FDA authorizes COVID-19 booster for kids 12-15

The US Food and Drug Administration (FDA) made multiple changes to the emergency use authorization for the Pfizer/BioNTech vaccine.

Who is at risk of Medicaid coverage disruption

Loss of coverage may lead to negative outcomes. A report scrutinizes who is likely to suffer coverage disruption and what the costs of it are.

Do repeated head injuries during play impact cognition and behavior?

Repeated concussions have been linked to severe negative neurological outcomes. Is there a similar experience with repeated impacts on the head during contact sports?

Reducing intravenous opioid duration with acetaminophen

Clinicians are seeking ways to reduce opioid exposure in a variety of settings. Could the use of acetaminophen before opioid use reduce opioid treatment duration in the inpatient setting?

Articles

It was a very busy week for the Contemporary Pediatrics team.

In case you missed it: January 3 to 7

More than 30 years after the Americans with Disabilities Act (ADA) became law, a study found that many American doctors aren’t confident they can provide the same level of care to patients with disabilities as those without, and a large majority erroneously believe that disabled people have worse quality of life than non-disabled people.

 in Health Affairs, researchers from Massachusetts General Hospital surveyed 714 physicians in 

 nationwide regarding their perceptions of people with disabilities. They found that 82.4% believe that disabled people have a worse quality of life than the non-disabled, even though, in a 1999 study, more than half these people said their quality of life was excellent or good.

The current survey also revealed that only 40% said they felt “very confident” in their ability to provide the same level of care to disabled and non-disabled patients, and 57% strongly agree that they welcomed patients with disability into their practice. Just under one in five—18%—strongly agree that the health care system treats

“Our findings suggest that large proportions of practicing US physicians might hold biased or stigmatized perceptions of people with disability,” the authors write, adding that the survey “did not assess whether participants appreciated that their perceptions are biased or instead believe that their views are justified and therefore do not negatively affect” the care they provide to disabled patients.

Passed in 1990, the ADA forbids discrimination against persons with disability. Among other provisions, it requires doctors and patients to collaborate in deciding what reasonable accommodations are needed to ensure that these patients get accessible and equitable care. However, the study found that 36% of respondents had little or no knowledge of their legal responsibilities under the ADA, 68% felt they were at risk for ADA-related lawsuits, and 71% could not correctly identify who determines reasonable accommodations.

“Despite the fact people with disabilities comprise 25 percent of the population, they often confront barriers to basic health care services such as physical examinations, weight measurement, and effective communication with their physicians,” lead author Lisa I. Iezzoni, MD, MSc, said in a news release, adding that “the lack of knowledge about who makes accommodation decisions raises troubling questions about healthcare quality and equity.”

The authors note that the COVID-19 pandemic has exposed aspects of the health care system that disadvantage people with disability. For example, some state standards of care developed to guide resource allocation, such as tests, ICU beds and ventilators specifically excluded people with disability. This caused the US Department of Health and Human Services Office for Civil Rights to warn in March 2020 that “persons with disabilities should not be denied medical care on the basis of stereotypes, assessments of quality of life, or judgments about a person’s relative ‘worth’ based on the presence or absence of disabilities.”

Addressing the problem, the researchers say, will require more training about disability, including disability cultural competence and etiquette. They also suggest finding ways for clinicians to gain greater empathy about the challenges disabled people face in their daily lives, such as through house calls, and adding a disability module to Implicit Association tests around race and ethnicity.

This article was originally published by sister publication Medical Economics.

More than 3 decades after the passage of the Americans with Disabilities Act (ADA), myths about people with disabilities and how to treat them persist.

Confusion over ADA obligations remains for clinicians

Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

The day after Thanksgiving 2021 the news of a new variant with several mutations was announced and quickly named Omicron, as well as a variant of concern. It has since become the predominant variant causing COVID-19 cases.



 sat down with Tina Q. Tan, MD, FAAP, FIDSA, FPIDS, to discuss what's known about the variant. She also discusses the latest on the vaccine for children aged younger than 5 years.

Podcasts

Contemporary Pediatrics sat down with Tina Q. Tan, MD, FAAP, FIDSA, FPIDS, to discuss what's known about the variant. She also discusses the latest on the vaccine for children aged younger than 5 years.

What Omicron could mean for the pandemic 

The US Food and Drug Administration (FDA) has approved Otsuka and Lundbeck’s supplemental new drug application (sNDA) of brexpiprazole for the treatment of schizophrenia in pediatric patients aged 13 to 17 years.

The FDA previously granted Priority Review for the sNDA. In 2015, brexpiprazole was approved in the US for the treatment of 

 in adults and for adjunctive treatment of 

“This approval further bolsters the mental health community’s efforts and resources to address a critical unmet need within the pediatric schizophrenia population,” said Robert McQuade, PhD, president of the McQuade Center for Strategic Research and Development, and chief strategic officer at Otsuka Pharmaceutical Development & Commercialization. “We will continue to raise awareness about schizophrenia in adolescents and educate this important community on the availability of effective treatment options.”

The mechanism of action for brexpiprazole is not fully understood; however, studies of brexpiprazole’s efficacy observed 

 at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors—for which, brexpiprazole exhibits high affinity.

“Brexpiprazole appears to be a viable option for treating an acute exacerbation of schizophrenia requiring hospitalization or adjunctive treatment of major depressive disorder in patients who showed an inadequate response to 1 to 3 antidepressants,” wrote Lauren A. Diefenderfer, PharmD, BCPP, and Courtney Iuppa, PharmD, BCPP, back in 2017.

The sNDA submission was based on an extrapolation analysis utilizing data from 3 groups of prior research: 1) studies among adult patients, 2) pharmacokinetic results from adult and pediatric trials, and 3) 6-month data from the ongoing open-label, long-term trial among adolescent patients with schizophrenia.

“We are proud to offer a treatment option for adolescents with schizophrenia who are navigating the complexities of their health during a transitional time in their lives – we hope this will help make a meaningful difference in reducing their schizophrenia symptoms so they can be their best,” said Johan Luthman, executive vice president of research and development at Lundbeck.

This article was originally published by sister publication Psychiatric Times.

1. Otsuka and Lundbeck announce FDA approval of supplemental new drug application for REXULTI® (brexpiprazole) to treat schizophrenia in pediatric patients ages 13-17. News release. BioSpace. January 6, 2022. 

https://www.biospace.com/article/releases/otsuka-and-lundbeck-announce-fda-approval-of-supplemental-new-drug-application-for-rexulti-brexpiprazole-to-treat-schizophrenia-in-pediatric-patients-ages-13-17/

2. Diefenderfer LA, Iuppa C. Brexpiprazole: a review of a new treatment option for schizophrenia and major depressive disorder. 

The supplemental new drug application of brexpiprazole for the treatment of schizophrenia in pediatric patients aged 13 to 17 received US Food and Drug Administration (FDA) approval. 

FDA approves treatment for schizophrenia in pediatric patients 

Opioids can be a highly effective way to manage pain, but with increasing scrutiny on opioid use and duration, it’s become imperative to find ways to reduce the duration of treatment. An 

 examines whether providing intravenous acetaminophen before introducing opioids could reduce the duration of opioid therapy during inpatient care.

Investigators ran a comparative effectiveness research study that looked at data for pediatric inpatients from 274 hospitals across the United States between January 2011 and June 2016. They compared outcomes using propensity score-matched analysis. Patients who only received intravenous opioids were the control cohort and those who received intravenous acetaminophen were the intervention group.

A pool of 893,293 pediatric patients were included in the evaluation with 287,504 given intravenous opioids and 18,197 given intravenous acetaminophen. Investigators removed patients who did not receive intravenous opioids, those without diagnostic information, and those without hospital information, leaving 118,908 receiving intravenous opioids and 16,068 received intravenous acetaminophen Additionally, patients who were given acetaminophen after receiving opioids were also excluded. In comparison to patients who only received opioids, those who had acetaminophen and then opioids were older (eg, ages 13 to 22 years: 59.1% [1027 patients] vs 56.4% [58 021 patients]; 

 < .001) and not mechanically ventilated (97.4% [1693 patients] vs 95.2% [97 858 patients]; 

 < .001); and were more likely to have a body temperature above 38° C (3.1% [54 patients] vs 1.7% [1706 patients]; 

 < .001). Following propensity match scoring, the median duration of intravenous opioid use was 33.5 hours (5.4-74.0 hours) for the control group and for the intervention group was 27.7 hours (4.0-76.1 hours) (

The investigators concluded that the use of intravenous acetaminophen before the administration of intravenous opioids was linked to a 15.5% reduction in the duration of opioid treatment. They believe that creating a pain management regimen that uses acetaminophen first could be a key way to reduce opioid exposure.

1. Patel A, Gai J, Trujillo-Rivera E, et al. Association of intravenous acetaminophen administration with the duration of intravenous opioid use among hospitalized pediatric patients. 

. 2021;4(12):e2138420. doi:10.1001/jamanetworkopen.2021.38420

  Reducing intravenous opioid duration with acetaminophen   

Professor Karen Schechter, RHIA, MBA, CMPE, is Director and Assistant Professor in the Online Healthcare Management and Health Administration Programs at Maryville University.

How quickly things can change. Not so long ago, it almost seemed that the terrible surge of the Delta variant that had dashed our hopes for a “summer of freedom” was finally ebbing. Now, once more, we are seeing 

 as we enter the holiday season. It is not just infections; hospitalizations are rising as well, and now the Centers for Disease Control and Prevention CDC 

 that the Omicron variant is a “variant of concern.” All this likely means that physicians will not be getting a much-deserved break anytime soon.

Meanwhile, the “Great Resignation” is affecting the health care sector with particular ferocity, with nearly 

 during the pandemic. Many in this sector had already been experiencing varying degrees of burnout due to numerous other factors, and there was already a 

. And the pandemic made an already challenging situation worse. Since one of 

 contributing to physician burnout is long-term stress, it becomes all the more vital now for physicians to proactively address these issues.

Before I begin, I do want to provide some context in that most of my work is with private practice physicians. Having said that, I do think there are many parallels between the experiences of physicians in private practice and those in other practice settings, including hospitals and urgent cares.

One thing that may be helpful to remember as a way of contextualizing physician burnout is that much of it is not due to COVID-19 itself, at least not directly. Social distancing guidelines earlier in the pandemic combined with people’s anxieties about going into medical care facilities in person have led to a backlog of work due to patients delaying their needed care. Regardless, the end result for physicians is the same: more work and more stress. Added to this is the aforementioned shortage of staff that may be creating more work for physicians as well.

Being mindful of burnout and addressing it when it occurs—or, better yet, to prevent it before it occurs—is important for the same reason that the “triple aim” of the medical profession has been updated as “the quadruple aim.” The fourth aim, the health and well-being of physicians and their staffs, is necessary for 

: enhancing the patient experience, and reducing the cost of care. This has always been true but it becomes all the more critical due to the pandemic and its secondary impacts.

There are ways to mitigate stress by managing its symptoms. However, there are also ways to lessen stress by preventing some of it in the first place. Most important is strengthening communication, both internally and externally. By internal communication I mean sitting down with staff and laying it all out, identifying priorities and brainstorming ideas for how to streamline workflow. One of the biggest problems during earlier periods of the pandemic had been mis- or lack of communication. Although more communication may seem like additional work, the amount of work and stress it saves in the long run makes it more than worth the while. Physicians, nurses, and staff can waste less time and energy on fixing mistakes or confusion caused by poor communication and focus instead on providing quality care.

In addition to internal communication, good external communication needs to also be prioritized. For instance, the backlog of patients wishing to come in for overdue checkups or treatment may necessitate longer wait times for appointments. Without sufficient communication, patients may become frustrated or dissatisfied. However, generally speaking, people get more frustrated about a lack of information than they do with the content of the information. Determine what communication approaches are most suitable for your practice and make sure that your staff is adequately trained regarding what needs to be communicated to patients and how.

Times like now may also warrant looking into and utilizing resources that lighten your burden somewhat. Many doctors spend unnecessary amounts of time and energy on tasks that could be done by other types of professionals—medical case managers, for instance, or members of their staff. Reallocating certain kinds of tasks not only lifts some of the burden from the shoulders of physicians but can also provide the additional benefit of empowering the staff.

In addition to resources that can make life easier for physicians and their staffs, there are also resources that physicians can refer their patients to as well. One of these is telehealth. Many patients may still, even now, not realize that their insurance plans offer telehealth services. Referring patients to these services can help reduce workload while ensuring that patients can still get the care they need for medical concerns that can be adequately addressed through telehealth.

Of course, in addition to referring patients to third party telehealth services offered through their insurance, physicians can offer their own telehealth services as well. Many who utilized telehealth during earlier parts of the pandemic have, for whatever reasons, stopped using it, but telehealth shouldn’t just be a temporary measure. Ideally, it should become a permanent tool that not only increases access to care but can also help streamline the act of providing care. In fact, not only is telehealth an important resource for patients, it can also be a wonderful resource for physicians by helping them to 

. And it is also worth noting that 42 states, along with the District of Columbia, 

 to reimburse for telehealth, and you can use the Center for Connected Health Policy’s 

 for the most current regulations in your state.

Although it may sound overly obvious, in my experience physicians need to be frequently reminded that they too are human. It is all-too-common for physicians to 

. Self-care is not just a good idea, it should be considered a professional imperative. Left unaddressed, chronic stress increases the risk of not just burnout but also 

. This is another area where telehealth can help, and there is no reason that physicians can’t also take advantage of the benefits and convenience of using telehealth for mental health services. Physician support groups such as the 

 on Facebook, or physician-focused support channels such as the peer-to-peer 

, while not expressly support groups, also feature many discussion threads where physicians and other healthcare professionals offer various kinds of 

 to each other. And digital tools such as Headspace, a leading mindfulness and stress management app, can serve as a useful adjunct to behavioral health services targeted towards physicians and healthcare providers. Normally a paid service, Headspace is offering a 

 for AMA members throughout the pandemic.

Finally, physicians should also try to heed the same recommendations that are often given to their patients, basic principles such as getting enough sleep, staying physically active, and eating as healthy as possible. Again, as obvious as these principles seem, physicians can be quite quick to forget them during busy and stressful times. Many useful reminders such as these can be found on the AMA’s resource page for 

 . While many of these things are certainly easier said than done, the important thing to remember is that they can indeed be done and often make all the difference.

The pandemic really has opened our eyes to different ways of delivering care. With many valuable and effective resources available, it shouldn’t just be about the doctor doing everything. We have learned many useful lessons over the last two years and, hopefully, applying those lessons will help reduce burnout and increase physician resilience.

There are ways to mitigate stress by managing its symptoms. However, there are also ways to lessen stress by preventing some of it in the first place.

Why physician burnout must be addressed

The days of “eating for 2” and seeing pregnancy as a time to not worry about calorie consumption has changed as more knowledge about the impact of weight gain on the mother has become available. The potential link between gestational weight gain and infant morbidity and mortality remains unclear. A 

 sought to identify optimal gestational weight gain ranges that are linked with a reduced risk of infant morbidity and mortality.

The report’s investigators linked birth and infant death data between 2011 and 2015 to look for association of gestational weight gain with infant morbidity and mortality. Their 2 main outcomes were significant morbidity, which was defined as seizures, antibiotic therapy, surfactant therapy, admission to the neonatal intensive care unit, and any assisted ventilation; as well as infant mortality at younger than 1 year of age, which was split into (<1 hour, 1-23 hours, 1-6 days, 7-27 days, or 28-365 days after birth

There were 15,759,945 mother/child pairs included in the study. Mothers had an average age of 28.1 years and gained 14.1 kg during pregnancy. The average gestational weight gain decreased with body mass index category: underweight, 15.7 [6.4] kg; normal weight, 15.4 [6.2] kg; overweight, 14.2 [7.4] kg; obesity class 1, 12.2 [8.0] kg; obesity class 2, 10.3 [8.4] kg; obesity class 3, 8.2 [9.2] kg; 

 < .001. In this cohort, 8.8% of the newborns had significant morbidity, with the lowest prevalence occurring in infant born to women in the normal weight body mass index class and the highest in infant born to women with class 3 obesity. Additionally, 0.34% of infants died within a year of birth, with the highest rate occurring in infants with mothers who had class 3 obesity and the lowest found in infants born to mothers with a normal weight body mass index class. Investigators determined that optimal gestational weight gain ranges were 12.0 to less than 24.0 kg for underweight and normal weight women, 10.0 to less than 20.0 kg for overweight women, 8.0 to less than 16.0 kg for women with class 1 obesity, 6.0 to less than 16.0 kg for class 2 obesity, and 6.0 to less than 10.0 kg for class 3 obesity. They noted that the lower bounds of the ranges were higher than existing recommendations for overweight women and those with class 1-3 obesity.

They concluded that extremes of gestational weight gain were tied to an increased risk of negative outcomes for the infant, which held across all body mass index categories. They believe that this indicated that weight maintenance and loss should not be used for routine guidelines.

1. Wang L, Zhang X, Chen T, et al. Association of gestational weight gain with infant morbidity and mortality in the United States. 

. 2021;4(12):e2141498. doi:10.1001/jamanetworkopen.2021.41498

Gone are the days of little guidance for weight gain during pregnancy, but determining the best weight range has been elusive. A new study provides some helpful advice.

Identifying the optimal gestational weight gain for infant health

With the growing knowledge of the potential damage caused by repeated head injuries, which can include chronic traumatic encephalopathy, from contact sports and in particular football, many parents have become increasingly wary of the potential for permanent damage to their child as a result of athletic participation. A

 whether repetitive head impacts in youth tackle football over the course of 4 seasons were linked to cognitive and behavioral difficulties.

Investigators conducted their prospective cohort study from July 2016 to January 2020 for a total of 4 seasons. They recruited players from 4 teams that included 5th and 6th graders. The age group was selected to both prioritize young age and ensure a wide potential pool of participants due to large team size. Head impacts were measured with helmet-based sensors at practices and games. They were summed to provide the cumulative head impact gravitational force equivalents per season. Cognitive and behavioral assessments were run before and after each season. Any pre-existing conditions were noted at the initial pre-first season visit. Interval concussions were recorded at the follow-up visits. Participants informed investigators about other contact sports participation at the final visit.

A total of 70 boys aged 9 to 12 years were enrolled in the study; 18 of them completed all 4 years of the study. In each of the 4 seasons, 1 player suffered a concussion and the same player had a concussion during seasons 2 and 3. For players who had a concussion, the symptoms were resolved and they had been medically cleared before the post-season assessment. The investigators stated that the premorbid diagnoses, pre-season 1 outcome measurements, and cumulative impacts in season 1 had no difference between the players who completed all 4 years of assessment and those who dropped out. Higher cumulative impacts were tied to lower self-reported symptom burden (β = −0.6; 95% CI, −1.0 to −0.2; 

 = .004). Following correction for multiple comparisons, they found no further association between impacts and outcome measures. Furthermore, premorbid conditions such as attention-deficit/hyperactivity disorder, anxiety, and depression were linked to worse cognitive or behavioral scores at multiple points in the investigation, whereas a history of concussion or premorbid headache disorder was less frequently tied to negative outcomes.

The investigators concluded that premorbid conditions were more associated with cognitive and behavioral outcomes than cumulative impact. More research may be needed to further confirm the results, but the study does offer some reassurance to parents of children who are involved in contact sports.

1. Rose S, Yeates K, Nguyen J, Pizzimenti N, Ercole P, McCarthy M. Exposure to head impacts and cognitive and behavioral outcomes in youth tackle football players across 4 seasons. 

. 2021;4(12):e2140359. doi:10.1001/jamanetworkopen.2021.40359

Continuous health coverage is an important way to ensure better health outcomes for children and young adults. Even short delays in resuming coverage can be linked to fewer preventive health care visits and more utilization of costly health care services like the emergency department. Understanding who is at risk of disrupted Medicaid coverage is key, as is understanding how much an intervention to prevent disenrollment might cost. A 

Investigators used North Carolina Medicaid claims data to perform a retrospective cohort study. Enrolled participants were age 1 to 20 years on January 1, 2016, and had 30 days of prior continuous enrollment. They were observed for 2 years. The risk of coverage disruptions of 1 to less than 12 months was assessed. Among those who had been disenrolled for 30 or more days, the investigators also examined the risk of reenrollment within 1 to 6 months and 7 to 11 months.

There were 831,173 people in the study who benefited from Medicaid aged 1 to 5 years (23%), 6 to 17 years (68%), and 18 to 20 years (9%). Among the 214,401 people who had a first disenrollment, the risk of reenrollment within 6 months and 7 to 11 months was 19% and 7%, respectively. In comparison to White children, the risk of disrupted coverage was higher for Black children (hazard ratio [HR], 1.21; 95% CI, 1.18-1.24), children of other races (Asian, American Indian, Hawaiian or Pacific Islander, multiple races, or unreported; HR, 1.37; 95% CI, 1.33-1.40), and Latinx children (HR, 1.65; 95% CI, 1.60-1.70). Children with higher medical complexity also had a higher risk of coverage disruption (HR, 1.15; 95% CI, 1.12-1.19).

Counties with the highest unemployment rates had lower risks of coverage disruption (HR, 0.89; 95% CI, 0.85-0.94). The estimated per member per month cost for the entire population in a situation where all medical costs were included was $125.73. In a scenario where disenrollment was prevented it was $122.14. 

The investigators concluded that disruption of coverage was high and that children who are members of historically marginalized groups often experience unstable enrollment. Not only could interventions to reduce disenrollment lead to better health outcomes, they could lead to cost reductions for Medicaid programs.

1. Cholera R, Anderson D, Raman S, et al. Medicaid coverage disruptions among children enrolled in North Carolina medicaid from 2016 to 2018. 

. 2021;2(12):e214283. doi:10.1001/jamahealthforum.2021.4283

A greater understanding of the harm of repeated concussions has led to many parents wondering if their child should be playing sports that may results in concussion or even just an impact to the head. A new study offers some insight into whether repeated head impact can have a negative effect on cognition and behavior.

A disruption in health care coverage can cause treatable conditions to go untreated or worsen to the point of needing emergency department care. An investigation looks into who is most at risk of Medicaid coverage disruption and whether mitigating that risk can lead to cost reduction.

A look at what to expect from Contemporary Pediatrics this week

Why physician burnout must be addressed

Identifying the optimal gestational weight gain for infant health

Do repeated head injuries during play impact cognition and behavior?

Who is at risk of Medicaid coverage disruption

What's new on Contemporary Pediatrics: January 3 to 7