Research Needed to Provide Pediatric Treatment During Disasters

Children’s health security is a weak spot in disaster preparedness planning, according to a new policy statement by the American Academy of Pediatrics that calls for research to be a high priority in order to develop pediatric dosing guidelines and formulations for life-saving medication, equipment, and supplies.

During a pandemic, natural disaster, or act of terrorism, children are particularly vulnerable because medical care must match their unique anatomic, physiologic, and developmental characteristics. Yet most medical countermeasures (MCMs), such as antitoxins, vaccines, and medical devices, in the Strategic National Stockpile available for rapid distribution during a public health emergency or disaster are not pediatric age-appropriate, according to the statement published in Pediatrics. For example, if a drug is only available in pill form, a child may not be able to swallow it.

In a related editorial, Laura Johnson Faherty, MD, MPH, a Robert Wood Johnson Foundation Clinical Scholar working with PolicyLab and the Center for Pediatric and Perinatal Disparities, both at The Children’s Hospital of Philadelphia, noted that research must be done during the short window of opportunity both during and after the event, to build evidence to ensure that pediatric treatments added to the stockpile will be safe and effective.

“Before an event, research in children is ethically challenging, but in the midst of a public health emergency, the risk/benefit ratio might shift, making the research acceptable and even ethically imperative,” Dr. Faherty said. “The twin goals of a robust research response are to help children affected by the current disaster, as well as address our current knowledge gaps to better prepare for future events.”

A challenge to accomplishing this advanced research is that within a commercial model, there is no strong incentive for the development and procurement of MCMs designed for the pediatric population. In many cases, the military has developed MCMs that have been evaluated and tested only in adults.

“Reliance on traditional market mechanisms for public health preparedness and response to disasters is risky,” according to the statement. “In the specific circumstance of MCM development for children, traditional market mechanisms for preparedness and response would create a gap that can be life-threatening for children.”

Another barrier is that when conducting research with children, they are afforded special protections, and parents must provide consent to include children in clinical trials. Yet, these considerations must not impede research efforts aimed at identifying pediatric indications for MCMs, said Dr. Faherty, who also is a Leonard Davis Institute of Health Economics fellow at the University of Pennsylvania.

“Although each situation is different, much of what we need to learn about children in public health emergencies can be anticipated ahead of time, and pediatric disaster experts could come up with research priorities, design generic research protocols that could be tweaked in real time, and have institutional review boards pre-approve these protocols to the extent possible to expedite getting these studies off the ground when time is of the essence,” Dr. Faherty said. “During and after disasters, there are many competing priorities. Research should be conducted in parallel to the response, not get in the way.”

The AAP statement, “Medical Countermeasures for Children in Public Health Emergencies, Disasters or Terrorism,” will be published in the February 2016 issue of Pediatrics (published online Jan. 4). It is the latest in a series of resources developed by the AAP to prepare pediatricians addressing the needs of children during times of crisis. Visit www.aap.org/disasters.