September 6, 2011 — Some hospitalized pediatric patients, particularly those with rare conditions, may be exposed to many drugs and therapeutic agents, according to a report published Online First by Archives of Pediatrics and Adolescent Medicine, one of the JAMA/Archives journals.
Some drugs lack established effectiveness and safety profiles, used for off-label indications
According to background information in the article, many drugs used for children in the hospital setting do not have well-established pediatric efficacy and safety profiles. Some medication use in this population is for off-label indications. Further, medication errors do occur, the authors note.
In the past decade, lawmakers have endorsed measures to encourage the study of pediatric treatments, improve labeling of medications intended for children and reduce medication errors in hospitalized children.
“To advance this agenda, we need to refine our knowledge of the overall patterns of pediatric inpatient drug and therapeutic agent use, including what drugs and therapeutic agents are used most commonly, the number of different drugs and therapeutic agents that hospitalized children receive, and potential differences in drug and therapeutic agent exposures across different types of hospitals,” write the authors.
“This knowledge, especially if based on population-level data, would enhance efforts to prioritize and design research studies regarding the effectiveness and safety of pediatric inpatient medications.”
Retrospective study included children treated in children's hospitals and general hospitals
Chris Feudtner, MD, PhD, MPH, from The Children’s Hospital of Philadelphia, and colleagues conducted a retrospective study of 2006 data from the Pediatric Health Information System, which includes children’s hospitals in U.S. major metropolitan areas, and the Perspective Data Warehouse, which includes U.S. academic medical centers, community-based hospitals and large systems of multiple hospitals. The researchers reassigned the records into two categories:
- 365,868 pediatric patients younger than 18 years who experienced 491,451 hospitalizations in 52 children’s hospitals
- 221,559 pediatric patients who experienced 260,740 hospitalizations in 411 general hospitals
These data represent roughly 19.9 percent of all U.S. pediatric inpatient hospitalizations. The researchers examined demographic and clinical characteristics as well as patients’ exposures to medications and therapeutic agents.
Children receive more drugs during longer hospital stays
The most common exposures varied by patient age and by hospital type, with acetaminophen, albuterol and antibiotics the most prevalent medication exposures. There was an association between length of stay and the number of drug and therapeutic agent exposures.
On day one of hospitalization:
- In children’s hospitals, patients younger than one year at the 90th percentile of daily medication exposure received 11 drugs and those one year or older received 13 drugs.
- In general hospitals, those younger than one year received 8 drugs and those one year or older received 12 drugs.
By day seven of hospitalization:
- In children’s hospitals, patients younger than one year in the 90th percentile of cumulative exposure to distinct medications had received 29 drugs; patients one year or older had received 35 drugs.
- In general hospitals, patients younger than one year had received 22 drugs; patients one year or older had received 28 drugs.
Pediatric patients with rare conditions appeared more likely than other pediatric patients to receive more exposures to drugs and other therapeutic agents.
Findings suggest ways to improve pediatric inpatient medication safety and effectiveness
“The findings and the data of this study offer at least three important means to improve pediatric inpatient medication efficacy, effectiveness, and safety,” write the authors.
- First, the rankings of drugs and therapeutic agents in terms of most frequent exposure for hospitalized children can suggest priorities for further research.
- Next, the level of polypharmacy (use of multiple drugs or therapeutic agents) that researchers found could raise concerns for patient safety, because polypharmacy in adults has been associated with adverse drug events.
- Lastly, the authors note, the information in these databases could provide the opportunity for comparative effectiveness and safety studies to be conducted.
Funding for the study
This study was supported by a grant from the Agency for Healthcare Research and Quality’s Center for Education and Research on Therapeutics.
Feudtner C, Dingwei D, Hexem KR, Luan X, Metjian TA. Prevalence of polypharmacy exposure among hospitalized children in the United States. Arch Pediatr Adolesc Med. Published online September 5, 2011. doi:10.1001/archpediatrics.2011.161.
Read the abstract.