Safety of cardiovascular disease drugs approved between 2014 and 2021 in the US: a pharmacovigilance analysis.

BACKGROUND: Recently FDA-approved drugs for cardiovascular disease (CVD) require robust post-marketing surveillance. The objective of this study was to assess their safety using a large pharmacovigilance database. RESEARCH DESIGN AND METHODS: We analyzed adverse event (AE) reports for 17 drugs approved from 2014 to 2021, utilizing the FDA Adverse Event Reporting System (FAERS). Descriptive and disproportionality analyses were conducted by estimating the reporting odds ratio (ROR) and its 95% confidence interval. RESULTS: Among the 43,664,773 AE reports 97,702 (0.22%) were related to newly approved CVD drugs. No AEs were reported for finerenone and evinacumab. The results from the disproportionality analyses revealed potential risks of acute kidney injury (ROR = 8.24, 95% CI: 6.05-11.22), cardiac failure (ROR = 4.80, 95% CI: 3.82-6.05), and hypotension (ROR = 3.98, 95% CI: 3.44-4.61) among sacubitril/valsartan users. Additionally, ivabradine was found to be associated with tachycardia (ROR = 11.94, 95% CI: 8.35-17.08), abnormal feeling (ROR = 4.40, 95% CI: 2.70-7.18), and dizziness (ROR = 2.56, 95% CI: 1.68-3.90). CONCLUSIONS: This study identified specific safety concerns related to recently approved CVD drugs. Further research is required to understand the underlying mechanisms and clinical implications of these findings.

Cost-Utility Analysis Comparing Direct Oral Anticoagulant and Low Molecular Weight Heparin Therapies for Secondary Prevention of Cancer-Associated Thrombosis.

BACKGROUND AND OBJECTIVE: Cancer patients are at elevated risk of cancer-associated thrombosis (CAT). Randomized controlled trials have found that direct oral anticoagulants (DOACs) are associated with fewer recurrent venous thromboembolism (VTE) events and an increased risk of bleeding than low molecular weight heparins (LMWHs) in CAT. With new clinical data available, this study aims to assess the comparative cost-effectiveness of DOACs and LMWHs over 6- and 60-month treatment durations from the US healthcare system and societal perspectives. METHODS: A Markov model for cancer patients eligible to receive rivaroxaban, edoxaban, apixaban, enoxaparin, or dalteparin was used to conduct a cost-utility analysis. Clinical scenarios were analyzed based on 6- and 60-month time horizons from the US healthcare system and societal perspectives. The main outcome was the incremental cost-effectiveness ratio (ICER), expressed as cost in US dollars per quality-adjusted life year (QALY). One-way and probabilistic sensitivity analyses were performed to evaluate the robustness of the results. RESULTS: DOACs were cost-saving and clinically superior to LMWHs and were associated with a cost change ranging from - $9134.66 to - $15,281.92 and incremental effectiveness of 0.43-1.25 QALYs among four clinical scenarios. The most influential model inputs for ICER were the utility associated with LMWH use and probabilities of non-VTE and non-bleeding related death. Probabilistic sensitivity analyses were consistent with the results. CONCLUSIONS: DOACs were found to dominate LMWHs, suggesting that DOACs may be a cost-effective alternative to LMWHs for CAT. This study can help inform decision-makers on the cost-effectiveness of anticoagulation strategies and help in the development of future practice recommendations for cancer patients.

Health care use and expenditures attributable to cancer: A population-based study.

BACKGROUND: As more people are living with cancer due to increases in cancer survival, it is important to understand cancer burden. Studies have examined cancer-related costs using data more than a decade ago. OBJECTIVE: To update the economic burden and uniquely provide health care service use attributable to cancer using a nationally representative sample of the U.S. METHODS: Data were obtained from the 2008-2015 Medical Expenditure Panel Survey (MEPS). Individuals with cancer were matched to those without cancer in terms of demographics and comorbidities based on a propensity score (PS). For outcomes of health care use, a (zero-inflated) negative binomial model was employed. To analyze the outcomes of health care spending, a generalized linear model with a log link function and gamma distributed errors (or a two-part model) was used. RESULTS: Compared to the PS-matched noncancer controls, individuals with cancer received 1.05, 1.08, and 1.76 times more frequent annual emergency department (ED) visit care, hospitalization care, and hospital outpatient visit care, respectively. Additionally, people with cancer received prescriptions and office-based visit care about 5 times and 20 times more frequently. An average annual total health care spending among those with cancer was about $4100 higher. Average annual expenses on hospitalizations, office-based visits, hospital outpatient visits, and prescriptions among those with cancer were also about $1,400, $1,400, $700, and $300 higher. However, there was no significant difference in expenses on ED visit and out-of-pocket expenses on prescriptions between people with cancer and noncancer controls. CONCLUSIONS: Individuals with cancer used all types of health care services more frequently than noncancer controls. Accordingly, expenditures on various types of health care services among those with cancer were higher.

Team Communication on Tasks Performed in Blood Pressure Clinics in Community Pharmacies.

Background: To successfully deliver pharmacy services, pharmacists and technicians need to work as a team and have effective communication. Objectives: To measure the amount of communication between community pharmacists and their technicians during monthly blood pressure (BP) clinics. Methods: Cross-sectional survey method was used to assess the amount of communication pharmacists and technicians had on each task. Study participants were pharmacist-technician pairs (teams) from 10 intervention community pharmacies in the Team Education and Adherence Monitoring (TEAM) trial. Each team provided services designed to improve BP among hypertensive African American patients. Thirteen specific tasks were identified as essential in providing monthly BP clinics, and they were being performed by either the pharmacist or technician. At the end of the trial, each pharmacist and technician were asked to report his/her perception of discussion levels that occurred for each task. The level of team communication was summarized for each task (task-specific) and for each team (team-specific). Results: For task-specific communication, 3 teams had communication regarding pharmacist tasks and 5 teams engaged in communication for technician tasks. More communication was reported for newly developed technician tasks in the BP clinic. For team-specific communication, 2 teams reported no communication on any task, and another 2 teams reported having communication on all the tasks. Overall, pharmacy teams showed different levels of communication in this study. Conclusion: The amounts of communication between pharmacists and technicians were found to vary for different tasks and teams. This suggests that the nature of tasks and the unique dynamics existing in each pharmacy team could influence pharmacist-technician communication.

Enhancing the educational value of direct-to-consumer advertising of prescription drugs.

OBJECTIVES: The educational value of direct-to-consumer advertising (DTCA) of prescription drugs hinges on its ability to convey important benefit and risk information to consumers. However, the literacy level required to understand some of the information presented in print advertisements may hinder DTCA's ability to educate consumers. The objective of this study was to compare the comprehension and retention of benefit and risk information between consumers who viewed an original print DTCA and those who viewed an advertisement modified according to health literacy principles. DESIGN: An experimental design was used to conduct the study. Participants were randomly assigned to view a modified print advertisement (experimental group) or the original print advertisement (control group) for an antidepressant medication. SETTING AND PARTICIPANTS: Study participants were recruited from the University of Wisconsin Kidney Clinic. OUTCOME MEASURES: Ten true-false and 10 multiple-choice questions were developed to assess participants' comprehension and retention of benefit and risk information. RESULTS: A total of 120 participants were randomized to view either the original or the modified version of the advertisement. Regarding the comprehension and retention of only the benefit information, no significant differences were observed between the 2 groups. Significant differences were observed for comprehension and retention of only the risk information. The experimental group had significantly higher scores in comprehension (U = 1224; P < 0.01) and retention (U = 965; P < 0.01) of the risk information compared with the control group. These differences were also significant in multivariate analyses controlling for extraneous variables that were found to have associations with comprehension and retention of information. CONCLUSION: Study results demonstrated that the health literacy techniques used to modify the advertisement were successful in enhancing both consumers' comprehension and their retention of information presented in a print DTCA. This was especially apparent for the risk information.

Development and evaluation of an instrument to measure community pharmacists' self-efficacy beliefs about communicating with Spanish-speaking patients.

BACKGROUND: Hispanics are the largest growing population in the United States, and their use of prescription medications can be influenced by the education and counseling they receive from pharmacists. However, little is known about pharmacists' communication with patients who speak Spanish or factors that can influence such communication. OBJECTIVES: The objective of the study was to develop and validate an instrument to measure pharmacists' self-efficacy in communicating with Spanish-speaking patients. METHODS: An initial pool of 15 items developed from previous research and suggestions from communication experts and practicing pharmacists was subjected to cognitive interviewing. Nine retained items were administered to 1022 licensed pharmacists by mail survey. Summary statistics and exploratory factor analysis (EFA) were conducted. Retained factors were determined by the examination of eigenvalues and scree test results. Cronbach's alpha coefficients were calculated to assess internal consistency. RESULTS: A total of 540 community pharmacists completed the survey. Item means ranged from 2.93±1.47 to 1.58±0.88 based on a 5-point scale (1: not at all confident to 5: extremely confident). EFA resulted in a 2-factor solution, accounting for 71% of the variance. The 2 factors consisted of health and drug information (alpha=0.92) and opening the encounter (alpha=0.75). The alpha for the overall scale was 0.88. CONCLUSIONS: The results provide evidence to support the reliability and validity of an instrument to measure pharmacists' self-efficacy beliefs about communicating with Spanish-speaking patients in community practice. Practitioners and researchers may use this instrument to inform pharmacy education, pharmacy practice improvement, and research efforts around communicating with Spanish-speaking clients.