Differences in quality of anticoagulation care delivery according to ethnoracial group in the United States: A scoping review.

Anticoagulation therapy is standard for conditions like atrial fibrillation, venous thromboembolism, and valvular heart disease, yet it is unclear if there are ethnoracial disparities in its quality and delivery in the United States. For this scoping review, electronic databases were searched for publications between January 1, 2011 - March 30, 2022. Eligible studies included all study designs, any setting within the United States, patients prescribed anticoagulation for any indication, outcomes reported for ≥ 2 distinct ethnoracial groups. The following four research questions were explored: Do ethnoracial differences exist in 1) access to guideline-based anticoagulation therapy, 2) quality of anticoagulation therapy management, 3) clinical outcomes related to anticoagulation care, 4) humanistic/educational outcomes related to anticoagulation therapy. A total of 5374 studies were screened, 570 studies received full-text review, and 96 studies were analyzed. The largest mapped focus was patients' access to guideline-based anticoagulation therapy (88/96 articles, 91.7%). Seventy-eight articles made statistical outcomes comparisons among ethnoracial groups. Across all four research questions, 79 articles demonstrated favorable outcomes for White patients compared to non-White patients, 38 articles showed no difference between White and non-White groups, and 8 favored non-White groups (the total exceeds the 78 articles with statistical outcomes as many articles reported multiple outcomes). Disparities disadvantaging non-White patients were most pronounced in access to guideline-based anticoagulation therapy (43/66 articles analyzed) and quality of anticoagulation management (19/21 articles analyzed). Although treatment guidelines do not differentiate anticoagulant therapy by ethnoracial group, this scoping review found consistently favorable outcomes for White patients over non-White patients in the domains of access to anticoagulation therapy for guideline-based indications and quality of anticoagulation therapy management. No differences among groups were noted in clinical outcomes, and very few studies assessed humanistic or educational outcomes.

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.

Features of electronic health records necessary for the delivery of optimized anticoagulant therapy: consensus of the EHR Task Force of the New York State Anticoagulation Coalition.

BACKGROUND: Oral anticoagulants are prescribed to millions of Americans, and consequently are among the medications most likely to contribute to emergency department visits and hospitalizations. Although guidelines and consensus statements promote systematic approaches to therapy, anticoagulation (AC) management is often suboptimal. Electronic health records (EHRs) have the potential to improve safety and quality but have not yet incorporated specialized features necessary to optimize therapy. OBJECTIVE: To generate a comprehensive, consensus-based list of EHR features clinically necessary to deliver optimized AC management, provide a "language bridge" to accelerate incorporation of features into EHR systems, and suggest mechanisms for the objective evaluation of available EHRs. METHODS: A multidisciplinary panel of AC specialists utilized the framework of a previously published consensus statement to map outpatient AC management and developed a comprehensive array of sequential computer logic steps using a restricted language scheme. Logic steps were then translated into narrative descriptions of potential EHR features, which were refined through multiple group evaluations. A finalized list of proposed features was ranked according to perceived clinical necessity by physician, pharmacist, and nurse panelists in a blinded manner using a 5-point Likert scale. Features receiving no more than 1 dissenting opinion were included in a finalized list of clinically necessary features. RESULTS: The task force generated 78 recommended EHR features across 20 key discrete areas and 425 individual logic steps. All recommended features received Strongly Agree or Agree rankings regarding their perceived clinical necessity, and no feature received more than a single Disagree response. CONCLUSION: The incorporation of key AC-related features into existing EHRs or specialized AC management systems has the potential to systematize the delivery of optimal AC care by health care professionals at the point of care. Optimized AC management has the potential to reduce adverse drug events associated with anticoagulant therapy in the outpatient setting.

Trends in Warfarin Monitoring Practices Among New York Medicare Beneficiaries, 2006-2011.

Anticoagulation with warfarin requires frequent evaluation of the international normalized ratio (INR), and less invasive testing devices are available for use by clinicians at the point-of-care (POC) and by patients who self-test (PST). Despite commercial availability and positive results of published studies, evidence suggests that adoption of less invasive (POC/PST) testing in the United States is slow. Considering the equivalence of results and logistical advantages of POC/PST testing, slow uptake may indicate a gap in quality of care warranting evaluation and possibly intervention. This study used Medicare fee for service claims data to explore the uptake of POC/PST INR monitoring across New York State over a 6 year time frame (2006-11), with additional analyses based on beneficiary age, sex, race and ethnicity and income by county. In 2006, only 28.3% of 103,410 analyzable beneficiaries presumed to be chronic warfarin users based on INR testing patterns were monitored by POC/PST, and increased to only 37.6% by 2011. Utilization of POC/PST testing varied widely by county (baseline range 1.2-89.4%), and uptake of these testing modalities in New York State was significantly lower among the very elderly, women, and ethnic minorities. We hypothesize that poor penetration of these less invasive INR testing modalities into highly populated New York City and barriers to POC utilization in long term care facilities may account for a portion of the variability in INR testing patterns observed in this study. However, additional research is needed to further explore whether disparities in warfarin monitoring practices exist.

Defining Minimum Necessary Communication During Care Transitions for Patients on Antihyperglycemic Medication: Consensus of the Care Transitions Task Force of the IPRO Hypoglycemia Coalition.

INTRODUCTION: Antihyperglycemic agents are significant contributors to adverse drug events, responsible for emergency department visits, hospitalizations, and death. Nationally, the rate of serious hypoglycemic events associated with these agents remains high despite widespread efforts to improve drug safety. Transitions of care between healthcare settings can lead to communication challenges between care professionals and increase the risk of adverse drug events. System-based improvements are needed to assure the safe transitions for patients with diabetes who are on antihyperglycemic agents. The objective of this study was to develop a consensus list of requisite elements that should be communicated between care settings during transitions of patients who are prescribed antihyperglycemic agents. METHODS: The Island Peer Review Organization (IPRO) Hypoglycemia Coalition identified suboptimal transitions of care as a barrier to improving patient safety and quality of diabetes care. The Coalition formed a multidisciplinary Task Force with experts in the field of diabetes care. The Task Force created a draft list of requisite communication elements through literature review and deliberation on monthly conference calls. A blinded iterative Delphi process was subsequently performed to generate a consensus list of requisite communication elements that participating experts agreed were necessary to safely and effectively assume the management of patients with diabetes upon care transitions. RESULTS: The Task Force completed a series of four iterative polls from September 2015 to August 2016, resulting in a final list of 22 requisite communication elements (the Diabetes Management Discharge Communication List), with the elements conceptually categorized into three domains: diagnosis and treatment, factors affecting glycemic control or patient risk, and patient self-management. CONCLUSIONS: The Diabetes Management Discharge Communication List provides an initial framework for the development of diabetes-specific resources to improve clinical communication between care settings.

Overactive bladder drugs and constipation: a meta-analysis of randomized, placebo-controlled trials.

BACKGROUND: Anticholinergic drugs are commonly prescribed for symptomatic treatment of overactive bladder (OAB). While recent meta-analyses have characterized the prevalence of dry mouth among patients utilizing OAB medications, prevalence of constipation has not been systematically reviewed. AIMS: To provide an effect measure for constipation associated with anticholinergic OAB drugs versus placebo. METHODS: A meta-analysis of trials with darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, and trospium was conducted. All randomized, placebo-controlled studies of anticholinergic OAB drugs published in English language and identified in Medline and Cochrane databases were considered for inclusion in this meta-analysis. Those meeting predetermined design characteristics and having sufficient duration (≥2 weeks) were included. Constipation-related data from all included studies were abstracted. RESULTS: One hundred two English-language, randomized, placebo-controlled trials were originally identified. Thirty-seven studies were ultimately included in the analysis, involving 19,434 total subjects (12,368 treatment+7,066 placebo patients). The odds ratios for constipation compared with placebo were as follows: overall [odds ratio (OR) 2.18, 95% confidence interval (CI)=1.82-2.60], tolterodine (OR 1.36, 95% CI=1.01-1.85), darifenacin (OR 1.93, 95% CI=1.40-2.66), fesoterodine (OR 2.07, 95% CI=1.28-3.35), oxybutynin (OR 2.34, 95% CI=1.31-4.16), trospium (OR 2.93, 95% CI=2.00-4.28), and solifenacin (OR 3.02, 95% CI=2.37-3.84). CONCLUSIONS: Our results demonstrate that patients prescribed anticholinergic OAB drugs are significantly more likely to experience constipation. Differences in muscarinic receptor affinities among individual agents may possibly account for the modest variation in constipation rates observed; however, such a determination warrants additional research.

Deeply discounted medications: Implications of generic prescription drug wars.

OBJECTIVE: To describe the history of generic prescription pricing programs at major pharmacy chains and their potential implications on prescribing, quality of care, and patient safety. DATA SOURCES: Publicly available generic prescription discount program drug lists as of May 1, 2009. SUMMARY: Fierce competition among major pharmacy chains such as Walgreens, CVS, and Walmart has led to a generic prescription pricing war with unclear public health implications. Introduced in 2006, currently 7 of the 10 largest pharmacy chains advertise a version of a deeply discounted medication (DDM) program, accounting for more than 25,000 locations nationally. By early 2008, almost 70 million Americans had used these programs. Although DDM programs lower drug costs for many patients, DDM formularies include potentially ineffective or harmful medications, have the potential to influence physician prescribing behavior, and may impair pharmacists' ability to review complete drug-dispensing records. CONCLUSION: DDMs are widespread but have the potential for unintended consequences on patients, providers, and the health care system. A systematic review of DDMs needs to evaluate the clinical, economic, and system-level implications of such programs.

Uptake and Utilization of the Management of Anticoagulation in the Periprocedural Period App: Longitudinal Analysis.

BACKGROUND: Anticoagulants are major contributors to preventable adverse drug events, and their optimal management in the periprocedural period is particularly challenging. Traditional methods of disseminating clinical guidelines and tools cannot keep pace with the rapid expansion of available therapeutic agents, approved indications for use, and published medical evidence, so a mobile app, Management of Anticoagulation in the Periprocedural Period (MAPPP), was developed and disseminated to provide clinicians with guidance that reflects the most current medical evidence. OBJECTIVE: The objective of this study was to assess the global, national, and state-level acquisition of a mobile app since its initial release and characterize individual episodes of use based on drug selection, procedural bleeding risk, and patient thromboembolic risk. METHODS: Data were extracted from a mobile app usage tracker (Google Analytics) to characterize new users and completed episodes temporally (by calendar quarter) and geographically (globally, nationally, and in the targeted US state of New York) for the period between April 1, 2016 and September 30, 2017. RESULTS: The app was acquired by 2866 new users in the measurement period, and the users completed nearly 10,000 individual episodes of use. Acquisition and utilization spanned 51 countries globally, predominantly in the United States and particularly in New York State. Warfarin and rivaroxaban were the most frequently selected drugs, and completed episodes most frequently included the selection of high bleeding risk (4888/9963, 49.06%) and high thromboembolic risk categories (4500/9963, 45.17%). CONCLUSIONS: The MAPPP app is a successful means of disseminating current guidance on periprocedural anticoagulant use, as indicated by broad global uptake and upward trends in utilization. Limitations in access to provider and patient-specific data preclude objective evaluation of the clinical impact of the app. An ongoing study incorporating app logic into electronic health record systems at participant health systems will provide a more definitive evaluation of the clinical impact of the app logic.

Recurrent acute nitrofurantoin-induced pulmonary toxicity.

Nitrofurantoin may be used for prophylaxis of recurrent urinary tract infections in women; however, this agent has been associated with acute, subacute, and chronic pulmonary adverse reactions. The acute reaction occurs in about 1/5,000 women after their first exposure to the drug. We report the occurrence of two successive, highly probable (by Naranjo score) nitrofurantoin-induced acute pulmonary reactions in the same patient. On day 4 of prophylaxis with nitrofurantoin 100 mg/day (to prevent urinary tract infections), the patient developed intense substernal pain and pressure. On day 8, she experienced intense substernal burning. She went to the emergency department, where she vomited and was hypotensive and febrile. Her chest radiograph showed bilateral infiltrates. The patient was diagnosed with pneumonia and was prescribed levofloxacin; she stopped taking the nitrofurantoin. Her symptoms subsided over the next 3 days. Ten days later, the patient restarted the nitrofurantoin, and she returned to the emergency department after again experiencing sudden intense substernal burning, nausea, vomiting, shivering, and weakness. Nitrofurantoin was discontinued; her symptoms resolved quickly, and prophylaxis with trimethoprim-sulfamethoxazole was begun. After 1 year, the patient had experienced no further pulmonary symptoms or urinary tract infections. Drug toxicity must be considered in patients who develop pulmonary symptoms while taking nitrofurantoin. Symptoms are often misdiagnosed as other ailments, potentially subjecting patients to unnecessary treatments and delaying discontinuation of nitrofurantoin. Patients should be advised to contact a physician if breathing difficulties or unusual symptoms develop while taking nitrofurantoin, as this could result in earlier recognition of this drug reaction.

Risk of adverse drug events by patient destination after hospital discharge.

PURPOSE: The prevalence of risk factors for adverse drug events (ADEs) in patients discharged from the hospital to various care settings was studied. METHODS: Data on patient risk characteristics for ADEs were collected for hospital discharges for 2000. Differences in the prevalence of 10 risk characteristics among home health care (HHC), self-care (SC), and long-term-care (LTC) patients at the point of discharge were determined. RESULTS: Data for 4250 discharges were analyzed. The three groups differed significantly in the distribution of risk characteristics. HHC patients had the highest prevalence of heart failure, cardiovascular medication use, and polypharmacy, and LTC patients had the highest prevalence of hypoalbuminemia, cognitive impairment, and psychiatric drug use. CONCLUSION: The risk of ADEs in patients discharged to HHC appeared to be comparable to or higher than that in patients discharged to LTC.

Conforming to HIPAA regulations and compilation of research data.

PURPOSE: A set of deidentified patient data compliant with the Health Information Portability and Accountability Act (HIPAA) was compiled, the data lost as a function of unique data elements (UDEs) were measured, and the deidentified data were tested for potential for reidentification. METHODS: After approval by the institutional review board of an integrated health system, a limited-data set was created by querying the health system's pharmacy, administrative, and financial files for patients discharged between January 1 and December 31, 2000. Using the HIPAA "safe-harbor" method, this limited-data set was converted into a deidentified-data table for future statistical analysis, and UDEs in both data sets were identified and quantified. Unique combinations of commonly available data were also identified. RESULTS: The limited-data set, representing 4,738 patient discharges, contained 810,456 UDEs in 322,657 records organized into four data tables (demographics, diagnoses, medication orders, and laboratory test results). The deidentified-data table, representing 4,722 discharges, contained 562,171 UDEs in 128 data-type columns in a single data table. About 31% of the data volume was lost. Much of the information lost was of the type that is of special interest to researchers (e.g., time between episodes of care, ages of >89 years). CONCLUSION: A study suggested that deidentified patient data with a reasonable degree of protection against reidentification were less complete than may be necessary for good research.

Resolution of drug-related problems in home care patients through a pharmacy referral service.

A referral-based, pharmacist-conducted medication management program designed to identify, categorize, and resolve drug-related problems (DRPs) in a home health care (HHC) population was studied. A clinical pharmacy service model was developed to identify patients at high risk for adverse health events resulting from DRPs. Policies and procedures were developed for this service model, including explicit referral criteria, patient-consent documentation, and physician orders. All identified DRPs were categorized, and pharmacist activities relating to the discovery and resolution of DRPs were tabulated. From July 1, 2001, through March 29, 2002, 80 patients were referred for and received clinical pharmacy services, and pharmacists identified 271 DRPs. Every patient referred had a DRP, and 32% of DRPs were identified by a visit to the patient's home. Nearly 65% of pharmacist recommendations were implemented. Using a referral-based practice model in an HHC setting, pharmacists were able to identify and resolve DRPs for every patient referred.

First renin inhibitor, aliskiren, for the treatment of hypertension.

AIM OF THE REVIEW: To systematically analyze the efficacy and safety of aliskiren for the treatment of hypertension in comparison to placebo, other monotherapy, and various combination therapies. METHOD: A PubMed database (1966-June 2008) search was conducted with aliskiren as a search term with limits of humans, written in English, and in title only. Phase III pivotal clinical studies retrieved by PubMed database and resources such as printed labeling, approval letter, pharmacology reviews, and medical reviews posted in Drug@FDA website were evaluated with regard to study design and outcomes of efficacy and safety. RESULTS: Six Phase III pivotal clinical studies compared various doses of aliskiren to placebo and some studies compared aliskiren to treatment with other monotherapies or combinations. Aliskiren in doses of 300 mg showed a statistically significant reduction in both systolic and diastolic blood pressure versus placebo. Comparison to other antihypertensive treatments suggest that aliskiren doses of 150 and 300 mg may induce blood pressure changes similar to those seen with moderate doses of hydrochlorothiazide or angiotensin receptor blockers. Aliskiren in combination with angiotensin receptor blockers or hydrochlorothiazide showed additional blood pressure reduction only when higher doses of aliskiren were used. Aliskiren appears to be well tolerated, with diarrhea being the only statistically significant adverse event. CONCLUSION: Aliskiren is a novel antihypertensive that exerts its effects through the direct inhibition of renin. Although the drug is well tolerated, its modest effects on blood pressure and the present lack of evidence of impact on objective cardiovascular outcomes appear to limit its utility in the general treatment of hypertension at this time.

Effect of pharmaceutical care services on outcomes for home care patients with heart failure.

PURPOSE: The effect of pharmaceutical care services for home care patients with heart failure on death and rehospitalization rates was studied. METHODS: Eligible patients had to be at least 21 years old and included those with a primary or secondary diagnosis of heart failure who were referred to receive skilled nursing services. Patients were then randomized to receive usual care or pharmaceutical care. Patients assigned to the usual care group received the services typically provided by the visiting nurses association, while patients in the pharmaceutical care group received usual care plus standardized services from a clinical pharmacist. Pharmaceutical care services consisted of an initial comprehensive in home medication assessment and two follow-up visits. Throughout the three-week intervention period, the clinical pharmacist accessed and reviewed all pertinent physician notes and laboratory test values and interacted with prescribers on behalf of the patients as necessary. RESULTS: A total of 154 patients met all criteria and participated in the study. The pharmacist made 79 specific therapy recommendations, 47 (60%) of which were related directly to drug therapy for heart failure or cardiovascular disease. Overall, 14 therapy recommendations were fully implemented, and 10 heart failure-specific recommendations were fully implemented. Patients for whom the pharmacist had made recommendations that were followed by the prescriber had a reduced rate of the composite primary endpoint, but this difference did not reach statistical significance. CONCLUSION: A home-based pharmaceutical care model for recently hospitalized patients with heart failure did not significantly improve the combined rate of death or rehospitalization.

Medication management model as experiential education tool for students of pharmacy.

A visiting nurse association (VNA) and a college of Pharmacy sought cost-effective models by which consultant pharmacy services could be offered at a rural branch office to improve medication management for high-risk patients. Through a collaborative relationship with the Albany College of Pharmacy, the Eddy VNA used the structure and support of the Partners In Care Foundation (The Model) Medication Management Model to simultaneously provide patient services and train Doctor of Pharmacy candidates. The Model brings the pharmacist into the homecare team to provide pharmaceutical care and can provide the framework by which pharmacist preceptors and interns can effectively provide services to high-risk patients identified through the agency's CQI process. Results from program implementation with 100 Medicaid waiver patients indicate positive staff response and an overall 43% acceptance rate with prescribers and suggest that this is a cost-effective medication management service with implications for adaptation by other HHAs.