Bulletin Today
AHA wants to engage pharmacists in AFib care
A new initiative from the American Heart Association (AHA) aims to educate and engage pharmacists in caring for patients with AFib.
“Atrial fibrillation is a complex disease state that can prove scary for patients and their families,” said Cody Parsons, PharmD, manager of clinical operations for Stanford Health Care’s cardiovascular health service line. “Pharmacists are able to provide the support necessary to ensure accurate and safe prescribing of anticoagulants while focusing on the patient to ensure a sound understanding and comfort with their medications and disease states.”
However, he noted that funding and empowering pharmacists to provide this support are essential to elevating the care that AFib patients receive.
The AHA initiative, which will be conducted through June 2025, is the next phase in the association’s Four Fs of Atrial Fibrillation program focused on patient health concerns that affect use of guideline-directed anticoagulant therapy: fear of falling; fear of bleeding; forgetfulness, or cognitive dysfunction; and frailty.
“Atrial fibrillation can appear in numerous patient populations, leading to multiple specialties, inpatient services, and clinics caring for this particular disease state. Despite a growth in pharmacist support in both inpatient and ambulatory settings over the years, many areas with less acute or complex patients still struggle to obtain significant pharmacist support. This can also hold true for patients receiving care outside of a population center,” Parsons said.
He added that the issue is compounded by the lack of pharmacist provider status on a federal level, which could assist in expanding pharmacist support for this initiative.
Over 6 million Americans are affected by AFib, according to AHA.Pharmacists can make contributions in the continuum of care for patients with AFib in all practice settings.
In ambulatory care, pharmacists are able to support chronic disease state management. This can occur through various avenues including shared and independent visits with AFib patients.
“Some of the earliest forms of support were anticoagulation clinics set up to provide narrow therapeutic monitoring of warfarin,” said Parsons. “Ambulatory pharmacists serve as exemplary educational support to the ambulatory team and the patient, family members, and caregivers. They assist in ensuring patients have uninterrupted access to their medications.”
In the health system setting, pharmacists partner with health care teams in evaluating the medical complexity of patients and how to most effectively use multiple medications. “This includes participation in multidisciplinary rounds, order evaluation and verification, education, and transitions of care services,” said Parsons. “The transitions of care and education role can be particularly important in relation to anticoagulation in AFib patients. In this role, pharmacists serve as expert support to not only the medical team but to the patient, family members, and caregivers both answering questions and providing medication and disease state support.”
Even in the community setting, pharmacists have a role in AFib care. “Pharmacists again serve as medication and chronic disease state experts to address any questions, concerns, or medication related issues,” Parsons said. “They ensure patients get and maintain access to their vital medications in partnership with prescribing providers. As the provider shortage expands, pharmacists are uniquely positioned and qualified to help support these and other patients.” ■
SGLT-2 and GLP-1 combo treatment lowers cardiovascular and renal risks
In a recent study published on April 25, 2024, in The BMJ, researchers found that using two new classes of T2D drugs together yielded benefits. When study participants added GLP-1 receptor agonist therapy to an SGLT-2 inhibitor, they curtailed their risk of major adverse cardiovascular events by about 30% compared with taking an agent from just one class. The likelihood for serious renal events was also lower with combination therapy.
Although technically a population-based cohort study, the research was designed to mimic a clinical trial, with outcomes in two new-user cohorts compared with monotherapy controls. Specifically, one cohort included 6,696 patients who initiated GLP-1 receptor agonist therapy and then added an SGLT-2 inhibitor; the other consisted of 8,942 patients who started an SGLT-2 inhibitor before adding a GLP-1 receptor agonist.
Combination users were matched one-to-one to counterparts using the same background medication, for the same duration.
While randomized clinical trials are needed to validate the results, the study authors believe their findings “highlight the potential benefit of combining these two effective drug classes in preventing cardiovascular and renal events in the treatment of type 2 diabetes.” ■
Analysis finds total reversal in heart failure deaths
Authors of a research letter published on April 24, 2024, in JAMA Cardiology report that declines in heart failure–related mortality from 1999 to 2012 have been entirely reversed from 2012 to 2021.
This means that “contemporary [heart failure] mortality rates are higher than in 1999,” wrote researchers. “The origins of these reversals preceded the COVID-19 pandemic, although the larger increases in 2020 to 2021 indicate that the pandemic may have accelerated them due to limitations to health care access and possible cardiac involvement.”
Data from death certificates from a CDC database revealed that from 1999 to 2009, heart failure deaths dropped but then plateaued in 2012 and began to rise steadily, only to be accelerated upward once the COVID-19 pandemic began. In examining age, sex, race, and ethnicity, reversals were observed the most in males; non-Hispanic Black individuals; and those living in rural areas, in the South, and in the Midwest.
The most alarming spike, however, was seen related to age: the heart failure death rate for those under 45 years jumped 906% between 1999 and 2021, compared to increases of 364% for people 45 to 64 years old and 84% for individuals aged 65 and older.
Researchers admit that death certificate data can misattribute some deaths, such as in cases when symptoms of heart failure cannot be easily differentiated from those due to other causes. ■
Migraine associated with PPIs and other acid suppressing medications, says study
A study of more than 11,000 U.S. adults suggests an association between acid-suppression therapy, including PPIs, H2RAs, and generic antacids, and an increased risk of migraine and severe headaches compared with people who do not take these medications. The risk was 70% higher for those using PPIs, 40% higher for those taking H2RAs, and 30% higher for those taking generic antacids. The cross-sectional analysis, published in the June 2024 issue of Neurology, included data from the 1999 to 2004 National Health and Nutrition Examination Survey.
A total of 11,818 individuals provided information on their use of acid-suppression therapy and whether they had migraine or severe headache in the past 3 months.
According to the data, there was an association between higher risk of migraine or severe headache for all types of acid-suppression therapy and use of any type of the drugs compared with not using the drugs.
“These observations in U.S. adults agree with previous findings that migraine or severe headache is a potential adverse event of PPIs, the most efficacious and most frequently used type of acid suppressing medication, and further suggest that other classes of acid suppressing medications (H2RAs and generic antacids) may also be implicated for migraine and severe headache,” the researchers reported. “Future prospective analyses are needed to investigate migraine risk associated with acid suppressing medications while current evidence is sufficient to evaluate patients with migraine in light of recent deprescribing advice for PPIs.” ■
Government releases paper on selected states’ regulation of PBMs
States have adopted their own laws to regulate PBMs, according to a new report from the U.S Government Accountability Office (GAO).
The report focused on five states: Arkansas, California, Louisiana, Maine, and New York. Each of these states has enacted a broad range of legislation regarding PBMs serving private health plans.
GAO reviewed the laws and interviewed state regulators, state pharmacy associations, state health plan associations, and national organizations representing the interests of various stakeholders.
The report found that except for Arkansas, the other four states—California, Louisiana, Maine, and New York—have adopted laws imposing a duty of care on PBMs.
The laws range from requiring a fiduciary duty to “lesser” standards such as a requirement to act in “good faith and fair dealing.”
These states have enacted laws about drug pricing and pharmacy reimbursement requirements, transparency, and pharmacy network and access requirements.
In interviews, regulators from four states asserted that giving regulators broad regulatory authority was more effective than implementing specific statutory provisions, as this enabled regulators to address emerging issues without new legislation.
Some of the regulators also highlighted the importance of robust enforcement of PBM laws and penalties to enforce the measures, while others stressed that having clear reporting requirements and definitions had a positive effect on enforcement. ■
d-mannose appears ineffective for UTI prevention
Authors of a recent study said that “d-mannose should not be recommended to prevent future episodes of medically attended UTI in women with recurrent UTI in primary care.”
The research findings, published on April 8, 2024, in JAMA Internal Medicine, found that the use of this supplement—a natural sugar used to treat UTIs—did not reduce future UTI episodes, outpatient visits, antibiotic prescriptions, or UTI symptoms compared with a placebo.
Researchers investigated whether daily use of d-mannose could be used as prophylaxis for women with recurrent UTIs (rUTIs). The randomized clinical trial included 598 women with rUTIs, which was defined as having two or more UTIs in 6 months or three within the past year. Participants were randomly assigned to d-mannose powder 2 mg or a matching volume of placebo powder.
The primary outcome—the proportion of women experiencing at least one further episode of clinically suspected UTI for which they contacted ambulatory care within 6 months of randomization—was 51.0% in the d-mannose group and 55.7% in the placebo group.
There were no statistically significant differences in any secondary outcome measures, including symptom duration, antibiotic use, time to next medically attended UTI, number of suspected UTIs, and UTI-related hospital admissions.
“In this randomized clinical trial, daily d-mannose did not reduce the proportion of women with recurrent UTI in primary care who experienced a subsequent clinically suspected UTI,” the researchers wrote. ■
Electronic prompts could improve antibiotic selection for pneumonia
Pneumonia remains the most common infection-related condition that lands U.S. patients in the hospital. Identifying strategies to curb antibiotic overuse for those hospitalized with pneumonia continues to be a national priority.
Based on results that compared the effect of a computerized provider order entry (CPOE) antibiotic stewardship bundle versus routine stewardship on antibiotic selection for noncritically ill pneumonia patients during their first 3 days in the hospital, researchers of a recent study published on April 19, 2024, in JAMA found that the group using CPOE prompts had a 28.4% reduction in empiric extended-spectrum days of therapy. Hospital length of stay and days to ICU transfer were unchanged.
“Currently, clinicians often prescribe vancomycin and/or antipseudomonal therapy for pneumonia at admission and deescalate to standard-spectrum antibiotics if nasal screening test results are negative for methicillin-resistant Staphylococcus aureus (MRSA) or if cultures do not reveal Pseudomonas or other MDROs [multidrug-resistant organisms],” study authors wrote. “Although most inpatients with pneumonia can be safely treated with standard-spectrum antibiotics, which do not cover Pseudomonas or MDROs, clinicians are reluctant to initially select them because of concern that the patient may be infected with an MDRO.”
Researchers evaluated data from 59 hospitals with 96,451 adult patients admitted with pneumonia to determine whether CPOE prompts that provided patient- and pathogen-specific MDRO infection risk estimates for pneumonia patients could reduce empiric extended-spectrum antibiotics.
Secondary outcomes of vancomycin and antipseudomonal days of therapy showed similar reductions, according to the findings. ■