Respiratory syncytial virus (RSV) is a major contributor to global morbidity and mortality, disproportionately affecting young children and infants. Annual worldwide estimates suggest more than 30 million cases of lower respiratory infection and 100,000 deaths are attributed to RSV in children younger than 5 years of age, making RSV prevention and treatment a global priority. Recently approved monoclonal antibodies and vaccines for the prevention of RSV in infants and children have the potential to significantly alter disease burden. Disease prevention is paramount as treatments with rigorously proven clinical efficacy are limited, and supportive care remains the primary management strategy for the majority of patients who contract RSV. However, new entities continue to be evaluated for the treatment of RSV in the pediatric population. This review aimed to synthesize and evaluate existing data on the approved RSV preventative therapies nirsevimab, RSVpreF, clesrovimab, and palivizumab. RSV disease, including its spread, virology, diagnosis, clinical presentation, and treatment, is also discussed.
Antibiotics constitute the majority of prescriptions for women during pregnancy. Common bacterial infections, including urinary tract infections, skin and soft tissue infections, and upper and lower respiratory tract infections, are expected in pregnancy, similar to the general public. These infections carry additional risks to both the woman and fetus; thus, antibiotics are often prescribed. Antibiotics, like other drugs, are not benign and may carry additional risks to the fetus beyond commonly encountered adverse drug events seen across most patient populations. Since 2014, 19 new antibiotics have been approved by the United States Food and Drug Administration. Additionally, in 2018, the previously held pregnancy category rating expired, and all manufacturers' labeling was updated with new narrative language reflecting safety in pregnancy, lactation, and males and females of reproductive potential. This review provides a comprehensive summary of available data and an update to the 2015 publication regarding the safe use of antibiotics in pregnancy. The primary focus of this review is on newly approved antibiotics, along with any additional published evidence on previously reviewed antibiotics. Data on lactation or antiviral or antifungal use in pregnancy are not included. Clinicians should remain updated on current available evidence and vigilant to provide safe and effective antibiotic decision-making in pregnant women.
Children often experience viral illnesses causing respiratory symptoms. Frequently, nonprescription medications are used in an attempt to decrease the severity and frequency of cough and cold symptoms. Cough and cold medications (CCMs) are not appropriate for all age groups and can have serious adverse effects, including death, especially when used incorrectly. Data surrounding the safety and efficacy of CCMs in patients younger than 6 years are lacking. Currently, the US Food and Drug Administration (FDA) does not recommend the use of cough and cold products that contain an antihistamine or decongestant in children younger than 2 years. Other treatments used by patients for cold symptoms include non-pharmacologic therapies or complementary alternative medications (CAMs), such as zinc or echinacea. Given this is a common ailment for pediatric patients, pharmacists should be knowledgeable about the risks and benefits of each of these therapies to make safe recommendations for patients and their families. This review discusses various cough and cold therapies and the recommendations for their use in pediatric patients.
Objective: This study aimed to assess the impact of curricular content reduction in a 3-year integrated course sequence in a Doctor of Pharmacy curriculum on student-reported mental and physical health. Methods: A 3-hour, 5-days-a-week integrated course sequence spanning 3 years of a curriculum was transitioned to a 3-hour, 4-days-a-week course, representing 207 h of reduced in-class time. After implementation, first- through third-year student pharmacists were asked to complete a 23-item voluntary survey regarding the impact of the curricular change on their mental and physical health, how they spent time on the non-Integrated Learning Experience course day, and additional demographic and social characteristics. Respondents were asked to participate in follow-up focus group sessions to elucidate the findings of the survey. Results: A total of 197 students (50.3% response rate) representing the classes of 2024, 2025, and 2026 responded to the survey, and 15 students participated in 1 of 4 focus group sessions. Most students indicated a preference for the 4-days-a-week over the 5-days-a-week course and reported improvement in mental and physical health during the 4-days-a-week course. Most students used the additional time to study or complete assignments, while many third-year students used it to work, but many also used it to complete personal errands and activities, which led to a positive impact on their well-being. Conclusion: Student self-reported mental and physical health improved with a reduction in curricular content by 1 course session (3 h) per week.
ObjectiveTo evaluate the effect of curricular content reduction in an integrated course sequence spanning three years of a Doctor of Pharmacy curriculum on student exam scores and course grades.MethodsThis two-year, pre-post study compared student overall average and final exam scores and overall course grades after the transition from a 5-day to 4-day week of an integrated learning experience (ILE) course sequence. Additionally, an anonymous, optional 23-item survey was distributed to P1-P3 students asking about the 4-day week change, how they utilized the non-ILE day, and additional demographic and social characteristics to identify factors influencing success on exam and course performance during the 4-day week.ResultsThere were 533 students included in the overall analysis with no significant differences in overall course grades in the 5-day versus 4-day week. Exam scores were not significantly different after the transition except in two of twelve courses where scores were higher and final exams scores were not significantly different, except for higher final exam scores in one course during the 5-day week. Significant positive influencers of top quartile of exam performance included pre-pharmacy GPA ≥ 3.5, age 25-29, and pre-pharmacy coursework at the parent institution, whereas using the non-ILE day primarily to sleep negatively influenced outcomes.ConclusionCurricular density is a prevalent problem and addressing it at a program level is essential. Reducing curricular content and hours at our institution did not adversely impact student exam and course performance and slight improvement was noted in some areas.
Objective: The objective was to summarize available data regarding the safety and efficacy of RSVpreF in the setting of maternal administration for infant protection against respiratory syncytial virus (RSV) while comparing RSVpreF to other RSV prevention strategies. Data sources: A literature search of PubMed was conducted utilizing the phrases “RSVpreF” and “pregnancy.” Additional references were identified through found sources of information. Organizational guidelines, medication labeling, and regulatory organization presentations were utilized. Study selection and data extraction: Clinical trials investigating RSVpreF administration to pregnant women were included as well as other references on pharmacology, pharmacokinetics, and vaccine uptake. Data synthesis: RSVpreF vaccine, administered once to pregnant women, demonstrated a 69.4% (97.58% confidence interval [CI] = 44.3 to 84.1) lower incidence of severe medically attended RSV lower respiratory tract infection (MA RSV-LRTI) and 51.3% (97.58% CI = 29.4 to 66.8) lower incidence of MA-RSV-LRTI at 180 days post birth in 1 placebo-controlled study. The RSVpreF vaccine administered at 24 to 36 weeks did not have a statistically significant higher rate of preterm births (relative risk = 1.20; 95% CI = 0.99 to 1.46) across two studies and in postmarketing data. Relevance to patient care and clinical practice in comparison with existing agents: The RSVpreF vaccine is the first maternal vaccine approved by the US Food and Drug administration for prevention of RSV in all infants. When compared with other agents, the optimal prophylaxis agent is unclear. Conclusions: Maternal immunization with RSVpreF demonstrated a reduction in MA RSV-LRTI, severe MA RSV-LRTI, and RSV-associated hospitalizations for infants. The vaccine is well tolerated, and adverse events continue to be evaluated.
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.
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.
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.
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.
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.
To pilot a program designed to provide students with precision feedback about their learning.
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. (c) 2023 American Pharmacists Association((R)). Published by Elsevier Inc. All rights reserved.
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.
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.
The Student Success Program at Auburn University Harrison College of Pharmacy is designed to support student success throughout all four years of our Practice Ready Curriculum, from the time of admission through graduation. The objective is to describe the formation and goals of student success program.