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Item Analyzing the Clinical Outcomes of a Rapid Mass Conversion From Rosuvastatin to Atorvastatin in a VA Medical Center Outpatient Setting(SAGE, 2017-10) Naville-Cook, Chad; Rhea, Leroy; Triboletti, Mark; White, Christina; Pharmacology and Toxicology, School of MedicineBackground: Medication conversions occur frequently within the Veterans Health Administration. This manual process involves several pharmacists over an extended period of time. Macros can automate the process of converting a list of patients from one medication to a therapeutic alternative. Objectives: To develop a macro that would convert active rosuvastatin prescriptions to atorvastatin and to create an electronic dashboard to evaluate clinical outcomes. Methods: A conversion protocol was approved by the Pharmacy & Therapeutics Committee. A macro was developed using Microsoft Visual Basic. Outpatients with active prescriptions for rosuvastatin were reviewed and excluded if they had a documented allergy to atorvastatin or a significant drug-drug interaction. An electronic dashboard was created to compare safety and efficacy endpoints pre- and postconversion. Primary endpoints included low-density lipoprotein (LDL), creatine phosphokinase (CPK), aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase. Secondary endpoints evaluated cardiovascular events, including the incidences of myocardial infarction, stroke, and stent placement. Results: The macro was used to convert 1520 patients from rosuvastatin to atorvastatin over a period of 20 hours saving $5760 in pharmacist labor. There were no significant changes in LDL, AST, ALT, or secondary endpoints (P > .05). There was a significant increase in alkaline phosphatase (P = .0035). Conclusions: A rapid mass medication conversion from rosuvastatin to atorvastatin saved time and money and resulted in no clinically significant changes in safety or efficacy endpoints. Macros and clinical dashboards can be applied to any Veterans Health Administration facility.Item Caregiver-Based Interventions to Optimize Medication Safety in Vulnerable Elderly Adults: A Systematic Evidence-Based Review(Wiley, 2018-11) Wagle, Kamal C.; Skopelja, Elaine N.; Campbell, Noll L.; Medicine, School of MedicineOBJECTIVES: To study the effect of caregiver-focused interventions to support medication safety in older adults with chronic disease. DESIGN: Systematic review. SETTING: Studies published before January 31, 2017, searched using Ovid Medline, PubMed, EMBASE, Scopus, CINAHL, PsycINFO, and Google Scholar. PARTICIPANTS: Caregivers with or without a care recipient. MEASUREMENTS: Inclusion criteria: interventions focused on caregivers aiming to improve medication safety. Studies not focusing on older adults, not evaluating medication safety, failing to include caregivers, or without a comparison group were excluded. RESULTS: The initial search revealed 1,311 titles. Eight studies met inclusion criteria. The strategies used in randomized trials were a home-based medication review and adherence assessment by a clinical pharmacist (2 home visits 6-8 weeks apart, with pharmacist and physician meeting independently) that found no difference in nonelective hospital admissions (p=.8) but fewer medications (p=.03); a 19-minute educational DVD and an hour-long medication education and training that improved caregiver satisfaction (p<.04); a medication education and adherence intervention (2-3 home visits per care recipient and caregiver dyad over 8 weeks) that found no difference in knowledge, administration, or accessibility of medications (p=.29); and a collaborative case management program (16-month program of assessment, meeting, and monthly follow-up telephone calls) that reduced perceived caregiver burden (p=.03). Quasi-experimental trials included collaborative care transitional coaches, an outpatient collaborative care model, and education and training programs. Of these, educational interventions showed improvements in self-efficacy, confidence, and preparedness. The collaborative care intervention reduced rehospitalizations (p=.04) and improved quality-of-care outcomes. CONCLUSION: Although some interventions improved caregiver medication knowledge and self-efficacy, effects on clinical outcomes and healthcare use were insufficiently studied. Two studies implementing collaborative care models with medication management components showed potential for improvement in quality of clinical care and reductions in healthcare visits and warrant further study with respect to medication safety. J Am Geriatr Soc 66:2128-2135, 2018.Item Establishing the Medication Safety Research Network of Indiana (Rx-SafeNet): Perspectives of Community Pharmacy Employees(University of Minnesota Libraries, 2012) Seel, Lindsey V.; Hultgren, Kyle E.; Snyder, Margie E.; Medicine, School of MedicineThe objective of this cross-sectional survey was to determine community pharmacy employee research project priorities and assess interest levels, barriers, and facilitators to joining a new community pharmacy practice-based research network (PBRN) and use this information in subsequent PBRN development. One hundred forty pharmacists and 40 support staff responded. The majority (72%) of respondents were somewhat interested or needed more information to determine their level of interest in joining a PBRN; 15% were very interested. While all research topics were regarded as important, dispensing errors were rated as the most important. Time constraints were considered the greatest barrier to participation. Greater knowledge of medication safety, enrichment of patient care, and improved patient and provider relationships were considered important reasons for joining a PBRN. Responses indicated favorable interest levels and project support from potential network members, though education and awareness campaigns are needed to enhance community pharmacy employee understanding of and involvement in research and PBRNs, specifically the Medication Safety Research Network of Indiana (Rx-SafeNet), a new network administered by the Purdue University College of Pharmacy. While the generalizability of survey results is limited, they were useful in determining policies and procedures of the new network. Surveying all employees involved in the future PBRN during the network development process is a unique approach to developing these types of networks in the U.S. Understanding support staff perspectives is important considering the critical role they play in project implementation and operations. Emerging PBRNs from any discipline may benefit from considering adding this step to their development.Item Experience Developing a Community Pharmacy Practice-based Research Network(University of Minnesota Libraries, 2012) Snyder, Margie E.; Frail, Caitlin K.; Seel, Lindsey V.; Hultgren, Kyle E.; Medicine, School of MedicineIn 2010, the Purdue University College of Pharmacy established the Medication Safety Research Network of Indiana (Rx-SafeNet), the first practice-based research network (PBRN) in Indiana comprised solely of community pharmacies. In the development of Rx-SafeNet and through our early project experiences, we identified several “lessons learned.” We share our story and what we learned in an effort to further advance the work of the greater PBRN community. We have formed the infrastructure for Rx-SafeNet, including an Executive Committee, Advisory Board, member pharmacies/site coordinators, and Project Review Team. To date, 22 community pharmacies have joined and we have recently completed data collection for the network's first project. Lessons learned during the development of Rx-SafeNet may benefit PBRNs nationally. Although community pharmacy PBRNs are not yet commonplace in the U.S., we believe their development and subsequent research efforts serve as an important avenue for investigating medication use issues.Item Human Factors and Ergonomics Methods for Pharmacy Research and Clinical Practice(Elsevier, 2021) Holden, Richard J.; Abebe, Ephrem; Russ-Jara, Alissa L.; Chui, Michelle A.; Medicine, School of MedicineBackground: Human factors and ergonomics (HFE) is a scientific and practical human-centered discipline that studies and improves human performance in sociotechnical systems. HFE in pharmacy promotes the human-centered design of systems to support individuals and teams performing medication-related work. Objective: To review select HFE methods well suited to address pharmacy challenges, with examples of their application in pharmacy. Methods: We define the scope of HFE methods in pharmacy as applications to pharmacy settings, such as inpatient or community pharmacies, as well as medication-related phenomena such as medication safety, adherence, or deprescribing. We identify and present seven categories of HFE methods suited to widespread use for pharmacy research and clinical practice. Results: Categories of HFE methods applicable to pharmacy include work system analysis; task analysis; workload assessment; medication safety and error analysis; user-centered and participatory design; usability evaluation; and physical ergonomics. HFE methods are used in three broad phases of human-centered design and evaluation: study; design; and evaluation. The most robust applications of HFE methods involve the combination of HFE methods across all three phases. Two cases illustrate such a comprehensive application of HFE: one case of medication package, label, and information design and a second case of human-centered design of a digital decision aid for medication safety. Conclusions: Pharmacy, including the places where pharmacy professionals work and the multistep process of medication use across people and settings, can benefit from HFE. This is because pharmacy is a human-centered sociotechnical system with an existing tradition of studying and analyzing the present state, designing solutions to problems, and evaluating those solutions in laboratory or practice settings. We conclude by addressing common concerns about the implementation of HFE methods and urge the adoption of HFE methods in pharmacy.Item Impact of a pilot community pharmacy system redesign on reducing over-the-counter medication misuse in older adults(Elsevier, 2003) Gilson, Aaron M.; Stone, Jamie A.; Morris, Ashley O.; Brown, Roger L.; Xiong, Ka Z.; Jacobson, Nora; Holden, Richard J.; Albert, Steven M.; Phelan, Cynthia H.; Walbrandt Pigarelli, Denise L.; Breslow, Robert M.; Welch, Lauren; Chui, Michelle A.; Medicine, School of MedicineBackground: No interventions have attempted to decrease misuse of over-the-counter (OTC) medications for adults aged 65 years or older (older adults) by addressing system barriers. An innovative structural pharmacy redesign (the Senior Section) was conceptualized to increase awareness of higher-risk OTC medications. The Senior Section contains a curated selection of OTC medications and is close to the prescription department to facilitate pharmacy staff-patient engagement to reduce misuse. Objective: This pilot study examined the Senior Section's effectiveness at influencing OTC medication misuse in older adults. Methods: A pretest-post-test nonequivalent groups design was used to recruit 87 older adults from 3 pharmacies. Using a hypothetical scenario, the participants selected an OTC medication that was compared with their medication list and health conditions, and their reported use was compared with the product labeling. Misuse outcomes comprised drug-drug, drug-disease, drug-age, and drug-label, with 5 subtypes. Patient characteristics were compiled into a propensity score matching logistic regression model to estimate their effects on the Senior Section's association with misuse at pre- or postimplementation. Results: Patient characteristics were uniform between pre- and postimplementation, and, once entered into a propensity score matching model, drug-label misuse (exceeds daily dosage) statistically significantly lessened over time (z = -2.42, P = 0.015). In addition, the Senior Section reduced drug-label misuse (exceeds single dosage) for both the raw score model (z = -6.38, P = 0.011) and the model in which the patient characteristics propensity score was added (z = -5.82, P = 0.011). Despite these limited statistical effects, misuse was found to decrease after implementation for 7 of 11 comparisons. Conclusion: These nascent outcomes begin providing an evidence base to support a well-conceived, pharmacy-based OTC medication-aisle redesign for reducing older adult OTC medication misuse. The Senior Section, when broadly implemented, creates permanent structures and processes to assist older adults to access risk information when selecting safer OTC medications.Item Improving over-the-counter medication safety for older adults: A study protocol for a demonstration and dissemination study(Elsevier, 2017-09) Chui, Michelle A.; Stone, Jamie A.; Holden, Richard; Medicine, School of MedicineBACKGROUND: Adverse drug events (ADEs) associated with over-the-counter (OTC) medications cause 178,000 hospitalizations each year. Older adults, aged 65 and older, are particularly vulnerable to ADEs. Of the 2.2 million older adults considered at risk for a major ADE, more than 50% are at risk due to concurrent use of an OTC and prescription medication. OBJECTIVES: To refine the intervention and implementation strategy through diagnostic and formative evaluation; to evaluate the effectiveness of the intervention for preventing misuse of high-risk OTC medications by older adults; and to evaluate the implementation of the intervention in community pharmacies. METHODS: A system redesign intervention to decrease high-risk OTC medication misuse will be tested to reduce misuse by improving communication between older adults and community pharmacists via the following features: a redesign of the physical environment to sensitize older adults to high-risk OTC medications, and the implementation of a clinical decision tool to support the pharmacist when critically evaluating the older adult's health status. The study will be conducted in three phases: a participatory design phase, a beta phase, and a test phase. The test phase will be conducted in three mass-merchandise stores. A total of 144 older adults will be recruited. A pre (control)/post (intervention) test will determine the effectiveness of the intervention. The primary outcome will be a comparison of proportion of older adults who misuse OTC medication from baseline to post-intervention. The process of implementation in the community pharmacy setting will be evaluated using the taxonomy proposed by Proctor et al. The participatory design phase has been approved by the institution's IRB (2016-0743). PROJECTED IMPACT: It is anticipated that this project, which focuses on achieving systems-based improvement in an underemphasized area of the medication use process, will reduce ADEs associated with inappropriate OTC medication use in older adults.Item Medication transitions: Vulnerable periods of change in need of human factors and ergonomics(Elsevier, 2021-01) Holden, Richard J.; Abebe, Ephrem; Medicine, School of MedicineWe present a novel view of transitions from the lens of patient ergonomics (the "science of patient work"), which posits that patients and other non-professionals perform effortful work towards health-related goals. In patient work transitions, patients experience changes in, for example, health, task demands, work capacity, roles and responsibilities, knowledge and skills, routines, needs and technologies. Medication transitions are a particularly vulnerable type of patient work transitions. We describe two cases of medication transitions-new medications and medication deprescribing-in which the patient work lens reveals many accompanying changes, vulnerabilities, and opportunities for human factors and ergonomics.Item Reducing Anticholinergic Medication Exposure among Older Adults using Consumer Technology: Protocol for a Randomized Clinical Trial(Elsevier, 2021) Abebe, Ephrem; Campbell, Noll L.; Clark, Daniel O.; Tu, Wanzhu; Hill, Jordan R.; Harrington, Addison B.; O’Neal, Gracen; Trowbridge, Kimberly S.; Vallejo, Christian; Yang, Ziyi; Bo, Na; Knight, Alexxus; Alamer, Khalid A.; Carter, Allie; Valenzuela, Robin; Adeoye, Philip; Boustani, Malaz A.; Holden, Richard J.; Medicine, School of MedicineIntroduction: A growing body of scientific evidence points to the potentially harmful cognitive effects of anticholinergic medications among older adults. Most interventions designed to promote deprescribing of anticholinergics have directly targeted healthcare professionals and have had mixed results. Consumer-facing technologies may provide a unique benefit by empowering patients and can complement existing healthcare professional-centric efforts. Methods: We initiated a randomized clinical trial to evaluate the effectiveness of a patient-facing mobile application (Brain Safe app) compared to an attention control medication list app in reducing anticholinergic exposure among community-dwelling older adults. Study participants are adults aged 60 years and above, currently using at least one prescribed strong anticholinergic, and receiving primary care. The trial plans to enroll a total of 700 participants, randomly allocated in 1:1 proportion to the two study arms. Participants will have the Brain Safe app (intervention arm) or attention control medication list app (control arm) loaded onto a smartphone (study provided or personal device). All participants will be followed for 12 months and will have data collected at baseline, at 6 months, and 12 months by blinded outcome assessors. The primary outcome of the study is anticholinergic exposure measured as total standard daily dose (TSDD) computed from medication prescription electronic records. Secondary outcomes of the study are cognitive function and health-related quality of life. Discussion: A consumer-facing intervention to promote deprescribing of potentially high-risk medications can be part of a multi-pronged approach to reduce inappropriate medication use among older adult patients. Delivering a deprescribing intervention via a mobile app is a novel approach and may hold great promise to accelerate deployment of medication safety initiatives across diverse patient populations.