Prevention of Parenteral Nutrition-associated Cholestasis Using Reduced Dose Soybean Lipid Emulsion: A Multicenter Randomized Trial.

INTRODUCTION: Reducing soybean lipid emulsion (SLE) dose may prevent parenteral nutrition-associated cholestasis (PNAC) but effects on growth and neurodevelopment are unknown. The purpose of this study was to evaluate the effect of reduced dose SLE on growth and neurodevelopment. METHODS: Surgical neonates at 4 centers were randomized to standard SLE (3 g/kg/day) or reduced SLE (1 g/kg/day) over a 12-week period. Bilirubin levels and growth parameters were measured baseline and weekly while on study. The effects of time and group on direct bilirubin and growth were evaluated with a linear mixed effects model. Neurodevelopmental outcomes were assessed at 12- and 24-months corrected gestational age. RESULTS: Twenty-one individuals were randomized (standard dose = 9, reduced dose = 12). Subjects in the reduced dose group had slower rates of direct bilirubin increase and overall levels decreased earlier than those in the standard dose group. There was a trend toward a faster direct bilirubin decrease in the reduced dose group (p = 0.07 at day 84). There were no differences in the rates of change in weight (p = 0.352 at day 84) or height Z-scores (p = 0.11 at day 84) between groups. One subject in the reduced dose group had abnormal neurodevelopmental testing at 24 months. CONCLUSIONS: Surgical neonates randomized to a reduced dose of SLE had improved trends in direct bilirubin levels without clinically significant differences in overall growth and neurodevelopment. TYPE OF STUDY: Randomized Controlled Trial. LEVEL OF EVIDENCE: II.

Treatment-Refractory Dravet Syndrome: Considerations for Novel Medications.

Before 2018, there were no U.S. Food and Drug Administration-approved medications for managing seizures in Dravet syndrome (DS). Common agents used in the antiepileptic drug regimens of patients with DS included clobazam, valproic acid, topiramate, and levetiracetam, among others; however, these agents alone rarely provide adequate seizure control. Management of seizures in DS changed in recent years with the approval of cannabidiol and stiripentol in 2018 and fenfluramine in 2020. This continuing education article summarizes available efficacy and safety data involving cannabidiol, stiripentol, and fenfluramine and provides a practical review of dosing strategies, pharmacokinetics, and monitoring interventions relevant to their use.

Allowable room temperature excursions for refrigerated medications: A 20-year review.

PURPOSE: The aim of this review was to build upon previous literature describing the maximum duration for which refrigerated medications can tolerate room temperature excursions while maintaining stability and potency. METHODS: During a 12-month period ending in June 2021, the prescribing information and published monographs from multiple pharmacy compendia were reviewed for all medications and biologic products approved by the US Food and Drug Administration (FDA) for human use since January 2000. Products that were subsequently withdrawn from the US market were excluded. When temperature excursion data was unavailable in published form, product manufacturers were surveyed via telephone and/or email. Acceptable storage information for all products for which storage is recommended at temperatures below room temperature (20-25 °C [68-77 °F]) was compiled and arranged in tabular format. RESULTS: Of the 705 products or formulations approved by FDA during the predefined time period, 246 were identified as requiring storage at temperatures below room temperature. After review of available prescribing information and manufacturer communications, if applicable, acceptable periods of excursion to temperatures at room temperature or higher were identified for 214 products (87%). CONCLUSION: Information related to acceptable periods of room temperature excursion was compiled for a total of 214 products approved for US distribution since 2000. The included tables may increase patient safety and decrease medication loss or related expenditures.

Optimizing the nutrition support care model: Analysis of survey data.

BACKGROUND: Malnutrition is underrecognized and underdiagnosed, despite high prevalence rates and associated poor clinical outcomes. The involvement of clinical nutrition experts, especially physicians, in the care of high-risk patients with malnutrition remains low despite evidence demonstrating lower complication rates with nutrition support team (NST) management. To facilitate solutions, a survey was designed to elucidate the nature of NSTs and physician involvement and identify needs for novel nutrition support care models. METHODS: This survey assessed demographics of NSTs, factors contributing to the success of NSTs, elements of nutrition education, and other barriers to professional growth. RESULTS: Of 255 respondents, 235 complete surveys were analyzed. The geographic distribution of respondents correlated with population concentrations of the United States (r = 90.8%, p < .0001). Most responding physicians (46/57; 80.7%) reported being a member of NSTs, compared with 56.5% (88/156) of dietitians. Of those not practicing in NSTs (N = 81/235, 34.4%), 12.3% (10/81) reported an NST was previously present at their institution but had been disbanded. Regarding NSTs, financial concerns were common (115/235; 48.9%), followed by leadership (72/235; 30.6%), and healthcare professional (HCP) interest (55/235; 23.4%). A majority (173/235; 73.6%) of all respondents wanted additional training in nutrition but reported insufficient protected time, ability to travel, or support from administrators or other HCPs. CONCLUSION: Core actions resulting from this survey focused on formalizing physician roles, increasing interdisciplinary nutrition support expertise, utilizing cost-effective screening for malnutrition, and implementing intervention protocols. Additional actions included increasing funding for clinical practice, education, and research, all within an expanded portfolio of pragmatic nutrition support care models.

Pharmacological Management of Pediatric Clostridioides difficile Infection: Clarifying the Controversies.

Clostridioides difficile infection (CDI) is a major public health concern for pediatric and adult patients. The management of pediatric CDI poses a challenge to healthcare providers due to lack of strong randomized controlled trials to guide pharmacological management. Additionally, recent updates to CDI guidelines recommend oral vancomycin over metronidazole for the management of CDI in adults, leaving questions regarding how to best manage pediatric patients. This continuing education pharmacotherapy review describes available evidence for the safety and efficacy of medications used in the treatment and management of pediatric CDI and aims to clarify discrepancies between pediatric and adult recommendations.

Complexity of Medication Regimens for Children With Neurological Impairment.

Importance: Parents of children with severe neurological impairment (SNI) manage complex medication regimens (CMRs) at home, and clinicians can help support parents and simplify CMRs. Objective: To measure the complexity and potentially modifiable aspects of CMRs using the Medication Regimen Complexity Index (MRCI) and to examine the association between MRCI scores and subsequent acute visits. Design, Setting, and Participants: This cross-sectional study was conducted between April 1, 2019, and December 31, 2020, at a single-center, large, hospital-based, complex care clinic. Participants were children with SNI aged 1 to 18 years and 5 or more prescribed medications. Exposure: Home medication regimen complexity was assessed using MRCI scores. The total MRCI score is composed of 3 subscores (dosage form, dose frequency, and specialized instructions). Main Outcomes and Measures: Patient-level counts of subscore characteristics and additional safety variables (total doses per day, high-alert medications, and potential drug-drug interactions) were analyzed by MRCI score groups (low, medium, and high score tertiles). Associations between MRCI score groups and acute visits were tested using Poisson regression, adjusted for age, complex chronic conditions, and recent health care use. Results: Of 123 patients, 73 (59.3%) were male with a median (interquartile range [IQR]) age of 9 (5-13) years. The median (IQR) MRCI scores were 46 (35-61 [range, 8-139]) overall, 29 (24-35) for the low MRCI group, 46 (42-50) for the medium MRCI group, and 69 (61-78) for the high MRCI group. The median (IQR) counts for the subscores were 6 (4-7) dosage forms per patient, 7 (5-9) dose frequencies per patient, and 5 (4-8) instructions per patient, with counts increasing significantly across higher MRCI groups. Similar trends occurred for total daily doses (median [IQR], 31 [20-45] doses), high-alert medications (median [IQR], 3 [1-5] medications), and potential drug-drug interactions (median [IQR], 3 [0-6] interactions). Incidence rate ratios of 30-day acute visits were 1.26 times greater (95% CI, 0.57-2.78) in the medium MRCI group vs the low MRCI group and 2.42 times greater (95% CI, 1.10-5.35) in the high MRCI group vs the low MRCI group. Conclusions and Relevance: Higher MRCI scores were associated with multiple dose frequencies, complicated by different dosage forms and instructions, and associated with subsequent acute visits. These findings suggest that clinical interventions to manage CMRs could target various aspects of these regimens, such as the simplification of dosing schedules.

Providers' perspectives on the clinical utility of pharmacogenomic testing in pediatric patients.

Aim: To assess providers' knowledge, attitudes, perceptions, and experiences related to pharmacogenomic (PGx) testing in pediatric patients. Materials & methods: An electronic survey was sent to multidisciplinary healthcare providers at a pediatric hospital. Results: Of 261 respondents, 71.3% were slightly or not at all familiar with PGx, despite 50.2% reporting prior PGx education or training. Most providers, apart from psychiatry, perceived PGx to be at least moderately useful to inform clinical decisions. However, only 26.4% of providers had recent PGx testing experience. Unfamiliarity with PGx and uncertainty about the clinical value of testing were common perceived challenges. Conclusion: Low PGx familiarity among pediatric providers suggests additional education and electronic resources are needed for PGx examples in which data support testing in children.

Perceived Versus Demonstrated Understanding of the Complex Medications of Medically Complex Children.

OBJECTIVES: Parents and caregivers of children with medical complexity (CMC) manage complex medication regimens (CMRs) at home. Parental understanding of CMRs is critical to safe medication administration. Regarding CMR administration, we 1) described the population of CMC receiving CMRs; 2) assessed parental perceived confidence and understanding; and 3) evaluated parental demonstrated understanding. METHODS: Cross-sectional clinic-based assessment of knowledge and understanding of CMC using CMRs who received primary care in a large pediatric complex care clinic. CMRs were identified by the receipt of ≥1 of the following: 1) ≥10 concurrent medications; 2) ≥1 high-risk medication; or 3) ≥1 extemporaneously compounded medication. Parents reported their perceived confidence and understanding of CMRs, and then demonstrated understanding through 3 medication-related tasks. RESULTS: Of 156 CMCs, most were <10 years of age (63.5%), white (75%), had neurologic impairment (76.9%), and used a median of 8 medications (IQR, 5-10). Parents were female (76.9%) with a mean age of 38.8 ± 11.5 years, white (69.9%), spoke English (94.2%), and had some college education (82.1%). On 11 confidence and understanding statements, most parents reported a high perceived level of understanding and confidence, with combined agreement or strong agreement ranging between 81.2% and 98.7%. Only 73.1% correctly identified medications taken for specified conditions, 40.4% reported complete dosing parameters, and 54.8% correctly measured 2 different medication doses. Significant differences existed between parental perceived understanding versus the 3 demonstrated tasks (all p < 0.05). CONCLUSIONS: Substantial opportunities exist to improve medication safety and efficacy in the outpatient, in-home setting including improved medication-specific education and medication-related supports.

Parent-Reported Symptoms and Medications Used Among Children With Severe Neurological Impairment.

Importance: Children with severe neurological impairment (SNI) often take multiple medications to treat problematic symptoms. However, for children who cannot self-report symptoms, no system exists to assess multiple symptoms and their association with medication use. Objectives: To assess the prevalence of 28 distinct symptoms, test whether higher global symptom scores (GSS) were associated with use of more medications, and assess the associations between specific symptoms and medications. Design, Setting, and Participants: This cross-sectional study was conducted between April 1, 2019, and December 31, 2019, using structured parent-reported symptom data paired with clinical and pharmacy data, at a single-center, large, hospital-based special health care needs clinic. Participants included children aged 1 to 18 years with SNI and 5 or more prescribed medications. Data analysis was performed from April to June 2020. Exposure: During routine clinical visits, parent-reported symptoms were collected using the validated 28-symptom Memorial Symptom Assessment Scale (MSAS) and merged with clinical and pharmacy data. Main Outcomes and Measures: Symptom prevalence, counts, and GSS (scored 0-100, with 100 being the worst) were calculated, and the association of GSS with medications was examined. To evaluate associations between symptom-medication pairs, the proportion of patients with a symptom who used a medication class or specific medication was calculated. Results: Of 100 patients, 55.0% were boys, the median (interquartile range [IQR]) age was 9 (5-12) years, 62.0% had 3 or more complex chronic conditions, 76.0% took 10 or more medications, and none were able to complete the MSAS themselves. Parents reported a median (IQR) of 7 (4-10) concurrent active symptoms. The median (IQR) GSS was 12.1 (5.4-20.8) (range, 0.0-41.2) and the GSS was 9.8 points (95% CI, 5.5-14.1 points) higher for those with worse recent health than usual. Irritability (65.0%), insomnia (55.0%), and pain (54.0%) were the most prevalent symptoms. Each 10-point GSS increase was associated with 12% (95% CI, 4%-19%) higher medication counts, adjusted for age and complex chronic condition count. Among the 54.0% of children with reported pain, 61.0% were prescribed an analgesic. Conclusions and Relevance: These findings suggest that children with SNI reportedly experience substantial symptom burdens and that higher symptom scores are associated with increased medication use. Paired symptom-medication data may help clinicians identify targets for personalized symptom management, including underrecognized or undertreated symptoms.

Pharmacological Management of Spasticity in Children With Cerebral Palsy.

Cerebral palsy (CP), a nonprogressive disease of the central nervous system, is the most common motor disability in childhood. Patients with CP often have a multitude of associated comorbidities, including impact on muscle tone. There are four main types of CP, with spastic as the most commonly diagnosed. Reduction in spasticity is important because it can affect not only the patient's quality of life, functional abilities, and well-being but also the lives of caregivers. The American Academy of Neurology and Child Neurology Society released a practice parameter regarding the pharmacological management of CP-related spasticity in 2010. Since then, data have been published evaluating the safety and efficacy of oral and parenteral medications to manage spasticity. This continuing education review evaluates the available safety and efficacy evidence for oral and parenteral pharmacological agents used to reduce spasticity in children with CP and provides a reference for practitioners managing these patients.

Significant Published Articles for Pharmacy Nutrition Support Practice in 2018.

Purpose: The purpose of this article is to assist the pharmacist engaged in nutrition support therapy in staying current with pertinent literature. Methods: Several clinical pharmacists engaged in nutrition support therapy compiled a list of articles published in 2018 considered important to their clinical practice. The citation list was compiled into a single spreadsheet where the author participants were asked to assess whether the article was considered important to nutrition support pharmacy practice. A culled list of publications was then identified whereby the majority of author participants (at least 5 of 8) considered the paper to be important. Guideline and consensus papers from professional organizations, important to practice but not scored, were also included. Results: A total of 117 articles were identified; 8 from the primary literature were voted by the group to be of high importance. An additional 13 organizational guidelines, position, recommendation, or consensus papers were also identified. The top-ranked articles from the primary literature were reviewed. Conclusion: We recommend that pharmacists engaged in nutrition support therapy be familiar with these articles as it pertains to their practice.

Academic Careers in Pediatric Pharmacy: Part 2-Academic Advancement.

An increasing number of pediatric clinical pharmacists are pursuing careers in academia. Once in an academic position, questions, challenges and benefits related to the processes of academic evaluation and advancement unique to pediatric academia often arise. This is the second article in a 2-part series that attempts to demystify pediatric faculty positions and address gaps in the literature regarding careers in pediatric-focused academic positions. The purpose of this article is to review key aspects pertaining to academic evaluation and the preparation for and process of academic advancement/promotion. A question and answer format is used to discuss common questions related to these processes and tips for success are provided. This article is primarily intended to be used as a helpful guide for junior faculty members as well as mid-level individuals seeking advancement; however, it will also benefit students, trainees, and practicing pharmacists seeking increased knowledge of pediatric academic career paths.

Overview and Preparation Guide for Academic Careers in Pediatric Pharmacy, Part 1: Career as a Pediatric Pharmacy Practice Faculty Member.

Pediatric clinical pharmacy is a growing and evolving field with an increasing number of pediatric clinical pharmacists in academia. In 2017, pediatric practice faculty members represented approximately 7.6% of all pharmacy practice faculty in the United States. The benefits of practicing in an academic environment are many, including, but not limited to, the ability to shape the future of pharmacy practice through the training of the next generation of pharmacists, contributing to science through research and scholarly activities for the care of pediatric patients, and positively impacting patient care for the most vulnerable of patients. Part one of this two-part series describes careers in academic pediatric pharmacy, as well as faculty roles and responsibilities, and provides information and advice related to the preparation and transition into careers in academic pediatric pharmacy.

Cannabidiol: A New Hope for Patients With Dravet or Lennox-Gastaut Syndromes.

OBJECTIVE: To review the efficacy, safety, pharmacology and pharmacokinetics of pure, plant-derived cannabidiol (CBD; Epidiolex) in the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). DATA SOURCES: Relevant information was identified through EMBASE and Ovid MEDLINE (1946 to October 2018). Product labeling and https://www.clinicaltrials.gov were also reviewed. STUDY SELECTION/DATA EXTRACTION: English language articles evaluating efficacy and safety in humans with treatment-resistant epilepsies were reviewed; additional pharmacology and pharmacokinetic studies in humans, animals, and in vitro were also included. DATA SYNTHESIS: Pure, plant-based CBD is a pharmaceutical grade extract that exhibits clinically significant antiseizure properties, with a hypothesized multimodal mechanism of action. In the GWPCARE trial series, CBD displayed superior efficacy in reducing key seizure frequencies (convulsive seizures in DS; drop seizures in LGS) by 17% to 23% compared with placebo as adjunctive therapy to standard antiepileptic drugs in patients 2 years of age and older. Common adverse effects were somnolence, diarrhea, and elevated hepatic transaminases. Noteworthy drug-drug interactions included clobazam, valproates, and significant inducers/inhibitors of CYP2C19 and 3A4 enzymes. Relevance to Patient Care and Clinical Practice: A discussion regarding CBD dosing, administration, adverse effects, monitoring parameters, and interactions is provided to guide clinicians. CBD offers patients with DS and LGS a new treatment option for refractory seizures. CONCLUSION: This is the first cannabis-derived medication with approval from the US Food and Drug Administration. This CBD formulation significantly reduces seizures as an adjunct to standard antiepileptic therapies in patients ≥2 years old with DS and LGS and is well tolerated.

Significant Published Articles for Pharmacy Nutrition Support Practice in 2017.

Purpose: The purpose of the article is to assist the pharmacist engaged in nutrition support therapy in staying current with pertinent literature. Methods: Several clinical pharmacists engaged in nutrition support therapy compiled a list of articles published in 2017 considered important to their clinical practice. The citation list was compiled into a spreadsheet where the author participants were asked to assess whether the article was considered important to nutrition support pharmacy practice. A culled list of publications was then identified whereby the majority (at least 5 out of 8 authors) considered the article to be of significance. Guideline and consensus articles from professional organizations, important to practice but not scored, were also included. Results: A total of 95 articles were identified; six from the primary literature were voted by the group to be of high importance. An additional 13 organizational guidelines, position, recommendation, or consensus papers were also identified. The top-ranked articles from the primary literature were reviewed. Conclusion: It is recommended that pharmacists engaged in nutrition support therapy be familiar with these articles as it pertains to their practice.

Clinical pharmacy academic career transitions: Viewpoints from the field.

The six authors of this commentary series, who have recently transitioned into or within an academic career, discuss challenging aspects of an academic career change. This is a three-part commentary series that explores select challenges: 1) feedback, evaluation, and advancement; 2) understanding and balancing of distribution of effort; 3) learning how and when to say yes. Faculty, or those interested in pursuing a career in pharmacy academia, can refer to this commentary series as a reference. Schools of pharmacy may utilize this as a tool for new faculty members during orientation in order to ensure smooth integration into the academic environment.

Clinical pharmacy academic career transitions: Viewpoints from the fieldPart 1: Understanding feedback, evaluation, and advancement.

The six authors of this commentary series, who have recently transitioned into or within an academic career, discuss challenging aspects of an academic career change. This is a three-part commentary series that explores select challenges: 1) feedback, evaluation and advancement; 2) understanding and balancing of distribution of effort; 3) learning how and when to say yes. Faculty, or those interested in pursuing a career in pharmacy academia, can refer to this commentary series as a reference. Schools of pharmacy may utilize this as a tool for new faculty members during orientation in order to ensure smooth integration into the academic environment.

Clinical pharmacy academic career transitions: Viewpoints from the field part 3: Learning when and how to say yes.

The six authors of this commentary series, who have recently transitioned into or within an academic career, discuss challenging aspects of an academic career change. This is Part 3 of a three-part commentary series that focuses on when and how to say yes to the multitude of opportunities available to pharmacy practice faculty. Part 1 discusses feedback, evaluation, and advancement. Part 2 explains distribution of effort (DOE) and how to marry the different components of teaching, research, and service. While the entire series is intended to be read in continuity, faculty, or those interested in pursuing a career in pharmacy academia, can refer to Part 3 as a reference on how to screen opportunities within academia to maximize professional and personal growth and minimize career burnout. Schools of pharmacy may utilize this as a tool for new faculty members during orientation to help ensure faculty success.

Implementation and Assessment of a Novel APPE Intersession Course to Assess Near-Terminal Student Competence.

Objective. To provide a novel culminating experience that assesses student competence and achievement of five curricular outcomes during the P4 year. Methods. This two-week Intersession course provided faculty assessment of student competence after completing five of seven Advanced Pharmacy Practice Experiences (APPEs). Students completed written pre-work assignments generated from real-world experiences from APPEs. Faculty assessed and provided feedback to improve students' competency on curricular outcomes related to four course components: clinical case, drug information, clinical pearl and reflection. After incorporating faculty feedback, students verbally presented to faculty and peers for additional assessment during the in-class portion of the course. Results. There were 149 students who completed the course in 2016; 145 (97%) demonstrated achievement of ability-based outcomes. Using the Kirkpatrick's Evaluation Model, level 1 data (reaction) indicated 93% of students and 100% of faculty believed the course was valuable. Level 2 data (learning) revealed that 80% of students and 85% of faculty agreed/strongly agreed learning occurred. Level 3 data (behavior) demonstrated increased student performance on assessments between pre-work and in-class components. Preliminary level 4 data (results) indicated this course complemented learning from previous courses and met the intended purpose. Conclusion: This novel Intersession course provided structured faculty assessment of student competence during the final experiential year and successfully provided a near-final evaluation of student competence of core curricular ability-based outcomes.

Significant Published Articles for Pharmacy Nutrition Support Practice in 2016.

Purpose: To assist the pharmacist engaged in nutrition support therapy in staying current with pertinent literature. Methods: Several clinical pharmacists engaged in nutrition support therapy compiled a list of articles published in 2016 considered important to their clinical practice. The citation list was compiled into a single spreadsheet where the author participants were asked to assess whether the paper was considered important to nutrition support pharmacy practice. A culled list of publications was then identified whereby the majority of author participants (at least 5 out of 8) considered the paper to be important. Guideline and consensus papers from professional organizations, important to practice but not scored, were also included. Results: A total of 103 articles were identified; 10 from the primary literature were voted by the group to be of high importance. An additional 11 organizational guidelines, position, recommendation, or consensus papers were also identified. The top-ranked articles from the primary literature were reviewed. Conclusion: It is recommended that pharmacists, engaged in nutrition support therapy, be familiar with the majority of these articles as it pertains to their practice.