scholarly journals A database of pediatric drug effects to evaluate ontogenic mechanisms from child growth and development

2021 ◽  
Author(s):  
Nicholas P Giangreco ◽  
Nicholas P Tatonetti
Keyword(s):  
Real World ◽  
Growth And Development ◽  
Adverse Drug Events ◽  
Significant Risk ◽  
Drug Effects ◽  
Child Growth ◽  
Additive Models ◽  
Drug Event ◽  
Pediatric Drug ◽  
Risk Dynamics

Adverse drugs effects (ADEs) in children are common and may result in disability and death. However, current pediatric drug safety methods have not gone beyond event surveillance to identify and evaluate potential biological mechanisms. Children undergo an evolutionarily conserved and physiologically dynamic process of growth and maturation that can alter pharmacokinetics and pharmacodynamics. Our hypothesis is that temporal patterns of drug event reporting are reflective of dynamic mechanisms from child growth and development. We generated a database of 460,837 pediatric ADEs using generalized additive models (GAMs) that we have previously shown identify dynamic risk estimates of adverse drug events. We identified 19,438 significant drug-event risks where drug risks corresponded with physiological development throughout childhood. Our results identified known pediatric drug effects and risk dynamics across child development that were not known previously. For example, we identified significant risk dynamics of montelukast-induced psychiatric disorders, including enriched risk (Odds Ratio 8.77 [2.51, 46.94]) within the second year of life. We developed a data-driven time-series clustering approach resulting in up to 95.2% precision and 97.8% sensitivity for categorizing risk dynamics across development stages for all ADEs including known but previously development-agnostic pediatric drug effects. We found that our real-world evidence may contain biologically-relevant underpinnings as well, where risk dynamics of CYP enzyme substrates were dependent on the enzyme's expression across childhood. We curated this database for the research community to enable, for the first time, evaluation of real-world hypotheses of adverse drug effects across child growth and development.

scholarly journals Safety of Memantine in Combination with Potentially Interactive Drugs in the Real World: A Pharmacovigilance Study Using the Japanese Adverse Drug Event Report (JADER) Database

2021 ◽  
pp. 1-12
Author(s):  
Kenichiro Sato ◽  
Tatsuo Mano ◽  
Atsushi Iwata ◽  
Tatsushi Toda
Keyword(s):  
Adverse Drug Event ◽  
Real World ◽  
Nmda Receptor Antagonist ◽  
Additive Models ◽  
Drug Event ◽  
Event Report ◽  
Real World Data ◽  
The Real ◽  
Potential Interactions ◽  
Robust Evidence

Background: Memantine, an NMDA receptor antagonist, is used for the treatment of Alzheimer’s disease. There is a caution to refrain from administrating memantine in combination with some specific drugs such as amantadine or dextromethorphan due to potential interactions that might augment the adverse effects of memantine. Objective: This notification has not been validated in real-world data, which we aim to address using a large self-reporting database from Japan. Methods: We conducted a disproportionality analysis using the Japanese Adverse Drug Event Report (JADER) database reported between April 2004 and March 2019 for detecting the neuropsychiatric adverse event (AE) signals associated with memantine and other potentially interactive drugs including amantadine, dextromethorphan, cimetidine, ranitidine, procainamide, quinidine, acetazolamide, citrate, and bicarbonate. Drug-drug interactions between memantine and these drugs were assessed using multiplicative and additive models. Results: There was no statistically robust evidence to support multiplicative or additive interactions between memantine and the aforementioned drugs to increase the reporting of any included neuropsychiatric AEs or AE categories. Conclusion: The real-world JADER data did not raise the concern about the interactive increase in the neuropsychiatric AEs in patients with dementia taking memantine in combination with amantadine or dextromethorphan, suggesting there may be no urgent need to prohibit the co-administration of these drugs presently.

scholarly journals Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jeffrey P. Hau ◽  
Penelope M. A. Brasher ◽  
Amber Cragg ◽  
Serena Small ◽  
Maeve Wickham ◽  
...  
Keyword(s):  
Health Information ◽  
Adverse Drug Event ◽  
Primary Outcome ◽  
Adverse Drug Events ◽  
Primary Objective ◽  
Drug Event ◽  
Controlled Trials ◽  
Drug Reactions ◽  
Main Trial ◽  
Randomized Controlled

Abstract Background Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. We designed ActionADE to enable rapid documentation of adverse drug events and communication of standardized information across health sectors by integrating with legacy systems. We will leverage ActionADE’s implementation to conduct two parallel, randomized trials: patients with adverse drug reactions in the main trial and those diagnosed with non-adherence in a secondary trial. Primary objective of the main trial is to evaluate the effects of providing information continuity about adverse drug reactions on culprit medication re-dispensations over 12 months. Primary objective of the secondary trial is to evaluate the effect of providing information continuity on adherence over 12 months. Methods We will conduct two parallel group, triple-blind randomized controlled trials in participating hospitals in British Columbia, Canada. We will enroll adults presenting to hospital with an adverse drug event to prescribed outpatient medication. Clinicians will document the adverse drug event in ActionADE. The software will use an algorithm to determine patient eligibility and allocate eligible patients to experimental or control. In the experimental arm, ActionADE will transmit information to PharmaNet, where adverse drug event information will be displayed in community pharmacies when re-dispensations are attempted. In the control arm, ActionADE will retain information in the local record. We will enroll 3600 adults with an adverse drug reaction into the main trial. The main trial’s primary outcome is re-dispensation of a culprit or same-class medication within 12 months; the secondary trial’s primary outcome will be adherence to culprit medication. Secondary outcomes include health services utilization and mortality. Discussion These studies have the potential to guide policy decisions and investments needed to drive health information technology integrations to prevent repeat adverse drug events. We present an example of how a health information technology implementation can be leveraged to conduct pragmatic randomized controlled trials. Trial registration ClinicalTrials.gov NCT04568668, NCT04574648. Registered on 1 October 2020.

scholarly journals Growth and development of children under 5 years of age with tetralogy of Fallot in a Chinese population

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Xin Li ◽  
Jin Zhu ◽  
Jun An ◽  
Yuqing Wang ◽  
Yili Wu ◽  
...  
Keyword(s):  
Body Weight ◽  
Tetralogy Of Fallot ◽  
Growth Retardation ◽  
Growth And Development ◽  
Heart Defects ◽  
Body Height ◽  
Child Growth ◽  
The Body ◽  
Early Age ◽  
Local Conditions

AbstractCongenital Heart Defects (CHDs) are associated with different patterns of malnutrition and growth retardation, which may vary worldwide and need to be evaluated according to local conditions. Although tetralogy of Fallot (TOF) is one of the first described CHDs, the etiology outcomes in growth and development of TOF in early age child is still unclear in most cases. This study was designed to investigate the growth retardation status of Chinese pediatric TOF patients under 5 years old. The body height, body weight and body mass index (BMI) of 262 pediatric patients (138 boys and 124 girls) who underwent corrective surgery for TOF between 2014 and 2018 were measured using conventional methods. The average body height, body weight and BMI of the patients were significantly lower than WHO Child Growth Standards, while the most affected was body height. Meanwhile, higher stunting frequency and greater deterioration of both the body height and weight happened in elder age (aged 13–60 months) rather than in infant stage (aged 0–12 months) among these patients. Our results confirmed that intervention should be given at early age to prevent the growth retardation of TOF patients getting severer.

scholarly journals JADE: A tool for medical researchers to explore adverse drug events using health claims data

2014 ◽  
Vol 05 (03) ◽  
pp. 621-629 ◽  
Author(s):  
S.K. Sauter ◽  
C. Rinner ◽  
L.M. Neuhofer ◽  
M. Wolzt ◽  
W. Grossmann ◽  
...  
Keyword(s):  
Adverse Drug Events ◽  
Claims Data ◽  
Age Groups ◽  
Rule Learning ◽  
Health Claims ◽  
Drug Event ◽  
Study Cohort ◽  
Defined Daily Doses ◽  
Health Claims Data ◽  
Medical Researchers

SummaryObjective: The objective of our project was to create a tool for physicians to explore health claims data with regard to adverse drug reactions. The Java Adverse Drug Event (JADE) tool should enable the analysis of prescribed drugs in connection with diagnoses from hospital stays.Methods: We calculated the number of days drugs were taken by using the defined daily doses and estimated possible interactions between dispensed drugs using the Austria Codex, a database including drug-drug interactions. The JADE tool was implemented using Java, R and a PostgreSQL database.Results: Beside an overview of the study cohort which includes selection of gender and age groups, selected statistical methods like association rule learning, logistic regression model and the number needed to harm have been implemented.Conclusion: The JADE tool can support physicians during their planning of clinical trials by showing the occurrences of adverse drug events with population based information.Citation: Edlinger D, Sauter SK, Rinner C, Neuhofer LM, Wolzt M, Grossmann W, Endel G, Gall W. JADE: A tool for medical researchers to explore adverse drug events using health claims data. Appl Clin Inf 2014; 5: 621–629http://dx.doi.org/10.4338/ACI-2014-04-RA-0036

scholarly journals US Emergency Department Visits for Adverse Drug Events From Antibiotics in Children, 2011–2015

2018 ◽  
Vol 8 (5) ◽  
pp. 384-391 ◽  
Author(s):  
Maribeth C Lovegrove ◽  
Andrew I Geller ◽  
Katherine E Fleming-Dutra ◽  
Nadine Shehab ◽  
Mathew R P Sapiano ◽  
...  
Keyword(s):  
Emergency Department ◽  
Adverse Drug Events ◽  
Emergency Department Visits ◽  
Drug Event ◽  
Injury Surveillance System ◽  
Adverse Event Data ◽  
Systemic Medication ◽  
Ed Visits ◽  
Pharmacy Dispensing Data

Abstract Background Antibiotics are among the most commonly prescribed medications for children; however, at least one-third of pediatric antibiotic prescriptions are unnecessary. National data on short-term antibiotic-related harms could inform efforts to reduce overprescribing and to supplement interventions that focus on the long-term benefits of reducing antibiotic resistance. Methods Frequencies and rates of emergency department (ED) visits for antibiotic adverse drug events (ADEs) in children were estimated using adverse event data from the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project and retail pharmacy dispensing data from QuintilesIMS (2011–2015). Results On the basis of 6542 surveillance cases, an estimated 69464 ED visits (95% confidence interval, 53488–85441) were made annually for antibiotic ADEs among children aged ≤19 years from 2011 to 2015, which accounts for 46.2% of ED visits for ADEs that results from systemic medication. Two-fifths (40.7%) of ED visits for antibiotic ADEs involved a child aged ≤2 years, and 86.1% involved an allergic reaction. Amoxicillin was the most commonly implicated antibiotic among children aged ≤9 years. When we accounted for dispensed prescriptions, the rates of ED visits for antibiotic ADEs declined with increasing age for all antibiotics except sulfamethoxazole-trimethoprim. Amoxicillin had the highest rate of ED visits for antibiotic ADEs among children aged ≤2 years, whereas sulfamethoxazole-trimethoprim resulted in the highest rate among children aged 10 to 19 years (29.9 and 24.2 ED visits per 10000 dispensed prescriptions, respectively). Conclusions Antibiotic ADEs lead to many ED visits, particularly among young children. Communicating the risks of antibiotic ADEs could help reduce unnecessary prescribing. Prevention efforts could target pediatric patients who are at the greatest risk of harm.

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