Off-Label Use of Drugs in Children

Neville, Kathleen; Frattarelli, Daniel A.C.; Galinkin, Jeffrey L.; Green, Thomas P.; Johnson, Timothy D.; Paul, Ian M.; Anker, John N. van den

doi:10.1542/peds.2013-4060

Cited by 320 publications

(146 citation statements)

References 5 publications

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“…10 In some patients, they may be cutting-edge, research-supported, or standard practices that are simply ahead of FDA approval. 7,11 In many patients, however, they lack solid scientific evidence 12 and can thus be risky.…”

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confidence: 99%

Predictors of Polypharmacy and Off-Label Prescribing of Psychotropic Medications

Kearns

Hawley

2014

Journal of Psychiatric Practice

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We employed a national survey of child psychiatrists to examine typical prescribing practices for children with anxiety, depression, and disruptive behavior disorders. We examined the extent to which polypharmacy and off-label prescribing occur in routine practice and the degree to which child characteristics, child psychiatrist characteristics, and medication availability may influence these prescribing practices. We found that child psychiatrists most often prescribed medications that were on-label according to U.S. Food and Drug Administration (FDA) guidelines, and that they were progressively less likely to choose medications with partial approval (i.e., medications having pediatric approval but not for the patient’s age or problem type), and then medications with no pediatric approval. We also found that prescribing multiple concomitant medications was the norm. We employed best subsets regression to determine the best theoretically relevant predictors to explain polypharmacy and off-label prescribing and found that the best fitting model only included number of child diagnoses. These findings suggest that comorbidity is an important issue in the pharmacotherapy of children with mental health disorders and one that must be addressed in future clinical trials. (Journal of Psychiatric Practice 2014;20:438–447)

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confidence: 99%

Predictors of Polypharmacy and Off-Label Prescribing of Psychotropic Medications

Kearns

Hawley

2014

Journal of Psychiatric Practice

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“…Similar legislation to promote pediatric clinical trials exists in Europe [8]. The legislation in the United States has resulted in labeling changes to over 500 pediatric therapeutics [9]. …”

Section: Pediatric Clinical Trials: Challenges and Solutionsmentioning

confidence: 99%

Clinical Trial Design in Juvenile Idiopathic Arthritis

et al. 2017

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Randomized clinical trials provide the gold standard evidence base to guide clinical practice. Despite major advances in trial design, pediatric clinical trials are still difficult to perform and pose unique challenges, including the need to consider the impact of developmental changes in trial design. Advances within pediatric rheumatology combined with the need to comply with legislative requirements have driven new approaches to performing pediatric clinical trials such as utilization of large research networks, incorporation of patient and family stakeholders in the planning and implementation of clinical trials, and the development of novel trial designs. The expansion of available biological therapeutics that now includes biosimilar drugs highlights the important and difficult balance of providing new and cost effective drugs to children while ensuring safety in a vulnerable population. Future advances in JIA clinical trials will likely be the application of precision medicine based on biologic, rather than phenotypic, classification of JIA, with improved understanding of pediatric clinical pharmacology. Clinical trial simulations and comparative effectiveness studies are important supplements to traditional clinical trials, permitting efficient studies and results that are more generalizable.

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“…[20] However, professional practice contemplates that the therapeutic decision-making of marketed drugs is also presumably assumed by the prescriber [21] who bases his expert judgment on the best available evidence, clinical experience, references of scientific articles and the risk-benefit balance, to obtain the guidelines to be followed in an individual patient therapy. [22] The official agency, which regulates medicines in different countries, determines whether the marketing authorization of the products is given, such authorization is specific to indications, doses and population.…”

Section: Baudrit Et Al World Journal Of Pharmaceutical Researchmentioning

confidence: 99%

Quality Verification of Six Medicines in Wholes and Halves Tablets, Re-Packaged in Individual Plastic Compartments During Sixty Days

Baudrit¹

2017

WJPR

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Plastic boxes with individual compartments are often used to improve medication compliance and only a few studies have been done on the stability of the tablet halves after placing them on these devices. In this investigation, wholes and halves tablets of furosemide, hydrochlorothiazide, spironolactone, warfarin sodium and atenolol and levothyroxine sodium were re-packaged and storing for sixty days under normal environmental conditions. The physical characteristics were observed and the quality attributes were verified. There were no changes in physical characteristics of all products. All products, except halves tablets of atenolol, showed accuracy according the test of uniformity of mass. The comparisons of dissolution profiles between whole tablets and tablets halves were adequate for hydrochlorothiazide and atenolol, but not for formulations of furosemide, spironolactone and warfarin sodium. Levothyroxine sodium showed a different dissolution behavior than expected. Whole tablets of atenolol do not meet specifications for uniformity of contents, neither the halves tablets of atenolol and spironolactone. According to the results, it is possible to re-package wholes tablets of furosemide, hydrochlorothiazide, spironolactone and warfarin sodium; but it is not advisable to maintain this practice for whole tablets of atenolol and levothyroxine sodium, neither for the halves of the rest of the products, except hydrochlorothiazide. These findings may become opportunities for improvement for pharmaceutical laboratories, as well as become a study topic for practitioners to advise the use of multi-compartment compliance aids, finally,

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Off-Label Use of Drugs in Children

Cited by 320 publications

References 5 publications

Predictors of Polypharmacy and Off-Label Prescribing of Psychotropic Medications

Predictors of Polypharmacy and Off-Label Prescribing of Psychotropic Medications

Clinical Trial Design in Juvenile Idiopathic Arthritis

Quality Verification of Six Medicines in Wholes and Halves Tablets, Re-Packaged in Individual Plastic Compartments During Sixty Days

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