Brexpiprazole toxicity in a paediatric patient.

Brexpiprazole is a relatively new drug that has no published research or applications within the paediatric population. Brexpiprazole targets multiple receptors and can manifest as multisystem symptoms when ingested in supratherapeutic quantities. In this report, we discuss the case of a child in early childhood who presented with delayed neurological and cardiac symptoms 24 hours after accidental ingestion of brexpiprazole. Due to delayed onset, this case highlights that a high index of suspicion and prolonged observation are necessary to appropriately manage brexpiprazole overdose or accidental ingestion.

The Impact of Montelukast's Black Box Warning on Pediatric Mental Health Adverse Event Reports.

OBJECTIVE: In March 2020, the US Food and Drug Administration (FDA) required a black box warning for montelukast due to serious mental health side effects. We hypothesized the warning would lead to an overall decrease in reports of mental health symptoms and disorders related to montelukast in both -pre-adolescent and adolescent groups. METHODS: Adverse events of pre-adolescent and adolescent children taking montelukast sodium were reviewed from March 1, 2018 to March 3, 2020 and March 4, 2020 to February 28, 2022 using the FDA's Adverse Events Reporting System. The objective was to determine if mental health adverse event reports were influenced by placement of a Boxed Warning. Adverse reactions were grouped into 8 categories deemed to be related to mental health guided by the research team's interpretation of the FDA Sentinel Report. Chi-square tests were used to compare time periods and reports of the mental health categories. RESULTS: Of the 1570 reports assessed, 1295 (82.5%) included ≥1 mental health concern. Nine hundred ninety-six (84.2%) of the 1183 reports involving pre-adolescents and 299 (77.3%) of the 387 reports involving adolescents included ≥1 mental health reaction. Statistically significant changes for pre-adolescents were found in reports related to depression (χ2 (1) = 4.30, p = 0.044), and sleep (χ2 (1) = 5.74, p = 0.019), which both decreased between the pre and post periods. The only statistically significant change across categories for adolescents was a reduction in aggression reports between time periods (χ2 (1) = 8.5, p = 0.004). CONCLUSIONS: After placement of an FDA black box warning on montelukast, total number of reports -including mental health adverse events decreased in pre-adolescents; however, several categories -assessed increased for adolescents.

Use of Omadacycline as a Component of Mycobacterium Abscessus Eradication in an Adolescent With Cystic Fibrosis.

Lung damage caused by non-tuberculous mycobacteria (NTM) infections can be devastating to individuals that are predisposed to chronic respiratory colonization. Cystic fibrosis patients are at increased risk for diminished lung function and increased mortality from NTM pulmonary infections. Treatment regimens are often intense and prolonged. The case described in this report is of a 16-year-old male with cystic fibrosis infected with Mycobacterium abscessus who showed evidence of severe nodular pulmonary disease on chest computerized tomography. His intensive treatment phase was complicated by neutropenia and drug resistance, leading to the use of omadacycline. Because of rapid improvement clinically and on computed tomography, he was successfully treated with a modified, less intense continuation phase that included azithromycin, omadacycline, and inhaled amikacin. The patient also was switched from tezacaftor/ivacaftor to elexacaftor/tezacaftor/ivacaftor during the course of NTM treatment.

Extended-Release Viloxazine for Children and Adolescents With Attention Deficit Hyperactivity Disorder.

Non-stimulant medication therapy for children, adolescents, and young adults with attention-deficit/hyperactivity disorder (ADHD) has included alpha 2-agonists (guanfacine and clonidine) as well as a norepinephrine reuptake inhibitor (atomoxetine) for multiple years. Although these may be effective options for some children, they are generally considered to be less effective than stimulant medications. In addition, there has been a suicidal ideation concern in early-late adolescence with atomoxetine, emphasizing the need for continued development of other treatment options. Extended-release viloxazine (SPN-812) has been shown in phase 2 and phase 3 trials to be an effective, well-tolerated alternative for some children with ADHD. The mechanism of action of viloxazine is unique, modulating activity of both serotonin and norepinephrine. Treatment-related adverse events most commonly seen included somnolence, decreased appetite, and headache. Although continued evaluation to confirm the reduced symptoms of ADHD in children along with the safety profile is needed, extended-release viloxazine may offer a once-a-day pharmaceutical treatment option for patients in which stimulant medication is not effective or not a favorable option. It may also be beneficial for those children and adolescents with a comorbidity of depression.

Predictors of FabAV use in copperhead envenomation.

CONTEXT: Crotaline snake envenomation is a serious medical condition affecting thousands of Americans each year. Variation in the treatment of Crotaline snakebites exists among physicians in the United States. Management of copperhead snakebites is controversial with some experts advocating minimal intervention, rarely necessitating antivenom use and, even more rarely, surgical intervention. This study assessed the use of Crotaline Polyvalent Immune Fab antivenom (Ovine) (FabAV) and explored factors influencing the decision to prescribe antivenom for copperhead envenomation in patients in Northeastern Oklahoma. METHODS: A retrospective cohort study examining electronic medical records of patients with copperhead snakebites from July 1, 2014 to August 31, 2019. Data collected included: patient demographics, transfer information, snake species, bite site, progression of local tissue effects, additional clinical and lab results, patient comorbidities, and treatment strategy. Associations between patient variables and treatment were evaluated using the chi-square test of independence, median test, and logistic regression analysis. Associations were statistically significant if p < 0.05. DISCUSSION: Of the 130 patients bitten by a copperhead, a majority (75%) received FabAV. Symptoms of copperhead envenomation were mostly limited to the progression of tissue damage. Predictors of treatment with FabAV included progression of venom effects across major joints, younger age, comorbidities, and upper extremity bites. CONCLUSIONS: Patients who have multiple comorbidities, upper extremity bites and progression of venom effects across major joints are more likely to be treated with FabAV. The high usage of FabAV at the study site underscores the need for continued work to optimize the use of antivenom for copperhead envenomations.

A clinician survey of use assessment, documentation, and education about cannabis in persons with cystic fibrosis.

INTRODUCTION: To help open the clinician dialogue regarding cannabis use in persons with cystic fibrosis (CF) in the United States, we aimed to describe current practices of use assessment and documentation processes related to cannabis. METHODS: A cross-sectional, anonymous survey study was distributed via email to CF directors and coordinators and to the Cystic Fibrosis Foundation (CFF) listservs of nurse, pharmacist, dietitian, social worker, and psychology care team members. The survey tool included multiple choice, scaled, and open-ended items, which assessed participants' awareness of current cannabis laws in their state, prescribing practices for medical marijuana, screening and documentation practices, knowledge of and what indications participants believe cannabis and cannabidiol (CBD) could be beneficial. Data were analyzed using descriptive statistics. RESULTS: There were 282 survey participants, with majority as providers (28%) and social workers (29%), representing all US regions. Participants varied in terms of frequency of evaluating cannabis use, with 15.4% "always," 48.4% "sometimes," and 41% "rarely," or "never" asking about it. Regarding recreational versus medical cannabis use, 55.4% and 62.5% reported documentation of each type in the medical record, respectively. Participants reported appetite, pain, and nausea as the top three advocated indications for use. About 35% and 72% of participants felt "slightly" or "not at all" prepared to answer patient/family questions about cannabis and CBD, respectively. CONCLUSIONS: The approach to cannabis use assessment, documentation, and education across CF care centers is variable. There is a need for care team and patient/caregiver education materials about cannabis/CBD and CF.

Elexacaftor-Tezacaftor-Ivacaftor: The First Triple-Combination Cystic Fibrosis Transmembrane Conductance Regulator Modulating Therapy.

Elexacaftor-tezacaftor-ivacaftor is a newly approved triple-combination cystic fibrosis transmembrane conductance regulator (CFTR) modulating therapy that contains 2 correctors and a potentiator of the CFTR channel. Its labeled indication for use is for persons 12 years of age and older with at least 1 F508del mutation for the CFTR gene. This drug combination provides potential therapy to many patients who had previously been excluded from CFTR modulation therapy due to the nature of their genetic mutations. The efficacy demonstrated in clinical trials surpasses the currently available therapies related to lung function, quality of life, sweat chloride reduction, and reducing exacerbations. The most common adverse events seen in clinical trials included rash and headache, and laboratory monitoring is recommended to evaluate liver function. Continued evaluation of patient data is needed to confirm its long-term safety and efficacy. Elexacaftor-tezacaftor-ivacaftor is a monumental and encouraging therapy for cystic fibrosis; however, approximately 10% of the CF population are not candidates for this or any other CFTR modulation therapy.

A survey of pediatric degree option program graduates in a doctor of pharmacy curriculum: Confidence and initial employment position.

BACKGROUND AND PURPOSE: Graduates from the pediatric degree option program (PDOP) were tracked to identify confidence with pediatric pharmacotherapy and categorize initial employment following graduation. EDUCATIONAL ACTIVITY AND SETTING: The PDOP was established in 2011 and requires 16 credits of pediatric-focused didactic coursework and advanced pharmacy practice experiences. Thirty PDOP graduates completed a 30-item questionnaire to assess confidence in pediatric pharmacotherapy knowledge and skill statements and employment position following graduation. Responses were compared between those completing post-graduate pediatric pharmacy training and those who did not. FINDINGS: Nineteen (63.3%) graduates responded. All expressed "very high" or "high" confidence with dose calculations, first-line treatment selection for otitis media, and counseling caregivers on medications. However, <75% expressed "very high" or "high" confidence with identification of pharmacokinetic differences in neonates vs. children, utilization of growth charts, and counseling children. Ten (52.6%) respondents completed post-graduate training, and the remainder had an initial position in community or hospital pharmacy. There were no significant differences in pharmacotherapy skill and knowledge statements between those completing residency vs. those who did not. The most beneficial experiences reported were gaining clinical experience in pediatric pharmacy and medication safety. SUMMARY: Overall, PDOP graduates noted high confidence in pediatric pharmacotherapy skills and knowledge. Most felt that the PDOP influenced their initial career plans and made them more competitive for their initial position following graduation. The PDOP was well received and provided an opportunity for additional knowledge and skill development for students interested in pediatrics.

Ambulatory Care Training Within Postgraduate Year 2 Pediatric Pharmacy Residency Programs.

OBJECTIVE: This study evaluates pediatric ambulatory care training opportunities for postgraduate year 2 (PGY2) pediatric pharmacy residents. METHODS: An online survey was disseminated to PGY2 pediatric pharmacy residency directors. The questions involved the number and type of pediatric ambulatory care rotations offered; number of preceptors who practice in pediatric ambulatory care; whether or not a pediatric ambulatory care rotation is a requirement of the program; length and format of the rotations; amount of time residents spend in the pediatric ambulatory care setting; and the resident's role during pediatric ambulatory care rotations. RESULTS: The survey yielded an 85% response rate (n = 41/48). Most residency programs offer at least 1 pediatric ambulatory care rotation (n = 38; 93%), most of which are longitudinal experiences, and two thirds of programs require their resident(s) to complete a pediatric ambulatory care rotation (n = 27; 66%). These experiences involve a variety of specialty clinics, and residents assume diverse roles and responsibilities. Few programs offer residents the opportunity to practice under a collaborative drug therapy management agreement (n = 6; 15%) or develop new clinical services (n = 6; 15%). Most residency program directors (n = 39; 95%) reported that less than 25% of their residency graduates work in the pediatric ambulatory care setting. CONCLUSIONS: Ambulatory care experiences in PGY2 pediatric pharmacy residency programs are diverse in number and scope. There is an opportunity to expand pediatric ambulatory care rotation offerings, particularly with respect to collaborative drug therapy management and the establishment of new clinical services.

Impact of Electronic Health Record Systems on Prescribing Errors in Pediatric Clinics.

Medication errors are commonly reported in the pediatric population. While evidence supports the use of e-prescribing to prevent certain errors, prescribing with an electronic health record (EHR) system is not devoid of errors. Furthermore, the majority of EHRs are not equipped with functionalities addressing pediatric needs. This study analyzes three unique EHRs in three pediatric clinics. It describes the functionality of each system and identifies errors found in e-prescribed prescriptions. Finally, the study estimates the proportion of e-prescribing errors that could have been avoided if those EHRs had met requirements set by the American Academy of Pediatrics (AAP). The number of prescriptions reviewed for Clinics 1, 2, and 3, respectively, were: 477, 408, and 633 with total error rates of 13.2%, 8.8%, and 6.6%. The clinic EHRs included 21%, 26%, and 47% of the AAP pediatric requirements for safe and effective e-prescribing for children. If all AAP elements had been included in the EHRs, over 83% of errors in the examined e-prescriptions could have been prevented. This study demonstrates that EHR systems used by many pediatric clinic practices do not meet the standard set forth by the AAP. To ensure our most vulnerable population is better protected, it is imperative that medical technology tools adequately consider pediatric needs during development and that this is reflected in selected EHR systems.

Technology for Augmenting Type 1 Diabetes Mellitus Management.

Type 1 diabetes mellitus has witnessed significant progress in its management over the past several decades. This review highlights technologic advancements in type 1 diabetes management. Continuous glucose monitoring systems are now available at various functionality and cost levels, addressing diverse patient needs, including a recently US Food and Drug Administration (FDA)-approved implantable continuous glucose monitoring system (CGMS). Another dimension to these state-of-the-art technologies is CGMS and insulin pump integration. These integrations have allowed for CGMS-based adjustments to basal insulin delivery rates and suspension of insulin delivery when a low blood glucose event is predicted. This review also includes a brief discussion of upcoming technologies such as patch-based CGMS and insulin-glucagon dual-hormonal delivery.

Medication Reconciliation Across Care Transitions in the Pediatric Medical Home.

OBJECTIVE: To characterize medication discrepancies for patients with chronic illnesses seen at outside facilities. METHODS: This was a retrospective evaluation of a medication reconciliation across care transitions (MRAT) program developed and piloted for one year in an academic pediatric primary care medical home. The MRAT involved chart review and contacting caregivers upon receiving external specialist notes or hospital discharge summaries. Data obtained from the program were used to determine the frequency and types of medication discrepancies for children with complex and noncomplex chronic conditions. RESULTS: MRATs for 124 encounters were evaluated, 74.0% in response to specialist appointments. Chart review revealed a mean of 3.64 discrepancies per patient, and telephone calls revealed 1.39 additional discrepancies per patient. The number of medication discrepancies from both chart review and telephone calls between complex and noncomplex patients was statistically significant, with a mean of 5.63 vs. 3.77 per patient (p = 0.005). Therapy delays occurred in 16.1% of patients due to insurance rejections, family not starting a new medicine, or confusion about the medication change. Mean time required for reconciliation was 24 minutes. In addition to medication reconciliation, 107 interventions completed during MRATs included patient education, adjusting drug therapy, coordinating care between providers, recommending laboratory monitoring, and facilitating patient appointments. CONCLUSION: Children with chronic illness often experience medication changes and delays in therapy when seen in the hospital or by specialists. Timely identification of these changes improves communication and offers the opportunity to identify and prevent problems with medication therapy.

The impact of new guidelines on the prevalence of hypertension in children: A cross-sectional evaluation.

Updated clinical practice guidelines for screening blood pressures in pediatric patients were published in 2017. They differ from the previous guideline, known as the Fourth Report, providing updated population normal values and blood pressure categorization. We hypothesized that the prevalence of abnormal blood pressure in children and adolescents would be higher using the new clinical practice guidelines. We present a cross-sectional study of screening blood pressure values for children 3 to 18 years of age obtained during well-child visits at a primary care clinic. All blood pressure values were categorized using both the Fourth Report and the Clinical Practice Guideline. A total of 2635 blood pressure measurements were extracted, and 2600 were eligible for analysis. Using the clinical practice guideline, the prevalence of hypertension increased to 17.85% compared to 9.5% per the Fourth Report (P < 0.0001). Of those patients classified as having a normal blood pressure by the Fourth Report, 12% changed to abnormal when applying the Clinical Practice Guideline. All subgroups had a significant increase in the prevalence of abnormal blood pressure. The most dramatic increase in the prevalence of stage 1 and stage 2 hypertension was seen in six patient subgroups: males, 3-12 years of age, Hispanic ethnicity, race designated as other, normal weight, and overweight. Applying the new Clinical Practice Guideline increased the prevalence of elevated blood pressure and stage 1 and stage 2 hypertension in children and adolescents, requiring more follow-up and intervention than previously expected for this patient population.

Acute Renal Failure Secondary to Inadvertent Propylene Glycol Overdose with Single-Day High-Dose Vitamin D (Stosstherapy).

Globally, there has been increasing attention paid to vitamin D deficiency and its treatment. Vitamin D stosstherapy with high-dose ergocalciferol in a single day is reemerging as a potential treatment option. We present an as yet unreported complication of acute renal injury due to propylene glycol toxicity in a 7-month infant treated with vitamin D stosstherapy. The product label for the vitamin D used for this patient states it is dissolved in propylene glycol (PG), but the amount is not listed on this or other US ergocalciferol liquid products that contain PG. Caution should be used when considering vitamin D stosstherapy with liquid ergocalciferol products available in the United States.

Evolving Pharmacotherapeutic Strategies for Type 1 Diabetes Mellitus.

Despite pharmacotherapeutic advancements in the management of type 1 diabetes mellitus during the past several decades, patients struggle to achieve glycemic goals. Additionally, hypoglycemia, especially in extremes of age, decreases quality of life. The lack of optimal glycemic control and risk for hypoglycemia are multifactorial. Nevertheless, endeavors aiming to develop pharmacotherapeutic options with enhanced pharmacokinetic, pharmacodynamic, and clinical profiles continue. This review article discusses recent ventures in 3 categories of insulin, non-insulin, and glucagon products.

Description of a pediatric degree option program in a doctorate of pharmacy curriculum and its impact on pediatric-focused advanced pharmacy practice experience rotations and faculty scholarly productivity.

PURPOSE: To describe the development of a Pediatric Degree Option program and its impact on pediatric-focused advanced pharmacy practice experiences (APPEs) and faculty scholarly productivity. EDUCATIONAL ACTIVITY: The Pediatric Degree Option program was established in 2011 and requires 16 h of didactic coursework and APPEs. The number of pediatric-focused APPEs and mean number of APPEs per pediatric faculty per year was compared pre- (2005-2010) and post-implementation (2011-2016). In addition, the median number of scholarship activities per student pre- and post-implementation was compared. The initial position obtained by graduates completing the degree option was collected. FINDINGS: Thirty students have completed the program. There were 146 pediatric-focused APPEs for the pre-implementation period and 259 post-implementation. However, there was an increase in pediatric faculty during the post-implementation, so there was no difference in the mean number of pediatric-focused APPEs per pediatric faculty in the pre- versus post-implementation period, 8.4 + 2.7 versus 6.9 +1.0, p = .224. A significant increase in the median number of pediatric-focused scholarly activities per student was observed pre-versus post-implementation, 3 (2-5) versus 5 (3-7), p = .005. Twenty-six (86.7%) students in the post-implementation period participated as a research assistant or coauthor in an original research or manuscript writing project. Students accepted a variety of positions after graduation including twelve (40%) accepting a PGY1 residency and eight (36.7%) as community pharmacists. SUMMARY: Although the number of pediatric-focused APPEs increased in the post-implementation, this did not result in an increase in the mean number of mean pediatric-focused APPEs per pediatric faculty member. However, it did allow a unique opportunity for 30 students with interest in pediatrics and allowed for content and skill development. The Pediatric Degree Option program allowed students to gain experience with pediatric-focused scholarly activities that also enhanced faculty productivity in scholarship and research.