet detailing the beneficial roles a pharmacy can have in improving their health and wellbeing. We created a pictorial survey of pharmacies near a refugee center to identify the pharmacies the refugees were utilizing in the area. Once we identified these pharmacies, we created a counseling aid booklet translating common pharmacy language/terms into English, Burmese, and Nepalese languages supported by pictorial diagrams. The counseling aid booklet was evaluated by pharmacists using a satisfaction scale. Overall, the counseling aid booklet was found to be helpful for the pharmacist’s daily interaction with refugee populations. Further plans for the counseling aid booklet include adding more pharmacy counseling terms for common disease states in refugee populations, making the book more inclusive of other languages, and implementation in more community pharmacies and other diverse healthcare settings.
Article Type: Student Projec
More Unnecessary Imaginary Worlds – Part 4: The ICER Evidence Report for Crizanlizumab, Voxelotor and L-Glutamine for Sickle Cell Disease
Get PDFA number of commentaries have been published over the past 4 years by the present author on the manifest flaws in the reference case value assessment framework of the Institute for Economic and Clinical Review. The recent release of the evidence report on sickle cell disease continues ICER’s commitment to what has been described as the creation of imaginary worlds to support value assessment. The purpose of the present commentary is to continue the critiques that have been presented for earlier evidence reports. This is important because of the apparent willingness to take ICER’s recommendations at face value rather than a critical review of the value assessment framework. The case presented here points to a number of weaknesses in the ICER framework: (i) the fabrication of imaginary constructs with a lifetime cost-per-incremental QALY framework; (ii) the consequent failure to meet the standards of normal science; (iii) the illogical reliance of assumptions drawn from the literature to create future scenarios; (iv) the rejection of hypothesis testing in favor of ‘approximate information’ and (v) a belief that in the construction of QALYS that the EQ-5D-3L utility scale has ratio properties. This last point is demonstrably false which means that the ICER value assessment framework collapses. It is impossible mathematically, a failure to meet the axioms of fundamental measurement, for an ordinal utility scale to be combined with time spent in a disease state. The result is that the pricing and access recommendations for Crizanlizumab, Voxelotor and L-glutamine in sickle cell disease (SCD) are complete nonsense and should be rejected
Lessons Learned from an Academic, Interdisciplinary, Multi-Campus, Research Collaboration
Get PDFBackground: The formation of productive academic research groups can be difficult, especially in environments without a robust and existing research infrastructure. Idaho and Alaska, are Institutional Development Award (IDeA)-eligible states, historically receiving low levels of funding from the National Institutes of Health (NIH).
Purpose/Methods: We present a case study highlighting an academic research collaboration established across two-disciplines, three-career stages, and three-campuses utilizing distance technology.
Results: One lesson learned from our experiences is that regardless of position (junior or senior faculty) or time at the institution/department (new or established), it is important to reach out to others. Collaborations require conscientious effort to establish and maintain. Second, a psychologically safe space must be created, establishing trust. Lastly, in order to eliminate distractions, optimize team performance, and improve deliverables, the team must have a shared mission. Team members must recognize, appreciate, and fully utilize each other and available resources.
Conclusion: Our experiences and lessons learned can be utilized by others to strengthen opportunities to form and grow interdisciplinary research collaborations and develop a stronger research infrastructure.
Article Type: Not
Interprofessional Care of Emergency Department Doctors and Pharmacists: Crossing a Collaboration Chasm
Get PDFRole clarity of emergency department doctors and pharmacists is essential to provide collaborative care. Evidence is available that interprofessional care of doctor-pharmacist collaboration improves patient care in emergency settings. Pharmacists need to improve their knowledge and skill in emergency practice to be more productive and sought after. Team dynamics, training, and administrative support are critical. Interprofessional collaboration should not be programmed to fail for the short-term convenience of any profession. With more considerable effort from different stakeholders, once a collaborative system is established that will sustain improved patient care and the public trust of healthcare. Crossing a collaboration chasm takes time and effort. Interprofessional education should be built-in essential competencies to be collaborative with role clarity, teamwork, better communication, and ultimately patient-centeredness.
Article Type: Commentar
Regulating Pharmacy Practice: Analysis of Pharmacy Laws in Ten States
Get PDFBackground: The National Association of Boards of Pharmacy (NABP) recently established a task force to help states develop regulations based on “standards of care” rather than “prescriptive rule-based regulation.” This signals a shift in orthodoxy as pharmacy has traditionally been a highly regulated profession. A benchmark report on the pharmacy, nursing, and medical statutes and regulations in Idaho found that pharmacy had a higher overall word count, more overall restrictions, and had to be amended more frequently to keep pace with change.
Objective: To identify opportunities to make the transition to a “standard of care” regulatory model in pharmacy law, this manuscript attempts to quantify the regulatory burden for 10 Western U.S. states.
Method: The relevant statutes and regulations were gathered from each of the 10 states, and key measures were extracted, including word count, restrictions, exemptions, and the composition.
Results: States exhibited wide variation in overall regulatory burden as measured by word count (average of 65,882 words, SD=35,057). The top categories of pharmacy law are: 1) professional practice standards (25,249 ± 16,077 words); 2) facility standards (15,230 ± 10,240 words); and 3) licensing (11,412 ± 6,191 words). More than 65% of all pharmacy regulations are in rule adopted by board of pharmacy rather than in statutes passed by the legislature.
Conclusions: States exhibited major variation in total regulatory burden, with the largest contributors to cross-state variation being regulations related to professional practice standards and facility standards. This analysis suggests these two areas should be the primary targets of states looking to decrease regulatory burdens and that regulatory boards have a significant opportunity to remove regulatory burdens even in the absence of legislative action
Smoking Cessation Considerations for People with Multiple Sclerosis
Get PDFBackground: Comprehensive care of people with multiple sclerosis integrates disease modifying therapy, symptom management and minimization of risk factors for disease progression. Cigarette smoking is a modifiable risk factor associated with development and progression of disease and increased disability. However, little is known about specific factors that affect smoking cessation in patients with multiple sclerosis or how to integrate smoking cessation into specialized multiple sclerosis care.
Methods: Twenty-nine active smokers with multiple sclerosis were surveyed at the James Q. Miller Multiple Sclerosis clinic at the University of Virginia Health. Demographics, smoking history, multiple sclerosis history, interest in quitting, barriers to quitting and cessation modalities of interest were collected, specifically interest in working with a clinical pharmacist for cessation.
Results: Seventy-six percent of individuals believed that there was no relationship between smoking and MS diagnosis and 52% were unaware of any relationship between smoking and disease progression. Less than half of patients (41%) reported receiving counseling from a primary care physician or neurologist about the importance of smoking cessation. Common barriers to quitting included enjoyment of smoking (76%) and cravings (55%). Seventy-six percent of patients expressed interest in utilizing pharmacotherapy and 37% were interested in working closely with a clinical pharmacist.
Conclusions: It is critical that providers caring for patients with multiple sclerosis assess smoking status and educate smokers about the relationship between smoking and disease progression. Efforts should be made to better understand patient-specific barriers to quitting and preferred methods of treatment, including pharmacotherapy and behavioral therapy. A multidisciplinary approach to smoking cessation that includes a clinical pharmacist may aid in the development of individualized care plans with frequent monitoring to improve patient success.
Article Type: Case Stud
Pharmacy Faculty Burnout: Cause for Concern that Requires Our Support and Use of Best Evidence
Get PDFRecent attention has been afforded to the concept of burnout and other quality of worklife issues among pharmacy faculty, underscoring the importance of organizational culture, citizenship, collegiality, and support. Support comes from the larger academic institution, the college/school, and individual colleagues. Evidence points to reassurance of worth, guidance, and positive affirmation as being among the most salient factors in mitigating burnout of faculty, who are caught in the midst of increasing demands and higher administrative burdens. A supportive culture that reassures worth of individual faculty is not a unidimensional typology, but rather, is one that permeates through all components of a multifaceted and strong culture that encourages citizenship. There is a growing body of research and evidence on faculty burnout and related factors. This commentary calls for the use of such evidence in guiding policies, creating mentoring programs, and carrying out daily activities in much the same manner that scholars use the best available evidence in their own specific lines of inquiry in teaching and research.
Article Type: Commentar
Examining Student Motivation to Use a Gamified System in an Immunology and Immunization Training Course
Get PDFBackground: Gamification is the process of adding game elements into classroom activities to encourage student participation and motivation. Classcraft® is a gamified learning system designed to integrate easily with normal classroom activities and to enhance collaboration and teamwork.
Educational activity and setting: This study explored the use of the Classcraft® system in an Immunology and Immunization Training course, specifically examining students’ motivation to use the system and potential impacts on their motivation.
Findings: Results showed that value and enjoyment motivated students to use Classcraft®. Furthermore, the ease of use of the system positively impacted students’ enjoyment of the system. Students’ choice regarding how much they were required to engage with the system positively impacted the value and enjoyment that they experienced with the system.
Summary: Students’ demonstrated motivation to use Classcraft® provides a foundation for further research into the use of gamified learning systems within pharmacy classrooms. Research is needed to understand if use of a gamified learning system positively impacts learning outcomes
Hospital and Community Pharmacists’ Views of and Perspectives on the Establishment of an Intraprofessional Collaboration in the Transition of Care for Newly Discharged Patients
Get PDFBackground Hospital and community pharmacists are increasingly involved in patients’ medication interventions related to the transition of care from the hospital to a patient’s home. These interventions may enable pharmacists to collaborate across healthcare sector boundaries. However, little is known about pharmacists’ views on intraprofessional collaboration across healthcare sectors and what affects the establishment of such collaboration.
Objectives The aim of this study was to understand the views and perspectives of hospital pharmacists (HPs) and community pharmacists (CPs) on establishing an intraprofessional collaboration in relation to newly discharging patients.
Methods Joint focus group interviews with HPs and CPs in the Zealand region of Denmark were conducted. The HPs were employed at the only hospital pharmacy in the region (Region Zealand Hospital Pharmacy). Five HPs and six CPs participated in two focus groups. The focus groups were analyzed using theoretical thematic analysis.
Results Three themes and seven subthemes were identified. The first theme, “Context”, was divided into two subthemes: “Prioritization of new tasks in the intraprofessional collaboration” and “The lack of insight into the patient’s hospital stay”. The second theme, “The hospital physicians and GPs as the focal points for the HPs’ and CPs’ work”, was divided into three subthemes: “The limitation of the CPs and HPs based on current roles and organizations”, “Lack of regular access to the physician gives the patients more responsibility” and “Lack of support from the GPs for the work conducted by HPs and CPs”. The last theme, “Individuals”, had two subthemes: “The motivation for working intraprofessionally” and “CPs’ hesitancy towards the new tasks in the intraprofessional collaboration”.
Conclusion Both HPs and CPs are highly influenced by their work context in regard to establishing a new intraprofessional collaboration. Limited resources for intraprofessional collaboration should be taken into account. Likewise, the collaboration should fit into daily routines, which may eliminate hesitancy towards new forms of collaboration and tasks shared between HPs and CPs. The physician was identified as an important key professional, since the work tasks of both HPs and CPs depend on the physician, which in turn limits the capability and success of solely intraprofessional collaboration.
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