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.

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.

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.

Inhaled anticholinergic agents and acute urinary retention in men with lower urinary tract symptoms or benign prostatic hyperplasia.

OBJECTIVE: To assess the risk of acute urinary retention with the use of inhaled anticholinergic agents in men with lower urinary tract symptoms (LUTS) or benign prostatic hyperplasia (BPH). DATA SOURCES: A literature search was performed with MEDLINE via PubMed from 1967 through May 2012 using the terms inhaled anticholinergics, urinary retention, benign prostatic hyperplasia, lower urinary tract symptoms, tiotropium, and ipratropium. In addition, references from reviewed publications were identified and official labeling was obtained from the manufacturers' Web sites. STUDY SELECTION AND DATA EXTRACTION: Only English-language publications were included. Randomized controlled trial data, observational studies, case reports, package labeling, and commentaries regarding men with BPH/LUTS using inhaled anticholinergic agents and the associated development of urinary retention were reviewed. DATA SYNTHESIS: Two case reports; 1 prospective, open-label, single-arm study; and 2 nested case-control studies evaluated or described the use of inhaled anticholinergic agents and the development of acute urinary retention in men with BPH/LUTS. Taken together, the available data demonstrate that treatment with inhaled anticholinergic agents is associated with acute urinary retention in men with preexisting LUTS or BPH. CONCLUSIONS: Men with LUTS or BPH who are treated with inhaled anticholinergic agents may develop acute urinary retention, but this cannot be quantified based on the limited information available. Inhaled anticholinergic agents should be used when indicated in men with LUTS or BPH, but close monitoring and patient education should be implemented.

Medication management: a case of brown bag-identified medication hoarding.

A 91-year-old woman living independently in the community presented along with her son for a medication therapy management (MTM) appointment with the clinical pharmacist at the University of Colorado Hospital Seniors Clinic. The purpose of the visit was to review the patient's medications, perform medication reconciliation, and identify ways to increase proper medication management. As requested for the MTM appointment, the patient and her son brought in several large bags of her over-the-counter (OTC) and prescription medications from her home, including those that she was not currently taking. The clinical pharmacist reviewed the medications and found multiple instances of duplicate therapies, nonadherence, discrepancies in her medication regimen, cost concerns, and other drug-therapy problems. In addition, the pharmacist's evaluation showed that the patient had been hoarding more than 100 medications, which increased her risk for drug-related problems. Most of the OTC and some prescription medications were voluntarily removed from the patient's possession to reduce the likelihood of potential overuse of medications.The pharmacist educated the patient and her son regarding her updated medication list and how to properly manage her medications. Finally, the patient's son volunteered to help his mother with medication management or hire someone to assist her. This case demonstrates the usefulness of requesting all medications-including OTC and prescription, active and inactive medications-be brought to the MTM appointment.The case also supports the need for family support for older adults struggling with managing polypharmacy.

Older adults with multi-morbidity: medication management processes and design implications for personal health applications.

BACKGROUND: Older adults often have multiple chronic problems requiring them to manage complex medication regimens overseen by various clinicians. Personal health applications (PHAs) show promise assisting in medication self-management, but adoption of new computer technologies by this population is challenging. Optimizing the utility of PHAs requires a thorough understanding of older adults' needs, preferences, and practices. OBJECTIVE: The objective of our study was to understand the medication self-management issues faced by older adults and caregivers that can be addressed by an electronic PHA. METHODS: We conducted a qualitative analysis of a series of individual and group semistructured interviews with participants who were identified through purposive sampling. RESULTS: We interviewed 32 adult patients and 2 adult family caregivers. We identified 5 core themes regarding medication self-management challenges: seeking reliable medication information, maintaining autonomy in medication treatment decisions, worrying about taking too many medications, reconciling information discrepancies between allopathic and alternative medical therapies, and tracking and coordinating health information between multiple providers. CONCLUSIONS: This study provides insights into the latent concerns and challenges faced by older adults and caregivers in managing medications. The results suggest that PHAs should have the following features to accommodate the management strategies and information preferences of this population: (1) provide links to authoritative and reliable information on side effects, drug interactions, and other medication-related concerns in a way that is clear, concise, and easy to navigate, (2) facilitate communication between patients and doctors and pharmacists through electronic messaging and health information exchange, and (3) provide patients the ability to selectively disclose medication information to different clinicians.

Cognitive effects of vortioxetine in older adults: a systematic review.

Many older adults experience a deterioration in cognitive function with aging, and this can have a negative impact on quality of life. Late-life depression has been linked to mild cognitive impairment and dementia, and treating depression with an agent that has procognitive effects could be beneficial. Vortioxetine is a novel antidepressant with a multimodal mechanism of action that works primarily via serotonin transporter inhibition, 5-HT1A receptor agonism and 5-HT3 receptor antagonism. A recent systematic review demonstrated procognitive effects of vortioxetine when indirectly compared with selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors in adults aged 18-65 years with major depressive disorder. While this systematic review demonstrated promising procognitive effects from vortioxetine, the included studies did not enroll older adults, who are at the highest risk of cognitive impairment. Therefore, our systematic review sought to investigate the effects of vortioxetine on cognitive functioning in patients over the age of 65 years. Three studies met the prespecified search criteria and were evaluated. Overall, these preliminary data suggest that vortioxetine has promising effects in improving cognition in older adults with depressive symptoms and may have a place in therapy in older adults with depression and/or cognitive impairment, including Alzheimer's disease. Additional long-term studies that include more diverse populations with comorbidities and direct comparisons with other antidepressants are needed to fully understand the potential cognitive benefits in older adults.

Implementation of Pharmacist Reviews to Screen for Potentially Inappropriate Medications in Patients With Cognitive Impairment.

Objective: To describe two pharmacist-led initiatives aimed to reduce potentially inappropriate medication (PIM) use in community-dwelling patients with dementia or cognitive impairment. Design: Retrospective, descriptive analysis of two clinical initiatives. Setting: Academic geriatric primary care clinics. Participants: Patients were included if they received a Memory Clinic pharmacist review May 1, 2017, to December 31, 2019, or a Living with Dementia (LWD) program pharmacist review November 15, 2018 to December 31, 2019 with provider follow-up within 6 months. Interventions: Both initiatives involved medication review by a clinical pharmacist to identify and make recommendations regarding medications that may contribute to cognitive impairment. The Memory Clinic served patients with concerns of cognitive impairment; whereas, the LWD program enrolled patients with an established diagnosis of dementia. Main Outcome Measure: Number of PIMs that could negatively impact cognition within each cohort. Additionally, 6-month implementation rates were analyzed for actionable pharmacist recommendations. RESULTS: Memory Clinic patients (n = 110) were taking an average of 2.4 PIMs; whereas, LWD patients (n = 40) were taking an average of 1.5 PIMs. Six-month implementation rates for all actionable pharmacist recommendations were 61.0% for the Memory Clinic and 42.4% for the LWD program. Specifically evaluating deprescribing recommendations, the 6-month PIM discontinuation rate was 63.6% for the Memory Clinic group and 60.0% for the LWD group. Conclusion: Pharmacists routinely identified PIMs during medication reviews, which led to successful recommendation implementation throughout multiple stages of cognitive decline. Both programs will continue to be adapted to ensure maximal impact.

Incorporation of Clinical Pharmacy Into a Geriatric Transitional Care Management Program.

Transitional care management (TCM) programs have been shown to decrease hospital readmission rates, health-care costs, and medication-related errors and adverse drug events. Pharmacists have been utilized during the medication reconciliation process, during admission, and after hospital discharge to prevent readmission and identify medication discrepancies. There is a lack of data utilizing clinical pharmacists in the geriatric patient population transitional care process after hospital discharge. Less is known about the depth of professional services a pharmacist can perform in the geriatric setting. We analyzed the scope of pharmacist-assisted implementation of transitional care. A total of 365 patients received the clinical pharmacist comprehensive medication review during a 14-month time period. During these reviews, clinical pharmacists identified more than 600 medication discrepancies and offered more than 1000 recommendations to the primary care physician. Additionally, specific medication classes that have been identified to increase the risk of adverse drug events, specifically in older adults, were identified and used to screen for adverse drug events. Using this list, clinical pharmacists were able to identify 39 adverse drug events. The implementation of clinical pharmacists into the TCM program was successful; however, full salary compensation is unlikely with TCM reimbursement alone.

Pharmacist-Led Transition of Care Pilot Targeting Older People After Emergency Department Discharge.

OBJECTIVE: To evaluate the impact of a pharmacist-led transitional care intervention targeting high-risk older people after an emergency department (ED) visit.
DESIGN: Retrospective cohort study of older people with ED visits prior to and during a pharmacist-led intervention.
SETTING: Patients receiving primary care from the University of Colorado Health Seniors Clinic.
PARTICIPANTS: The intervention cohort comprised 170 patients with an ED visit between August 18, 2018, and February 19, 2019, and the historical cohort included 166 patients with an ED visit between August 18, 2017, and February 19, 2018. All included patients either had a historical diagnosis of heart failure or chronic obstructive pulmonary disease, or they had an additional ED visit in the previous six months.
INTERVENTIONS: The pilot intervention involved postED discharge telephonic outreach and assessment by a clinical pharmacist, with triaging to other staff if necessary.
MAIN OUTCOME MEASURE: The primary outcome was the proportion of patients with at least one repeat ED visit, hospitalization, or death within 30 days of ED discharge. Outcome rates were also assessed at 90 days postdischarge.
RESULTS: The primary outcome occurred in 21% of the historical cohort and 25% of the intervention cohort (adjusted P-value = 0.48). The incidence of the composite outcome within 90 days of ED discharge was 43% in the historical group compared with 38% in the intervention group (adjusted P-value = 0.29).
CONCLUSION: A pharmacist-led telephonic intervention pilot targeting older people did not appear to have a significant effect on the composite of repeat ED visit, hospitalization, or death within 30 or 90 days of ED discharge. A limited sample size may hinder the ability to make definitive conclusions based on these findings.

Optimal Melatonin Dose in Older Adults: A Clinical Review of the Literature.

OBJECTIVE: To review clinical studies evaluating melatonin doses and their effects on sleep in adults 65 years of age and older. DATA SOURCES: The MEDLINE databases were searched (1946 to October 10, 2018) using the following Medical Subject Heading terms: melatonin and: sleep initiation and maintenance disorders, dyssomnia, sleep wake disorders, insomnia, sleep disorders intrinsic, and sleep disorders circadian rhythm. Sources were limited to English and human data. STUDY SELECTION/DATA EXTRACTION: An initial search resulted in 144 publications, with 25 included in this review. Studies were selected for full review based on design, mean age of participants, use of exogenous melatonin, and reports on any sleep-related outcome. DATA SYNTHESIS: Because of the side effect profiles of most prescription and nonprescription sleep aids, safe and effective alternative therapies are necessary. Based on the current literature, no dose-related response to sleep improvement has been identified for melatonin in older adults. Variations in melatonin formulation and dosages, as well as available tools to measure sleep outcomes, make it challenging to compare studies. CONCLUSIONS: This review evaluated a variety of melatonin doses, 0.5 mg to 10 mg, and their effects on sleep in older adults. The results varied, with some studies finding no difference in sleep outcomes when compared with placebo, while other studies found statistically significant improvements in sleep outcomes. Doses of melatonin between 1 mg and 6 mg appear to be effective for improving sleep in older adults; however, further studies are needed to find the optimal minimum effective dose.