Lois Levine

Both pediatricians and parents can breathe a sigh of relief: The US Food & Drug Administration (FDA) is about to authorize use of the Pfizer-BioNTech COVID-19 vaccine for adolescents aged 12 to 15 over the next several days, according to federal officials.

The news means not only that millions more Americans can get vaccinated, but the goal of reaching herd immunity can be attained even more quickly. It also means that children in this age group would be able to be fully immunized for the 2021 summer as well as for the beginning of the school year 2021-2022.


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The US Food & Drug Administration is about to authorize use of the Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15 years old.

The FDA plans to authorize Pfizer-BioNTech vaccine for children aged 12 to 15 years

Julia Reading, medical student at the David Geffen School of Medicine at UCLA in Los Angeles, California started her session at the 2021 Pediatric Academic Societies virtual meeting with a definition of ACEs. She noted they were stressful and often traumatic experiences that included abuse, neglect, and house challenges, are associated with poor health outcomes

 and that despite what this could mean in terms of public health implications, screening is still not a widely adopted practice for these experiences. 

For this study, individual phone interviews were conducted, questions adapted from previous surveys and barriers, and structure was adapted from prior semi-structured interviews on social risk.

 Process flow diagrams were made for each physician's ACEs screening workflow and overall groupings according to guidelines from the Institute for Healthcare Improvement.

The aims of the study were to describe common ACEs screening workflow processes; provide examples of clinical ACEs screening workflows; and look at key informant interview study design.

The common workflow elements consisted of patient check in; question delivery (either verbally or via questionnaire by a patient portal or clinical staff at visits); and questions answered. Results included screenings based on predetermined protocolized criteria (ie, score and/or presence of symptoms) as well as primary provider intervention on an ad hoc basis, based on individual factors. The study noted substantial variations in these screening workflows, with protocolization hinging on factors that included availability of administration; beliefs about patient risk; availability of support staff; and intervention resource accessibility. 

It was also noted that almost all participants conducted a screening at preventive care visits, with more than a third adding a screening if relevant symptoms were reported (using either the Adverse Childhood Experiences Questionnaire (ACE-Q) or the Pediatric Adverse Childhood Experiences abnd Related Life-Events Screener (PEARLS).

The study concluded that ACEs screening workflow variations is largely a result of differences in intervention thresholds as well as access to intervention resources. It also noted that successful screenings can be accomplished regardless of the degree of workflow protocolization; and workflows should be tailored to the needs and limitations of an individual practice.

References
1. Bethel CD, Solloway MR, Guinosso S, et al. Prioritizing possibilities for child and family health: an agenda to address adverse childhood experiences and foster the social anbd emotional roots of wellbeing in pediatrics. 

 2017;17(7s):S36-S50. doi:10.1016/j.acap.2017.06.002
2. Bodendorfer V, Koball AM, Rasmussen C, et al. Implementation of the adverse childhood experiences conversation in primary care. 

 2020;37(3):355-359. doi:10.1093/fampra/cmz065
3. Hamity C, Jackson A, Peralta L, Bellows J. Perceptions and experience of patients, staff, and clinicians with social needs assessment. 

 2018;22:18-105. doi:10.7812/tpp/18-105.
4. Institute for Healthcare Improvement. Accessed May 3, 2021. http://www.ihi.org/resources/Pages/Tools/Flowchart.aspx

Adverse childhood experiences (ACEs) are associated with poor health outcomes over the course of a life, but there is still little information on clinical workflows to guide these implementation practices. At the virtual 2021 virtual Pediatric Academic Societies meeting, Julia I. Reading discussed models and variations in ACE screening workflows.

A study of pediatrician's adverse childhood experiences screening workflows

In the spring of 2020, the Bronx had 1 of the highest rates of COVID-19 infections in the country. Sarah Rogal, MD, MPH at the Jacobi Medical Center Rego Park, New York, discusses the results of her 2020 study, coauthored with Raidour Ahmed, MD, Jacobi Medical Center, Rego Park, New York, comparing how children and teenagers living in lower socioeconomic settings in the Bronx fared in mental health issues compared to the year prior. The study was done from May 1, 2020 to October 31, 2020, and compared children and adolescents admitted to the hospital for self-harm/substance abuse; suicide attempt by ingestion; suicide attempt by self-harm; and psychosis, from 2019 and 2020.

In accordance with the study criteria, mental health admissions increased from 1.28% in 2019 to 5.65%, with an overall increase in psychiatric patients admissions. Those admitted with a known history of mental illness increased by 90% (compared to 58% in 2019). Furthermore, in 2019, 17% of admissions were for self harm and substance abuse; that number lept to 48% in 2020.

The Jacobi pediatric ward was closed and primarily was changed to an adult ward during early the early surge of the pandemic. When the pediatric ward reopened in May of 2020, there was a substantial increase in mental health admissions compared to 2020 over a period of 4 months. 

The investigators concluded there was, overall, a significant increase in mental health admissions to the pediatric floor and intensive care during the initial months of the pandemic, and suggested that further studies should be done to look at resources and community efforts to assess access to mental health help.

The Bronx experienced 1 of the highest mortality rates of COVID-19 during the beginning of the pandemic. Some early research suggests that quarantine and school closures had a major psychosocial impact on children during this time. A study presented at the virtual 2021 Pediatric Academic Societies meeting looks at how children and teenagers living in low socioeconomic settings were affected by the pandemic.

Pediatric admissions of substance abuse, suicide, and psychosis in a New York City hospital during the COVID-19 pandemic

Today, the US Food & Drug Administration (FDA) announced 2 new tobacco product standards to decrease disease and death due to smoking and hopefully discourage nonsmokers from becoming future smokers.

The first proposed product standard, which will be issued within the next year, will be to ban menthol as a characterizing flavor in cigarettes and cigars. The decision is a result of evidence-based science that shows menthol as both harmful and addictive. "With these actions, the FDA wil help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ+ individuals...whom are far more likely to use these tobacco products," said acting FDA Commissioner Janet Woodcock, MD.

Studies show that menthol increases the appeal of tobacco and masks unpleasant flavors and the harsh taste of tobacco, which entices more people to smoke. Furthermore, tobacco products with menthol can be more addictive. 

If implemented, the FDA enforcement of a ban on menthol tobacco products will only address manufacturers, distributors, wholesalers, importers and retailers. It cannot and will not enforce against individual consumer possession.

Secondly, the FDA continues to provide oversight in an attempt to end the selling of illegal e-cigarettes and other electronic nicotine delivery systems (ENDS). To that end, the FDA's Center for Tobacco Products issued warning letters to ENDS product manufacturers and retailers who continue to sell products that are illegally on the market. Finally, the FDA's public education campaign targets nearly 10.7 million young people aged 12 to 17 years who have never used e-cigarettes or might consider trying them, highlighting information about the potential risk of e-cigarette use.

Reference
1. US Food & Drug Administration. FDA commits to evidence-based actions aimed at saving lives and preventing future generations of smokers. April 29, 2021. 


https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers?utm_medium=email&utm_source=govdelivery

The FDA announces 2 standards to reduce disease and death from tobacco products.

Lois Levine

Articles

The FDA plans to authorize Pfizer-BioNTech vaccine for children aged 12 to 15 years

A study of pediatrician's adverse childhood experiences screening workflows

Pediatric admissions of substance abuse, suicide, and psychosis in a New York City hospital during the COVID-19 pandemic

FDA commits to campaign to prevent future smokers