Limited guidance on opioid use exists in the pediatric population, causing medication safety concerns for pain management in children and adolescents. Opioid misuse and opioid use disorder continue to greatly affect adolescents and young adults in the United States, furthering the apprehension of their use. The Pediatric Pharmacy Association (PPA) recommends that pharmacists contribute their knowledge to pain management in children, including discussing the appropriate use of non-opioid alternatives for pain and when to recommend co-prescribing naloxone. The PPA also supports the review of electronic prescription drug monitoring programs before opioid prescribing and dispensing by both prescribers and pharmacists, respectively. Education by pharmacists of children and their families regarding proper administration, storage, and disposal, as well as the awareness of opioid misuse and use disorder among adolescents and young adults, is key to prevention. If opioid use disorder is diagnosed, PPA encourages improved access among adolescents to evidence-based medications, including methadone, buprenorphine, and naltrexone. Furthermore, pharmacists should assist with, or in some settings perform, screening and referral to evidence-based treatments.

PURPOSE:The purpose of this review is to discuss treatment modalities for obesity in children and adolescents, including nonpharmacological, pharmacological, and surgical interventions. SUMMARY:The prevalence of pediatric obesity has dramatically risen, with rates of 20.7% and 22.2% among children and adolescents, respectively. Obesity is a complex medical condition with multifactorial risk factors, including diet and exercise, social determinants of health, and environmental and genetic factors. The management approach among children and adolescents with obesity includes nutrition counseling, increased physical activity, and readiness for behavioral change. Pharmacotherapy may be recommended, yet the literature has not elucidated the most appropriate first-line treatment. Metformin and orlistat have been studied and may be considered in pediatric patients with comorbid complications, including type 2 diabetes and nonalcoholic fatty liver disease. Phentermine and topiramate in combination, as well as glucagon-like peptide-1 receptor agonists, have provided modest benefits in weight reduction among youth. Setmelanotide has a unique mechanism of action and may be considered for those with obesity due to genetic disorders. Bariatric surgery should be reserved for adolescents meeting criteria for severe obesity. CONCLUSION:Treatment for obesity in children and adolescents includes a comprehensive approach with structured lifestyle programs, mental health support, and mitigation of social determinants of health. Pharmacotherapy may also be considered, yet no medication is recommended over another, giving flexibility for shared decision-making with the patient and family regarding comorbidities and potential drug interactions. Adolescents with severe obesity who meet specified criteria may also be referred for surgical evaluation.

BACKGROUND:There are sparse data to guide resumption of direct oral anticoagulants (DOACs) versus warfarin in patients with atrial fibrillation (AF) who survive a major gastrointestinal bleeding (GIB) event. OBJECTIVE:To compare the risk-benefit profile of restarting DOACs versus warfarin among patients with AF following hospitalization for major GIB. METHODS:Using claims submitted to a commercial health insurance database from January 2010 to December 2017, we identified adult patients with AF hospitalized for a major GIB while receiving oral anticoagulants. Eligible patients were required to have survived and restarted oral anticoagulation with DOACs or warfarin within 90 days following hospital discharge for major GIB. The outcomes of interest were subsequent hospitalization for major bleeding, hospitalization for ischemic stroke/systemic embolism (SE), all-cause mortality, and net adverse clinical effect (NACE), which was a composite of all-cause mortality, hospitalization for ischemic stroke/SE, and hospitalization for major bleeding. Stabilized inverse probability of treatment weighting was used to balance measured covariates. RESULTS:Overall, 4,389 patients resumed oral anticoagulation, with 3016 (68.7%) on warfarin and 1373 (31.3%) on DOACs, within 90 days of hospital discharge for major GIB. The median (interquartile range) time from hospital discharge for major GIB to resumption of oral anticoagulant was 24 (10, 47) days. The weighted hazards ratio (HR) among individuals that resumed DOACs versus warfarin after major GIB was 0.76 (95% confidence interval, CI: 0.60, 0.96) for subsequent hospitalization for major bleeding, 0.91 (95% CI: 0.53, 1.55) for subsequent hospitalization for ischemic stroke/SE, and 0.83 (95% CI: 0.72, 0.97) for NACE. CONCLUSIONS:Among patients with AF who survived and resumed oral anticoagulation within the first 90 days after hospitalization for a major GIB event, restarting oral anticoagulation treatment with DOACs was associated with a lower risk of subsequent hospitalization for major bleeding and the composite outcome of ischemic stroke, SE, all-cause mortality, and recurrent or incident major bleeding.

OBJECTIVE:The objective was to update the KIDs List, a list of drugs and excipients that are potentially inappropriate for use in pediatric patients, accounting for emerging pharmacologic agents and published evidence. METHODS:A panel of 12 pediatric pharmacists from the Pediatric Pharmacy Association (PPA) evaluated primary, secondary, and tertiary literature; FDA Pediatric Safety Communications; the UpToDate Lexidrug database; and product information for drugs that may be considered potentially inappropriate for use in pediatric patients. A PubMed search identified new publications from October 1, 2017, to November 1, 2023. All agents included in the previous publication and those anecdotally identified as candidates for the list by the authors or PPA members were evaluated. Evidence was reviewed by all authors. The draft list underwent a 30-day public comment period prior to being finalized. RESULTS:A PubMed search yielded 917 unique titles of which 17 were deemed relevant for full review. Sixty-seven drugs and/or drug classes and 10 excipients from the original publication were also reviewed. Author and PPA member recommendations highlighted an additional 25 drugs or drug classes. The UpToDate Lexidrug database extraction yielded 1470 drugs, which were filtered to 145 agents for author review. After critical analysis and reorganization, the second edition of the KIDs List contains 39 drugs and/or drug classes and 10 excipients. CONCLUSIONS:This article updates the initial list of drugs and excipients that are potentially inappropriate for prescribing in all or a select subgroup of pediatric patients. The second edition should stimulate novel research to inform future updates.

OBJECTIVE:Celiac disease and gluten sensitivities are on the rise, with a greater prevalence of the condition in children than adults. Resources to ascertain gluten content exist but can be incomplete and focus on medications for adults. The objective of this research is to determine gluten-free status of the top 100 pediatric medications dispensed. METHODS:The top 100 pediatric medications were identified by using Optum Clinformatics Data Mart database. After list creation, manufacturers and National Drug Code (NDC) for each drug were procured and used to contact manufacturers directly for gluten content information. RESULTS:Evaluation of 689 NDCs was completed with 50.2% of medications documented to be gluten-free. Additional categories were confirmed gluten-free but cannot confirm cross-contamination (22.6%), cannot confirm gluten-free (25.7%), and contains gluten (1.5%). Resource tables were developed from findings though information may change, based on manufacturing ingredients and processing. CONCLUSIONS:Pediatric medications differ in gluten content, compared with medications for adults. Incomplete information exists regarding gluten content of medications, especially pediatric resources. Development of a pediatric-specific resource for gluten content of commonly dispensed medications in children and adolescents will hopefully benefit patients with celiac disease.

BACKGROUND AND OBJECTIVE:The medication management of children with sickle cell disease (SCD), especially since the release of the 2014 National Heart, Lung, and Blood Institute (NHLBI) SCD treatment guidelines, is not well described in the published literature. This study assessed medication utilization trends overall and by patient demographics. METHODS:This retrospective study examined children aged 1-17 years diagnosed with SCD from January 1, 2010 to December 31, 2018, in Optum's de-identified Clinformatics Data Mart database. Changes in medication utilization over time were assessed using Joinpoint regression. Stratified time trends were evaluated by patient age, sex, race/ethnicity, region, and household income level. RESULTS:Over the 8-year study period, a total of 1868 children with SCD were identified. Hydroxyurea prescriptions increased 8.8%, on average, each year of the study period (p < 0.001), indicating rising adherence to recommended disease-modifying strategies. Shifts in opioid prescribing showed increased oxycodone use (6.3% average annual increase, p < 0.001) and decreased acetaminophen-codeine use (24.3% average annual decrease, p < 0.001). Notably, non-steroidal anti-inflammatory drug (NSAID) use increased by 4.0% annually (p = 0.010), reflecting shifts toward alternative pain management strategies. Significant shifts in medication utilization, overall and by patient demographics, were observed since the 2014 NHLBI SCD treatment guidelines were released. CONCLUSIONS:Our study findings underscore the dynamic nature of SCD management in children, and highlight the need for continuous evaluation of treatment guideline adherence, as well as treatment effectiveness and safety with the newer SCD medications and treatment guidelines, to optimize clinical outcomes among this vulnerable patient population.

Approximately 14.7 million US children aged 2 to 19 years are obese. This creates significant challenges to dosing medications that are primarily weight based (mg/kg) and in predicting pharmacokinetics parameters in pediatric patients. Obese individuals generally have a larger volume of distribution (Vd) for lipophilic medications. Conversely, the Vd of hydrophilic medications may be increased or decreased owing to increased lean body mass, blood volume, and decreased percentage of total body water. They may also experience decreased hepatic clearance secondary to fatty infiltrates of the liver. Hence, obesity may affect loading dose, dosage interval, plasma half-life, and time to reach steady-state concentration for various medications. Weight-based dosing is also a cause for potential medication errors. This position statement of the Pediatric Pharmacy Association recommends that weight-based dosing should be used in patients ages <18 years who weigh <40 kg; weight-based dosing should be used in patients ≥40 kg, unless the recommended adult dose for the specific indication is exceeded; clinicians should use pharmacokinetic analysis for adjusting medications in children diagnosed with overweight and obesity; and research efforts continue to evaluate dosing of medications in children diagnosed with overweight and obesity.

Background:Little to no data exist to guide treatment decision in patients with venous thromboembolism (VTE) and chronic liver disease. Objectives:To assess the effectiveness and safety of direct oral anticoagulants (DOACs)-individually and as a class-vs warfarin and between 2 DOACs in patients with acute VTE and chronic liver disease. Methods:We conducted a retrospective, US claims-based, propensity score-matched cohort study in adults with acute VTE and chronic liver disease who had newly initiated oral anticoagulants between 2011 and 2017. The primary outcome was a composite of hospitalization for recurrent VTE and hospitalization for major bleeding. Results:The cohorts included 2361 DOAC-warfarin, 895 apixaban-warfarin, 2161 rivaroxaban-warfarin, and 895 apixaban-rivaroxaban matched pairs. Lower risk of the primary outcome was seen with DOACs (hazard ratio [HR], 0.72; 95% CI, 0.61-0.85), apixaban (HR, 0.48; 95% CI, 0.35-0.66) or rivaroxaban (HR, 0.73; 95% CI, 0.61-0.88) vs warfarin but not apixaban-rivaroxaban (HR, 0.68; 95% CI, 0.43-1.08). The HRs of hospitalization for major bleeding were 0.69 (95% CI, 0.57-0.84) for DOAC-warfarin, 0.43 (95% CI, 0.30-0.63) for apixaban-warfarin, 0.72 (95% CI, 0.58-0.89) for rivaroxaban-warfarin, and 0.60 (95% CI, 0.35-1.06) for apixaban-rivaroxaban. Recurrent VTE risk was lower with apixaban (HR, 0.47; 95% CI, 0.26-0.86), but not DOACs (HR, 0.81; 95% CI, 0.59-1.12) or rivaroxaban vs warfarin (HR, 0.81; 95% CI, 0.57-1.14) or apixaban-rivaroxaban (HR, 0.92; 95% CI, 0.42-2.02). Conclusion:While the magnitude of clinical benefit varied across individual DOACs, in adults with acute VTE and chronic liver disease, oral factor Xa inhibitors (as a class or individually) were associated with lower risk of recurrent VTE and major bleeding.

The authors declare no conflicts of interest.

Background:The benefit-risk profile of direct oral anticoagulants (DOACs) compared with warfarin, and between DOACs in patients with atrial fibrillation (AF) and chronic liver disease is unclear. Methods:We conducted a new-user, retrospective cohort study of patients with AF and chronic liver disease who were enrolled in a large, US-based administrative database between January 1, 2011, and December 31, 2017. We assessed the effectiveness and safety of DOACs (as a class and individually) compared with warfarin, and between DOACs in patients with AF and chronic liver disease. The primary outcomes were hospitalization for ischemic stroke/systemic embolism and hospitalization for major bleeding. Inverse probability treatment weights were used to balance the treatment groups on measured confounders. Results:Overall, 10 209 participants were included, with 4421 (43.2%) on warfarin, 2721 (26.7%) apixaban, 2211 (21.7%) rivaroxaban, and 851 (8.3%) dabigatran. The incidence rates per 100 person-years for ischemic stroke/systemic embolism were 2.2, 1.4, 2.6, and 4.4 for DOACs as a class, apixaban, rivaroxaban, and warfarin, respectively. The incidence rates per 100 person-years for major bleeding were 7.9, 6.5, 9.1, and 15.0 for DOACs as a class, apixaban, rivaroxaban, and warfarin, respectively. After inverse probability treatment weights, the risk of hospitalization for ischemic stroke/systemic embolism was significantly lower between DOACs as a class (hazard ratio [HR], 0.64 [95% CI, 0.46-0.90]) or apixaban (HR, 0.40 [95% CI, 0.19-0.82]) compared with warfarin, but not significantly different between rivaroxaban versus warfarin (HR, 0.76 [95% CI, 0.47-1.21]) or rivaroxaban versus apixaban (HR, 1.73 [95% CI, 0.91-3.29]). Compared with warfarin, the risk of hospitalization for major bleeding was lower with DOACs as a class (HR, 0.69 [95% CI, 0.58-0.82]), apixaban (HR, 0.60 [95% CI, 0.46-0.78]), and rivaroxaban (HR, 0.79 [95% CI, 0.62-1.0]). However, the risk of hospitalization for major bleeding was higher for rivaroxaban versus apixaban (HR, 1.59 [95% CI, 1.18-2.14]). Conclusions:Among patients with AF and chronic liver disease, DOACs as a class were associated with lower risks of hospitalization for ischemic stroke/systemic embolism and major bleeding versus warfarin. However, the incidence of clinical outcomes among patients with AF and chronic liver disease varied between individual DOACs and warfarin, and in head-to-head DOAC comparisons.

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Sickle cell disease is a chronic and life-limiting disorder. Approximately 100,000 Americans are affected with sickle cell disease with most being African Americans. Newborn screening for sickle cell is available in the United States, leading to early detection and management of the disease beginning in infancy. According to the 2014 National Heart, Lung, and Blood Institute sickle cell disease guidelines, supportive care has been primary management of sickle cell disease, with hydroxyurea being the only FDA-approved, disease-modifying pharmacotherapy available and allogeneic hematopoietic stem cell transplant the only cure. Since 2017, three new disease-modifying therapies have been approved by the FDA: L-glutamine, crizanlizumab, and voxelotor. This review will discuss pertinent trials, dosing, interactions, side effects, access, cost, and their role in sickle cell management.

Background: Sexually transmitted infections (STIs) in the United States are at an all-time high. Expedited partner therapy (EPT) has been endorsed by the Centers for Disease Control and Prevention to prevent reinfection of patients and their partners. Although this practice is permissible in 46 states, including all of New England and New York, it is underutilized by prescribers and pharmacists. Objectives: To collect and analyze data on pharmacists' knowledge of EPT using a Web-based survey and to determine the best methods to deliver EPT continuing pharmacy education and related resources. Methods: A link to a 26-question survey was sent through e-mail listservs, social media, and newsletters to members of pharmacists' associations in 6 New England states and New York. In addition to demographic information, the questions assessed pharmacists' familiarity with and awareness of EPT, their roles in using this clinical service, and options for type, length, and location of related training plus types of information resources that would be most helpful for them. Results: A total of 133 pharmacists completed the survey. Only 50% overall were familiar with EPT as a concept, and more than 80% of pharmacists did not know which STIs are covered by their state EPT regulations. However, 85% of pharmacists responded they believed they played a potential role in EPT. A majority responded that a less than 2-hour live webinar would be the best format for EPT education, in addition to other resources distributed from their respective state boards of pharmacy. Conclusion: Pharmacists in the Northeastern United States lack overall awareness of EPT and how it is regulated. With continuing pharmacy education delivered in their preferred format, augmented by State Board of Pharmacy resources, pharmacists can play a critical role to facilitate access for patient and partner treatment of STIs. (c) 2022 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.

One fundamental strategy to address the public health threat of antimicrobial resistance (AMR) is improved awareness among the public, prescribers, and policy makers with the aim of engaging these groups to act. World Antimicrobial Awareness Week is an opportunity for concerted and consistent communication regarding practical strategies to prevent and mitigate AMR. We highlight 10 ways for antimicrobial stewards to make the most of World Antimicrobial Awareness Week.

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OBJECTIVE:To understand adolescent substance use and its known risk factors at the local and state level; to inform the development of future programs to reduce substance misuse among adolescents.METHODS:Survey data collected from a convenience sample of Rhode Island 9th-grade students prior to administration of the RAMS curriculum in 2016 and 2017 was compared to 2017 Rhode Island and National Youth Risk Behavior Survey Data.RESULTS:Seventeen percent (2016 RAMS), 10% (2017 RAMS), 6% (RIYRBS) and 11% (NYRBS) of students reported ever using prescription pain reliever without a physician prescription. One percent (2016 RAMS, 2017 RAMS), 3% (RIYRBS), and 2% (NYRBS) reported ever using heroin. Seven percent (2016 RAMS, 2017 RAMS), and 12% (RIYRBS, NYRBS) reported using cannabis in previous 30 days.CONCLUSION:These findings highlight a unique need for targeted education based on school and community risk and protective factors and misuse differences.

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Several studies have reported increasing prevalence of prescription opioid use among pregnant women. However, little is known regarding the effects of maternal opioid use on neurodevelopmental disorders in early childhood in pregnant women with no evidence of opioid use disorders or drug dependence. The aim of this study was to quantify the association between prenatal opioid exposure from maternal prescription use and neurodevelopmental outcomes in early childhood. This retrospective study included pregnant women aged 12–55 years and their live-birth infants born from 2010 to 2012 present in Optum’s deidentified Clinformatics® Data Mart database. Eligible infants born to mothers without opioid use disorders or drug dependence were followed till occurrence of neurodevelopmental disorders, loss to follow-up, or study end (December 31, 2017), whichever came first. Propensity score by fine stratification was applied to adjust for confounding by demographic characteristics, obstetric characteristics, maternal comorbid mental and pain conditions, and measures of burden of illnesses and to obtain adjusted hazard ratios (HR) and 95% confidence intervals (CI). Exposed and unexposed infants were compared on the incidence of neurodevelopmental disorders. Of 24,910 newborns, 7.6% (1899) were prenatally exposed to prescription opioids. Overall, 1562 children were diagnosed with neurodevelopmental disorders, with crude incidence rates of 2.9 per 100 person-years in exposed children versus 2.5 per 100 person-years in unexposed children. After adjustment, we observed no association between fetal opioid exposure and the risk of neurodevelopmental disorders (HR 1.10; 95% CI 0.92–1.32). However, increased risk of neurodevelopmental disorders were observed in children with longer cumulative exposure duration (HR 1.70; 95% CI 1.05–2.96) or high cumulative opioid doses (HR 1.22; 95% CI 1.01–1.54). In pregnant women without opioid use disorders or drug dependence, maternal opioid use was not associated with increased risk of neurodevelopmental disorders in early childhood. However, increased risks of early neurodevelopmental disorders were observed in children born to women receiving prescription opioids for longer duration and at higher doses during pregnancy.