Bulletin Today
APhA Staff
HHS, along with leading clinicians, researchers, and policy experts, has established a standard clinical definition for opioid withdrawal in infants. Additionally, they have created a set of foundational principles that highlight bioethical uses for the definition that focus on identifying clinical and supportive care needs for mothers and their infants.
The new standard clinical definition for diagnosis includes prenatal exposure and specific evidence-based clinical signs such as excessive crying, fragmented sleep, tremors, increased muscle tone, and gastrointestinal dysfunction.
“As a pediatrician, I have seen the need for a standard clinical definition for opioid withdrawal in neonates and am excited to see this step in improving care for infants and their families as part of the HHS Overdose Prevention Strategy,” said HHS Assistant Secretary for Health ADM Rachel Levine. “I look forward to working across all health sectors to get this definition adopted into clinical practice.”
The lack of a standard clinical definition has led to a number of challenges in medical coding, public health surveillance, research, public health policy, and program development.
The new definition can be applied in the context of neonatal abstinence syndrome or neonatal opioid withdrawal syndrome, terms that are often used to describe withdrawal due to prenatal substance exposure in infants. The new standard clinical definition of opioid withdrawal in neonates is published in the Journal of Pediatrics.
Two powerful drugs now adding to overdoses in U.S.
A new report published by CDC reveals that medical examiners are seeing a growing number of overdose deaths linked to two opioids: parafluorofentanyl and metonitazene. These drugs are frequently taken or blended with fentanyl and are said to be more powerful than fentanyl.
The report was written by officials from the DEA; a toxicology lab at the University of California, San Francisco; and the Knox County Regional Forensic Center in Knoxville, TN.
The authors noted that the Knoxville area recorded 770 unintentional drug overdose deaths from November 2020 through August 2021. Test results for 562 of them identified fentanyl only, 188 tested positive for fentanyl and methamphetamine, 48 involved parafluorofentanyl, and 26 involved metonitazene, according to the report.
Parafluorofentanyl is a synthetic opioid similar to fentanyl that has increasingly been found in heroin packets and as counterfeit tablets. Metonitazene is an opioid developed in the 1950s that was never authorized for medical treatment.
Most patients see pharmacists as crucial part of their health care team
Nearly 80% of patients said they see pharmacists as an integral part of their health care team, according to a new survey from Columbia University Mailman School of Public Health.
The Prescription of Trust report, which surveyed more than 3,000 patients, 1,000 pharmacists, and 500 medical providers—including physicians and nurse practitioners—was designed to more deeply understand the expanding role of pharmacists in transforming patient care.
Overall, the survey found that amid growing provider shortages, pharmacists in the United States are well-trusted by patients and projected to play an increasingly integral role in care management. However, pharmacists may need more advanced training to meet growing demand and fill gaps in care.
Roughly 53% of pharmacists agreed their current training and education is sufficient to manage patients. However, pharmacists did identify opportunities for additional training in chronic disease education, diagnosing, and prescribing.
“The results of the report are clear. Most people trust pharmacists to play a greater role in providing their care. As the shortage of doctors and nurses persists, and as complex new therapies and digital health care technology solutions are developed, the role of the pharmacist will continue to evolve,” said John McHugh, PhD, an assistant professor in the Department of Health Policy and Management at Columbia University Mailman School of Public Health.
The survey was conducted in conjunction with Express Scripts.
Review finds too few innovative drugs in antibiotic development pipeline
A review in Antimicrobial Agents and Chemotherapy found that the antibiotic development pipeline has few clinically differentiated products in late-stage clinical development, particularly against critical, multidrug-resistant pathogens.
Researchers examined all conventional and nonconventional antibacterial drug candidates that were being evaluated in clinical trials as of June 30, 2021. They tallied 76 products, of which 45 are conventional antibacterial agents and 31 nonconventional agents. Sixty of those candidates (79%) are in phase 1 or phase 2 trials (28 and 32, respectively), while 12 are in phase 3 trials and 4 are under regulatory review.
Of the 76 candidates, 42 are being developed to address pathogens regarded as critical (26) and high/medium priority (16) by WHO. Furthermore, 16 products are being developed to treat mycobacterial infections (14 for tuberculosis and 2 for nontuberculosis mycobacteria), and 15 to treat Clostridioides difficile infections.
However, only 18 of the antibacterial agents in development have new pharmacophores, one of the components that can determine if an antibacterial candidate belongs to a new class or subclass of antibiotics. Only 4 have new overarching modes of action. The review also revealed that 12 new antibacterial products have been approved globally since 2017, but only one, vaborbactam, belongs to a new antibiotic class.
Research seeks to shed light on aspirin uptake for women at risk for preeclampsia
Although the U.S. Preventive Services Task Force (USPSTF) recommends aspirin therapy for women with prepregnancy diabetes, obesity, and hypertension to prevent preeclampsia, uptake was less than optimal, according to a study published in JAMA.
Researchers characterized the use of low-dose aspirin as prophylaxis against preeclampsia in expectant mothers who were diagnosed with diabetes, obesity, and/or chronic hypertension before conceiving.
The study included 371,237 births in Ontario, Canada, from April 2018 through December 2020, with at-risk mothers accounting for about 21% of the sample.
Aspirin was used by 17.2% of pregnant women with diabetes, 6.9% of those with obesity, and 27.6% of women with high blood pressure. Utilization increased when expecting mothers suffered from multiple risk factors, but remained subpar. The rate of use in this subset was 22.2% among women with both diabetes and obesity, 36.6% among women with diabetes and hypertension, 32.3% among women with obesity and hypertension, and 38.8% among women with all 3 comorbidities.
“For the 2021 USPSTF recommendations to be more influential,” researchers with the Diabetes, Obesity, and Hypertension in Pregnancy Research Network wrote, “more data are needed to characterize barriers for aspirin adoption among suitable women at the patient and practitioner level, and additional knowledge translation initiatives developed.”