Nirsevimab: Expansion of Respiratory Syncytial Virus Prevention Options in Neonates, Infants, and At-Risk Young Children.

OBJECTIVE: Review available data from clinical trials of nirsevimab for efficacy and safety in the setting of respiratory syncytial virus (RSV) prophylaxis in infants and children, while exploring nirsevimab's role in clinical practice and highlighting continuing questions. DATA SOURCES: A literature search of PubMed was conducted utilizing the phrases "nirsevimab" and "medi8897." Additional references were identified through found references. Organizational guidelines, medication labeling, and regulatory organization presentations were utilized. STUDY SELECTION AND DATA EXTRACTION: Relevant clinical trials investigating nirsevimab in infants and children were included as well as other references on pharmacology, pharmacokinetics, and pharmacoeconomics. DATA SYNTHESIS: Nirsevimab, a once-a-season monoclonal antibody, demonstrated a 79.5% (95% CI, 65.9-87.7; P < 0.00001) lower incidence of RSV-associated medically attended lower respiratory tract infections (MA RSV-associated LRTI) and 77.3% (95% CI, 50.3-89.7; P = 0.0002) reduction in hospitalizations for RSV-associated MA-LRTI across 2 placebo-controlled studies. Nirsevimab demonstrated comparable safety to placebo with minor dermatologic reactions being the most common adverse event (0.9% vs 0.6%). RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON WITH EXISTING AGENTS: Nirsevimab was approved by the US Food and Drug Administration, and recommended by the Advisory Committee on Immunization Practices and American Academy of Pediatrics for broad administration to infants entering their first RSV season and at risk patients during their second RSV season. Questions remain over efficacy in infants born < 29-week gestation and other economical considerations. CONCLUSIONS: Nirsevimab demonstrated clinical efficacy in reducing RSV-associated MA-LRTI and RSV-associated hospitalizations in infants and was well tolerated.

Diagnosis and Treatment of ADHD in the Pediatric Population.

Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in childhood with approximately 6 million children (age 3 to 17 years) ever diagnosed based on data from 2016-2019. ADHD is characterized by a constant pattern of inattention and/or hyperactivity-impulsivity symptoms that interferes with development or functioning. Specific criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th edition Text Revision assist with the diagnosis with multiple guidelines available providing non-pharmacologic and pharmacologic recommendations for the treatment of ADHD in the pediatric population. While all guidelines similarly recommend behavioral and/or stimulant therapy as first-line therapy based on age, not all stimulant products are equal. Their differing pharmacokinetic profiles and formulations are essential to understand in order to optimize efficacy and safety for patients. Additionally, new stimulant products and non-stimulant medications continue to be approved for use of ADHD in the pediatric population and it is important to know their differences in formulation, efficacy, and safety to other products currently available. Lastly, due to drug shortages, it is important to understand product similarities and differences to select alternative therapy for patients.

Updates in the treatment of asthma in pediatrics: A review for pharmacists.

PURPOSE: The purpose of this review is to summarize the management of asthma in children and to highlight different guideline-based approaches. This review also discusses literature regarding the use of corticosteroids, both inhaled and systemic, as well as biologic agents, in asthma management. SUMMARY: Asthma is a common chronic respiratory condition in the pediatric population and has evolved into a highly patient-specific disease. Of the 2 main asthma guidelines, one developed by the National Asthma Education and Prevention Program was recently published as a focused update in 2020. The other, from the Global Initiative for Asthma, focuses on a global strategy for management and prevention, with the most recent update in 2023. Both reports discuss diagnosis, assessment, and treatment of asthma in adults and children. Treatment is designed as a stepwise approach in both reports, although there are key differences. This article focuses on gaps in these guidelines, including the use of bronchodilators and inhaled corticosteroids with single maintenance and reliever therapy and long-acting muscarinic antagonists in children. It also reviews treatment in children under 5 years of age, although recommendations are limited due to a lack of evidence in this age group. Finally, this review discusses considerations for emerging treatments, including biologics, for patients who are difficult to treat. CONCLUSION: New treatment strategies and agents have emerged in the treatment of pediatric asthma. Pharmacists play a key role in providing education about, dispensing, and recommending the newest evidence-based treatment options for children.

A few small steps or giant leap? De-densify the curriculum in one move.

INTRODUCTION: We describe a two-year, stepwise curricular change plan with a goal to address student and faculty wellbeing by reducing curricular density and rescheduling courses. METHODS: At year five of a new practice-ready curriculum, we strategically assessed and redesigned our integrated learning experience (ILE) course sequence to minimize curricular density with consideration for student and faculty wellbeing. This stepwise approach to curricular revision involved converting an in-class day (three hours) to asynchronous delivery in 12 core didactic courses (first- through third-professional years) for one year followed by a transition to a four-day vs. five-day course week the following year. Additional scheduling changes were implemented to improve the use of physical classroom space and overlapping student activities. RESULTS: Whereas thinking a gradual transition would be more accepted, moving straight to a four-day ILE week would have been more beneficial for faculty workload and wellbeing and decreased student confusion. However, the rescheduling of courses freed up classroom space allowing all classes to be held in person in a physical classroom and alleviated overlapping curricular activities during the week. CONCLUSIONS: The stepwise change of including an asynchronous day resulted in confusion and stress during the transition to a four-day class week and additional faculty work. However, adjusting the course schedule increased uncommitted student and faculty time, alleviated classroom constraints, and eliminated overlapping curriculum activities. Learning about our process and approach to reduce curricular density, what worked well, and lessons learned may allow other programs to be more efficient when making curricular changes.

Mentorship Landscape and Common Practices in an Academic Pharmacy Association.

OBJECTIVES: To explore the landscape of mentorship within professional associations in pharmacy academia, including reviewing available literature and describing currently available programs within the American Association of Colleges of Pharmacy, and recommend key considerations for the development of mentorship programs within professional associations. FINDINGS: A literature review of mentorship programs within professional associations for pharmacy academics was conducted, with a total of 5 articles identified and summarized. Additionally, a survey was conducted to determine the landscape of available mentorship programs within American Association of Colleges of Pharmacy affinity groups to capture unpublished experiences. Information regarding common characteristics and assessment methods was collected for groups that have mentorship programs, while needs and barriers were collected for those who did not. SUMMARY: Literature, while limited, supports positive perceptions of mentorship programs within professional associations. Based on the responses and working group experience, several recommendations are proposed for mentorship program development, including the need for clearly defined goals, relevant program outcomes, association support to reduce redundancies and promote participation, and, in some cases, implementation of an association-wide program to ensure access to mentorship.

Considerations for Treating Nonobstetric Diseases in Pregnant Patients in the Emergency Department Setting.

OBJECTIVE: To provide nonobstetric practitioners with an overview of key concepts for the pregnant patient and review treatment of 3 common acute nonobstetric diseases encountered in the emergency department setting. DATA SOURCES: A literature search of PubMed was performed (1997-February 2023) using key search terms related to pregnancy, pain, urinary tract infection (UTI), venous thromboembolism (VTE), and anticoagulants. STUDY SELECTION AND DATA EXTRACTION: Relevant articles in English and humans were considered. DATA SYNTHESIS: When caring for a pregnant patient, it is important to utilize appropriate assessments, understand terms used in this population, and recognize how the physiological and pharmacokinetic changes that occur in pregnancy can influence medication use. Pain, UTIs, and VTE are common in this population. Acetaminophen is the most widely used medication for the management of pain during pregnancy and the drug of choice for mild pain in pregnancy not responsive to nonpharmacologic treatment. Pyelonephritis is the most common nonobstetric cause of hospitalization for pregnant patients. Antimicrobial treatment should consider maternal-fetal safety and local resistance patterns. Pregnant and postpartum patients have a 4- to 5-fold increased risk of developing a VTE compared with nonpregnant patients. Low-molecular-weight heparin is the preferred treatment. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Pregnant patients often seek acute care in the emergency department setting for nonobstetric needs. Pharmacists in this setting should understand appropriate assessment questions and terms used within this population, the basics of physiological and pharmacokinetic changes in pregnancy that can impact treatment, and which resources are best to utilize for drug information of the pregnant patient. CONCLUSION: Practitioners in the acute care setting commonly encounter pregnant patients seeking care for nonobstetric concerns. This article covers key pregnancy-related information for the nonobstetric practitioner and focuses on the management of acute pain, UTI, and VTE during pregnancy.

Call to expand access to vaccines for children through pharmacist education, collaboration, and advocacy.

Vaccines are a daycare and school requirement for children. The Public Readiness and Emergency Preparedness (PREP) Act 3rd amendment grants pharmacists and pharmacy interns the capability to vaccinate children at ages 3-18 years according to the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices schedule of recommended vaccines. Before this, only some state boards of pharmacy allowed pharmacists to administer pediatric vaccines. Despite these opportunities, immunization training programs lack the comprehensive training of pediatric vaccines and administration for pharmacists and pharmacy interns without additional financial cost. All pharmacists should be adequately trained and pharmacies be reimbursed to provide vaccines to all ages of pediatric patients. Advocacy is necessary to ensure children have reliable, affordable, and convenient access to lifesaving vaccines today and after the PREP Act expires.

A Review of the Data Supporting Use of COVID-19 Vaccinations in the Pediatric Population.

OBJECTIVE: The objective of this study was to review the effectiveness and safety of COVID-19 vaccinations in the pediatric population. DATA SOURCES: PubMed/Medline (September 2020 to December 2022), the Centers for Disease Control and Prevention, and Food and Drug Administration (FDA) websites. STUDY SELECTION AND DATA EXTRACTION: Publications regarding the safety and efficacy of COVID-19 vaccinations in children were included. DATA SYNTHESIS: Vaccines authorized for use in children include two monovalent mRNA vaccines (≥6 months old) and one monovalent protein subunit adjuvant vaccine (adolescents only). Omicron-specific mRNA bivalent boosters are authorized for children ≥6 months old. Studies after monovalent vaccine authorization illustrated efficacy in children >5 to 6 years of age, specifically decreased severe COVID-19 (including mortality) and multisystem inflammatory response syndrome occurrence (including during Omicron predominance). Available data for children <5 to 6 years suggests efficacy, although data are limited. Monovalent vaccine efficacy against Omicron infections may wane as early as 2 months, but protection against severe disease complications may last longer, and bivalent Omicron boosters are anticipated to increase effectiveness. Myocarditis/pericarditis is a safety concern associated with the COVID-19 vaccinations but occurs less frequently then COVID-19 complications and thus the benefit outweighs the risks. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Caregivers seek information from health care professionals regarding vaccine safety and efficacy. Pharmacists can use the objective information in this review to educate caregivers and effectively administer COVID-19 vaccines to patients. CONCLUSIONS: There is sufficient and continually growing safety and efficacy data available to recommend COVID-19 vaccinations for children ≥6 months of age.

Developing Authentic Mentorship Through Professional Organizations.

Harsh realities in pandemic fatigue, burnout, inequities, and isolation are impacting academic pharmacy. Mentoring programs, especially inter-institutional programs such as those provided within the Sections and Special Interest Groups (SIGs) of the American Association of Colleges of Pharmacy (AACP), may combat some of these issues. Unfortunately, year after year, Academy members continue to request information from these groups on mentoring, whether it be the opportunity to pair up, for advice on how to be better mentors, or for guidance on how to develop a program on mentoring for the Sections and SIGs without an existing program. The need for authentic mentoring is vital to the success and retention of faculty and staff within the Academy. Therefore, it may be appropriate to take a closer look at why, despite ongoing mentoring programs scattered within AACP Sections and SIGs, these programs are unable to fulfill the needs of participants.

Teaching of the patient workup process improves students' perceptions of preparation for advanced pharmacy practice experiences.

BACKGROUND AND PURPOSE: One of the most common daily tasks on Advanced Pharmacy Practice Experiences (APPEs) is "working up" patients for inpatient rounds or outpatient visits. The purpose of this study was to assess a change in student pharmacist comfort level in performing a patient workup before and after the Pre-APPE Workshop by specifically teaching this process. EDUCATIONAL ACTIVITY AND SETTING: The patient workup process was included in the Pre-APPE Workshop, a one-week APPE orientation course at the end of the third professional year. Students completed a 34 question self-assessment prior to instruction and after completion of the course to assess their comfort level with working up patients and readiness for APPEs. Student perceptions were compared pre- and post-assessment. Additionally, performance on assignments and results from a voluntary course evaluation were assessed. FINDINGS: One hundred and fifty-two (100%) students enrolled in the Pre-APPE Workshop completed the pre- and post- self-assessments. Differences in student comfort level were found between the pre- and post-course self-assessments (median, [interquartile range]) related to performing an inpatient workup (3 [2-3] versus 3 [3-3], median change 0 [range - 2, 3]), and the outpatient workup (3 [2-3] versus 3 [3-4], median change 1 [range - 2, 3]), Overall, students felt more prepared to start APPEs after the Pre-APPE Workshop (3 [2-3] versus 3 [3-4]). SUMMARY: Incorporating teaching of the patient workup process into the pre-APPE curriculum improved student pharmacist's comfort level with completing patient workups, and perceptions of preparation for APPE rotations.

Article Club to Encourage Meaningful and Impactful Conversations on Leadership Among Pharmacy Faculty and Staff.

Objective. To describe outcomes from an article club that was designed to foster leadership within a pharmacy school by informally gathering interested faculty and staff and providing a safe environment for discussion on leadership concepts.Methods. At each monthly meeting, participants discussed an article from Harvard Business Review's top 10 leadership articles. After 10 sessions, participants were asked to complete an electronic survey about their perspectives on the activities and invited to participate in an interview. Descriptive statistics were calculated, and qualitative software was used to analyze the interview transcripts. Videoconferencing allowed for off-campus faculty and staff participation. No direct programmatic costs were incurred.Results. Four to 24 participants attended each session. Sixteen participants completed the survey, and five volunteered to be interviewed. All participants strongly agreed that the sessions increased awareness of leadership concepts, and 15 strongly agreed or agreed that the activities influenced their leadership decision-making and facilitated building a culture of leadership at the school. Interviews revealed that mid-career faculty participated to learn about general leadership concepts from discussions and a few junior faculty participated to gain leadership skills to help with promotion. All participants noted they were exposed to novel leadership styles by participating in the article discussion sessions. Teaching and practice commitments were the two reasons most often given for not participating.Conclusion. Providing an interactive discussion forum for pharmacy education faculty and staff to learn and discuss leadership concepts and qualities is effective for personal growth and professional development. Other schools and institutions can implement similar activities to foster leadership.

Key articles and guidelines for the pediatric clinical pharmacist from 2019 and 2020.

PURPOSE: To summarize recently published research reports and practice guidelines deemed to be significantly impactful for pediatric pharmacy practice. SUMMARY: Our author group was composed of 8 board-certified pediatric pharmacists. Eight major themes were identified: critical care, hematology/oncology, medication safety, general pediatrics, infectious diseases, neurology/psychiatry, gastrointestinal/nutrition, and neonatology. The author group was assigned a specific theme(s) based on their practice expertise and were asked to identify articles using MEDLINE and/or searches of relevant journal articles pertaining to each theme that were published from January 2019 through December 2020 that they felt were "significant" for pediatric pharmacy practice. A final list of compiled articles was distributed to the authors, and an article was considered significant if it received a vote from 5 of the 8 authors. Thirty-two articles, including 16 clinical practice guidelines or position statements and 16 review or primary literature articles, were included in this review. For each of these articles, a narrative regarding its implications for pediatric pharmacy practice is provided. CONCLUSION: Given the heterogeneity of pediatric patients, it is difficult for pediatric pharmacists to stay up to date with the most recent literature, especially in practice areas outside their main expertise. Over the last few years, there has been a significant number of publications impacting the practice of pediatric pharmacists. This review of articles that have significantly affected pediatric pharmacy practice may be helpful in staying up to date on key articles in the literature.

Development and assessment of a nationwide, cross-discipline women faculty mentoring program.

INTRODUCTION: Professional health care associations present a unique opportunity for formal mentorship programs, with membership often spanning a variety of experiences, professional ranks, and institutions. However, scarce literature describes the role of professional associations in the development and assessment of mentoring programs. This paper describes development of the American Association of Colleges of Pharmacy Women Faculty Special Interest Group (SIG) mentoring program and characterizes the impact of the program. METHODS: The task force collaboratively developed the mission, vision, and structure of the mentoring program, posted the program description on the SIG's electronic forum, and called for mentors and mentees via an online survey asking for matching preferences. The task force reviewed responses and designated matches. Participants were emailed match information and a guidance document. The program was assessed at three, six, and 12 months via electronic survey. RESULTS: The program matched 43 mentors with 77 mentees, with each mentor assigned one to three mentees. At the three- and six-month assessments, 89% and 87% of respondents, respectively, indicated they had met with their mentor/mentee. At the 12-month assessment, 86% of mentor respondents and 80% of mentee respondents stated the mentoring program met their needs/expectations. Career goal development, work/life integration, and difficult work situations were the most frequently discussed topics. Most participants stated they would continue to serve as a mentor/mentee in a future cycle and recommend other faculty members participate. CONCLUSIONS: Results from three-, six-, and 12-month assessments indicated a positive impact of developing a nationwide, organizational, cross-discipline mentoring program.

Improving Student Pharmacists' Learning Through the Use of Pediatric Simulation.

OBJECTIVE: The purpose of this study was to assess the effect of low-fidelity simulation on students' confidence, knowledge, and skills in pediatric physical assessments, and to compare students' interest ratings of topics and effectiveness of learning activities between students' who experienced simulation and those who did not. METHODS: Within a pediatric elective, a vital signs and physical assessment activity was re-designed to incorporate a low-fidelity heart and breath sounds simulator. Students rated their confidence in completing 9 different physical assessment skills before and after the activity and assessment. Students' perspectives of the activity were also assessed. Course evaluation surveys were compared with prior course offerings (without simulation) to determine a change in students' interest ratings of the topic and effectiveness of learning activities. The Wilcoxon signed rank test, thematic analysis, and descriptive statistics were used to analyze outcomes. RESULTS: All 106 second professional year students in the elective completed the pre- and post-simulation surveys and course evaluations for 3 offerings. Students' post-simulation average confidence scores increased statistically on all 9 skills compared with pre-simulation scores. All students agreed or strongly agreed "the lecture and simulation activity done in class helped me overcome challenges I had with learning the skill." Students (98%) successfully demonstrated competency on the formal assessment. Compared with previous course offerings, students reported higher interest ratings in the topics and instruction effectiveness when simulation was incorporated into the activity. CONCLUSIONS: Low-fidelity simulation is an effective teaching and learning approach to increase students' confidence, knowledge, and interest in pediatric vital signs and physical assessment.

Less common bacterial, fungal and viral infections: review of management in the pregnant patient.

This review is a comprehensive summary of treatment options for pregnant patients with less common bacterial, fungal, and viral infections. It offers guidance to clinicians based on the most recently published evidence-based research and expert recommendations. A search of MEDLINE (inception to March 2021) and the CDC website was performed. Liposomal amphotericin B is the preferred therapy for cryptococcosis, histoplasmosis, oesophageal candidiasis, and coccidioidomycosis, especially during the first trimester due to teratogenic concerns with azole antifungals. For oral candidiasis, clotrimazole troches or miconazole mucoadhesive buccal tablets are recommended. A ß-lactam antimicrobial is preferred over doxycycline for various manifestations of Lyme disease and the drug of choice for Pneumocystis pneumonia is trimethoprim/sulfamethoxazole. Acyclovir is the preferred antiviral for varicella zoster virus. Fluoroquinolones, macrolides, and aminoglycosides should be avoided if possible and there are alternate agents available for an effective treatment regimen. There is a scarcity of clinical data in pregnant patients with less common bacterial, fungal and viral infections. This population lacks definitive recommendations in many clinical practice guidelines. The key to optimizing therapy is a comprehensive review of the available evidence and a careful balance of risks and benefits before final treatment decisions.

The Influence of the Food and Drug Administration Pregnancy and Lactation Labeling Rule on Drug Information Resources.

BACKGROUND: Drug information resources are commonly used by health-care providers answering pregnancy-related medication questions. In 2015, the United States Food and Drug Administration approved a new pregnancy and lactation medication labeling content and format, removing the pregnancy category, and using a narrative. Despite labeling requirements changing, it is unknown if drug information resources updated monographs to reflect these changes. OBJECTIVE: The primary objective was to evaluate if commonly used drug information resources provide pregnancy information listed similar to the requirements of the Pregnancy and Lactation Labeling Rule (PLLR). Secondary analyses included evaluating the references and inclusion of the pregnancy category rating. METHODS: Pregnancy recommendations for 23 medications were evaluated in 9 drug information resources (Clinical Pharmacology, Drugs in Pregnancy and Lactation, Epocrates®, First Databank, LexiComp® Online, LexiComp® Online Pregnancy & Lactation, In-Depth, Medi-Span®, Micromedex®, and Multum®). The number of references per drug monograph and most recent reference publication year was obtained. RESULTS: LexiComp® Online Pregnancy & Lactation, In-Depth mimics the new PLLR structure and consistently had the highest number of and most recent references when the medication was included. Drugs in Pregnancy and Lactation was the next most similar in content with the PLLR and second in most references per monograph; however, the most recent reference was the textbook publication year. CONCLUSION AND RELEVANCE: LexiComp® Online Pregnancy & Lactation, In-Depth and Drugs in Pregnancy and Lactation provided pregnancy information in a format most similar to the PLLR. However, several drug information resources contained pregnancy categories ratings that were to be removed from medication labeling per the PLLR.

How to Incorporate the Experiential Student Pharmacist Into the Pediatric Practice Setting.

Experiential education conducted in the pediatric practice setting provides student pharmacists the opportunity to learn about a unique patient population. For many students, experiential rotations may be the only form of pediatric education they receive in pharmacy school. Providing quality pediatric experiences is essential to stimulate students' interest in this practice area and train those with goals to become pediatric pharmacists. It is also important to ensure graduating pharmacists have exposure to fundamental pediatric pharmacy concepts. Although pediatric practice areas and institutions differ in patient populations and services, a well-rounded rotation experience should be provided for the pharmacy student. Preceptors must decide what concepts to teach and what activities students should be incorporated into during this experiential period. This article provides goals and activities for student pharmacists that can be included in newly designed introductory pharmacy practice experiences and advanced pharmacy practice experiences within various pediatric settings.