Attention-deficit/hyperactivity disorder (ADHD) treatment options for children continue to evolve. This year, however, caregivers may face a new challenge: finding the best treatment strategy for their child during a pandemic.

“It’s pretty clear that the pandemic has created unprecedented challenges at every level of society, particularly health care,” said John Beckner, RPh, senior director of strategic initiatives at the National Community Pharmacists Association (NCPA).

The coronavirus disease 2019 (COVID-19) pandemic has created significant challenges for all children and their families, but those obstacles may be “considerably greater” for those with ADHD, Beckner said, with some students facing virtual classrooms or less access to their regular physicians.

Lea S. Eiland, PharmD, BCPS, BCPPS, FASHP, FPPA, a clinical professor and associate department head of the Department of Pharmacy Practice at Auburn University Harrison School of Pharmacy in Alabama, said parents and health care providers need to consider the child’s unique needs and struggles when determining the best care plan.

The good news, she said, is that the ADHD drug market provides multiple options in type of medication, dosageformulation, and dosage requirements. As the market grows, pharmacists can help patients get optimal results from customized regimens.

Treatment Advances

Drug treatment options for ADHD fall into 2 categories: stimulants and nonstimulants.

According to Eiland, stimulants continue to be the first-line drug class recommended for both adults and children with ADHD.

With this drug class, which includes amphetamines and methylphenidates, pharmacokinetics and dosage formulations greatly affect the medication’s distribution in the body and its efficacy, according to Eiland. “You’re seeing, I would say even in the last several years, additional products that are marketed that have longer efficacy with a 1-time dose, and we’re still continuing to see that,” she said.

Most ADHD medications require dosing in the morning, but in 2019, Jornay PM arrived on the market, signaling the first FDA-approved stimulant designed for evening dosing. The methylphenidate product is taken at night but isn’t released in the body until morning, which helps reduce the severity of symptoms early in the day.

Earlier this year, it seemed another drug to treat ADHD could soon enter the market, but in May, Sunovion Pharmaceuticals Inc announced it was withdrawing its new drug application for dasotraline, a dopamine and norepinephrine reuptake inhibitor. The drug had also been studied for treating binge eating disorder (BED).

“[Although] Sunovion considers dasotraline to be a promising, novel treatment for BED and ADHD, we believe that further clinical studies would be needed to support a regulatory approval for dasotraline in these indications,” the drugmaker said in a statement announcing the decision. The company said it did not plan to pursue further development of the drug at this time.¹

Sunovion seems to have hit the brakes on dasotraline, but Vallon Pharmaceuticals Inc recently announced positive data from a pilot study of Abuse Deterrent Amphetamine Immediate Release (ADAIR).² “Results from this pilot study suggest that Vallon’s investigational immediate-release stimulant, ADAIR, may demonstrate less abuse potential than standard dextroamphetamine when manipu- lated and misused intranasally,” Timothy Whitaker, MD, a board-certified psychiatrist and Vallon’s chief medical officer, said in a statement.²

If the drug continues to jump approval hurdles, it would be the first intranasal product for ADHD, Eiland said. Overall, most of the chemical entities in clinical trials focus on the adult ADHD population rather than the pediatric setting. However, in some pediatric studies, investigators are looking into the neurobehavioral effect of drug holidays—stopping medication for a brief period of time, such as during summer break or weekends—or examining the effects of certain behavioral therapy interventions, Eiland said.

Ways Pharmacists Can Help

As more drug formulations and options enter the market, Eiland said, the key to determining the best strategy often requires looking at the child’s own needs.

“Do they wake up with symptoms? Do they wake up and it’s hard to get them dressed, get them to school, get them to day care? Or is it that you can get them up, but they have a harder time focusing during school, during the lunch hour, afternoon hours or evenings when they come home? And so we can actually select a stimulant product that works best based on when the child needs the most control for symptoms,” she said.

Pharmacists on a health care team can talk with physicians about individual drug options, the medications’ release in the body, and even the “vast pharmacokinetic difference” between a tablet, capsule, and liquid suspension form of the drug, Eiland said.

Community pharmacists can also play a valuable role by counseling a patient or caregiver on how to administer the medication and what adverse events to watch out for, Eiland said. Pharmacists should also alert the patient’s physician if a patient is struggling with a particular dosage form or there might be an adherence concern.

New Challenges From COVID-19

As a result of the ongoing global pandemic, visits to primary care physicians and specialists are down, Beckner said, which suggests that children with ADHD and parents may not get the 1-on-1 time with the physician they had in the past.

As more accessible health care providers, pharmacists can lend a hand by answering patient questions, counseling patients and their caregivers even during refills to identify possible concerns, and helping parents navigate dosage timing.

Children adjusting to new daily schedules may be spending much more time at home than they did in the past. “Behavioral parenting strategies are taking on an even greater role as a supplement to medications,” Beckner said. Some children may head back to the classroom; others may continue with virtual learning. Parents will need to consider individual needs to decide whether a new schedule requires changes to dosage timing or when a child learning from home seems to struggle the most with symptoms.

“There are some students that thrive in the virtual setting, and there are some students that struggle in the virtual setting, and we’re just learning that. That’s going to be something to try to figure out,” Eiland said.

Parents who opt for a medication holiday during summer break may also need to decide whether they want their child to resume medication dur- ing virtual learning.

In each case, experts say, pharmacists can help caregivers and children navigate the possible changes ahead. “It’s just talking with them, inquiring...checking on adherence, checking on administration, and checking on [adverse drug reactions],” Eiland said.

References:

1. Sunovion discontinues dasotraline program. News release. Sunovion Pharmaceuticals Inc. May 13, 2020. Accessed July 14, 2020. https://news.sunovion.com/press-releases/press-releases-details/2020/Sunovion-Discontinues-Dasotraline-Program/default.aspx
2. Vallon Pharmaceuticals presents positive data from pilot intranasal human abuse study of its investigational abuse deterrent stimulant, ADAIR, at the American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting. News release. Vallon Pharmaceuticals Inc. January 21, 2020. Accessed July 14, 2020. https://www.vallon-pharma.com/press-release-index/vallon-pharmaceuticals-presents-positive-data-from-pilot-intranasal-human-abuse-study
3. FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD. News release. FDA. June 15, 2020. Accessed July 14, 2020. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd