Bulletin Today
New risk equation could change statin and antihypertensive therapy eligibility for patients
The American Heart Association (AHA) has developed a new formula, Predicting Risk of Cardiovascular Disease EVENTs (PREVENT), to address perceived flaws in pooled cohort equations, including possible overestimation of CVD risk, omission of key kidney and metabolic factors, and the inclusion of Black race as an input.
Currently, pooled cohort equations from the American College of Cardiology (ACC) and AHA are used to gauge 10-year risk of atherosclerotic CVD, but researchers wanted to explore how changing risk-measurement approaches might affect eligibility for statin therapy or treatment for high BP.
To better understand the effect of using PREVENT, investigators considered a nationally representative sample of 7,765 adults who participated in the National Health and Nutrition Examination Surveys during 2011–2020. Analysis determined that PREVENT would reclassify very few people to a higher ACC or AHA risk tier. However, about one-half of U.S. adults, or 15.8 million people, would likely have their risk downgraded.
As a result, the pool of individuals receiving or recommended for statin therapy or antihypertensive therapy would shrink by 14.3 million and 2.62 million, respectively, with females affected more than males, and Black individuals affected more than whites.
Due to the changes in treatment eligibility, the study authors calculated that 107,000 more myocardial infarctions or strokes could occur over 10 years.
“Although PREVENT advances the important goal of more accurate and precise cardiovascular risk prediction, the magnitude of these projected changes warrants careful reconsideration of current treatment thresholds using decision-analytic or cost-effectiveness frameworks,” researchers wrote. ■
AHA research shows pharmacist interventions effective in achieving BP control
Interventions led by pharmacists and community health workers are most likely to help patients with hypertension achieve disease control, according to research published July 19, 2024, in the American Heart Association’s (AHA’s) journal Circulation: Cardiovascular Quality and Outcomes.Circulation: Cardiovascular Quality and Outcomes.
With a pharmacist guiding them, participants in the meta-analysis saw their systolic number fall by as much as 7.3 points and their diastolic reading drop by as much as 3.9 points.
Researchers focused on randomized controlled trials of different interventions meant to address barriers to BP control, stratified according to what category of health care professional delivered the care.
Using random effects models and generalized estimating equations, investigators found that the biggest reductions in systolic BP and diastolic BP occurred under the direction of pharmacists, followed by community health workers.
In pairwise comparisons, pharmacists were much more effective than physicians, nurses, and other health care professionals at providing interventions.
The study authors conclude that, going forward, pharmacists and community health workers should have preferred roles in spearheading hypertension control efforts. ■
PQA pilots demonstrate how pharmacists positively affect BP, diabetes outcomes
A new report from the Pharmacy Quality Alliance (PQA) details two proof-of-concept pilots that included two BP and two blood glucose pharmacy measure concepts in value-based payment arrangements between payers and pharmacies.
At 1 year, patients in both pilots achieved improvements from baseline for all reportable measures. PQA noted that although pilot participants could calculate the measure concepts for blood glucose and BP control and exchange data between payers and pharmacies, there were challenges in calculating the measure concepts for blood glucose and BP improvement and the BP improvement measure was not calculated as a result.
The pilots included more than 2,000 pharmacists and more than 100,000 patients. Kroger participated in a collaboration between Kroger Prescription Plans and Arkansas Blue Cross Blue Shield along with its regional pharmacy networks.
“These pilots demonstrated that pharmacies, working with health plans through value-based arrangements, can positively impact patients’ outcomes for blood pressure and diabetes,” said Micah Cost, PharmD, and PQA CEO, in a news release. “Structural improvements are needed in how the industry captures and shares data, but the results underscore the importance of standardized measures to advance pharmacist-provided care and pharmacy reimbursement for clinical services.” ■
Researchers assess risks of online semaglutide purchases
A new research letter published August 2, 2024, in JAMA Network Open JAMA Network Open found that products including semaglutide—the key ingredient found in popular new diabetes and weight-loss drugs—are readily available online without a prescription.
Researchers identified websites offering semaglutide without a prescription and ordered two prefilled pens from each one. The products were then subjected to visual inspection for comparison to legitimate semaglutide (Ozempic—Novo Nordisk) pens. They also were tested for quality, including sterility and microbiological contamination, and assessed for quantification of active ingredients.
Of six products ordered, only three were delivered.
Compared with genuine Ozempic, the test products lacked reliable regulatory registration information and accurate labeling, suggesting they were likely unregistered or unlicensed.
Investigators also uncovered evidence of payment scams associated with unregistered or falsified semaglutide products shipped by online vendors. Among more than 1,000 hyperlinks, researchers detected 317 online pharmacies—134 of which were illegal operations and six of which were labeled as “rogue” or not recommended by LegitScript and/or the National Boards of Pharmacy.
“U.S. poison centers have reported a 1,500% increase in calls related to semaglutide, highlighting the need for enhanced pharmacovigilance including for online sourcing harms,” researchers wrote.
The surge in calls to national poison control centers is also directly related to compounded GLP-1s (the drug class to which semaglutide belongs).
A shortage of semaglutide has paved the way for compounding facilities to make their own versions of the drugs. However, in the absence of FDA review, testing, and authorization, compounded semaglutide carries a certain measure of risk—including the potential for overdose. Unlike FDA-approved semaglutide, which is packaged in prefilled pens housing measured doses, users of compounded products typically use a syringe and vial to draw the medicine themselves. ■
CDC releases update to practice recommendations for contraceptive use
CDC released a 2024 update to its evidence-based guidance for health care providers related to contraceptive use by their patients. The latest iteration of the U.S. Selected Practice Recommendations for Contraceptive Use (U.S. SPR), last revised in 2016, considers new evidence and expert feedback to reshape the guidelines.
Noteworthy changes include updated recommendations for provision of medications for the placement of intrauterine devices and for bleeding irregularities during implant use. The document also introduces new guidance addressing testosterone use and risk for pregnancy as well as for self-administration of injectable contraception.
“Each U.S. SPR recommendation addresses what a patient or health care provider can do in specific situations,” CDC noted.
The resource can also be used hand-in-hand with the companion document, the U.S. Selected Practice Recommendations for Contraceptive Use, 2024, to determine medical eligibility for use of specific contraceptive methods based on patients’ individual medical profile. ■