Direct-Acting Oral Anticoagulants and Potential Inconsistencies with FDA-Approved Dosing for Non-Valvular Atrial Fibrillation: A Retrospective Real-World Analysis Across Nine US Healthcare Systems.

BACKGROUND: Direct-acting oral anticoagulants (DOACs) are recommended to reduce risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). However, DOAC dosing inconsistent with FDA-approved product labels is common and associated with poor clinical outcomes. OBJECTIVES: Identify DOAC dosing inconsistent with FDA-approved product labels in ambulatory care patients with NVAF; identify variables associated with dosing lower and higher than label. DESIGN: Retrospective analysis using electronic health records from nine US healthcare systems. PATIENTS: Adults with NVAF receiving DOAC therapy in 2022. MAIN MEASURES: Rates of label-inconsistent dosing; multivariable regression analysis to identify demographic and clinical variables associated with dosing lower and higher than label. KEY RESULTS: Among 51,128 NVAF patients (56.1% male, 94.3% White, mean [SD] age 73.5 [10.5] years), 5008 (9.8%) were prescribed label-inconsistent doses of DOACs (6.8% lower and 3.0% higher than label). Age ≥ 75 years, renal impairment, and hypertension were significantly associated with inconsistent dosing both higher and lower than label. Female sex and higher weight were significantly associated with dosing lower than label, as were heart failure, vascular or liver disease, and bleeding history. Dosing higher than label was significantly associated with male sex, race (African American/Black), weight < 60 kg, and use of drugs with potential drug-drug interactions. When prescribed by primary care physicians, DOAC doses were 37% (95% CI, 27-49%) more likely to be lower than label and 30% (95% CI, 16-46%) more likely to be higher than label than when prescribed by cardiologists or electrophysiologists. Label-inconsistent dosing varied (6.7 to 15.8%) across participating systems. CONCLUSIONS: DOAC dosing inconsistent with label varied by demographics, clinical characteristics, prescriber specialty, and healthcare system, suggesting a need to monitor and assess dosing decisions in NVAF. Identification of variables associated with dosing inconsistencies may enable targeted interventions to ensure label-consistent dosing in vulnerable populations.

Vaccine administration by pharmacy technicians: Impact on vaccination volume, pharmacy workflow and job satisfaction.

Background: Immunizing pharmacy technicians (IPTs) have become more prevalent in recent years, but their impact on community pharmacy practice has yet to be determined. Objectives: Determine the impact of implementing IPTs on vaccination volume in a community pharmacy chain and assess pharmacy staff's perspectives on the clinical abilities of IPTs and their impact on pharmacy workflow and job satisfaction. Methods: Retrospective data analysis comparing the number of vaccines administered in a supermarket pharmacy chain from September to March 2019-2020 and 2020-2021 in pharmacies with IPT(s) versus those without IPT(s). For the secondary objective, investigators developed and deployed two role-based mixed quantitative/qualitative surveys among pharmacy staff. Results: Pharmacies with IPT(s) observed a greater mean increase in vaccination volume from 2019-2020 to 2020-2021 versus those without IPTs (+159.35 vs. +104.57, p = 0.011). Among IPT survey respondents, 50/75 (66.7%) felt more satisfied with their job after receiving immunization training. Among pharmacist respondents, 80/119 (67.3%) felt that IPTs positively impacted their job satisfaction and 61.7% felt that pharmacist clinical services were either somewhat positively affected, or positively affected. Conclusion: Implementing IPTs can increase the volume of vaccines administered in a chain pharmacy and may positively affect job satisfaction and pharmacy workflow.

Impact of Electronic Chronic Pain Questions on patient-reported outcomes and healthcare utilization, and attitudes toward eCPQ use among patients and physicians: prospective pragmatic study in a US general practice setting.

Objective: The Electronic Chronic Pain Questions (eCPQ) has been developed to help healthcare providers systematically capture chronic pain data. This study evaluated the impact of using the eCPQ on patient-reported outcomes (PROs) and healthcare resource utilization (HCRU) in a primary care setting, and patient and physician perceptions regarding use of, and satisfaction with, the eCPQ. Methods: This was a prospective pragmatic study conducted at the Internal Medicine clinic within the Henry Ford Health (HFH) Detroit campus between June 2017 and April 2020. Patients (aged ≥18 years) attending the clinic for chronic pain were allocated to an Intervention Group to complete the eCPQ in addition to regular care, or a control group to receive regular care only. The Patient Health Questionnaire-2 and a Patient Global Assessment were assessed at baseline, 6-months, and 12-months study visits. HCRU data were extracted from the HFH database. Telephone qualitative interviews were conducted with randomly selected patients and physicians who used the eCPQ. Results: Two hundred patients were enrolled, 79 in each treatment group completed all 3 study visits. No significant differences (p > 0.05) were found in PROs and HCRU between the 2 groups. In qualitative interviews, physicians and patients reported the eCPQ as useful, and using the eCPQ improved patient-clinician interactions. Conclusion: Adding the eCPQ to regular care for patients with chronic pain did not significantly impact the PROs assessed in this study. However, qualitative interviews suggested that the eCPQ was a well-accepted and potentially useful tool from a patient and physician perspective. By using the eCPQ, patients were better prepared when they attended a primary care visit for their chronic pain and the quality of patient-physician communication was increased.

Low-density lipoprotein cholesterol goal attainment among high-risk patients: Does a combined intervention targeting patients and providers work?

BACKGROUND: Physicians are aware of the National Cholesterol Education Program guidelines; however, most patients fail to attain cholesterol goals. OBJECTIVE: To determine whether a combined program of patient education and provider awareness could improve the National Cholesterol Education Program goal attainment among patients at high risk for cardiovascular events. METHODS: One hundred seven high-risk patients with cardiovascular disease were educated in a single 15-minute session regarding their cholesterol levels, risk factors, and medication adherence. Those with scores of 2 or lower on the Morisky questionnaire were classified as low-adherence patients, and those with scores of 3 or higher were classified as high-adherence patients. Seven physicians were provided this information and were requested to evaluate the dyslipidemia management of these patients. Lipid levels were reevaluated 8 to 12 weeks after the intervention. RESULTS: At the start of the study, 38 (35.5%) of the 107 patients were at target low-density lipoprotein cholesterol (LDL-C) levels, and 64 of the 107 patients (59.8%) were at target levels after the intervention. High-adherence patients decreased their LDL-C levels from a mean of 118.6 mg/dL (3.07 mmol/L) to 98.6 mg/dL (2.55 mmol/L); low-adherence patients increased their LDL-C levels after the intervention from 134.5 mg/dL (3.48 mmol/L) to 142.1 mg/dL (3.68 mmol/L). A comparison between the LDL-C goal achievers vs nonachievers revealed a significant difference in adherence (P = .001). Among the goal achievers, significant decreases in preintervention vs postintervention total cholesterol levels (P = .001) and LDL-C levels (P = .001) were also noted. CONCLUSION: This study demonstrates that an intervention simultaneously targeting patients and providers is successful in improving goal attainment among high-risk patients.

Enhancing adherence to long-term medical therapy: a new approach to assessing and treating patients.

Poor adherence to medical therapy may cause as much as dollar 100 billion in unnecessary healthcare expenses each year. Nonadherence is a complicated and dynamic problem that involves patient, medication, and prescriber factors. The Case Management Adherence Guidelines (CMAG-1) are an evidence-based algorithm that introduces concepts and strategies for assessing medical knowledge and readiness to change (motivational interviewing). Once the assessment has been made, the guidelines can be used regularly to help patients become and remain adherent to their medication regimens. CMAG-1 and its tools, based on up-to-date information about adherence and ways to promote behavioral change, are designed to identify motivational and knowledge deficiencies that may block adherence. As information accumulates from centers that use it, CMAG-1 will be modified accordingly, with the goal of creating structured interaction with patients that will increase their knowledge and motivation to take medication appropriately.