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.

Digital dashboards for direct oral anticoagulant surveillance, intervention and operational efficiency: uptake, obstacles, and opportunities.

Direct oral anticoagulants (DOAC) are the most widely prescribed oral anticoagulants in the United States. Despite advantages over warfarin, system-level improvements are needed to optimize outcomes. While Veterans Health Administration and others have described successful DOAC management dashboard implementation, the extent of use nationally is unknown. A survey of Anticoagulation Forum's members was conducted to assess access to digital tools available within a dashboard and to describe implementation models. An Expert Forum was subsequently convened to identify barriers to dashboard development and adoption. Responses were received from 340 targeted recipients (8.5% of invitees). Only a minority of inpatient (25/52, 48.1%) and outpatient (47/133, 35.3%) respondents outside of Veterans Health Administration were able to generate rosters of DOAC users on-demand, and fewer had the ability to digitally display key clinical data elements, identify drug-related problems, document interventions, or generate reports. The lack of regulatory requirements regarding Anticoagulation Stewardship was identified by the Expert Forum as the major barrier to widespread development of digital tools for improved anticoagulation management. While some health systems have demonstrated the feasibility of DOAC dashboards and described their impact on quality and efficiency, these tools do not appear to be widely available in the United States apart from Veterans Health Administration. The lack of regulatory requirements for Anticoagulation Stewardship may be the primary barrier to the development of digital resources to better manage anticoagulants. Efforts to secure regulatory requirements for Anticoagulation Stewardship are needed, and evidence of improvements in clinical and financial outcomes through DOAC dashboard use will likely bolster such efforts.

Digital dashboards for oral anticoagulation management: a literature scoping review.

This scoping review summarizes the extent and characteristics of the published literature describing digital population management dashboards implemented to improve the quality of anticoagulant management. A standardized search protocol was executed to identify relevant manuscripts published between January 1, 2015 and May 31, 2022. The resulting records were systematically evaluated by multiple blinded reviewers and the findings from selected papers were evaluated and summarized. Twelve manuscripts were identified, originating from 5 organizations within the US and 2 from other countries. The majority (75%) described implementation in the outpatient setting. The identified papers described a variety of positive results of dashboard use, including a 24.5% reduction of questionable direct oral anticoagulant dosing in one organization, a 33.3% relative improvement in no-show appointments in an ambulatory care clinic, and a 75% improvement in intervention efficiency. One medical center achieved a 98.4% risk-appropriate venous thromboembolism risk prophylaxis prescribing rate and 40.6% reduction in anticoagulation-related adverse event rates. The manuscripts primarily described retrospective findings from single-center dashboard implementation experiences. Digital dashboards have been successfully implemented to support the anticoagulation of acute and ambulatory patients and available manuscripts suggest a positive impact on care-related processes and relevant patient outcomes. Prospective studies are needed to better characterize the implementation and impact of dashboards for anticoagulation management. Published reports suggest that digital dashboards may improve the quality, safety, and efficiency of anticoagulation management. Additional research is needed to validate these findings and to understand how best to implement these tools.

Reductions in 30-day readmission, mortality, and costs with inpatient-to-community pharmacist follow-up.

OBJECTIVES: To determine the impact of pharmacist-provided continuous care and electronic communication on readmissions among a group of high-risk patients. DESIGN: Pragmatic interventional study with 5:1 matched control. SETTING AND PARTICIPANTS: Patients discharged from any of 4 hospitals with chronic obstructive pulmonary disease, pneumonia, heart failure, acute myocardial infarction, or diabetes within Pennsylvania. Patients in the intervention group received consultative services from inpatient pharmacists before discharge and inpatient-to-community pharmacist communication of hospitalization information facilitated with the use of a secure messaging system. After discharge, patients received up to 5 in-person or telephonic medication management consultations with their community pharmacists. MAIN OUTCOME MEASURES: The principal end point was 30-day readmission. Secondary end points included time to event (readmission, emergency department [ED] visit, death, or composite of hospitalization, ED, or death) over 90 days after discharge. Financial feasibility and sustainability were also assessed with the use of a return-on-investment (ROI) model based on information within the subset of patients with health plan coverage. RESULTS: Among patients who received inpatient intervention plus consultation with community pharmacists compared with matched control patients, we observed a lower 30-day readmission rate (9% vs. 15%, respectively; P = 0.02), 30-day all-cause mortality (2% vs. 5%; P = 0.04), and composite 30-day end point of readmission, ED visit, or death (22% vs. 28%; P = 0.09). Differences between the groups diminished and no longer maintained statistical significance at 90 days. An estimated average ROI of 8.1 was also observed among the subset with health plan information (worst base case range 1.9-16.3). CONCLUSION: Connecting community pharmacists to inpatient pharmacists during the transitional hospital-to-home time frame is feasible and resulted in lower 30-day readmissions and significant ROI, that is, significant impact on health care utilization and total health care costs. Results of this study have broad implications for improving the care of high-risk patients moving from hospital to home, most notably in the engagement of community pharmacists after discharge to assure medication use and follow-up to reduce readmissions and total costs of care.

Unused medications and disposal patterns at home: Findings from a Medicare patient survey and claims data.

OBJECTIVE: To examine what medications are most frequently left unused by patients, how much is left unused, and how these medications are disposed of among Medicare beneficiaries. DESIGN: Secondary data analysis combining insurance claims and telephone survey data of Medicare Advantage members. SETTING: Regional health plan in Central Pennsylvania. PARTICIPANTS: Seven hundred twenty-one Medicare Advantage members who had Part D coverage through the plan as of December 31, 2013, and completed the telephone survey in May 2014. INTERVENTION: Telephone survey conducted by a survey research center. MAIN OUTCOME MEASURE: Member survey response. RESULTS: Of the 2,994 medications in the dataset, 247 (8%) were reported being left unused by patients. Of the 247, the most common medications were those for pain (15%), hypertension (14%), antibiotics (11%), and psychiatric disorders (9%). Approximately 15% of unused medications were controlled substances. The reasons for being unused varied by drug type. For example, for pain medications, adverse effects and overprescribing were the most commonly cited reasons; for hypertension medications, "dosage changed by doctor" was the most common reason. Most commonly, unused portions accounted for approximately 25% to 50% of the unused medications identified by patients. Approximately 11% of unused medication was disposed of via drug take-back programs, whereas the majority was kept in a cabinet (55%), thrown in the trash (14%), or flushed down the toilet (9%). CONCLUSION: A lack of patient adherence alone does not explain unused medications and their improper disposal. Community-level interventions designed to improve prescription efficiency and patient awareness of appropriate disposal methods-particularly of controlled substances-are necessary to reduce the potentially harmful effects of improper disposal of unused medications.

Multimodal Postoperative Pain Control Is Effective and Reduces Opioid Use After Laparoscopic Roux-en-Y Gastric Bypass.

BACKGROUND: Opioids have been the mainstay for postoperative pain relief for many decades. Recently, opioid-related adverse events and death have been linked to postoperative dependency. Multimodal approaches to postoperative pain control may be part of the solution to this health care crisis. The safety and effectiveness of multimodal pain control regimens after laparoscopic Roux-en-Y gastric bypass (LRYGB) has not been well studied. The primary aim of our study was to determine if an evidence-based, multimodal pain regimen during hospitalization could decrease the total oral morphine equivalent (TME) use after LRYGB. STUDY DESIGN: We conducted a retrospective cohort study comparing outcomes prior to the implementation of a multimodal pain protocol (December 2010-December 2012) to those after implementation (April 2013-July 2015). The protocol utilized oral celecoxib and scheduled oral acetaminophen for pain control, with opioids used only as needed for breakthrough pain. Data was extracted from an electronic medical record and an institutionally maintained database of all patients undergoing bariatric surgery at a single center. RESULTS: Compared to controls, the multimodal pain regimen significantly reduced TME used and maximum pain scores with no change in mean pain scores. Multimodal pain protocol patients had a shorter length of stay with no increase in bleeding complications or marginal ulcer rates. CONCLUSIONS: An opioid-sparing multimodal pain regimen adequately controls pain while reducing TME use. The regimen appears to be safe and was associated with a reduced length of stay in patients undergoing LRYGB.

Pharmacotherapy in the critically ill obese patient.

Despite the growing epidemic of obesity in the United States, dosing medications in such patients remains poorly studied and understood. Most recommendations are based on small independent studies, case reports, and expert opinion. Applying manufacturer kinetics and dosing recommendations in the obese patient may result in toxicity or treatment failure, leading to increased morbidity, mortality, and hospital length of stay.