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.
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 last 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."
Chris Feudtner, M.D., Ph.D., M.P.H., from 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; and 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.
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.
"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. (Arch Pediatr Adoles Med. Published online September 5, 2011.
Editorial: Pediatric Polypharmacy
In an accompanying editorial, Nancy E. Morden, M.D., M.P.H., and David Goodman, M.D., M.S., both from the Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth Medical School, Lebanon, N.H., examine the implications of the article by Feudtner et al. "Polypharmacy is the norm for hospitalized infants and children," they write. "Should we be concerned?"
Morden and Goodman note that they "share the authors' unease with the level of polypharmacy in pediatric inpatient settings." However, they add, additional data could provide a clearer picture of the effect that polypharmacy actually has on children. Noting that other research suggests undertreatment of pain and possible overuse of antimicrobial and respiratory agents in this population, Morden and Goodman ask, "Are pediatric patients receiving too much or too little?"
According to Morden and Goodman, the article by Feudtner and colleagues suggests that medication exposure varies across hospitals for asthma, appendectomy and seizure. They recommend these variations as an area for further study, as well as other related topics. For instance, linking exposure patterns to outcomes data could reveal ways to better use medications, and research might also examine outpatient pediatric polypharmacy or how long-term polypharmacy affects children.
"Clinicians, policy makers, researchers, and patient advocates should collaborate on efforts aimed at promoting the development of evidence to inform pediatric pharmacotherapy," Morden and Goodman conclude. "Moving toward an understanding of the balance of risks and benefits will require better data, a sustained research program, and a commitment to translating new knowledge into better practice."
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