Off-label use of antimicrobials among hospitalized children: a retrospective study of 3,406 patients

Abstract

IntroductionOff-label drug use is a global problem for which many countries and regions have issued legal provisions or reached an expert consensus. Off-label use is sometimes a necessity, especially since antibacterial drugs have become one of the most widely used drugs in pediatric settings and the issue of causing antimicrobial resistance has increasingly become unavoidable. It also poses additional risks, such as adverse drug reactions.MethodsOur study analyzed the antimicrobial prescriptions of pediatric inpatients in a large Chinese hospital in the first half of 2021. This retrospective investigation included 6,829 prescriptions, including 2,294 off-label prescriptions. We performed descriptive analyses of prescription antimicrobial agents among pediatric populations and reported the percentages and frequencies.Results It was found that off-label use of antibiotics was present in many children (n = 1,665, 48.9%) and was most common in newborns (n = 328, 82.8%). Among the commonly used antibiotics in pediatric patients, cephalosporins (n = 2,778, 40.7%) accounted for a relatively low proportion of offlabel use (n = 360, 15.7%), while macrolides (n = 628, 27.4%) and penicillins (n = 610, 26.6%) accounted for a higher proportion. The off-label type mainly referred to the appropriate population (46.5%) and dosage (dose, 10.0%; frequency of administration, 48.3%).DiscussionOff-label use was due to imperfect labels, improper medications, or medication errors. Only a few consensuses could apply to pediatric patients. More clinical trials are required to update the consensus, and drug labels must be continuously improved. The prescription behavior of doctors is also needed to be regulated. Rational use of drugs, especially antimicrobials, is the responsibility of all people, including the states, medical institutions, and individuals.

Cephalosporins in pediatrics: Navigating antimicrobial resistance impact and adverse effects – A comprehensive review

“…There should be a specialised approach to managing off-label medication as the risk of antibiotic resistance is rising globally. 32 Additionally, The use of third-generation cephalosporins is sharply increasing in the paediatric population, which, in light of the statement above, maybe the root of the emergence of resistance. Third-generation cephalosporin usage is ubiquitous, which aids in the development and spread of bacterial infections that produce ESBL.…”

Editorial: Model-based evaluation of antimicrobial agents in children—volume II

“…In case of vancomycin, steady-state trough concentration (C 0 ) and area under the steady-state curve (AUC 0-24 ) targets are often used for dose optimization of vancomycin. C 0 -based and AUC 0-24 -based machine learning models of vancomycin have been successfully developed and can achieve individualized initial dose prediction and further optimization based on therapeutic drug monitoring results in neonates by accurately predicting C 0 and AUC 0-24 ( Tang L et al, 2023 ).…”

Quality assessment of paediatric randomized controlled trials published in China from 1999 to 2022: a cross-sectional study

“…Due to a lack of sufficient information on children’s medication on drug labels and difficulties in conducting clinical trials [ 1 , 2 ], off-label prescribing in children is common globally and in China [ 3 ]. Overall, the off-label prescribing rates in children ranged from 46.9 to 98.1% in China [ 1 , 4 – 10 ], 53.0–98.1% in neonates [ 1 , 5 , 6 ], 57.2–82.7% in outpatients [ 7 , 8 ] and 48.9–79.0% [ 9 , 10 ] in inpatients; thus, increased risks related to treatment and legal practices exist in the treatment of children’s diseases [ 4 ]. In addition to drug labels, clinical treatment guidelines and expert consensuses based on clinical research have become the main sources and basis of physicians’ medication evidence [ 11 ], especially paediatricians, and the clinical research evidence in the guidelines and expert consensuses are generally graded according to the research design type.…”