A coordinated approach for managing polypharmacy among children with medical complexity: rationale and design of the Pediatric Medication Therapy Management (pMTM) randomized controlled trial.

BACKGROUND: Children with medical complexity (CMC) often rely upon the use of multiple medications to sustain quality of life and control substantial symptom burden. Pediatric polypharmacy (≥ 5 concurrent medications) is prevalent and increases the risk of medication-related problems (MRPs). Although MRPs are associated with pediatric morbidity and healthcare utilization, polypharmacy is infrequently assessed during routine clinical care for CMC. The aim of this randomized controlled trial is to determine if a structured pharmacist-led Pediatric Medication Therapy Management (pMTM) intervention reduces MRP counts, as well as the secondary outcomes of symptom burden and acute healthcare utilization. METHODS: This is a hybrid type 2 randomized controlled trial assessing the effectiveness of pMTM compared to usual care in a large, patient-centered medical home for CMC. Eligible patients include all children ages 2-18 years old, with ≥ 1 complex chronic condition, and with ≥ 5 active medications, as well as their English-speaking primary caregivers. Child participants and their primary parental caregivers will be randomized to pMTM or usual care before a non-acute primary care visit and followed for 90 days. Using generalized linear models, the overall effectiveness of the intervention will be evaluated using total MRP counts at 90 days following pMTM intervention or usual care visit. Following attrition, a total of 296 CMC will contribute measurements at 90 days, which provides > 90% power to detect a clinically significant 1.0 reduction in total MRPs with an alpha level of 0.05. Secondary outcomes include Parent-Reported Outcomes of Symptoms (PRO-Sx) symptom burden scores and acute healthcare visit counts. Program replication costs will be assessed using time-driven activity-based scoring. DISCUSSION: This pMTM trial aims to test hypotheses that a patient-centered medication optimization intervention delivered by pediatric pharmacists will result in lower MRP counts, stable or improved symptom burdens, and fewer cumulative acute healthcare encounters at 90 days following pMTM compared to usual care. The results of this trial will be used to quantify medication-related outcomes, safety, and value for a high-utilization group of CMC, and outcomes may elucidate the role of integrated pharmacist services as a key component of outpatient complex care programs for this priority pediatric population. TRIAL REGISTRATION: This trial was prospectively registered at clinicaltrials.gov (NCT05761847) on Feb 25, 2023.

Pragmatic trials in long-term care: Challenges, opportunities, recommendations.

Randomized controlled trials are considered the most rigorous research design in efficacy and effectiveness research; however, such trials present numerous challenges that limit their applicability in real-world settings. As a consequence, pragmatic trials are increasingly viewed as a research design that overcomes some of these barriers with the potential to produce data that are more reproducible. Although pragmatic methodology in long-term care is receiving increasing attention as an approach to improve successful dissemination and implementation, pragmatic trials present complexities of their own. To address these complexities and related issues, experts with experience conducting pragmatic trials, developing nursing home policy, participating in advocacy efforts, and providing clinical care in long-term care settings participated in a virtual consensus conference funded by the National Institute on Aging in Spring 2021. Participants recommended 4 cross-cutting principles key to dissemination and implementation of pragmatic trial interventions: (1) engage stakeholders, (2) ensure diversity and inclusion, (3) assess organizational strain and readiness, and (4) learn from adaptations. Specifically related to implementation, participants provided 2 recommendations: (1) integrate interventions into existing workflows and (2) maintain agility and responsiveness. Finally, participants had 3 recommendations specific to dissemination: (1) package the message for the audience, (2) engage diverse audiences, and (3) apply dissemination and diffusion tools. Participants emphasized that implementation processes must be grounded in the perspectives of the people who will ultimately be responsible for implementing the intervention once it is proven to be effective. In addition, messaging must speak to long-term care staff and all others who have a stake in its outcomes. Although our understanding of dissemination and implementation strategies remains underdeveloped, this article is designed to guide long-term care researchers and community providers who are increasingly aware of the need for pragmatism in disseminating and implementing evidence-based care interventions.

Effectiveness of Methenamine for UTI Prevention in Older Adults.

Background: Methenamine is a drug used for the prevention of lower urinary tract infections (UTIs). However, efficacy has not been established in older adults or patients with varying degrees of kidney function. Objective: To evaluate the effectiveness of methenamine for the prevention of UTI in adults 60 years and older. Methods: This was a retrospective, pre-post, observational study. The study included primary care patients 60 years and older who were taking methenamine between January 1, 2015, and September 30, 2018. The primary outcome was the time to first UTI after methenamine initiation compared with the average time between UTIs in the 12 months prior to methenamine initiation. Results: Of 434 patients reviewed, 150 met inclusion criteria. The average time to UTI was 3.3 months prior to methenamine initiation compared with 5.5 months after methenamine initiation (P = 0.0004). There were 33 patients (22%) who did not have a UTI after methenamine initiation. Also, 14 patients (9.3%) had a calculated CrCl <30 mL/min at baseline. The average time to UTI in these patients was 3.3 months prior to methenamine initiation compared with 12.7 months after initiation (P < 0.0001). Conclusion and Relevance: Methenamine use was associated with a longer time to UTI in older adults with varying degrees of kidney function. The effectiveness of methenamine appeared to be similar regardless of kidney function, which is new evidence. Because of a lack of acquired resistance, methenamine may be an effective option for UTI prophylaxis in older adults.

Comparison of faculty assessment and students' self-assessment of performance during clinical case discussions in a pharmacotherapy capstone course.

OBJECTIVES: The primary objective of this study was to compare faculty assessment and third year students' self-assessment of performance in clinical case discussions. The secondary objective was to evaluate if student characteristics influence self-assessments. METHODS: This retrospective analysis compared faculty and student self-assessment scores for two clinical case discussions using Spearman's correlation and Wilcoxon's signed ranks test. Chi-squared test was used to compare frequency of faculty and student self-assessments indicating the highest possible rating for the pooled score and for each individual component. The pooled score included three individual components: level of engagement, quality of contribution, and professionalism. RESULTS: Pooled faculty and student self-assessments correlated for both the first (r = 0.41, p < 0.001) and second (r = 0.35; p < 0.001) clinical case discussions. The frequency that faculty and student self-assessment ratings were the highest possible pooled score was similar for both the first (51.3% vs. 44.7%, respectively, p = 0.25) and second (58.6% vs. 47.4%, p = 0.05) clinical case discussions. Student characteristics (age, gender, and grade point average at graduation) did not influence self-assessments. CONCLUSIONS: Students' self-assessment correlated with faculty assessment of performance during clinical case discussions. Increased use of self-assessments for professional development in pharmacy and other healthcare professional curricula should be considered.

Self-Administered Assessment of Health Literacy in Adolescents Using the Newest Vital Sign.

The "Newest Vital Sign" (NVS) is a validated health literacy assessment tool typically administered by clinicians. The objective of this study was to assess if the NVS could be self-administered in adolescents to measure health literacy. Sixth graders in a Colorado middle school were provided a self-administered survey containing the NVS, a section for parent permission, and a section for the student's age, gender, grade, and previous elementary school. In all, 167 sixth graders returned usable surveys (45% return rate), and the average health literacy score was 3.75 ± 1.70. Almost two thirds (62.9%) of the students scored in the adequate health literacy range, while only 12.6% scored in the limited health literacy range. Health literacy scores were similar when evaluated based on gender. However, when students were grouped based on prior elementary school attendance, students who matriculated from one elementary school had an average NVS score significantly lower than two other elementary schools (p < .001 and p < .05). Self-administration of the NVS was successful and showed similar health literacy scores compared to other studies in adolescents. Using the NVS as a self-administered tool could greatly increase its function as a quick health literacy assessment for adolescents, both in clinical practice and in school-based health education.

Identifying Cognitive Impairment in an Older Adult Using Two Different Screening Tools.

A 78-year-old Hispanic woman presented to an ambulatory care clinic for older adults describing memory impairment and requesting an assessment of her cognitive status. A Mini-Mental State Examination (MMSE) was performed and found to be 29/30 (normal). One year later, the same situation occurred and her MMSE was again found to be 29/30 (normal). However, a Saint Louis University Mental Status (SLUMS) examination administered that same day demonstrated a different result: a score of 19/30 (dementia). Fourteen months later, the patient returned again and scored 26/30 (normal) on the MMSE and 22/30 (mild neurocognitive disorder) on the SLUMS. Our patient case illustrates inherent differences between the MMSE and SLUMS in the ability to detect mild cognitive impairment and dementia, along with the variability that may occur with testing.

Over-the-Counter Drugs to Avoid in Older Adults with Kidney Impairment.

Older adults (age 65 years or older) are at especially high risk of having adverse events from over-the-counter (OTC) drugs, and older adults who have kidney disease are at an even higher risk. These older adults with kidney impairment may need to completely avoid, or at the least reduce, their exposure to certain OTC products, such as nonsteroidal inhibitors. When older adults with kidney impairment are counseled about the safety of OTC drugs, they need to be made aware that some drugs may also require dose adjustments. Several categories of drugs that commonly require dosage changes include antihistamines, histamine-2 receptor antagonists, oral decongestants, codeine, and a few gastrointestinal drugs. Another concern is for the possibility of there being a drug-drug interaction between an OTC medication and a prescription drug. Careful consideration needs to be paid to the choice of drugs given to older adults. Patient education is essential to reduce the occurrence of adverse events.

Antidepressant-Induced Hyponatremia in Older Adults.

OBJECTIVE: To describe the prevalence of hyponatremia in older adults related to antidepressive agents and identify potential alternative options in older adults with a low-baseline serum sodium concentration and/or when a patient has experienced hyponatremia as a result of taking an antidepressant. DATA SOURCES: A PubMed search was conducted on November 10, 2015. Search terms included: antidepressive agents, antidepressive agents second-generation, bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, hyponatremia, milnacipran, mirtazapine, paroxetine, reboxetine, syndrome of inappropriate antidiuretic hormone, sertraline, trazodone, venlafaxine, and vilazodone. Filters included English language. A search of product labeling was also conducted. STUDY SELECTION: Out of 363 results, 124 publications were identified and reviewed along with 11 additional references. Publications were chosen based on relevance to the review: case reports of patients 60 years of age or older or clinical investigations of the association between hyponatremia and antidepressants in older adults. DATA EXTRACTION: Hyponatremia was counted as an adverse effect if an antidepressant was the likely cause of hyponatremia, and hyponatremia was resolved after withdrawal. DATA SYNTHESIS: Antidepressant-induced hyponatremia in older adults is fairly common. Selective serotonin reuptake inhibitors, serotonin/norepinephrine reuptake inhibitors, and mirtazapine were implicated in the majority of the case reports and clinical studies evaluating older adults. Bupropion, trazodone, and tricyclic antidepressants were implicated less often in the same literature. CONCLUSION: Given its unique mechanism of action, bupropion may be the most appropriate antidepressant for older adults at risk for antidepressant-induced hyponatremia.

Proper Disposal of Unused Household Medications: The Role of the Pharmacist.

As the number of unused household medications within the United States continues to rise, so does the need for proper education among patients and health care professionals on proper drug disposal. Consumers have been provided conflicting directions on how to properly dispose of medications; as a result, harmful and unsafe disposal practices have been used that increased the risk for diversion and environmental damage. Recently, several governmental agencies have published recommendations for household medication disposal, and the number of national and statewide drug take-back programs has increased. Although these programs now have taken hold, consumers are often unaware of their presence or benefit. Pharmacists have a unique opportunity to educate the public and themselves on the importance of proper medication disposal as well as the programs available for patients to access.

Priapism induced by boceprevir-CYP3A4 inhibition and α-adrenergic blockade: case report.

A 44-year-old white man presented to the emergency department with a 3-day history of priapism requiring a surgically performed distal penile shunt. A drug-drug interaction is the suspected cause whereby CYP3A4 inhibition by boceprevir led to increased exposures of doxazosin, tamsulosin, and/or quetiapine, resulting in additional α-adrenergic blockade.

Evaluation of Aspirin Prescribing and Gastrointestinal Bleeding in Adults 60 Years of Age and Older in a Large, Academic Health System.

Background National guidelines no longer recommend adults 60 years of age and older to begin treatment with low-dose daily aspirin for primary prevention of atherosclerotic cardiovascular disease (CVD) due to a lack of proven net benefit and a higher risk of bleeding. Objective The objective of this cross-sectional retrospective analysis was to evaluate the appropriateness of low-dose aspirin prescribing and subsequent gastrointestinal bleeding in older persons receiving primary care in a large academic health system. Setting Large, academic health system within Colorado. Patients Patients with an active order for daily low-dose aspirin as of July 1, 2021, were assessed for appropriateness based on indication (primary vs secondary prevention) and use of a concomitant proton-pump inhibitor (PPI). Incident gastrointestinal bleeds (GIBs) in the subsequent 12 months and GIB risk factors were also evaluated. Results A total of 19,525 patients were included in the analysis. Eighty-nine percent of patients identified as White and 54% identified as male. Of the total cohort, 44% had CVD and 19% were co-prescribed a PPI. GIB occurred in 247 patients (1.27%) within the subsequent year. Risk factors significantly associated with a GIB within 1 year included: history of GIB, history of peptic ulcer disease, other esophageal issue (esophagitis, Barrett's esophagus, Mallory Weiss tears, etc.), 75 years of age or older, and history of gastroesophageal reflux disease. Conclusion This evaluation found that many older persons at this institution may be inappropriately prescribed aspirin, providing opportunities for pharmacists to improve medication safety by deprescribing aspirin among primary prevention patients or potentially co-prescribing a PPI in secondary prevention patients.

Pharmacy student use of ChatGPT: A survey of students at a U.S. School of Pharmacy.

OBJECTIVE: To learn how students in an accredited PharmD program in the United States are using ChatGPT for personal, academic, and clinical reasons, and whether students think ChatGPT training should be incorporated into their program's curriculum. METHODS: In August 2023, an 18-item survey was developed, pilot tested, and sent to all students who were enrolled during the Spring 2023 semester in the entry-level PharmD program at the University of Colorado. E-mail addresses were separated from survey responses to maintain anonymity. Responses were described using descriptive statistics. RESULTS: 206 pharmacy students responded to the survey for a 49% response rate. Nearly one-half (48.5%) indicated they had used ChatGPT for personal reasons; 30.2% had used it for academic reasons; and 7.5% had used it for clinical reasons. The most common personal use for ChatGPT was answering questions and looking-up information (67.0%). The top academic reason for using ChatGPT was summarizing information or a body of text (42.6%), while the top clinical reason was simplifying a complex topic (53.3%). Most respondents (61.8%) indicated they would be interested in learning about how ChatGPT could help them in pharmacy school, and 28.1% thought ChatGPT training should be incorporated into their pharmacy curriculum. CONCLUSION: At the time of the survey, ChatGPT was being used by approximately one-half of our pharmacy student respondents for personal, academic, or clinical reasons. Overall, many students indicated they want to learn how to use ChatGPT to help them with their education and think ChatGPT training should be integrated into their curriculum.

Evaluation of type 2 diabetes mellitus medication management and control in older adults.

OBJECTIVES: The primary aims of this study were to characterize glycemic control and pharmacologic management in older patients and to compare glycemic control and pharmacological management in patients 65 to 79 years of age ("young-old") with those 80 to 89 years of age ("old-old"). We hypothesized that patients 80 to 89 years of age would be prescribed fewer medications and would have higher A1c values compared with younger patients. DESIGN: Retrospective medical record review. SETTING: This study was conducted in outpatient clinics within a university hospital setting. PATIENTS, PARTICIPANTS: This study included 400 adults 65 to 89 years of age with a diagnosis of type 2 diabetes mellitus and at least one A1c measurement over 12 months. MAIN OUTCOME MEASURES: A1c measurements and diabetes mellitus medications were assessed in these patients. RESULTS: The overall mean A1c was similar in the young-old compared with the old-old (7.1 ± 1.1% vs. 7.0 ± 1.1%; P = NS). There was no difference between groups for any of the A1c ranges studied. Fewer diabetes medications were prescribed in the old-old compared with the young-old (P = 0.003). In the young-old compared with the old-old, metformin (51.0% vs. 33.0%; P < 0.01), glucagon-like peptide-1 agonists (6.7% vs. 0%; P < 0.01), insulin glargine/detemir (24.7% vs. 13.0%; P < 0.05), and short-acting insulin (15.0% vs. 7.0%; P < 0.05) were more frequently prescribed. CONCLUSION: Our results indicate that glycemic control was similar between the young-old and old-old. However, the old-old required fewer diabetic medications for this same level of glycemic control.