Off label drugs in pediatrics?

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Manley Emard asked a question: Off label drugs in pediatrics?
Asked By: Manley Emard
Date created: Sun, May 23, 2021 4:46 PM
Date updated: Sun, Nov 6, 2022 11:50 AM

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Top best answers to the question «Off label drugs in pediatrics»

  • The types of drugs most commonly prescribed off-label to children under 18 were antihistamines (allergy medications), antibiotics and antidepressants. Antihistamines and antibiotics were often prescribed for respiratory infections, the researchers said.

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However, off-label drug use remains an important public health issue for infants, children, and adolescents, because an overwhelming number of drugs still have no information in the labeling for use in pediatrics. The purpose of off-label use is to benefit the individual patient. Practitioners use their professional judgment to determine these uses.

Off-label medication use is common in the pediatric population, especially in neonates and younger age groups. More age-specific research is needed to provide adequate drug safety and effectiveness for children. Until more data is provided, clinical decision making should be guided by the best available evidence.

Inadequate clinical trials increase exposure to drugs that lack safety-efficacy data in pediatric population. Hence, off-label and unlicensed drug use must be regarded as a patient safety-issue that is known to be associated with increased risks of adverse drug reactions apart from under- or overdosing due to lack of pharmacokinetic data.

CONCLUSIONS: Although off-label drug use at major US pediatric hospitals is declining, 1 out of every 4 medications is not in accordance with FDA label indications for patient age. There exists substantial variation in off-label drug use among drug categories and encounter types.

About half the drugs used in the pediatric intensive care unit are off-label. Up to 100% of children, in some studies, receive at least one off-label drug during their hospitalization. (1,2,3) Examples of these drugs include dexmedetomidine, ketamine, and hydromorphone.

Off-Label Prescribing in Pediatrics Many drugs are not FDA-approved for use in kids but are still used "off-label," meaning that they are used in children younger than the approved age or for other conditions that they are not approved for yet.

PREA —. Pediatric Research Equity Act. The US Food and Drug Administration requires that medications be tested for safety and efficacy at a specific dosage, and for a specific time period, before approval for clinical use in a particular population. 1 Use of medications outside these parameters is considered “off-label” drug use.

A median of 3 (interquartile range, 2–6) unique drugs per patient were used off-label. Those who received ≥1 drug off-label (85% of the cohort) had longer median PICU (2 days vs 1 day) and hospital (6 days vs 3 days) lengths of stay and higher mortality (3.6% vs 0.7%), p < 0.001.

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