Effectiveness and Safety of Direct Oral Anticoagulants Versus Warfarin in Patients with Atrial Fibrillation and Cancer: A Target Trial Emulation from SEER-Medicare Database.

BACKGROUND: Direct oral anticoagulants (DOACs) are preferred over warfarin in patients with atrial fibrillation (AFib). However, their safety and effectiveness in patients with AFib and cancer are inconclusive. METHODS: We conducted a retrospective cohort study by emulating a target trial. Patients with a record of cancer (breast, prostate, or lung), newly diagnosed with AFib initiated DOACs or warfarin within 3 months after AFib diagnosis from the 2012-2019 Surveillance, Epidemiology, and End Results (SEER)-Medicare database were included. We compared the risk of ischemic stroke, major bleeding, and secondary outcomes (venous thromboembolism, intracranial bleeding, gastrointestinal bleeding, and non-critical site bleeding) between patients who initiated DOACs and warfarin. Inverse probability treatment weights and inverse probability censoring weights were used to adjust imbalanced patient and disease characteristics and loss to follow-up between the two groups. Weighted pooled logistic regression were used to estimate treatment effect with hazard ratios (HRs) with 95% confidence interval (95% CIs). RESULTS: The incidence rates of stroke and major bleeding between DOAC and warfarin initiators were 9.97 vs. 9.91 and 7.74 vs. 9.24 cases per 1000 person-years, respectively. In adjusted intention-to-treat analysis, patients initiated DOACs had no statistically significant difference in risk of ischemic stroke (HR = 0.87, 95% CI 0.52-1.44) and major bleeding (HR = 1.14, 95% CI 0.77-1.68) compared to those initiated warfarin. In adjusted per-protocol analysis, there was no statistical difference in risk of ischemic stroke (HR = 1.81, 95% CI 0.75-4.36) and lower risk for major bleeding, but the 95% CI was wide (HR = 0.35, 95% CI 0.12-0.99) among DOAC initiators compared to warfarin initiators. The benefits in secondary outcomes were in favor of DOACs. The findings remained consistent across subgroups and sensitivity analyses. CONCLUSION: DOACs are safe and effective alternatives to warfarin in the management of patients with AFib and cancer.

Benefit and risk of oral anticoagulant initiation strategies in patients with atrial fibrillation and cancer: a target trial emulation using the SEER-Medicare database.

Oral anticoagulants (OACs) are recommended for patients with atrial fibrillation (AFib) having CHA2DS2-VASc score ≥ 2. However, the benefits of OAC initiation in patients with AFib and cancer at different levels of CHA2DS2-VASc is unknown. We included patients with new AFib diagnosis and a record of cancer (breast, prostate, or lung) from the 2012-2019 Surveillance, Epidemiology, and End Results (SEER)-Medicare database (n = 39,915). Risks of stroke and bleeding were compared between 5 treatment strategies: (1) initiated OAC when CHA2DS2-VASc ≥ 1 (n = 6008), (2) CHA2DS2-VASc ≥ 2 (n = 8694), (3) CHA2DS2-VASc ≥ 4 (n = 20,286), (4) CHA2DS2-VASc ≥ 6 (n = 30,944), and (5) never initiated OAC (reference group, n = 33,907). Confounders were adjusted using inverse probability weighting through cloning-censoring-weighting approach. Weighted pooled logistic regressions were used to estimate treatment effect [hazard ratios (HRs) and 95% confidence interval (95% CIs)]. We found that only patients who initiated OACs at CHA2DS2-VASc ≥ 6 had lower risk of stroke compared without OAC initiation (HR 0.64, 95% CI 0.54-0.75). All 4 active treatment strategies had reduced risk of bleeding compared to non-initiators, with OAC initiation at CHA2DS2-VASc ≥ 6 being the most beneficial strategy (HR = 0.49, 95% CI 0.44-0.55). In patients with lung cancer or regional/metastatic cancer, OAC initiation at any CHA2DS2-VASc level increased risk of stroke and did not reduce risk of bleeding (except for Regimen 4). In conclusion, among cancer patients with new AFib diagnosis, OAC initiation at higher risk of stroke (CHA2DS2-VASc score ≥ 6) is more beneficial in preventing ischemic stroke and bleeding. Patients with advanced cancer or low life-expectancy may initiate OACs when CHA2DS2-VASc score ≥ 6.

Impact of a Multicomponent Educational Intervention on Community Pharmacy-Based Naloxone Services Implementation: A Pragmatic Randomized Controlled Trial.

BACKGROUND: Despite US naloxone access laws, community pharmacists lack training and confidence in providing naloxone. OBJECTIVE: To assess the impact of the Empowering Community Pharmacists program on pharmacists' knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services implementation, as well as naloxone prescriptions dispensed. METHODS: A 3-month pragmatic randomized controlled trial was conducted from December 2018 to March 2019. Alabama community pharmacists were recruited by mail, email, phone, and fax and randomized to intervention (monthly resources/reminders + educational webinar) or control (monthly reminders only). Outcome measures were assessed via online surveys at baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3), including naloxone knowledge (%correct); perceived barriers, attitudes, confidence, and intention regarding naloxone services implementation (7-point Likert-type scale; 1 = strongly disagree, 7 = strongly agree); and number of naloxone prescriptions dispensed. Mean differences between control and intervention from T1 to T3 were assessed using 2-way mixed analysis of variance and adjusted analyses were conducted using generalized estimating equations with negative binomial distribution to assess associations between variables. RESULTS: Of 55 participants (n = 27 intervention, n = 28 control), most were female (80.3%), white (80.6%), in independently owned pharmacies (39.1%). Increases in mean [SD] confidence (5.52 [1.03]-6.16 [0.74], P < 0.0005) and intention (5.35 [1.51]-6.10 [0.96], P = 0.023) occurred from pre- to post-program within the intervention group and were statistically significant compared with control (confidence P = 0.016, intention P = 0.014). Confidence (exp(ß) = 1.46, P = 0.031) and perceived barriers (exp(ß) = 0.75, P = 0.022) were associated with number of naloxone prescriptions dispensed. CONCLUSION AND RELEVANCE: The Empowering Community Pharmacists program improved community pharmacists' confidence and intention regarding naloxone services implementation. Other states can adapt program elements according to their laws. CLINICALTRIALS.GOV IDENTIFIER: NCT05093309.

Screening for clinically relevant drug-drug interactions between direct oral anticoagulants and antineoplastic agents: a pharmacovigilance approach.

BACKGROUND: Use of direct oral anticoagulants (DOACs) in patients with cancer remains suboptimal due to the concern regarding potential drug-drug interactions (DDIs) with antineoplastic treatments. However, the clinical relevance of these DDIs is unknown. METHODS: We conducted a pharmacovigilance study of adverse event (AE) reports from the US Food and Drug Administration Adverse Event Reporting System from 1/1/2004 to 12/31/2021. AE reports containing DOACs and antineoplastic agents with CYP3A4/P-gp inhibitory or inducing activity suggested by published pharmacokinetic studies were included (n = 36,066). The outcomes of interest were bleeding or stroke, identified by MedDRA dictionary version 25.0. We used disproportionality analyses (DPA), logistic regression models (LR), and Multi-item Gamma-Poisson Shrinker (MGPS) (Empirical Bayes Geometric Means (EBGM) and 90% credible intervals (90% CIs)) algorithms to identify the safety signal of DDIs. RESULTS: The highest bleeding reporting rates for each drug class were the combination of DOACs with neratinib (39.08%, n = 34), tamoxifen (21.22%, n = 104), irinotecan (20.54%, n = 83), and cyclosporine (19.17%, n = 227). The highest rate of stroke was found for prednisolone (2.43%, n = 113). In the primary analysis, no signal of DDIs by the antineoplastic therapeutic class was detected by MGPS, DPA, and LR approaches. By individual antineoplastic drug, DOACs-neratinib was the only signal detected [EBGM (EB05-EB95) = 2.71 (2.03-3.54)]. CONCLUSION: No signal of DDIs between DOACs and antineoplastic agents was detected, except for DOAC-neratinib. Most DDIs between DOACs and antineoplastic agents may not be clinically relevant. The DDIs between DOACs and neratinib should be further examined in future research.

A state-wide education program on opioid use disorder: influential community members' knowledge, beliefs, and opportunities for coalition development.

BACKGROUND: Deep South states, particularly Alabama, experience disproportionately higher opioid prescribing rates versus national rates. Considering limited opioid use disorder (OUD) providers in this region, collaborative efforts between non-healthcare professionals is critical in mitigating overdose mortality. The Alabama Opioid Training Institute (OTI) was created in 2019 to empower community members to take action in combatting OUD in local regions. The OTI included: 1) eight full-day in-person conferences; and 2) an interactive mobile-enabled website ( https://alabamaoti.org ). This study assessed the impact of the OTI on influential community members' knowledge, abilities, concerns, readiness, and intended actions regarding OUD and opioid overdose mitigation. METHODS: A one-group prospective cohort design was utilized. Alabama community leaders were purposively recruited via email, billboards, television, and social media advertisements. Outcome measures were assessed via online survey at baseline and post-conference, including: OUD knowledge (percent correct); abilities, concerns, and readiness regarding overdose management (7-point Likert-type scale, 1 = strongly disagree to 7 = strongly agree); and actions/intended actions over the past/next 6 months (8-item index from 0 to 100% of the time). Conference satisfaction was also assessed. Changes were analyzed using McNemar or Marginal Homogeneity tests for categorical variables and two-sided paired t-tests for continuous variables (alpha = 0.05). RESULTS: Overall, 413 influential community members participated, most of whom were social workers (25.7%), female (86.4%), and White (65.7%). Community members' OUD knowledge increased from mean [SD] 71.00% [13.32] pre-conference to 83.75% [9.91] post-conference (p < 0.001). Compared to pre-conference, mean [SD] ability scale scores increased (3.72 [1.55] to 5.15 [1.11], p < 0.001) and concerns decreased (3.19 [1.30] to 2.64 [1.17], p < 0.001) post-conference. Readiness was unchanged post-conference. Attendees' intended OUD-mitigating actions in the next 6 months exceeded their self-reported actions in the past 6 months, and 92% recommended the OTI to others. CONCLUSIONS: The Alabama OTI improved community leaders' knowledge, abilities, and concerns regarding OUD management. Similar programs combining live education and interactive web-based platforms can be replicated in other states.

Increasing use of immunization information systems for routine vaccinations in independent community pharmacies: A randomized controlled trial.

BACKGROUND: Only 60% of adults nationwide and just 36.8% of adults in Alabama have immunization data recorded in an Immunization Information System (IIS). The objective of this study, which took place before the coronavirus disease 2019 (COVID-19) pandemic, was to evaluate the impact of an IIS training program on pharmacists' IIS enrollment, participation, awareness, knowledge, intention, and attitudes. METHODS: A randomized controlled trial was conducted in 2019 among Alabama pharmacists (N = 41) practicing in independently owned pharmacies and providing vaccination services but whose pharmacy was not enrolled in Alabama's IIS (Immunization Patient Registry with Integrated Technology [ImmPRINT]). Intervention pharmacists were offered a 2-hour IIS training program, including an online continuing pharmacy education article, demonstration videos, implementation guide, and informational flyer. Control pharmacies received the informational flyer only. Pharmacy-level outcomes, including enrollment and participation, were obtained from ImmPRINT administrative records. Pharmacist-level outcomes, including awareness, knowledge, intention, and attitudes, were self-reported using baseline, 1-month, and 3-month surveys. Two-way mixed analysis of variance, chi-square, and independent t tests were used to analyze differences in outcomes between and within groups. RESULTS: Enrollment in ImmPRINT was significantly greater among intervention pharmacists' pharmacies (P = 0.035). In particular, 59.1% of intervention pharmacies compared with 26.3% of control pharmacies were enrolled in ImmPRINT at 3 months. No statistically significant differences were found between groups in terms of participation in ImmPRINT. Intervention pharmacists' awareness of IIS was significantly greater than control pharmacists (P = 0.028) at 1 month (postintervention). Furthermore, the IIS training program significantly improved intervention pharmacists' knowledge (P = 0.030) and attitudes (P = 0.016) toward IIS over 3 months compared with the control group. CONCLUSIONS: This pharmacist-centered training program focused on practical strategies to integrate IIS into pharmacy workflow. Results show that pharmacists' enrollment, awareness, knowledge, and attitudes significantly improved as a result of this training. As pharmacists become more involved in immunization efforts, particularly in response to COVID-19, awareness of and participation in responsible immunization documentation are critical.

Pharmacist-led motivational interviewing for diabetes medication adherence in a worksite wellness program.

OBJECTIVE: The primary objective was to evaluate the impact of a pharmacist-delivered motivational interviewing (MI) intervention for diabetes medication adherence; the secondary objectives were to assess the changes in clinical outcomes and health-related quality of life (HRQoL). METHODS: A quasi-experimental intervention study was conducted with baseline, postintervention, and follow-up data collections. The study duration was 6 months. Pharmacists trained in MI delivered 3 face-to-face encounters using MI-based semistructured conversation tools to address barriers or challenges to medication adherence. A diabetes worksite wellness program (WWP) at a 350-bed regional hospital in the southeastern United States was the setting, and the study participants were WWP employees or dependents (with type 1 diabetes or type 2 diabetes). The primary outcome was a change in self-reported diabetes medication adherence; the secondary outcomes included the changes in clinical indicators (glycated hemoglobin [HbA1c], blood pressure, and depressive symptoms), and HRQoL. The measures included the Medometer, Summary of Diabetes Self-Care Activities-Medication Subscale (SDSCA-MS), Audit of Diabetes-Dependent QoL (ADDQoL-19), and the Short Form-12 (SF-12) health survey. RESULTS: Fifty-three WWP participants enrolled, and 36 completed the full intervention protocol. Medication adherence (through the Medometer) demonstrated statistically significant improvement after the intervention (P = 0.010); the SDSCA-MS score improved, but was not statistically significant. The change in diastolic blood pressure was statistically significant (P = 0.034), but the changes in HbA1c, systolic blood pressure, presence of depressive symptoms, and ADDQoL-19 were not statistically significant. The SF-12 physical component summary (PCS) and mental component summary (MCS) scores were statistically significant: PCS, P = 0.003, and MCS, P = 0.025. CONCLUSION: The findings from this pilot study support the effectiveness of a pharmacist-delivered, semistructured MI-based intervention for medication adherence in persons with diabetes in a hospital-based WWP. Pharmacists can support patients' behavior change using MI communication skills to explore salient barriers to medication adherence and to facilitate goal setting to overcome these in encounters aimed at shared clinical and behavioral decision-making.

Cognitive Computing and Watson: Implications for Hospital Pharmacy.

This installment explores the domain of cognitive computing, using the well-known Watson as an example. The migration of computer manufacturers from a focus on hardware to a focus on services suggests the potential of these tools. Considerations for use of these tools in the health care system are provided.

Are You Practicing in a Learning Health System?

Learning never ceases. While continuing education is important for all of us, we are not speaking of licensure requirements. We are speaking of learning within your health system that systematically incorporates knowledge gained through research and clinical care into individual care.

Are Pharmacists Participating in Postdischarge Patient Reminders?

In this column, we are making a short revisit to the technology that can assist in satisfaction of Meaningful Use criteria and can assist health systems that are increasing their population health initiatives to help improve outcomes while containing costs.

Hospital Participation in Prescription Drug Monitoring Programs.

The prescription drug abuse epidemic continues to grow. This multifaceted problem requires a multifaceted solution. In this installment, we discuss prescription drug monitoring programs and their relevance to hospital pharmacies.

Virtual Reality and Pharmacy: Opportunities and Challenges.

We often find inspiration in tech happenings. This month, we explore the opportunities and challenges for using one of the most popular tech gifts of 2016 to advance safe and efficacious medication use.

Community pharmacy owners' views of star ratings and performance measurement: In-depth interviews.

OBJECTIVES: The star rating system implemented by Medicare has the potential to positively affect patient health and may have financial implications for community pharmacies. Learning from owners of community pharmacies with high performance on these quality measures may help us to identify and further understand factors contributing to their success. This study described high-performing community pharmacy owners' current awareness and knowledge of star ratings, attitudes toward star ratings and performance measurement, and initiatives being offered in pharmacies that aim to improve the quality of care. METHODS: Qualitative interviews with owners of independent community pharmacies were conducted in Spring 2015. Fifteen community pharmacies with high performance on the star rating measures were invited to participate. Recruitment did not end until the saturation point had been reached. All interviews were transcribed verbatim. Interview data were analyzed with the use of ATLAS.ti by 2 coders trained in thematic analysis. Krippendorf's alpha was calculated to assess intercoder reliability. RESULTS: Ten high-performing pharmacy owners participated. Analysis identified 8 themes, which were organized into the following categories: 1) current awareness and knowledge (i.e., superficial or advanced knowledge); 2) attitudes toward star ratings (positive perceptions, skeptical of performance rewards, and lack a feeling of control); and 3) pharmacy initiatives (personal patient relationships, collaborative employee relationships, and use of technology). Intercoder reliability was good overall. CONCLUSION: Interviews with high-performing pharmacies suggested that awareness of the star rating measures, overall positive attitudes toward the star ratings, the relationships that pharmacy owners have with their patients and their employees, and the use of technology as a tool to enhance patient care may contribute to high performance on the star rating measures. Future research is needed to determine if and how these constructs are associated with pharmacy performance in a larger population.

Digital Health Solutions: An Important Tool in Patient Engagement.

Hospitals and health systems are facing increased pressure to improve quality and outcomes while reducing expense. Quality-based reimbursement models are providing the necessary incentives for health care institutions to focus on issues such as avoidable hospital-acquired conditions and 30-day readmission rates. While our health care facilities certainly play a vital role in achieving optimal outcomes, patient engagement remains at the center of these efforts.

Keeping Up with Advancements in Health Information Technology.

We all face an onslaught of information on a daily basis in our personal and professional lives. We view it as a significant part of our professional responsibility to help our colleagues stay abreast of the latest advancements related to health information technology (HIT). This month we explore some of the key resources that we find helpful for keeping up-to-date with emerging and disruptive technology.

Patient-Centered Technology to Enhance Population Health Management.

Take a little walk with us this month as we explore how things such as reimbursement systems are changing. Health systems are adopting population health strategies and performing experiments in rendering this type of care. Many health systems start with the care of their own employees, if they are self-insured. Perhaps you are already seeing this change and experiencing how your care is being impacted.

Precision Medicine: Considerable Potential Combined with Important Challenges.

While not necessarily a new idea, precision medicine has recently gained traction as the future of health care. The potential benefits are almost difficult to believe, while the challenges are multifaceted. We provide an overview of the current state of precision medicine.

Does Your Department Have a Technology Innovation Strategy?

There are ways to facilitate the successful implementation of technological innovations. These are especially important in a time of rapid development of new tools to support safe and effective medication therapy. This installment addresses some of the key components of a successful technology innovation strategy.

Clinical and Business Intelligence: Why It's Important to Your Pharmacy.

According to the Healthcare Information Management and Systems Society, "Clinical & Business Intelligence (C&BI) is the use and analysis of data captured in the healthcare setting to directly inform decision-making" (http://www.himss.org/library/clinical-business-intelligence). Some say that it is the right information given to the right person at the right time in the right way. No matter how you define it, the fact remains that timely access, synthesis, and visualization of clinical data have become key to how health professionals make patient care decisions and improve care delivery.

Consider Adopting Collaborative Project Management Software.

Pharmacy administrators are often tasked with a range of responsibilities, from strategic planning and human resources to information systems management. Because of this, tools to support administrators' efficient and appropriate attention to everything on their plate can be valuable. Identification and evaluation of the available tools should be guided by careful consideration of the department's needs.