Electronic health record (EHR) based postmarketing surveillance of adverse events associated with pediatric off‐label medication use: A case study of short‐acting beta‐2 agonists and arrhythmias

Czaja, Angela S.; Ross, Michelle; Liu, Weiwei; Fiks, Alexander G.; Localio, Russell; Wasserman, Richard C.; Grundmeier, Robert W.; Adams, William

doi:10.1002/pds.4562

Cited by 13 publications

(12 citation statements)

References 38 publications

(59 reference statements)

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“…Therefore, in these situations, close monitoring of the side effects associated with off-label use is a prerogative. Studies in the literature support the importance to assess the safety of off-label prescribing in populations where randomized clinical trials are unlikely to be performed [ 89 ]. Monitoring the safety of off-label use of medicines can be done through several methods, which have been described by Dal Pan [ 90 ]: spontaneous reports, observational pharmacoepidemiologic studies, registries, and clinical trials.…”

Section: Safety Initiativesmentioning

confidence: 99%

Off-Label Medication: From a Simple Concept to Complex Practical Aspects

Rusz

Ősz

Jîtcă

et al. 2021

IJERPH

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Off-label use of drugs is widely known as unapproved use of approved drugs, and it can be perceived as a relatively simple concept. Even though it has been in existence for many years, prescribing and dispensing of drugs in an off-label regimen is still a current issue, triggered especially by unmet clinical needs. Several therapeutic areas require off-label approaches; therefore, this practice is challenging for prescribing physicians. Meanwhile, the regulatory agencies are making efforts in order to ensure a safe practice. The present paper defines the off-label concept, and it describes its regulation, together with several complex aspects associated with clinical practices regarding rare diseases, oncology, pediatrics, psychiatry therapeutic areas, and the safety issues that arise. A systematic research of the literature was performed, using terms, such as “off-label”, ”prevalence”, ”rare diseases”, ”oncology”, ”psychiatry”, ”pediatrics”, and ”drug repurposing”. There are several reasons for which off-label practice remains indispensable in the present; therefore, efforts are made worldwide, by the regulatory agencies and governmental bodies, to raise awareness and to ensure safe practice, while also encouraging further research.

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Section: Safety Initiativesmentioning

confidence: 99%

Off-Label Medication: From a Simple Concept to Complex Practical Aspects

Rusz

Ősz

Jîtcă

et al. 2021

IJERPH

View full text Add to dashboard Cite

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“…A known but still unsolved problem is detection of ADEs in children and their comparison to adults 75 . Population stratification is a popular approach to identify ADEs within the paediatric population and was used to discover the arrhythmogenic effects of short‐acting beta‐agonists from electronic health records 76 . In other applications, paediatric populations are compared directly to adult populations, as was used to identify renal toxicity associated with enalapril in EudraVigilance 77 .…”

Section: Systems Biology and Informatics Approaches To Improve Paedia...mentioning

confidence: 99%

No population left behind: Improving paediatric drug safety using informatics and systems biology

Giangreco

Elias

Tatonetti

2021

Brit J Clinical Pharma

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Adverse drugs effects (ADEs) in children are common and may result in disability and death. The current paediatric drug safety landscape, including clinical trials, is limited as it rarely includes children and relies on extrapolation from adults. Children are not small adults but go through an evolutionarily conserved and physiologically dynamic process of growth and maturation. Novel quantitative approaches, integrating observations from clinical trials and drug safety databases with dynamic mechanisms, can be used to systematically identify ADEs unique to childhood. In this perspective, we discuss three critical research directions using systems biology methodologies and novel informatics to improve paediatric drug safety, namely child versus adult drug safety profiles, agedependent drug toxicities and genetic susceptibility of ADEs across childhood. We argue that a data-driven framework that leverages observational data, biomedical knowledge and systems biology modelling will reveal previously unknown mechanisms of pediatric adverse drug events and lead to improved paediatric drug safety.

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“…This network was developed to study pediatric medication tolerability and effectiveness and has facilitated observational research on many other questions, including in infectious disease. [65][66][67][68]…”

Section: Fundamentals Of Ehr-based Research Networkmentioning

confidence: 99%

Electronic Health Record Network Research in Infectious Diseases

Jhaveri

John

Rosenman

2021

Clinical Therapeutics

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With the marked increases in electronic health record (EHR) use for providing clinical care, there have been parallel efforts to leverage EHR data for research. EHR repositories offer the promise of vast amounts of clinical data not easily captured with traditional research methods and facilitate clinical epidemiology and comparative effectiveness research, including analyses to identify patients at higher risk for complications or who are better candidates for treatment. These types of studies have been relatively slow to penetrate the field of infectious diseases, but the need for rapid turnaround during the COVID-19 global pandemic has accelerated the uptake. This review discusses the rationale for her network projects, opportunities and challenges that such networks present, and some prior studies within the field of infectious diseases.

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Electronic health record (EHR) based postmarketing surveillance of adverse events associated with pediatric off‐label medication use: A case study of short‐acting beta‐2 agonists and arrhythmias

Abstract: Using EHR data, we could estimate the risk of a rare event associated with medication use and determine difference in risk related to on-label versus off-label status. These findings support the value of EHR-based data for postmarketing drug studies in the pediatric population.

Cited by 13 publications

References 38 publications

Off-Label Medication: From a Simple Concept to Complex Practical Aspects

Off-Label Medication: From a Simple Concept to Complex Practical Aspects

No population left behind: Improving paediatric drug safety using informatics and systems biology

Electronic Health Record Network Research in Infectious Diseases

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