Publications

PURPOSE: We sought to describe how often and circumstances in which supply chain disruptions were associated with outpatient drug shortages within the Veterans Health Administration (VHA).

METHODS: We conducted a descriptive analysis of VHA purchasing data for drugs used to treat chronic conditions for outpatients with a supply chain report from 2017 to 2020. In primary analyses, a VHA drug shortage was defined as a ≥ 10% absolute decrease in percentage of doses ordered that were filled by the wholesaler and/or a ≥ 10% relative decrease in total number of doses filled, comparing the 3 months after the reporting date with the 6 months before. We also examined longitudinal ordering and filling data over 12 months before and after the reporting date by whether the medication resulted in a shortage to VHA.

RESULTS: Of 64 medications with supply chain disruptions, 67% (n = 43) resulted in a shortage to VHA. Bivariable analyses did not identify covariates significantly associated with VHA experiencing a shortage. For medications with a shortage, dosage units ordered sharply increased over the 4 months before the reporting date, peaked at the reporting date (336.0%), and then generally decreased over the remaining 11 months. The monthly dosage units filled slowly declined leading up to the reporting date, dropped more quickly to 60% at two months post-reporting date, and then increased.

CONCLUSIONS: Among ambulatory-focused medications for chronic conditions, a high proportion of those with supply chain disruptions were associated with shortages to VHA. Sharp increases in medication ordering may serve as an early signal of shortages.

BACKGROUND: Guidelines on primary prevention of atherosclerotic cardiovascular disease (ASCVD) recommend considering risk enhancing factors (REFs) to inform decisions on use of lipid-lowering therapies for the 44 million Americans with borderline or intermediate estimated ASCVD risk.

OBJECTIVE: To quantify REF burden and estimate whether REFs are associated with higher likelihood of statin use.

DESIGN: Cross-sectional using National Health and Nutrition Examination Survey pooled 2015 to March 2020.

PARTICIPANTS: Adults aged 40-75 without known ASCVD.

MAIN MEASURES: Nine REFs were measurable in NHANES including family history of premature ASCVD, rheumatoid arthritis, metabolic syndrome, premature menopause, chronic kidney disease and biomarkers of hypercholesteremia, hypertriglyceridemia, elevated low-density lipoprotein cholesterol and elevated C-reactive protein. Prevalence of REFs and association with statin use were calculated overall and across ASCVD treatment categories based on diabetes and 10-year ASCVD risk.  KEY RESULTS: In the sample of 3,111 participants (mean age 56 years; 52.6% female) weighted to represent 115.7 million US adults, 77% had at least one REF and 28% had at least three. The most common REFs were elevated high sensitivity C-reactive protein (49.6%) metabolic syndrome (48.3%), and hypertriglyceridemia (18.9%). The presence of any REF was associated with a 2.17 (95% CI, 1.42-3.33) greater odds of statin use. Metabolic syndrome, family history of premature ASCVD, hypertriglyceridemia and hypercholesteremia were associated with greater odds of statin use (aORs ranging from 1.5 to 2.3). The presence of any REF was associated with higher likelihood of statin use in participants with low (< 5%), intermediate (7.5-19%), and high ASCVD risk (≥ 20%), but not borderline ASCVD risk (5-7.4%) or diabetes categories.

CONCLUSIONS: REFs are highly prevalent and inconsistently associated with statin use. Achieving the potential benefit of individualizing ASCVD risk estimates will require clearer guidance on when and how to incorporate REFs into primary prevention prescribing decisions.

BACKGROUND: Risks related to long-term opioid therapy for chronic pain are high and may increase over time with aging. Deprescribing may be a beneficial intervention for older adults prescribed chronic opioids.

METHODS: Semi-structured interviews with hypothetical clinical cases of older adults prescribed opioids for chronic pain: (1) low-risk case: a patient prescribed low-dose opioids without concerns; (2) moderate-risk case: a patient with multimorbidity and concurrent benzodiazepine use prescribed moderate opioid doses; (3) high-risk case: a patient prescribed high-dose opioids with signs of an opioid use disorder (OUD). PCPs were asked, in an open-ended fashion, to discuss whether they would initiate a deprescribing conversation, how they would approach deprescribing, and how they would approach a patient who declined recommendations to deprescribe.

PARTICIPANTS AND SETTING: PCPs from a Massachusetts health system.

RESULTS: 18 PCPs participated (56% female, 78% academic). More than half of PCPs would initiate a deprescribing conversation across the three cases. PCPs' approach to deprescribing and mitigating risks differed based on clinical risk. In low and moderate-risk cases, PCPs emphasized a patient-directed taper plan and education on opioid risks. In the high-risk case, some PCPs were uncertain about initiating a deprescribing conversation due to concerns about the patient's mental health and the risk of illicit opioid use. Naloxone was infrequently recommended across the three cases, but in the high-risk case, approximately half of PCPs suggested medications for OUD.

CONCLUSIONS: PCPs reported that they would often initiate opioid deprescribing conversations with older adults, but were less confident in managing older adults with signs of OUD. PCPs require additional support to implement successful conversations on opioid deprescribing with older adults.

BACKGROUND: Healthcare utilization and cost impacts, of medication adherence above or below the 80% threshold remains unclear for cardiometabolic medications.

OBJECTIVE: To evaluate the differences in cardiovascular (CV)-related emergency department (ED) visits and total cost-of-care associated with changes in medication adherence around the 80% threshold.

METHOD: Retrospective observational analysis of claims spanning from Jan 1, 2021, to June 30, 2023. Patients aged 50-80 years with a history of cardiovascular disease (CVD) and specific cardiometabolic medications were followed for 12 months, and pre-post index-fill outcomes compared. Patients were categorized into pre- and post-index groups: 3 pre-index groups (Pre1-moderate, Pre2-high, Pre3-very-high) based on their pre-index 12-month adherence [PDC] and 4 post-index groups based on post-index PDC (Post0-low, Post1-moderate, Post2-high, Post3-very-high), for 4 medication classes (Antidiabetics, direct oral coagulants[DOACs], antiplatelets, and anti-heart-failure meds [HF]). Group definitions: Post0-low (PDC<=69%), Pre1-moderate or Post1-moderate (PDC 70 to <80%), Pre2-high or Post2-high (PDC 80 to <90%), and Pre3-very-high or Post3-very-high (PDC >=90). Outcomes included per-member-per-year [PMPY] total cost-of-care, and cardiovascular-related ED visits.

RESULTS: There were 55,934(antidiabetics), 46,290 (DOACs), 65,659 (antiplatelets), and 49, 670 (HF) patients in the final sample. Most of the patients in the HF (46-53%) and DOAC (51-57%) groups were in the 70+ age group. Among patients in the antidiabetic (45-47%) and antiplatelet (39-43%) groups, the majority were in the 60-69 age group. In general, patients who moved from a lower adherence group to a higher adherence group had lower total cost-of-care in almost all groups and medication classes. Moving from PDC >= 90 to PDC <90%, total cost-of-care was higher in all 4 medication classes.

CONCLUSION: Improving adherence to and beyond the traditional 80% target was associated with lower total cost-of-care.

BACKGROUND: Chronic benzodiazepine use remains common among older adults, despite limited evidence of benefit and substantial risks. Evidence-based approaches that are feasible in primary care settings are needed to support benzodiazepine deprescribing for older adults.

OBJECTIVES: To determine the feasibility, acceptability, and exploratory patient-centered outcomes of a team-based approach to benzodiazepine deprescribing in primary care.

DESIGN: Single-arm prospective clinical trial.

PARTICIPANTS: Adults age 65 and older prescribed long-term benzodiazepines recruited from four primary care clinics in an academic health system.

INTERVENTIONS: Ten-week virtual primary care embedded program consisting of pharmacist-guided tapering and three psychologist-led mindfulness-informed cognitive behavioral therapy (CBT) sessions.

MAIN MEASURES: Feasibility outcomes included enrollment, retention, and intervention adherence. Acceptability outcomes were collected through qualitative interviews. Exploratory efficacy outcomes included change in mean daily benzodiazepine dose, change in PROMIS anxiety score, and change in PROMIS sleep disturbance score.

KEY RESULTS: Seventeen participants (mean age 72, 29% female, mean 17 years of benzodiazepine use) enrolled and completed all six study visits (100% fidelity). Participants' mean (SD) baseline daily benzodiazepine dose was 9.0 (8.6) diazepam milligram equivalents. At completion, participants had a mean 60.5 percentage point reduction in benzodiazepine use (95% CI -69.9% to -51.3%; p < .001), with all participants reducing their dose and 3 stopping completely. Mean PROMIS anxiety scores decreased from 55.2 to 51.8 (-3.5 point change, 95% CI -6.5 to -0.7; p = 0.02) and mean PROMIS sleep disturbance scores were unchanged at week 10 (-1.7 point change, 95% CI -4.9 to 1.5; p = 0.30). Qualitative interviews indicated the program may target increased self-efficacy to reduce benzodiazepines and endorsed utility from both pharmacist- and psychologist-led components.

CONCLUSIONS: A primary care embedded virtual intervention involving pharmacist-led tapering and mindfulness-informed CBT sessions to support benzodiazepine deprescribing is feasible, acceptable, may reduce older adults' benzodiazepine use, and warrants multi-site testing.

GOV TRIAL NUMBER: NCT06119308.

GOV REGISTRATION DATE: 10/27/2023.

BACKGROUND: In older adults with osteoarthritis (OA) and hypertension (HTN), analgesic use may elevate blood pressure and cardiovascular risk. Whether comorbid HTN influences initial analgesic choice remains unclear; we examined initial analgesic use in Medicare beneficiaries with incident OA, comparing those with and without HTN.

METHODS: We conducted a retrospective cohort study using 2011-2022 nationally representative Medicare beneficiaries (≥ 65 years) with incident OA who initiated an analgesic within 30 days of diagnosis and had continuous enrollment for ≥ 365 days prior through ≥ 30 days post-index. Patients with baseline HTN were classified as OA + HTN; others as OA-only. We assessed overall analgesic trends using the Cochran-Armitage test and evaluated differences by HTN status using logistic regression with year as an interaction term. For stratified analyses by joint type, we applied weighted logistic regression.

RESULTS: Among 179,033 beneficiaries (mean age 75 ± 7.3 years; 62.7% women; 80.7% White), 57.1% had baseline HTN. Overall, the most commonly initiated analgesic classes were intra-articular injections (30.3%), and oral NSAIDs only (28.2%). Notable changes from 2012 to 2022 were increase in topical NSAIDs use (3.1%-5.7%) and decrease in opioid combination use (25.4%-13.9%), with no significant trend differences by HTN status. In joint-specific analyses, OA + HTN versus OA-only showed no differences in odds of initiating oral opioids (OR: 0.97, 95% CI: 0.92-1.03), intra-articular injections (OR: 1.01, 95% CI: 0.96-1.07) or topical NSAIDs (OR: 0.88, 95% CI: 0.78-1.01) versus oral NSAIDs.

CONCLUSION: Baseline HTN did not influence the choice of initial analgesic in incident OA patients. Safer, evidence-based alternatives are needed for older adults with comorbid HTN.

AIM: The "2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia" retires and replaces the "2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol."

METHODS: A comprehensive literature search was conducted from October 2024 to December 2024 to identify clinical studies, systematic reviews and meta-analyses, and other evidence conducted on human participants that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline.

STRUCTURE: The focus of this clinical practice guideline is to address the evaluation, management, and monitoring of individuals with dyslipidemias, including high blood cholesterol, hypertriglyceridemia, and elevated lipoprotein(a).

AIM: The "2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia" retires and replaces the "2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol."

METHODS: A comprehensive literature search was conducted from October 2024 to December 2024 to identify clinical studies, systematic reviews and meta-analyses, and other evidence conducted on human participants that were published in English from MEDLINE (through PubMed), EMBASE, the Cochrane Library, Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline.

STRUCTURE: The focus of this clinical practice guideline is to address the evaluation, management, and monitoring of individuals with dyslipidemias, including high blood cholesterol, hypertriglyceridemia, and elevated lipoprotein(a).