Protecting Children

UHCOP’s Hua Chen Focuses on Improving Pediatric Medication Safety, Outcomes

Assessing the safety and efficacy of medications in the pediatric patient population is profoundly more complicated than in the adult patient population due to legitimate ethical, legal, and physiological concerns. Yet, researchers like University of Houston Professor Hua Chen, M.D., Ph.D., are committed to filling the gap to safeguard the health and development of this vulnerable group.

To comprehensively assess the effectiveness of drugs, the only way to factually determine its success is by studying its use and effects in a large population. Nevertheless, this is harder than it seems.

For Chen, the life cycle of medications is like meeting someone online.

"You can have lots of communication with the drug in the lab; like sending pictures or videos to someone you meet online, you get snaps of what the effects of the medication might be," said Chen, who also serves as assistant chair of the college's Department of Pharmaceutical Health Outcomes and Policy. "But just like in online dating, you only get to know that individual (or in this case the effects of the medication) until you meet in person and spend some time together."

When a new drug is authorized by the FDA, it is determined that it is safe and effective to use, based on the manufacturer’s reported data via lab and clinical trials. Nonetheless, the only way to truly understand its effects is by studying the drug application and efficacy in the population.

"You cannot see only one or a couple of patients because what one patient took might not work with another with the same condition," Chen said. "Nevertheless, you can only see the results a while after the drug has been launched. This is the moment when researchers may discover safety-related issues."

Challenges of analyzing pediatric medication

When it comes to pediatric medication, analysis and research becomes even more important.

"Physicians oftentimes just directly adapt adult data to kids and assume whatever works in adults will work with kids," Chen said.

Yet, despite this ongoing problem in pediatric medicine, there is a significant gap in research conducted on children. While parental worries about potential impacts on their child’s development are understandable, the lack of research is also potentially harmful.

"It is very difficult to recruit kids to participate in a study, and there are many ethical concerns as well, so it makes it even more challenging," Chen said.

There is a need to understand the impact of medication on children given that it can affect their growth and their future health.

SGAs and weight gain

Chen says that she is deeply passionate about pediatric medication safety. She has recently been studying the effects of second-generation antipsychotics (SGA) medication, which are commonly used and highly effective for the management of severe mental disorders, like bipolar or autism spectrum disorders.

Given the severity of those disorders, patients require long-term treatments using SGAs. Yet, while this second-generation medication has fewer effects than their first-generation counterparts, they cause serious weight gain in children and teenagers. 

"During the research, my students and I were shocked to find out the incredible costs SGA treatment comes with," Chen said. "One patient gained almost 110 pounds in a year of treatment!"

According to Chen and her students’ study published in the Journal of Child and Adolescent Psychopharmacology, assessing patient’s characteristics at the beginning of the treatment could help clinicians with their prescriptions to regulate weight gain.   

Opioids and asthma risks

One of her students noticed an opioid medication’s warning label advised against opioid use in patients with asthma outside of an inpatient setting, where clinicians are generally better prepared to handle, and acute episode of asthmatic reaction vs. at home or other areas.

Chen could not find any evidence associated with the label warning. She noticed that there was a lack of data and realized the crucial need for evidence to support pediatric practices. “I noticed that a lot of FDA warnings on pediatric populations are not based on solid evidence or scientific data,” Chen said.

Future plans

For furthering her research, Chen is looking to expand her research network with academicians and experts of different fields.

"We would like to bring the work of these people; we want people outside of healthcare into healthcare to help with their methods and expertise," Chen said.

— By Elias Lilienfeld