Dosing information in a standard drug reference: Are pediatrics still therapeutically neglected?

Permala, Jesmin; Awaisu, Ahmed; Shafie, Asrul Akmal

doi:10.1111/j.1442-200x.2009.02958.x

Cited by 14 publications

(7 citation statements)

References 11 publications

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“…It is important to emphasize that the high number of off‐label and unlicensed prescriptions in NICU involve legal issues for clinicians because of the health risk for patients due to over‐ or under‐treatment . We also emphasize the importance of accurate information about these limitations in drug prescription and, overall, the need for truthful and qualified relationship with the patients and their parents …”

Section: Discussionmentioning

confidence: 96%

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Off‐label and unlicensed drug use among neonatal intensive care units in Southern Italy

Laforgia¹,

Nuccio

Schettini³

et al. 2014

Pediatrics International

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show abstract

Section: Discussionmentioning

confidence: 96%

“…We performed an investigation of unlicensed or off-label drug use among eight tertiary-level NICUs in a large area of southern Italy. NICU have a median of six tertiary-level beds (range, 4-10) and 11 level-II beds (range, [8][9][10][11][12][13][14][15][16][17][18].…”

Section: Methodsmentioning

confidence: 99%

Off‐label and unlicensed drug use among neonatal intensive care units in Southern Italy

Laforgia¹,

Nuccio

Schettini³

et al. 2014

Pediatrics International

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“…These drawbacks limit the role played by RCTs in pharmacovigilance because RCTs may not be able to detect adverse drug events that are relatively rare or that occur after long‐term treatment 6 . In addition, individuals who are vulnerable to adverse drug events, such as elderly people, children, pregnant women, and patients with multiple comorbidities or polypharmacy, are often unable to participate in RCTs 7‐9 . In contrast, real‐world data (RWD) collected during routine clinical care have promising potential with regard to reflecting the entire picture of drug utilization and adverse drug events 5 …”

Section: Introductionmentioning

confidence: 99%

“…6 In addition, individuals who are vulnerable to adverse drug events, such as elderly people, children, pregnant women, and patients with multiple comorbidities or polypharmacy, are often unable to participate in RCTs. [7][8][9] In contrast, real-world data (RWD) collected during routine clinical care have promising potential with regard to reflecting the entire picture of drug utilization and adverse drug events. 5 Global regulatory authorities such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have attempted to generate RWE to support regulatory decision making.…”

mentioning

confidence: 99%

Using real‐world evidence for pharmacovigilance and drug safety‐related decision making by a resource‐limited health authority: 10 years of experience in Taiwan

Chen

Lin

Huang

et al. 2020

Pharmacoepidemiology and Drug

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Purpose: Real-world evidence has become increasingly relevant in regulatory decision making. Compared to large regulatory bodies, the national pharmacovigilance system in Taiwan is still under development, and the aim of this study is to demonstrate how a resource-limited health authority utilizes real-world evidence in decision making. Methods: We described different sources of real-world data available in Taiwan and illustrated the structural framework that integrates real-world evidence into Taiwan's national pharmacovigilance system. Additionally, we reviewed real-world studies conducted in the past 10 years and provided examples to show how these studies influenced drug safety-related decision making in Taiwan. Results: During the past 10 years, real-world evidence used when making drug safety-related regulatory decisions in Taiwan was mainly generated from nationwide claims databases, but other sources of real-world data, such as national registries and large electronic hospital databases, also became available recently. Different types of real-world evidence, including drug utilization studies, risk evaluation studies, and risk minimization measure evaluation studies, have been used to support regulatory decisions in Taiwan. Conclusions: Through collaborations between the government and academics, Taiwan has started to integrate real-world evidence into the national pharmacovigilance system. However, future efforts, including linkages between different sources of real-world data and improvements in procedural and methodological practices, are needed to generate more regulatory-quality real-world evidence.

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“…Children are subjected to therapy risk because they have different pharmacokinetic and pharmacodynamic mechanisms according to age and compared to adults (Rosa et al, 2006;OMS, 2007;Jadhav, Kern, 2010). The lack of accurate and adequate information on the use of pediatric medicines or the lack of appropriate formulations for the indicated dosages led to the spread of the term "therapeutic orphans" when referring to children (Permala et al, 2010).…”

Section: Introductionmentioning

confidence: 99%

Preformulation of a liquid dosage formulation of captopril for pediatric use: drug-excipient compatibility and stability studies

Goes

Freire

Moura

et al. 2019

Braz. J. Pharm. Sci.

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Currently, medications used in children are typically modified from pharmaceutical dosage forms designed for adults. Captopril is widely adapted to liquid formulations for use in hospitals. Its stability in the aqueous medium is reduced since it undergoes oxidation producing captopril disulfide (its main metabolite). The aim of this formulation study was to suggest favorable conditions for the development of a stable captopril formulation. The compatibility between the drug and excipients was evaluated by differential scanning calorimetry analysis (DSC). For studies in solution, different formulations were prepared according to a factorial design varying EDTA concentration, water purity and pH. The resultant formulations were stored at 60°C and analyzed over a twelve-day period using HPLC. The DSC curves obtained suggested, although not conclusive to elucidation, interactions of captopril with citric acid and sucralose. The stability study of these solutions revealed that the variables significantly influenced captopril content, which degraded at zero order kinetics and rates differing by a factor of up to 7 times, where pH proved the most influential factor. Interactions between variables were observed. Therefore, development of a stable captopril formulation is feasible provided EDTA and a buffering agent is used at suitable concentrations (0.08% and pH 3.85).

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Dosing information in a standard drug reference: Are pediatrics still therapeutically neglected?

Cited by 14 publications

References 11 publications

Off‐label and unlicensed drug use among neonatal intensive care units in Southern Italy

Off‐label and unlicensed drug use among neonatal intensive care units in Southern Italy

Using real‐world evidence for pharmacovigilance and drug safety‐related decision making by a resource‐limited health authority: 10 years of experience in Taiwan

Preformulation of a liquid dosage formulation of captopril for pediatric use: drug-excipient compatibility and stability studies

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