INNOVATIONS in pharmacy (Iip - E-Journal)
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Value Assessment in Cystic Fibrosis: ICER’s Rejection of the Axioms of Fundamental Measurement
Full text linkOne of the features of the ICER stakeholder involvement in the development of ICER evidence reports is the ability for public comment. Unfortunately, and this may just a miscommunication, the replies from ICER to public comments frequently miss the point or fail to provide backup for their claims. The purpose of this commentary is to review ICER’s responses to public comments by the author on the just released final evidence report on cystic fibrosis. The message is quite simple: the ICER value assessment framework lacks credibility. It fails to meet the standards of normal science. This is seen in ICERs apparent ignorance or rejection of the axioms of fundamental measurement which point quite clearly to the mathematical impossibility of creating QALYs from generic multiattribute utility scores. The ICER report also fails standards by creating a model from prior assumptions; there is no logical basis for constructing a value assessment claim. Either ICER should withdraw its value claims or admit the dubious basis on which the model is built, as a duty to its readership.
Article Type: Commentar
An Infographic Assignment to Translate Self-Care Therapeutics into Practical Application
Full text linkInnovation: An infographic assignment was developed and integrated into an advanced self-care therapeutics elective course in a School of Pharmacy to facilitate practical communication of dynamic and innovative approaches to patient care while supporting diversity in assessment.
Description: The ‘Spotlight on Self-Care’ assignment required pharmacy students to develop three infographic deliverables detailing comprehensive care for one minor ailment. The three deliverables were: 1) a magazine insert for healthcare professionals, 2) a patient-friendly handout, and 3) a pharmacists’ companion practice tool. All deliverables were assessed by rubrics using consistent criteria, including: clinical content, logical presentation, research quality, visual elements and formatting. The five highest-scoring magazine inserts were offered publication in the Pharmacy Practice and Business Magazine after peer review.
Critical Appraisal: The submitted infographics put clinical content from the course into action by leveraging recent trends in effective communication. As an assessment, the infographic assignment recognized a unique profile of skills in the students that was statistically different from the profile of skills that was evaluated by the multiple-choice examinations. The key issues to address include reducing grading time requirements and developing strategies to detect copyrighted materials. Future investigations into the nature of the skills gained by the students through the exercise, as well as their perceptions regarding the professional value of the exercise, are important for refining the administration of this assignment.
Article Type: Not
Early Implementation of Comprehensive Medication Management within an Academic Medical Center Primary Care Pharmacy Team
Full text linkIntroduction: University of Utah Health is an academic health care system that serves residents in Utah and beyond. Clinical pharmacists with the health care system’s pharmacy primary care services (PPCS) team provide medication education, population-based care, and medication management through collaborative practice agreements. With the expansion of clinical pharmacist and technician positions and services, the need to measure and assess the impact of pharmacy services and create a value proposition for internal and external stakeholders became an important goal, and the decision was made to better align practices across all PPCS sites. This paper highlights University of Utah Health’s approach to implement comprehensive medication management (CMM) across all primary care clinics with embedded clinical pharmacy staff and subsequent evaluation of implementation fidelity.
Methods: Implementation of CMM was assisted by participation in the National A3 Collaborative and by using selected principles from the Active Implementation Framework. Stages of implementation included exploration, instillation, and initiating improvement cycles. An implementation team consisting of PPCS employees was created to help with standardization, developing implementation plans, and creating a dissemination strategy for all PPCS team members. The CMM care process was subsequently presented and implemented by clinical pharmacists in primary care clinics. Following implementation, fidelity measures were collected including identification and resolution of medication therapy problems (MTPs) and responses from a questionnaire distributed to the clinical pharmacists to self-report understanding and implementation of CMM key elements. The number and type of MTPs identified were tracked over 18 months.
Results: Within the measurement window, clinical pharmacists identified 17,953 MTPs. Of the total number of MTPs identified, 21% were related to indication, 53% to efficacy, 15% to safety and 11% to adherence. The questionnaire was distributed to clinical pharmacists 9 months after CMM implementation, with a 71% response rate. Pharmacists reported “always” or “often” performing each step in the patient care process as follows: indication (93%), effectiveness (93%), safety (87%), and adherence (93%). Reported barriers to implementation of the CMM include lack of time to complete all aspects of the process efficiently, lack of a standardized format for documentation, and changing practice habits.
Conclusion: Implementation of a CMM process within University of Utah Health’s PPCS services with the help of a national collaborative and implementation framework yielded identification of 17,953 MTPs over 18 months and foundational fidelity to core principles. 
Patient Assistance Programs and Technology in Medication Adherence
Full text linkBackground: Patient assistance programs, including medication management and counseling, have the potential to improve care in chronic disease states with complex therapies. Incorporating technology as a tool to foster adherence is becoming more commonplace in practice.
Objectives: The purpose of this report is to identify barriers of medication adherence and review the impact of patient assistance programs and technology on medication adherence.
Methods: A literature search was conducted in secondary databases, PubMed/MEDLINE and EBSCOhost of peer-reviewed systematic reviews, experimental, quasi-experimental, and observational reports published in English within the last fifteen years. Terms searched included patient assistance program, pharmacist role, technology, adherence or compliance, income and health.
Results: Ten studies met our prespecified criteria. Male sex, several self-reported chronic diseases, negative expectancy of treatment, engagement in polypharmacy, financial hardships and lower education level correlated with lower medication adherence. Patient care assistance programs and utilization of technology (e.g., use of a mobile application) improved medication adherence.
Conclusions: Patient assistance programs and technological tools, such as mobile applications, are necessary resources in improving medication adherence.
Article Type: Idea Pape
Impact of Neostigmine and Sugammadex on Time to Leaving the Operating Room in a Community Hospital
Full text linkPurpose: The purpose of this study was to evaluate the impact of sugammadex on operating room (OR) times versus neostigmine in patients recovering from rocuronium or vecuronium induced neuromuscular blockade.
Methods: This retrospective cohort study evaluated patients 18 years or older with an American Society of Anesthesiologists (ASA) physical status of I-III who received sugammadex or neostigmine (January- October 2017) for reversal of rocuronium or vecuronium at a 500 bed, community hospital. Patients who were pregnant or breastfeeding were excluded. The primary outcome measure was the time from sugammadex or neostigmine administration to OR exit. The primary outcome was evaluated using a linear regression model adjusting for inpatient procedures, age, sex, body mass index, and ASA score. Secondary outcomes included the incidence of bradycardia as well as nausea and vomiting.
Results: The baseline characteristics of the patients in the cohort (sugammadex=134, neostigmine=143) were similar. The median time from drug administration to OR exit was similar for neostigmine and sugammadex (16 vs. 15.5 minutes, p=0.11). Sugammadex had a statistically significant reduction in time from drug administration to OR exit (coefficient -2.7 minutes, 95% confidence interval -5.2 to -0.2 minutes) in the multivariable linear regression model. Sugammadex had lower rates of bradycardia (5.6 vs. 2.2%) or nausea and vomiting (18 vs. 11%) that did not reach statistical significance.
Conclusions: Sugammadex had statistically shorter OR exit times after drug administration in the cohort. The mean 2.7 minute benefit is unlikely to be clinically meaningful and limits its application in practice unless larger cohorts detect a benefit due to a significant reduction.in.adverse.events.
Original Researc
Eliminating the Board of Pharmacy’s Role in Designating a Pharmacist-in-Charge
Full text linkNearly all states require that each licensed pharmacy designate a pharmacist-in-charge (PIC). By law, the PIC typically has responsibility for all professional practice laws and facility standards laws and can be held accountable for such. However, the extent to which the PIC has actual authority over many facility standards varies by organization. This can seemingly put a target on the back of the PIC for decisions they wield little authority over. Idaho recently removed the legal references to the PIC, signaling that facilities are responsible for facility standards and insulating pharmacists from discipline for matters that are outside their control.
Lette
Neuron Model of Interprofessional Education and Evidence-Based Practice
Full text linkInterprofessional education (IPE) and evidence-based practice (EBP) are relatively new concepts in health professions education in many parts of the world. These critical reforms are implemented with great effort. As clinical practice has become more collaborative and evidence-based, teamwork and research need to be well integrated in the curriculum. However, many stakeholders struggle to visualize the work of IPE and EBP in the context of health professions education and practice. The Neuron Model, using parts of the neuron, is designed to detail how IPE and EBP integrate in health professions curriculum design or reveal a hidden curriculum. Evidence-based interprofessional care has been implemented with limitations in academic health systems. Lack of a common understanding of how it works is a limitation. The neuron model thus aims to visualize IPE and EBP in health professions education and practice.
Article Type: Commentar
Pharmacy Phamilies as a Component of a Co-Curricular Program for Doctor of Pharmacy Students
Full text linkBackground: Pharmacy student professional growth depends heavily on co-curricular involvement, in addition to classroom learning. Co-curricular programming can be supported by an innovative structure using self-directed learning and a unique mentorship process.
Innovation: A novel faculty and peer mentorship structure, called Pharmacy Phamilies, is integrated into a credited Lifelong Learning course that spans the 4 years of our PharmD program. This course is comprised of student-chosen activities to meet requirements in six domains, as well as reflections and other assignments. Recent changes include a new Pharmacy Phamily group reflection process and the use of co-curricular logs to document student activities.
Findings: Based on a student survey, the majority of respondents were satisfied with their level of engagement with their Pharmacy Phamily (72%) and with their advisor (76%). The majority also reported that the Pharmacy Phamily program is meeting its goals of establishing a sense of community at the college (76%) and enhancing students’ professional development (72%). A total of 86% of students preferred the Pharmacy Phamily group reflection over the former six individual reflections and 93% of students agreed the co-curricular log was a useful tool to document involvement in professional activities.
Conclusion: Pharmacy Phamilies and peer-reviewed, group reflection can provide an inclusive structure of support and social connection for students at the college of pharmacy
Knowledge, Perception and Attitude Regarding Generic Medicines among Iraqi Physicians
Full text linkObjectives: The study aim was to explore the knowledge, perceptions, and attitudes of Iraqi physicians regarding generic and locally manufactured medicines.
Methods: A total of 124 physicians were involved in this cross -sectional study. The convenience sample was collected from five public hospitals in Baghdad. A self-administered questionnaire was distributed and collected in-person. Fisher's Exact Test was used to measure the association between physician years of experience, gender and categorical (perception and knowledge) variables.
Results: Most respondent answers regarding the knowledge of generic medicines were incorrect. Only up to one-third of the participants knew that generic medicines are therapeutically equivalent to brand name medicines (26.6%), as safe as brand name medicines (34.7%) and required to meet similar safety standards as brand name medicines (12.1%). With respect to perception, many physicians had negative perceptions about generic medicines such as viewing generic medicines as lower quality (57.3%) and cause more side effects (41.1%) compared to brand name medicines. Regarding physician attitudes toward generic medicines, about two-thirds (64.5%) of the physicians were willing to prescribe low cost medicines; however, only about half (51.6%) of the physicians reported they offer generic medicines to their patients. Finally, 64.5% of the participants were not comfortable with pharmacist replacing prescribed brand with generic medicines.
Conclusions: In general, Iraqi physicians have negative perceptions and attitudes about generic and locally manufactured medicines. Significant gaps were identified in the knowledge and perceptions among physicians regarding generic medicines especially in relation to efficacy and safety of generic medicines.
Article Type: Original Research
 
More Unnecessary Imaginary Worlds - Part 1: The Institute for Clinical and Economic Review’s Evidence Report on Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis
Full text linkPrevious 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 evidence report for Janus Kinase (JAK) Inhibitors. As ICER continues, in the case of JAK Inhibitors, to apply its modeled cost utility framework with consequent recommendations for pricing adjustments, these recommendations also lack credibility. In contrast with previous ICER evidence reports, the present report adopts only a 12-month timeframe, one due, in large part, to ICER being unable to justify assumptions to drive its construction of imaginary worlds beyond 12 months. This commentary emphasizes again, why the ICER methodology fails to meet the standards of normal science. Claims made by ICER for the competing JAK Inhibitor therapies lack credibility, are impossible to evaluate, let alone replicate across treatment settings. Even so, it is important to examine a number of key elements in the ICER invention of the 12-month JAK Inhibitor imaginary world. While this does not imply any degree of acceptance of the ICER methodology, one element that merits particular attention is the failure of the ICER modeling to meet logically defensible measurement standards in its application of generic health related quality of life (HRQoL) ordinal metrics to create its QALY claims. The failure to meet the required standards of fundamental measurement means that the cost-per-QALY claims are invalid. This raises the issue of the application of Rasch Measurement Theory (RMT) in instrument development and the potential role of patient centric outcome (PCO) instruments that represent the patient voice in value claims. The case made here is that the ICER approach should be abandoned as an unnecessary distraction. If we are to meet standards for the discovery of new facts in therapy response then our focus must be on proposing credible, evaluable and replicable claims within disease states. Instruments, such as the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire that build on the common construct that QoL is the extent to which human needs are fulfilled should be the basis for value claims. HRQoL Instruments that are clinically focused and reflect the value calculus of providers and not patients in measuring response by symptoms and activity limitations are irrelevant. This puts to one side the belief that incremental cost-per-QALY models, the construction of imaginary worlds are, in any sense, a ‘gold standard’; a meme embraced by the health technology assessment profession. Claims for incremental cost per QALY outcomes and recommendations for pricing and access driven by willingness to pay thresholds are irrelevant to formulary decisions.
Article Type: Commentar