Lea S. Eiland

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.

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.

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.

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.

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.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.