Switching patterns of immediate-release forms of generic mixed amphetamine salts products among privately and publicly insured individuals aged 15-64 years in the United States, 2013-2019.

Purpose: Immediate-release forms of generic mixed amphetamine salts (MAS) have been the subject of passive surveillance reports signaling lack of effectiveness. We examined switching patterns that might suggest whether long-term users of specific MAS are more likely to switch away or switch back after use of the MAS of interest in the FDA's Sentinel Distributed Database.

Methods: We required at least 60-day continuous supply of selected MAS grouped by Abbreviated New Drug Application (ANDA) to describe patterns of switching away from and to generics approved under the ANDAs of interest among individuals ages 15-64 years with attention deficit hyperactivity disorder or narcolepsy during 2013-2019.

Prescription medication use and baseline health status of women with live-birth deliveries in a national data network.

Background: The US Food and Drug Administration increasingly uses administrative databases to conduct surveillance of medications used during pregnancy. To assess adverse fetal effects, administrative records must be linked between the mother and infant. The Sentinel Initiative's Mother-Infant Linkage Table provides a large cohort of linked deliveries from national, regional, and public insurance claims in the United States for the US Food and Drug Administration to conduct surveillance.

Placental DNA methylation and associations with neonatal opioid withdrawal syndrome, a pilot study.

Aims: Epigenetic variation of DNA methylation of the mu-opioid receptor gene () has been identified in the blood and saliva of individuals with opioid use disorder (OUD) and infants with neonatal opioid withdrawal syndrome (NOWS). It is unknown whether epigenetic variation in exists within placental tissue in women with OUD and whether it is associated with NOWS outcomes. In this pilot study, the authors aimed to 1) examine the association between placental DNA methylation levels and NOWS outcomes, and 2) compare methylation levels in opioid-exposed non-exposed control placentas.

A General Propensity Score for Signal Identification Using Tree-Based Scan Statistics.

The tree-based scan statistic (TreeScan; Martin Kulldorff, Harvard Medical School, Boston, Massachusetts) is a data-mining method that adjusts for multiple testing of correlated hypotheses when screening thousands of potential adverse events for signal identification. Simulation has demonstrated the promise of TreeScan with a propensity score (PS)-matched cohort design. However, it is unclear which variables to include in a PS for applied signal identification studies to simultaneously adjust for confounding across potential outcomes.

Pilot Study Comparing Adverse Cardiorespiratory Events among Pharmacologically and Nonpharmacologically Treated Infants Undergoing Monitoring for Neonatal Abstinence Syndrome.

There is variation in cardiorespiratory monitoring practices for neonatal abstinence syndrome. We examined the incidence of cardiorespiratory adverse events in infants with neonatal abstinence syndrome who were treated or nontreated pharmacologically. Eight (10%) in the nontreated and 23 (19%) in the treated group experienced adverse events.

Standard Fixed-Schedule Methadone Taper Versus Symptom-Triggered Methadone Approach for Treatment of Neonatal Opioid Withdrawal Syndrome.

Objectives: We compared hospitalization outcomes in infants with neonatal opioid withdrawal syndrome (NOWS) treated with a novel symptom-triggered methadone approach (STMA) versus a fixed-schedule methadone taper (FSMT).

Methods: This was a single-center quality-improvement study of infants pharmacologically treated for NOWS. Outcomes were compared over time by using statistical process control charts and between the baseline FSMT (July 2016-November 2017) and intervention STMA (December 2017-May 2018) groups, including median hospital length of stay (LOS), methadone treatment days, total milligrams of methadone, and need for adjunctive agents.