Compliance to a Standardized Protocol for Stock Albuterol Medication among School Staff.

A stock inhaler program provided access to rescue medication (albuterol sulfate) for school children. School staff were provided with a standardized protocol for medication administration. We hypothesized licensed nurses were more likely to report compliant events compared to unlicensed school staff. Stock inhaler events were defined as either compliant or non-compliant. A school protocol compliance score was calculated using the total number of compliant events divided by the total number of all events. The protocol for administration indicated 4 puffs for mild respiratory distress and 8 puffs for severe respiratory distress; therefore, events were defined as compliant if the dose of medication was divisible by 4. A Cragg Poisson hurdle regression was used to examine the association between compliance score and school staff experience. One-hundred fifty-two schools reported 999 stock inhaler events. Of these events, 28% were compliant and 72% of events were non-compliant. After controlling for school organizational type, grades served, and school size, school staff experience was not predictive of protocol compliance. Future efforts should focus on improving protocol compliance among licensed nurses and unlicensed school staff.

Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study.

BACKGROUND: Assessing the real-world effectiveness of COVID-19 vaccines and understanding the incidence and severity of SARS-CoV-2 illness in children are essential to inform policy and guide health care professionals in advising parents and caregivers of children who test positive for SARS-CoV-2. OBJECTIVE: This report describes the objectives and methods for conducting the Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study. PROTECT is a longitudinal prospective pediatric cohort study designed to estimate SARS-CoV-2 incidence and COVID-19 vaccine effectiveness (VE) against infection among children aged 6 months to 17 years, as well as differences in SARS-CoV-2 infection and vaccine response between children and adolescents. METHODS: The PROTECT multisite network was initiated in July 2021, which aims to enroll approximately 2305 children across four US locations and collect data over a 2-year surveillance period. The enrollment target was based on prospective power calculations and accounts for expected attrition and nonresponse. Study sites recruit parents and legal guardians of age-eligible children participating in the existing Arizona Healthcare, Emergency Response, and Other Essential Workers Surveillance (HEROES)-Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER) network as well as from surrounding communities. Child demographics, medical history, COVID-19 exposure, vaccination history, and parents/legal guardians' knowledge and attitudes about COVID-19 are collected at baseline and throughout the study. Mid-turbinate nasal specimens are self-collected or collected by parents/legal guardians weekly, regardless of symptoms, for SARS-CoV-2 and influenza testing via reverse transcription-polymerase chain reaction (RT-PCR) assay, and the presence of COVID-like illness (CLI) is reported. Children who test positive for SARS-CoV-2 or influenza, or report CLI are monitored weekly by online surveys to report exposure and medical utilization until no longer ill. Children, with permission of their parents/legal guardians, may elect to contribute blood at enrollment, following SARS-CoV-2 infection, following COVID-19 vaccination, and at the end of the study period. PROTECT uses electronic medical record (EMR) linkages where available, and verifies COVID-19 and influenza vaccinations through EMR or state vaccine registries. RESULTS: Data collection began in July 2021 and is expected to continue through the spring of 2023. As of April 13, 2022, 2371 children are enrolled in PROTECT. Enrollment is ongoing at all study sites. CONCLUSIONS: As COVID-19 vaccine products are authorized for use in pediatric populations, PROTECT study data will provide real-world estimates of VE in preventing infection. In addition, this prospective cohort provides a unique opportunity to further understand SARS-CoV-2 incidence, clinical course, and key knowledge gaps that may inform public health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/37929.

School-based Stock Inhaler Programs and Neighborhood Disadvantage.

INTRODUCTION: Ensuring students with asthma residing in disadvantaged communities have access to rescue medication (albuterol) is important. METHODS: Using the Area Deprivation Index (ADI), we examined relationships between albuterol use and neighborhood deprivation among schools participating in the Pima County (Arizona) Stock Inhaler Program. Schools were categorized into quartiles based on their census block ADI. A hurdle regression examined associations between ADI and stock inhaler use after controlling for school characteristics. RESULTS: Among 228 participating schools, only those in the second worst ADI quartile were more likely to use a stock inhaler than those in the most deprived quartile (referent), OR 1.9 (95% CI 1.2-2.9). Middle schools had 2.1 times higher odds (95% CI 1.3-3.4) of ever using a stock inhaler than elementary schools (referent). CONCLUSION: Students attending schools in the second most deprived communities, as opposed to most deprived, may have the most tenuous albuterol access.

Effectiveness of 2-Dose BNT162b2 (Pfizer BioNTech) mRNA Vaccine in Preventing SARS-CoV-2 Infection Among Children Aged 5-11 Years and Adolescents Aged 12-15 Years - PROTECT Cohort, July 2021-February 2022.

The BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine was recommended by CDC's Advisory Committee on Immunization Practices for persons aged 12-15 years (referred to as adolescents in this report) on May 12, 2021, and for children aged 5-11 years on November 2, 2021 (1-4). Real-world data on vaccine effectiveness (VE) in these age groups are needed, especially because when the B.1.1.529 (Omicron) variant became predominant in the United States in December 2021, early investigations of VE demonstrated a decline in protection against symptomatic infection for adolescents aged 12-15 years and adults* (5). The PROTECT† prospective cohort of 1,364 children and adolescents aged 5-15 years was tested weekly for SARS-CoV-2, irrespective of symptoms, and upon COVID-19-associated illness during July 25, 2021-February 12, 2022. Among unvaccinated participants (i.e., those who had received no COVID-19 vaccine doses) with any laboratory-confirmed SARS-CoV-2 infection, those with B.1.617.2 (Delta) variant infections were more likely to report COVID-19 symptoms (66%) than were those with Omicron infections (49%). Among fully vaccinated children aged 5-11 years, VE against any symptomatic and asymptomatic Omicron infection 14-82 days (the longest interval after dose 2 in this age group) after receipt of dose 2 of the Pfizer-BioNTech vaccine was 31% (95% CI = 9%-48%), adjusted for sociodemographic characteristics, health information, frequency of social contact, mask use, location, and local virus circulation. Among adolescents aged 12-15 years, adjusted VE 14-149 days after dose 2 was 87% (95% CI = 49%-97%) against symptomatic and asymptomatic Delta infection and 59% (95% CI = 22%-79%) against Omicron infection. Fully vaccinated participants with Omicron infection spent an average of one half day less sick in bed than did unvaccinated participants with Omicron infection. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations.

Incidence of SARS-CoV-2 infection among COVID-19 vaccinated and unvaccinated healthcare personnel, first responders, and other essential and frontline workers: Eight US locations, January-September 2021.

BACKGROUND: We sought to evaluate the impact of changes in estimates of COVID-19 vaccine effectiveness on the incidence of laboratory-confirmed infection among frontline workers at high risk for SARS-CoV-2. METHODS: We analyzed data from a prospective frontline worker cohort to estimate the incidence of COVID-19 by month as well as the association of COVID-19 vaccination, occupation, demographics, physical distancing, and mask use with infection risk. Participants completed baseline and quarterly surveys, and each week self-collected mid-turbinate nasal swabs and reported symptoms. RESULTS: Among 1018 unvaccinated and 3531 fully vaccinated workers, the monthly incidence of laboratory-confirmed SARS-CoV-2 infection in January 2021 was 13.9 (95% confidence interval [CI]: 10.4-17.4), declining to 0.5 (95% CI -0.4-1.4) per 1000 person-weeks in June. By September 2021, when the Delta variant predominated, incidence had once again risen to 13.6 (95% CI 7.8-19.4) per 1000 person-weeks. In contrast, there was no reportable incidence among fully vaccinated participants at the end of January 2021, and incidence remained low until September 2021 when it rose modestly to 4.1 (95% CI 1.9-3.8) per 1000. Below average facemask use was associated with a higher risk of infection for unvaccinated participants during exposure to persons who may have COVID-19 and vaccinated participants during hours in the community. CONCLUSIONS: COVID-19 vaccination was significantly associated with a lower risk of SARS-CoV-2 infection despite Delta variant predominance. Our data demonstrate the added protective benefit of facemask use among both unvaccinated and vaccinated frontline workers.

Medication Administration Practices in United States' Schools: A Systematic Review and Meta-synthesis.

Schools often provide medication management to children at school, yet, most U.S. schools lack a full-time, licensed nurse. Schools rely heavily on unlicensed assistive personnel (UAP) to perform such tasks. This systematic review examined medication management among K-12 school nurses. Keyword searches in three databases were performed. We included studies that examined: (a) K-12 charter, private/parochial, or public schools, (b) UAPs and licensed nurses, (c) policies and practices for medication management, or (d) nurse delegation laws. Three concepts were synthesized: (a) level of training, (b) nurse delegation, and (c) emergency medications. One-hundred twelve articles were screened. Of these, 37.5% (42/112) were comprehensively reviewed. Eighty-one percent discussed level of training, 69% nurse delegation, and 57% emergency medications. Succinct and consistent policies within and across the United States aimed at increasing access to emergency medications in schools remain necessary.

Interim Estimate of Vaccine Effectiveness of BNT162b2 (Pfizer-BioNTech) Vaccine in Preventing SARS-CoV-2 Infection Among Adolescents Aged 12-17 Years - Arizona, July-December 2021.

The BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine has demonstrated high efficacy in preventing infection with SARS-CoV-2 (the virus that causes COVID-19) in randomized placebo-controlled Phase III trials in persons aged 12-17 years (referred to as adolescents in this report) (1); however, data on real-word vaccine effectiveness (VE) among adolescents are limited (1-3). As of December 2021, the Pfizer-BioNTech vaccine is approved by the Food and Drug Administration (FDA) for adolescents aged 16-17 years and under FDA emergency use authorization for those aged 12-15 years. In a prospective cohort in Arizona, 243 adolescents aged 12-17 years were tested for SARS-CoV-2 by reverse transcription-polymerase chain reaction (RT-PCR) each week, irrespective of symptoms, and upon onset of COVID-19-like illness during July 25-December 4, 2021; the SARS-CoV-2 B.1.617.2 (Delta) variant was the predominant strain during this study period. During the study, 190 adolescents contributed fully vaccinated person-time (≥14 days after receiving 2 doses of Pfizer-BioNTech vaccine), 30 contributed partially vaccinated person-time (receipt of 1 dose or receipt of 2 doses but with the second dose completed <14 days earlier), and 66 contributed unvaccinated person-time. Using the Cox proportional-hazards model, the estimated VE of full Pfizer-BioNTech vaccination for preventing SARS-CoV-2 infection was 92% (95% CI = 79%-97%), adjusted for sociodemographic characteristics, health information, frequency of social contact, mask use, location, and local virus circulation. These findings from a real-world setting indicate that 2 doses of Pfizer-BioNTech vaccine are highly effective in preventing SARS-CoV-2 infection among Arizona adolescents. CDC recommends COVID-19 vaccination for all eligible persons in the United States, including persons aged 12-17 years.

Randomized trial of the feasibility of ED-initiated school-based asthma medication supervision (ED-SAMS).

BACKGROUND: While using an inhaled corticosteroid (ICS) in the weeks after an ED visit reduces repeat visits, few children receive a needed prescription. Because a prescription may not be filled or used, dispensing ICS at discharge and supervising its use at school could overcome both barriers until follow-up care is established. To assess the feasibility of such an intervention, we conducted a pilot study among elementary-age school children with persistent asthma who were discharged from the ED following an asthma exacerbation. METHODS: Eligible children were randomly assigned to ED-dispensing of ICS with home supervision or ED-dispensing of ICS with home and school supervision. The primary outcomes were ability to recruit and retain participants, ability to initiate school-supervised medication administration within 5 days of discharge, and participant satisfaction. RESULTS: Despite identifying 437 potentially eligible children, only 13 (3%) were enrolled with 6 being randomized to the intervention group and 7 to the control group. Eleven (85%) randomized participants completed the 90-day interview (primary outcome) and 8 (62%) completed the 120-day interview (safety endpoint). Four (67%) intervention participants started their school regimen within 5 business days and 2 started within 6 business days. CONCLUSION: While our pilot study did not meet its recruitment goal, it did achieve its primary purpose of assessing feasibility before undertaking a larger, more intensive study. Several major recruitment barriers need to be mitigated before EDs can successfully partner with schools to establish supervised ICS treatment. TRIAL REGISTRATION: ClinicalTrials.gov , NCT03952286 . Registered 16 May 2019.

Ensuring Access to Albuterol in Schools: From Policy to Implementation. An Official ATS/AANMA/ALA/NASN Policy Statement.

Rationale: For children with asthma, access to quick-relief medications is critical to minimizing morbidity and mortality. An innovative and practical approach to ensure access at school is to maintain a supply of stock albuterol that can be used by any student who experiences respiratory distress. To make this possible, state laws allowing for stock albuterol are needed to improve medication access.Objectives: To provide policy recommendations and outline steps for passing and implementing stock albuterol laws.Methods: We assembled a diverse stakeholder group and reviewed guidelines, literature, statutes, regulations, and implementation documents related to school-based medication access. Stakeholders were divided into two groups-legislation and implementation-on the basis of expertise. Each group met virtually to review documents and draft recommendations. Recommendations were compiled and revised in iterative remote meetings with all stakeholders.Main Results: We offer several recommendations for crafting state legislation and facilitating program implementation. 1) Create a coalition of stakeholders to champion legislation and implement stock albuterol programs. The coalition should include school administrators, school nurses and health personnel, parents, or caregivers of children with asthma, pediatric primary care and subspecialty providers (e.g., pulmonologists/allergists), pharmacists, health department staff, and local/regional/national advocacy organizations. 2) Legislative components critical for effective implementation of stock albuterol programs include specifying that medication can be administered in good faith to any child in respiratory distress, establishing training requirements for school staff, providing immunity from civil liability for staff and prescribers, ensuring pharmacy laws allow prescriptions to be dispensed to schools, and suggesting inhalers with valved holding chambers/spacers for administration. 3) Select an experienced and committed legislator to sponsor legislation and guide revisions as needed during passage and implementation. This person should be from the majority party and serve on the legislature's health or education committee. 4) Develop plans to disseminate legislation and regulations/policies to affected groups, including school administrators, school nurses, pharmacists, emergency responders, and primary/subspecialty clinicians. Periodically evaluate implementation effectiveness and need for adjustments.Conclusions: Stock albuterol in schools is a safe, practical, and potentially life-saving option for children with asthma, whether asthma is diagnosed or undiagnosed, who lack access to their personal quick-relief medication. Legislation is imperative for aiding in the adoption and implementation of school stock albuterol policies, and key policy inclusions can lay the groundwork for success. Future work should focus on passing legislation in all states, implementing policy in schools, and evaluating the impact of such programs on academic and health outcomes.

COVID-19 Infection, Reinfection, and Vaccine Effectiveness in a Prospective Cohort of Arizona Frontline/Essential Workers: The AZ HEROES Research Protocol.

BACKGROUND: The Arizona Healthcare, Emergency Response, and Other Essential workers Study (AZ HEROES) aims to examine the epidemiology of SARS-CoV-2 infection and COVID-19 illness among adults with high occupational exposure risk. OBJECTIVE: Study objectives include estimating incidence of SARS-CoV-2 infection in essential workers by symptom presentation and demographic factors, determining independent effects of occupational and community exposures on incidence of SARS-CoV-2 infection, establishing molecular and immunologic characteristics of SARS-CoV-2 infection in essential workers, describing the duration and patterns of rRT-PCR-positivity, and examining post-vaccine immunologic response. METHODS: Eligible participants include Arizona residents aged 18-85 years who work at least 20 hours per week in an occupation involving regular direct contact (within three feet) with others. Recruitment goals are stratified by demographic characteristics (50% aged 40 or older, 50% women, and 50% Hispanic or American Indian), by occupation (40% healthcare personnel, 30% first responders, and 30% other essential workers), and by prior SARS-CoV-2 infection (with up to 50% seropositive at baseline). Information on sociodemographics, health and medical history, vaccination status, exposures to individuals with suspected or confirmed SARS-CoV-2 infection, use of personal protective equipment, and perceived risks are collected at enrollment and updated through quarterly surveys. Every week, participants complete active surveillance for COVID-19-like illness (CLI) and self-collect nasal swabs. Additional self-collected nasal swab and saliva specimens are collected in the event of CLI onset. Respiratory specimens are sent to Marshfield Laboratories and tested for SARS-CoV-2 by real-time reverse transcription polymerase chain reaction (rRT-PCR) assay. CLI symptoms and impact on work and productivity are followed through illness resolution. Serum specimens are collected every 3 months and additional sera are collected following incident rRT-PCR positivity and after each COVID-19 vaccine dose. Incidence of SARS-CoV-2 infections will be calculated by person-weeks at risk and compared by occupation and demographic characteristics and by seropositivity status and infection and vaccination history. RESULTS: The AZ HEROES study was funded by the Centers for Disease Control and Prevention. Enrollment began July 27, 2020 and as of May 1, 2021 a total of 3,165 participants have been enrolled in the study. CONCLUSIONS: AZ HEROES is unique in aiming to recruit a diverse sample of essential workers and prospectively following strata of SARS-CoV-2 seronegative and seropositive adults. Survey results combined with active surveillance data on exposure, CLI, weekly molecular diagnostic testing, and periodic serology will be used to estimate the incidence of symptomatic and asymptomatic SARS-CoV-2 infection, assess the intensity and durability of immune responses to natural infection and COVID-19 vaccination, and contribute to the evaluation of COVID-19 vaccine effectiveness. INTERNATIONAL REGISTERED REPORT: DERR1-10.2196/28925.

Managing respiratory emergencies at school: A county-wide stock inhaler program.

BACKGROUND: A total of 15 states allow schools to manage respiratory emergencies among multiple students by using a single albuterol inhaler (stock inhaler) paired with a disposable holding chamber. OBJECTIVE: Our aim was to evaluate implementation barriers and facilitators, as well as satisfaction with a stock inhaler program across K through12 schools in Pima County, Arizona. METHODS: All public, charter, private, and parochial schools were offered supplies, web-based training, and technical assistance at no cost. The RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework was used to evaluate program implementation. School documentation logs were reviewed, school health personnel were surveyed, and a convenience sample of health personnel were interviewed. Chi-square tests evaluated categoric outcomes and Poisson hurdle regression examined stock inhaler use by school organization type, grade levels served, and type of school health personnel employed. RESULTS: In all, 229 schools (68%) participated, reaching 82% of students in the county. A total of 152 schools (66%) used a stock inhaler, accounting for 1038 events. The mean number of puffs administered was 2.7 (SD = 1.2) per event, and most events (79%) involved students with asthma. Although most events (83.9%) resulted in the student returning to class, 15.6% resulted in students being sent home. Only 6 events resulted in 911 calls, and 5 of these led to an ambulance transport. School health personnel reported high levels of satisfaction, and all schools renewed participation for a second year. Program costs were $156 per school. CONCLUSION: With technical assistance, stock inhaler programs can be feasibly implemented by schools in a wide range of settings, thereby increasing their capacity to safely manage respiratory emergencies.

Incidence of SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential Workers During a Prevaccination COVID-19 Surge in Arizona.

Importance: Understanding the relative risk of SARS-CoV-2 infection across occupations can inform guidance to protect workers and communities. Less is known about infection risk for first responders and other essential workers than for health care personnel. Objective: To compare the prevaccination incidence of SARS-CoV-2 infection among first responders and other essential workers with incidence among health care personnel. Design Setting and Participants: This was a prospective cohort study of health care personnel, first responders, and other essential workers in Arizona from July 20, 2020, to March 14, 2021. Participants were seronegative at enrollment, had frequent direct contact with others at work, worked at least 20 hours per week, and submitted weekly nasal swab specimens for real-time reverse transcriptase polymerase chain reaction analysis. Data analyses were performed from April 19, 2021, to June 4, 2021. Exposures: Occupation was the primary exposure of interest. Confounders assessed were sociodemographic characteristics, health status, community exposure, and work exposure. Main Outcomes and Measures: Crude incidence of SARS-CoV-2 infection was defined as the sum of first positive SARS-CoV-2 infections in participants divided by person-weeks at risk. Negative binomial regression was used to model SARS-CoV-2 infection by occupation to estimate unadjusted and adjusted incidence rate ratios (IRRs). The least absolute shrinkage and selection operator (LASSO) method was used to generate a parsimonious multivariable model. Results: The study cohort comprised 1766 Arizona workers (mean age [SD], 43.8 [11.1] years; 1093 [61.9%] female; 401 [22.7%] were Hispanic and 1530 [86.6%] were White individuals) of whom 44.2% were health care personnel, 22.4% first responders, and 33.4% other essential workers. The cohort was followed up for 23 393 person-weeks. Crude incidence of SARS-CoV-2 infection was 6.7, 13.2, and 7.4 per 1000 person-weeks at risk for health care personnel, first responders, and other essential workers, respectively. In unadjusted models, first responders had twice the incidence of infection as health care personnel (IRRs, 2.01; 95% CI, 1.44-2.79). While attenuated, this risk remained elevated in adjusted LASSO-optimized models (IRR, 1.60; 95% CI, 1.07-2.38). Risk of infection among other essential workers was no different than for health care personnel in unadjusted or adjusted models. Conclusions and Relevance: This prospective cohort study found that first responders had a higher incidence of SARS-CoV-2 infection than health care personnel, even after adjusting for potential confounding factors. Given their frequent contact with each other and with the public and their high rates of SARS-CoV-2 infection, the safety challenges for first responders warrant greater public health attention and research.

Cost-benefit of point-of-use devices for lead reduction.

BACKGROUND: Lead exposure represents a significant human health concern that often occurs with little warning to the consumer. Water lead levels can be mitigated by point-of-use (POU) devices such as reverse osmosis, distillation, or activated carbon with lead reduction media. OBJECTIVES: This study assessed a partial cost-benefit of residential installation of POU devices to reduce lead concentrations in drinking water and examined the economic impact at the community level based on exposures reported in Flint, Michigan. METHODS: We calculated the individual consumer breakeven point for each lead abatement option by subtracting the lifetime cost of device installation and maintenance from the lifetime cost of lead exposure through its impact on intelligence (IQ) and lifetime earnings. This approach was then extrapolated to the community level based on reported lead exposures in Flint, Michigan. RESULTS: Based on operating POU device costs, lead absorption from water, and economic losses associated with reduced IQ, initial water lead levels associated with consumer breakeven points for reverse osmosis (7.31 µg/L), activated carbon (3.73 µg/L), and distillation (12.0 µg/L) were calculated. For example, an individual consuming water with 25 µg/L of lead, similar to the 90th percentile of concentrations measured in Flint, Michigan, would have an expected blood lead level of 1.25 µg/dL, a corresponding loss of 0.641 IQ points, and a lifetime economic earnings loss of $14,284. Over 70 years of continued use, activated carbon with lead reduction media is the least expensive device to maintain and operate as compared to reverse osmosis and distillation. CONCLUSIONS: Infrastructure failures related to drinking water are unpredictable and exposure to contaminates can have significant economic ramifications. POU devices represent a cost-effective option to reduce the impact of lead exposure, particularly when water lead concentrations exceed regulated levels.