The impact of real-world cardiovascular-related pharmacogenetic testing in an insured population.

BACKGROUND: Pharmacogenomics is intended to help clinicians provide the right drug to the right patient at an appropriate dose. However, limited evidence of clinical utility has slowed uptake of pharmacogenomic testing (PGT). OBJECTIVE: To evaluate the impact of real-world cardiovascular (CV)-related PGT on clinical outcomes, healthcare resource utilisation (HCRU) and cost in a large, heterogeneous population. METHODS: Individuals with Medicare Advantage Prescription Drug, Medicaid, or commercial coverage between 1/1/2011 and 9/30/2015 and ≥1 atherosclerotic CV-related diagnosis were identified. Those with ≥1 claim for CV-related PGT were included in the test group (index date = 1st PGT claim) and matched 1:2 to controls without PGT. Individuals aged <22 or ≥90 years old on the index date, with <12 months continuous enrollment before and after the index date, or without an ASCVD-related diagnosis in the 12-month pre-index period were excluded. The primary outcome was occurrence of a major CV event during the 12-month post-index period. RESULTS: After adjustment, the PGT group was significantly more likely to experience ischaemic stroke, pulmonary embolism, deep vein thrombosis or a composite event compared with controls. Adjusting for baseline characteristics, HCRU was significantly higher for the test group across all measured outcomes except all-cause and ASCVD-related inpatient admissions. Median all-cause and ASCVD-related healthcare costs were significantly higher for the test group. CONCLUSIONS: Real world PGT in a large population did not improve outcomes. Tailoring medication therapy to each patient holds great promise for providing quality care but a deeper understanding of how widespread utilisation of PGT might impact objective health outcomes is needed.

Association of Health-Related Social Needs With Quality and Utilization Outcomes in a Medicare Advantage Population With Diabetes.

Importance: Recent research highlights the association of social determinants of health with health outcomes of patients with type 2 diabetes (T2D). Objective: To examine associations between health-related social needs (HRSNs) and health care quality and utilization outcomes in a Medicare Advantage population with T2D. Design, Setting, and Participants: This cross-sectional study used medical and pharmacy claims data from 2019. An HRSN survey was given between October 16, 2019, and February 29, 2020, to Medicare Advantage beneficiaries. Inclusion criteria were diagnosis of T2D, age of 20 to 89 years, continuous Medicare Advantage enrollment in 2019, and response to the HRSN survey. Data were analyzed between June 2021 and January 2022. Exposures: Enrollment in Medicare Advantage, diagnosis of T2D, and completion of a survey on HRSNs. Main Outcomes and Measures: Quality outcomes included diabetes medication adherence, statin adherence, completion of a glycated hemoglobin (HbA1c) laboratory test in the past 12 months, and controlled HbA1c. Utilization outcomes included all-cause hospitalization, potentially avoidable hospitalization, emergency department discharge, and readmission. Results: Of the 21 528 Medicare Advantage beneficiaries with T2D included in the study (mean [SD] age, 71.0 [8.3] years; 55.4% women), most (56.9%) had at least 1 HRSN. Among the population with T2D reporting HRSNs, the most prevalent were financial strain (73.6%), food insecurity (47.5%), and poor housing quality (39.1%). In adjusted models, loneliness (odds ratio [OR], 0.85; 95% CI, 0.73-0.99), lack of transportation (OR, 0.80; 95% CI, 0.69-0.92), utility insecurity (OR, 0.86; 95% CI, 0.76-0.98), and housing insecurity (OR, 0.78; 95% CI, 0.67-0.91) were each associated with lower diabetes medication adherence. Loneliness and lack of transportation were associated with increased emergency visits (marginal effects of 173.0 [95% CI, 74.2-271.9] and 244.6 [95% CI, 150.4-338.9] emergency visits per 1000 beneficiaries for loneliness and transportation, respectively). Food insecurity was the HRSN most consistently associated with higher acute care utilization (marginal effects of 84.6 [95% CI, 19.8-149.4] emergency visits, 30.4 [95% CI, 9.5-51.3] inpatient encounters, and 17.1 [95% CI, 4.7-29.5] avoidable hospitalizations per 1000 beneficiaries). Conclusions and Relevance: In this cross-sectional study of Medicare Advantage beneficiaries with T2D, some HRSNs were associated with care quality and utilization. The results of the study may be used to direct interventions to the social needs most associated with T2D health outcomes and inform policy decisions at the insurance plan and community level.

Health-Related Social Needs Among Older Adults Enrolled In Medicare Advantage.

Among older adults enrolled in Medicare Advantage, health-related social needs are highly prevalent, with financial strain, food insecurity, and poor housing quality the most commonly reported. The distribution of health-related social needs is uneven, with significant disparities according to race, socioeconomic status, and sex.

Association Between Self-reported Health-Related Social Needs and Acute Care Utilization Among Older Adults Enrolled in Medicare Advantage.

Importance: There is increased focus on identifying and addressing health-related social needs (HRSNs). Understanding how different HRSNs relate to different health outcomes can inform targeted, evidence-based policies, investments, and innovations to address HRSNs. Objective: To examine the association between self-reported HRSNs and acute care utilization among older adults enrolled in Medicare Advantage. Design Setting and Participants: This cross-sectional study used data from a large, national survey of Medicare Advantage beneficiaries to identify the presence of HRSNs. Survey data were linked to medical claims, and regression models were used to estimate the association between HRSNs and rates of acute care utilization from January 1, 2019, through December 31, 2019. Exposures: Self-reported HRSNs, including food insecurity, financial strain, loneliness, unreliable transportation, utility insecurity, housing insecurity, and poor housing quality. Main Outcomes and Measures: All-cause hospital stays (inpatient admissions and observation stays), avoidable hospital stays, all-cause emergency department (ED) visits, avoidable ED visits, and 30-day readmissions. Results: Among a final study population of 56 155 Medicare Advantage beneficiaries (mean [SD] age, 74.0 [5.8] years; 32 779 [58.4%] women; 44 278 [78.8%] White; and 7634 [13.6%] dual eligible for Medicaid), 27 676 (49.3%) reported 1 or more HRSNs. Health-related social needs were associated with statistically significantly higher rates of all utilization measures, with the largest association observed for avoidable hospital stays (incident rate ratio for any HRSN, 1.53; 95% CI, 1.35-1.74; P < .001). Compared with beneficiaries without HRSNs, beneficiaries with an HRSN had a 53.3% higher rate of avoidable hospitalization (incident rate ratio, 1.53; 95% CI, 1.35-1.74; P < .001). Financial strain and unreliable transportation were each independently associated with increased rates of hospital stays (marginal effects of 26.5 [95% CI, 14.2-38.9] and 51.2 [95% CI, 30.7-71.8] hospital stays per 1000 beneficiaries, respectively). All HRSNs, except for utility insecurity, were independently associated with increased rates of ED visits. Unreliable transportation had the largest association with increased hospital stays and ED visits, with marginal effects of 51.2 (95% CI, 30.7-71.8) and 95.5 (95% CI, 65.3-125.8) ED visits per 1000 beneficiaries, respectively. Only unreliable transportation and financial strain were associated with increased rates of 30-day readmissions, with marginal effects of 3.3% (95% CI, 2.0%-4.0%) and 0.4% (95% CI, 0.2%-0.6%), respectively. Conclusions and Relevance: In this cross-sectional study of older adults enrolled in Medicare Advantage, self-reported HRSNs were common and associated with statistically significantly increased rates of acute care utilization, with variation in which HRSNs were associated with different utilization measures. These findings provide evidence of the unique association between certain HRSNs and different types of acute care utilization, which could help refine the development and targeting of efforts to address HRSNs.

Improving laboratory monitoring at initiation of drug therapy in ambulatory care: a randomized trial.

BACKGROUND: The importance of laboratory monitoring for drugs is reflected in product labeling and published guidelines, but monitoring recommendations are followed inconsistently. Opportunity exists to improve monitoring, with the potential to decrease therapy complications. METHODS: The objective of this randomized trial was to determine whether computerized alerts were effective at increasing the percentage of ambulatory patients with laboratory monitoring at initiation of drug therapy. Physicians and pharmacists teamed up to develop organization-specific guidelines for monitoring selected drugs. In collaboration with physicians, pharmacists were alerted to missing laboratory test results, ordered missing tests, reminded patients to obtain tests, assessed test completion, reviewed test results, and managed abnormal results. Eligible individuals included patients with therapy initiated for any of 15 drugs among 400,000 health plan members. RESULTS: In the intervention group, 79.1% (n = 4076; 95% confidence interval [CI], 78.0%-80.2%) of dispensings were monitored compared with 70.2% (n = 3522; 95% CI, 68.9%-71.5%) in the usual-care group (P < .001). For example, 78.6% of amiodarone (95% CI, 73.1%-83.5%) dispensing was monitored in the intervention group vs 51.4% (95% CI, 44.4%-58.4%) in the group receiving usual care (P < .001). CONCLUSIONS: This study demonstrates the effectiveness of a computerized tool plus collaboration among health care professionals at increasing the percentage of patients receiving laboratory monitoring at initiation of therapy. Coupling data available from information systems with the knowledge and skills of physicians and pharmacists can result in improved patient monitoring.

Laboratory monitoring of drugs at initiation of therapy in ambulatory care.

BACKGROUND AND OBJECTIVES: Product labeling and published guidelines reflect the importance of monitoring laboratory parameters for drugs with a risk of organ system toxicity or electrolyte imbalance. Limited information exists about adherence to laboratory monitoring recommendations. The objective of this study was to describe laboratory monitoring among ambulatory patients dispensed medications for which laboratory testing is recommended at therapy initiation. DESIGN AND SUBJECTS: We conducted a retrospective cross-sectional analysis of patients in 10 geographically distributed health maintenance organizations who were newly prescribed medications with recommended laboratory test monitoring. The main outcome measure was the proportion of initial drug dispensing without recommended baseline laboratory monitoring for 35 newly initiated drugs or drug classes. RESULTS: One hundred seven thousand, seven hundred sixty-three of 279,354 (39%) initial drug dispensings occurred without recommended laboratory monitoring. Patients without monitoring were younger than patients who had monitoring (median 57 vs 61 years, P<.001). Thirty-two percent of dispensings where a serum creatinine was indicated did not have it evaluated (range across drugs, 12% to 61%); 39% did not have liver function testing (range 10% to 75%); 32% did not have hematologic monitoring (range 9% to 51%); and 34% did not have electrolyte monitoring (range 20% to 62%) (P<.001). CONCLUSIONS: Substantial opportunity exists to improve laboratory monitoring of drugs for which such monitoring is recommended. This study emphasizes the need for research to identify the clinical implications of not conducting recommended laboratory monitoring, existing barriers to monitoring, and methods to improve practice.

Compliance with dosing guidelines in patients with chronic kidney disease.

OBJECTIVE: To assess the level of reported compliance with renal dosing guidelines in inpatient, long-term care, and ambulatory settings. DATA SOURCES: Available databases (MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, ACP Journal Club) were searched (1966-December 2002) to identify published literature pertaining to renal dosing guideline compliance in patients with chronic kidney disease. STUDY SELECTION AND DATA EXTRACTION: All articles addressing renal dosing guideline compliance in inpatient, long-term care or ambulatory settings were included. Six articles matching our inclusion criteria were reviewed. DATA SYNTHESIS: Patients with chronic kidney disease require appropriate medication dosing for disease severity and level of renal function for avoiding adverse drug events, preventing additional renal injury, and optimizing patient outcomes. Consensus-based medication dosing guidelines are readily available and provide initial dose estimations, which can be further individualized based on disease severity and therapeutic response. Studies conducted in hospitals found renal dosing guideline noncompliance rates ranged from 19% to 67%. Limited data in long-term care reported a noncompliance rate of 34%. While published studies concerning compliance to renal dosing recommendations in ambulatory settings are not available, an abstract indicated 69% noncompliance. CONCLUSIONS: Based on limited published data, improvements in renal dosing guideline compliance are needed in all settings where data are available. Research is needed to further assess the appropriateness of renal dosing in ambulatory settings and inform quality improvement efforts in all settings.