Drugs for Children

Itô, Shinya

doi:10.1002/cpt.675

Cited by 11 publications

(9 citation statements)

References 7 publications

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“…Here, it is important to distinguish between off-label use "on evidence" and off-label use "off evidence." 46 The first may often be clinically appropriate while the latter might reflect irrational drug use. If data on diagnoses are not available, dispensed drugs can be used as a proxy for comorbidity.…”

Section: Characterizing Drug Users and Prescribersmentioning

confidence: 99%

Core concepts in pharmacoepidemiology: Measures of drug utilization based on individual‐level drug dispensing data

Rasmussen

Wettermark

Steinke

et al. 2022

Pharmacoepidemiology and Drug

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Background Drug utilization studies are essential to facilitate rational drug use in the society. Aim In this review, we provide an overview of drug utilization measures that can be used with individual‐level drug dispensing data, referencing additional reading on the individual analysis. This is intended to serve as a primer for those new to drug utilization research and a shortlist from which researchers can identify useful analytical approaches when designing their drug utilization study. Results and Discussion We provide an overview of: (1) basic measures of drug utilization which are used to describe changes in drug use over time or compare drug use in different populations; (2) treatment adherence measures with specific focus on persistence and implementation; (3) how to measure drug combinations which is useful when assessing drug–drug interactions, concomitant treatment, and polypharmacy; (4) prescribing quality indicators and measures to assess variations in drug use which are useful tools to assess appropriate use of drugs; (5) proxies of prescription drug misuse and skewness in drug use; and (6) considerations when describing the characteristics of drug users or prescribers.

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Section: Characterizing Drug Users and Prescribersmentioning

confidence: 99%

Core concepts in pharmacoepidemiology: Measures of drug utilization based on individual‐level drug dispensing data

Rasmussen

Wettermark

Steinke

et al. 2022

Pharmacoepidemiology and Drug

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“…Since children in all countries are to some extent deprived of access to well-validated, safe, and effective medicines, child caregivers have become too much resigned to the use of off-label therapies or have resorted to extrapolation of dosage and therapeutic expectations from adult studies. Ito [ 2 ] has recently estimated that 50% of drug prescribing in his highly specialized Canadian children’s hospital is off-label. The proportion of off-label treatment escalates dramatically to 80% or higher in neonatal intensive care and other critical care settings [ 2 ].…”

Section: The Needmentioning

confidence: 99%

“…Ito [ 2 ] has recently estimated that 50% of drug prescribing in his highly specialized Canadian children’s hospital is off-label. The proportion of off-label treatment escalates dramatically to 80% or higher in neonatal intensive care and other critical care settings [ 2 ]. The need for expanded focus on obstetrical and neonatal clinical pharmacology research has been recognized for some time, but relevant human resources are scarce and logistical challenges are abundant [ 15 , 16 ].…”

Section: The Needmentioning

confidence: 99%

“…From the perspective of those committed to improving therapeutics for childhood disorders, many of the forces described may be seen as focused within the disciplines of pediatric clinical pharmacology and pharmacy. Never have the opportunities been greater than at present for pediatric pharmacologists to achieve treatment breakthroughs of lasting benefit for children building on recent progress [ 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 ]. However, if such breakthroughs are to be achieved, a more carefully orchestrated approach and integration of expertise from diverse researchers and clinicians will be required [ 9 , 10 , 11 , 12 ].…”

Section: Introductionmentioning

confidence: 99%

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Key Challenges in the Search for Innovative Drug Treatments for Special Populations. Converging Needs in Neonatology, Pediatrics, and Medical Genetics

MacLeod¹

2017

Children

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The explosion of knowledge concerning the interplay of genetic and environmental factors determining pathophysiology and guiding therapeutic choice has altered the landscape in pediatric clinical pharmacology and pharmacy. The need for innovative research methods and design expertise for small clinical trials to be undertaken in sparse populations has been accentuated. At the same time, shortfalls in critical human resources represent a key challenge, especially in low- and middle-income countries where the need for new research and education directions is greatest. Unless a specific action plan is urgently developed, there will be a continuing gap in availability of the essential expertise needed to address treatment challenges in special patient populations such as neonates, patients suffering from rare or neglected diseases, and children of all ages.

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“…However, sometimes off-label use of drugs could be inappropriate or without proven therapeutic benefit. Medical decisions involving off-label drug use should thus be based on the existing evidence ( Frattarelli et al, 2014 ; Ito, 2017 ) to avoid irrational medication use. Clinical Practice Guidelines (CPGs) that aim to collect, grade and summarize the latest available evidence are the best option for mitigating the risk of irrational pharmaceutical use and the liability associated with the off-label use of drugs ( guidelines., 2011 ).…”

Section: Introductionmentioning

confidence: 99%

Recommendations on Off-Label Drug Use in Pediatric Guidelines

et al. 2022

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Objective: To systematically analyze the supporting evidence, drug information, and the type of off-label drug use in recommendations on off-label drug use in pediatric guidelines.Methods: A cross-sectional study was performed by systematic search through MEDLINE (via PubMed) and Embase databases to identify literature published from 1 January 2018, to 31 December 2020. Only pediatric clinical practice guidelines that included recommendations on off-label use of drugs were included. We present descriptive information on the sources of the included guidelines, country, publication year, evidence grading system used, details on the types of off-label drug use, and the types of studies used as references to support the recommendations.Results: A total of 66 pediatric guidelines with 605 recommendations were included. Eighty-seven (14.4%) recommendations did not cite any references; and the remaining 518 recommendations were supported by 2,240 references (mean 4.3 references/recommendation). The most common types of studies cited were pediatric RCTs (n = 314, 14.0%), pediatric case series studies (n = 260, 11.6%), and reviews (n = 255, 11.4%). Twenty-one percent (n = 470) of the references were studies on adults. One hundred and forty (23.1%) recommendations were graded using the Grading of Recommendations, Assessments, Development, and Evaluations (GRADE) system, of which 37 (26.4%) were graded as strong but supported with only C or D level of evidence. The most commonly reported type of information in the recommendations was indication (n = 499, 82.5%). The most commonly addressed type of off-label drug use in the 523 positive recommendations was unapproved population (n = 255, 48.8%). Sixty-nine (11.4%) recommendations explicitly reported the drug use as off-label.Conclusion: Children may be exposed to medical risks due to gaps in reporting and evidence of off-label drug use recommendations in pediatric guidelines.

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Drugs for Children

Cited by 11 publications

References 7 publications

Core concepts in pharmacoepidemiology: Measures of drug utilization based on individual‐level drug dispensing data

Core concepts in pharmacoepidemiology: Measures of drug utilization based on individual‐level drug dispensing data

Key Challenges in the Search for Innovative Drug Treatments for Special Populations. Converging Needs in Neonatology, Pediatrics, and Medical Genetics

Recommendations on Off-Label Drug Use in Pediatric Guidelines

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