Trending Topics in Health-System Pharmacy
Continuous glucose monitoring can decrease hypoglycemia
Point-of-care (POC) blood glucose testing is commonly used to monitor hospitalized insulin-treated patients with type 2 diabetes. The results of a recent study published in Diabetes Care on August 5 show that real-time continuous glucose monitoring (FT-CGM) can decrease hypoglycemia in this patient population.
The randomized clinical trial, conducted by researchers at the University of Maryland and the Baltimore Veterans Affairs Medical Center, involved 72 participants. Of these, 36 received POC monitoring and 36 received RT-CGM using a glucose telemetry system (GTS). The primary study outcome was the difference in inpatient hypoglycemia and patients who developed received protocol-driven carbohydrate supplementation. The study was halted early due to the COVID-19 pandemic, but interim analysis results were reported.
The results showed that patients in the RT-CGM/GTS group experienced fewer hypoglycemic events (<70 mg/dL) per patient, fewer clinically significant hypoglycemic events (<54 mg/dL) per patient, and a lower percentage of time spent below 70 mg/dL than patients in the POC group. No differences in nocturnal hypoglycemia, time in range 70–180 mg/dL, and time above range >180–250 mg/dL and >250 mg/dL were found between the groups.
Low-dose glucocorticoids may increase risk for serious infection in patients with rheumatoid arthritis
A recent study published in the Annals of Internal Medicine on September 22 showed that low-dose glucocorticoids may be linked to an increased risk for hospitalized infection in patients with rheumatoid arthritis (RA) receiving stable disease-modifying antirheumatic drug (DMARD) therapy.
Researchers at the University of Pennsylvania, Oregon Health & Science University, and the University of Alabama at Birmingham conducted a retrospective cohort study using data from Medicare claims and Optum’s deidentified Clinformatics Data Mart database from 2006 to 2015 for adult patients with RA who had received a stable DMARD regimen for more than 6 months. They looked at associations between glucocorticoid dose (none, ≤5 mg/d, >5–10 mg/d, and >10 mg/d) and hospitalized infection using inverse probability–weighted analyses, with 1-year cumulative incidence predicted from weighted models.
The study showed that after 6 months of stable DMARD use, 47.1% of Medicare patients and 39.5% of Optum patients were receiving glucocorticoids. It also found that the 1-year cumulative incidence of hospitalized infection in Medicare patients not receiving glucocorticoids was 8.6% compared with 11.0% in those receiving 5 mg or less per day, 14.4% in those receiving 5 to 10 mg per day, and 17.7% in those receiving greater than 10 mg per day.
In Optum patients not receiving glucocorticoids, the 1-year cumulative incidence of hospitalized infection was 4.0% compared with 5.2% in those taking 5 mg or less per day, 8.1% in those taking 5 to 10 mg per day, and 10.6% in those taking greater than 10 mg per day.
The authors concluded that glucocorticoids are associated with a dose-dependent increase in the risk for serious infection in patients with RA on DMARD therapy, with small but significant risks even at doses of 5 mg or less per day. When considering treatment for these patients, clinicians should weigh the benefits of low-dose glucocorticoids against this risk.
Oral beta-lactam step-down therapy effective for uncomplicated streptococcal bloodstream infections
Although fluoroquinolones (FQs) are often used as oral step-down therapy for bloodstream infections (BSIs), they have been associated with serious adverse events.
A new study, led by Jennifer Dela-Pena from the Department of Pharmacy at Advocate Lutheran General Hospital and published on August 24 in Antimicrobial Agents and Chemotherapy, compared clinical outcomes for patients who received an oral FQ versus an oral beta-lactam (BL) as step-down therapy for uncomplicated streptococcal BSIs.
The multi-center, retrospective cohort study included 220 adult patients who completed therapy with an oral FQ or BL with at least one blood culture positive for a Streptococcus species from January 1, 2014 to June 30, 2019.
The primary outcome was clinical success, defined as lack of all-cause mortality, recurrent BSI with the same organism, and infection-related readmission at 90 days.
The results indicated that step-down therapy with an oral BL was non-inferior to an oral FQ, and no differences were seen in 90-day mortality, 90-day recurrent BSI, 90-day infection-related readmission, or 90-day incidence of C. difficile-associated diarrhea.
FDA releases new guidelines on COVID-19 vaccine EUA
On October 6, FDA issued guidance about the needed information and scientific data manufacturers would need to supply in order to support FDA issuing an emergency use authorization (EUA) for an investigational COVID-19 vaccine.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, in a statement.
An EUA is a different standard than an FDA approval. However, FDA noted that in the case of an investigational vaccine developed for the prevention of COVID-19, both pathways require the submission of data demonstrating any vaccine’s safety and effectiveness.
Marks said the new guidance on an EUA for a COVID-19 vaccine underscores FDA’s commitment by “further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.”
Some of that key information included in the guidance describes chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.
FDA said the guidance also makes clear that an EUA will be made on a case-by-case basis, considering target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product.
“In addition to outlining our expectation for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved,” said Marks.
Guidance needed on HHS COVID-19 reporting rule
Hospitals are looking for guidance from CMS on the interim final rule on daily reporting of COVID-19 data.
The new rule, which took effect on September 2, requires all Medicare- and Medicaid-certified hospitals to provide daily updates to the U.S. Department of Health and Human Services (HHS) on several COVID-related measures, including the number of infections, test results, ICU patient counts, and PPE supplies. Facilities that do not comply with the new rule could lose access to Medicare and Medicaid reimbursement. But hospitals are requesting guidance that spells out hospitals’ rights and responsibilities under the rule.
The rule is causing particular concern among hospitals that don’t care for COVID-19 patients, such as psychiatric hospitals, that were told earlier they did not need to report COVID-19 data. In addition, many hospitals do not do their own reporting, but rather rely on their state or private contractors to provide data to CMS, and are concerned about how missing data will be communicated to the hospital to allow resolution of the omission.
The American Hospital Association and the Federation of the American Hospitals expressed dissatisfaction that the new rule was enacted without feedback through the formal rulemaking process. At press time, HHS had not responded to requests for additional guidance.